THE MEDICARE APPEALS PROCESS P. 16 • RESEARCH BRIEFS P. 60 OCTA AND GLAUCOMA P. 62 • THE LATEST TECHNOLOGY AND DRUGS P. 70 WILLS EYE RESIDENT CASE SERIES P. 77 Review of Ophthalmology Vol. XXV, No. 5 • May 2019 • Charting Your Issues • Uveitic Own Course • The Glaucoma Questionable Cataract • EHR

MAYMAY 20192019

reviewofophthalmology.comreviewofophthalmology.com CHARTING YOUR OWN COURSE Experts share tips on how to go solo, but note that there are many challenges to overcome as well. P. 20

ALSO INSIDE:

• EHR: Room for Improvement? P. 32 • The Questionable Cataract: Who Decides? P. 40 • How to Manage Uveitic Glaucoma P. 48 • Strong Moves for Weak Zonules P. 54

001_rp0519_fc.indd 1 4/16/19 10:03 AM +3.25 D

RP0519_J & J Surgical.indd 1 4/5/19 9:57 AM REVIEW NEWS Volume XXV • No. 5 • May 2019 Calcium Intake and Age- Related Macular Degeneration

In a recently published study, a secondary the association between calcium in- analysis of patients enrolled in the take and AMD have produced mixed Age-Related Eye Disease Study was results. Findings from the Blue conducted to determine whether an Mountains Eye Study show that Emily Chew, MD Emily Chew, association exists between dietary and calcium may be an important factor supplementary calcium intake and in limiting AMD development/pro- age-related macular degeneration. gression.1 Conversely, fi ndings from Emily Chew, MD, director of the di- the Nutrition Examination Survey vision of epidemiology and clinical ap- suggest that increased calcium in- plications at the National Eye Institute take is harmful in terms of macular at the National Institutes of Health, degeneration.2 However, Dr. Chew conducted the retrospective analy- says the latter was only based on sis. She says studies have suggested cross-sectional data. “[In our analy- calcium might play a role in macular sis], we looked longitudinally, using a degeneration, so she wanted to see if dietary and supplemental calcium baseline to see how calcium is asso- it had any effect on the disease. “We intake and the risk of developing ciated with worsening of AMD over were not only interested in dietary in- AMD, as well as the disease’s pro- time,” she says. “We think the longi- take of calcium, but also supplemen- gression to intermediate and late tudinal data was more powerful.” tary intake since it’s common, particu- stages. A total of 4,751 participants Similar to fi ndings in the Blue larly for women with osteoporosis, to who had no macular degeneration, Mountains Eye study, other results be taking calcium supplements,” says as well as those with mild, moder- include an inconsistent associa- Dr. Chew. ate and severe disease, were fol- tion between calcium consumption The pathology of AMD is poorly lowed for a mean of 10 years. The and the different stages of AMD. understood, and experts are still trying study found a signifi cant association Dr. Chew says that there are signs to determine its risk factors. “Unfor- between higher levels of dietary and showing changes occurring at dif- tunately, we don’t know the pathway supplementary calcium intake and ferent stages of the disease. “We through which macular degeneration a lower incidence of progression to think there’s more than one pathway occurs,” says Dr. Chew. “We can only late AMD. Dr. Chew notes that addi- in which macular degeneration oc- understand it by looking at risk factors, tional fi ndings showed that patients curs,” she says. “We know that cer- genetics, studying long-term follow- weren’t harmed by the increased cal- tain genetic associations are impor- up and seeing what drugs and dietary cium intake, similar to fi ndings from tant for getting the disease, but for it infl uences might be affecting it.” She the Blue Mountains Eye Study. to progress, other factors may come says it’s not surprising that calcium may Dr. Chew notes that, since the into play.” affect macular degeneration, however. study was retrospective, they don’t With this in mind, the researchers “It’s been recognized and demon- know whether any biases exist or if say additional study is required. “We strated by scientists that the heart of the individuals involved are typical of have new ideas suggesting calcium drusen, which are the hallmark for the general public. Additionally, she might be important but we can’t [determining] macular degeneration, adds that most of the subjects were say whether increased intake pre- is actually calcium,” she says. white, so the data may not apply to vents macular degeneration without Retrospectively, the study investi- all groups of people. a randomized trial that studies it,” gated possible associations between Previous studies that looked into (Continued on page 8

May 2019 | reviewofophthalmology.com | 3

003_rp0519_news.indd 3 4/16/19 3:02 PM Ophthalmic Product Development Insights Aki Tobaru, Hiro Matsuda, PhD, & Matthew Chapin • Ora Inc., Andover, Mass. REVIEW Matthew Chapin and Ryan Bouchard

Basics of Medical Devices for the New Entrepreneur

he ARVO and ASCRS meetings are ing through the Premarket Notifi cation mology, such as radiology. Image manage- upon us, and these conferences process, or 510(k). When a 510(k) is granted, ment and manipulation are common in other Trepresent opportunities for physician- the device’s sponsor is then allowed to therapeutic areas as well. entrepreneurs to build momentum in their say the product is cleared to be marketed. Class III devices require a Pre-Market development of their new devices, get input The 510(k) process grants clearance, not Approval (PMA) to demonstrate safety and from colleagues and meet with potential approval (this is a common mistake in how effi cacy, and are typically interventions, partners and investors. In this column, sponsors talk about the process and one that such as a retinal prosthesis or an IOL. (It’s a we’ll provide a brief overview of regulatory the FDA takes very seriously.) In a 510(k), little-known fact that extended wear contact considerations and pearls related to the de- there must be a comparison of the investiga- lenses are actually Class III devices, too— velopment of new devices in ophthalmology tional device to one or more similar, legally the agency treats daily wear and extended for the fi rst-time physician-entrepreneur. marketed devices (called predicate devices). wear differently based on the underlying In ophthalmology, medical devices For a device to be cleared for marketing risks.) include such things as hand-held surgical by the FDA, the 510(k) submission must For Class III devices, the FDA has 180 days instruments, sutures, diagnostic imagers, demonstrate that the investigational device to review the PMA and make a determina- intraocular lenses, contact lenses, lasers, is ‘substantially equivalent’ to the predicate tion for approval. PMA approval is based on and software for image analysis, smart device. Once submitted, the FDA has 90 a determination by the agency that the PMA phones and tablets. The government agency days to review the 510(k). In ophthalmology, contains suffi cient valid scientifi c evidence charged with evaluating these devices for a large portion of the devices commonly to ensure that the device is safe and ef- approval and overseeing their manufactur- seen today that are cleared through the fective for its intended use(s). When a PMA ing, performance and safety is the Center for 510(k) process, such as optical coherence is granted, these devices are considered tomographers, artifi cial-intelligence-based Devices and Radiological Health, a branch of approved by the FDA. programs and some lasers, require clinical the FDA. The De Novo pathway is used for a new trials. device that hasn’t previously been classi- Before a company can begin selling a med- fi ed, and there’s a chance that it could be ical device, it needs to prepare what’s known considered Class II based on the criteria as a premarket submission. The nature of discussed earlier. The process was this regulatory fi ling is largely based on modifi ed in 2012 to not require a the classifi cation of the device. Devices 510(k) submission in advance. Upon generally fall into one of three classes submission of the request, the FDA will based on technology complexity, intend- conduct a review of substantial equiva- ed use (i.e., diagnostic or intervention) lence, as well as determine whether a and, to an extent, their risk profi le. Most new product code is warranted, which of the classifi cations in ophthalmology were would allow the device to be marketed. defi ned in the late 1980s, but new ones are Some very important recent advances in still generated today, and sometimes a clas- Selecting the predicate device for compari- ophthalmology have come via the De Novo sifi cation will change as a technology and son is half the battle. Substantial equiva- pathway, such as the fi rst AI screening its uses are better understood. Classifi cation lence is determined if the investigational program for diabetics from IDx, and a new determines the extent of regulatory control device, in comparison to a predicate: dry-eye treatment from Oculeve (now owned required by the FDA for the device to be • has the same intended use and has the by Allergan). A key element of this program marketed, and the type of preclinical and same technological characteristics; or allows the new products to serve as predi- clinical testing required. • has the same intended use but has dif- cates, which may make it easier to bring ferent technological characteristics and the new technology to patients in the future. Classifi cations & Premarket information has been submitted to the FDA; For software, there’s another risk-profi le Submissions • doesn’t raise new questions of safety assessment that applies to how the data will About 90 percent of Class I devices are ex- and effi cacy; and be used, and if there will be an impact on empt from premarket submission (i.e., FDA • demonstrates that the device is at least potential diagnosis or treatment decisions. approval is not required). Instead, they’re as safe and effective as the legally marketed We’ll cover the development and approval required to follow what the FDA terms device. path of software- and AI-based devices in a “General Controls”: In many cases the predicate is obvious, separate column. • Establishment Registration; such as comparing a new daily wear contact The other pathway is the Humanitarian De- • Medical Device Listing; lens to a lens that’s already being marketed. vice Exemption. The HDE pathway is intend- • Quality Systems Regulation; In other cases one needs to be more creative ed to support development of a new product • labeling requirements; and to identify a predicate and justify its use in designated as a Humanitarian Use Device • Medical Device Reporting. the comparison. For example, some of the (intended to diagnosis or treat a disease Class II devices (and some Class I devices software platforms may actually pick a that are nonexempt) are cleared for market- predicate from an area outside of ophthal- (Continued on page 6)

4 | Review of Ophthalmology | May 2019

003_rp0519_news.indd 4 4/16/19 2:11 PM DID YOU KNOW? KEELER has slit lamps!

For over 100 years, we have been creating innovative products. The Keeler slit lamp is one of them – designed with you and your patients in mind. The KSL delivers a visually pleasing, customizable device equipped with excellent, high-quality optics.

SLIT LAMP FEATURES

Sharp & clear KSL-H series: KSL-Z series: Keeler Optics tower illumination lower illumination

Digital-ready 3x magnification 5x magnification & full digital units drum (10x, 16x, 25x) drum (6x, 10x, 16x, 25x, 40x)

Unique 1mm Bright & white We also carry square for Uveitis LED illumination portable slit lamps! evaluation

VISIT OUR WEBSITE FOR MORE PRODUCT DETAILS

www.keelerusa.com / 800-523-5620

RP0319_Keeler Slit.indd 1 2/14/19 3:16 PM OPDI E DITORIAL STAFF Aki Tobaru, Hiro Matsuda, PhD, & Matthew Chapin • Ora Inc., Andover, Mass. REVIEW

Editor in Chief Walter C. Bethke (Continued from page 4) Preparing for Clinical Trials (610) 492-1024 Every device is classifi ed into one of two [email protected] that exists in no more than 8,000 patients) categories as preparations are made for for rare diseases. Also, there should be no a clinical trial: Nonsignifi cant risk (NSR) or Senior Editor comparable device marketed in the United signifi cant risk (SR). Christopher Kent States. The threshold for safety is the same Nonsignifi cant risk devices generally don’t (814) 861-5559 as for a Class III PMDA device, but benefi ts pose a signifi cant risk to human subjects. Examples include most daily-wear contact [email protected] only need to outweigh the risks, thus mak- ing the effi cacy threshold lower. lenses and lens solutions, imaging devices When marketed, devices must be labeled and non-contact tonometry devices. A Associate Editor as an HUD, and not sold for profi t (some nonsignifi cant risk device study requires Alexandra Skinner exceptions exist). The Argus II Retina Pros- only institutional review board approval (610) 492-1025 thesis System, and INTACS for keratoconus prior to its initiation. The IRB would make [email protected] were two devices that were approved with the determination of NSR in its approval the HDE pathway. letter for the study. Notice of IRB approval Chief Medical Editor While these are the main pathways for allows the device to be shipped to the Mark H. Blecher, MD devices to enter the commercial arena in investigational site. the United States, there are other programs If the device presents a potential for serious risk to the health, safety or welfare Art Director that can help along the way. The FDA has designations such as Breakthrough and of a subject, it’s deemed to be a signifi cant Jared Araujo Early Feasibility, which can work in concert risk device. Signifi cant risk devices may (610) 492-1032 with the pathways mentioned above. We’ll include implants, devices that support or [email protected] discuss these programs and their potential sustain human life and devices that are benefi ts in the future. substantially important in diagnosing, Senior Graphic Designer curing, mitigating or treating disease, or Matt Egger Getting Early Feedback from the FDA preventing impairment to human health. (610) 492-1029 The fi rst step toward securing approval For these devices, the sponsor must submit an Investigational Device Exemption (IDE) [email protected] for your product occurs at what’s known as the Pre-submission Meeting. application to the FDA, and it will need both FDA and IRB approval prior to initiation of a Graphic Designer At this meeting, you can get initial feedback from the FDA on your device’s clinical study. Ashley Schmouder classifi cation, the premarket submission While the IRB determines the level of risk, (610) 492-101048 most appropriate for it, and the preclinical the FDA can also weigh in on the subject [email protected] and clinical requirements you’ll have to and has guidance documents that cover fulfi ll. The meeting is held roughly 75 to 90 situations that are on the border between International coordinator, Japan days after submitting a meeting request. NSR and SR. Prior to any submission, the risk assess- Mitz Kaminuma This request will include the “briefi ng ment of the device, which justifi es why the [email protected] package,” which is all of the background data required for the FDA to answer your sponsor chose a particular risk classifi ca- questions. tion for the device, should be completed Business Offi ces Scheduling a meeting early in your de- by the sponsor and included among its 11 Campus Boulevard, Suite 100 velopment process is best, in order to help submissions to the FDA and IRB. Newtown Square, PA 19073 with your business and funding plans. The Here are a few hypothetical examples of (610) 492-1000 guidance documents you’ll receive from the sample products and some preliminary Fax: (610) 492-1039 FDA in advance of the meeting will provide considerations: suggested questions and content to make • Surgical instrument. A metal instrument Subscription inquiries: sure the meeting is as productive as pos- (forceps, scleral depressor, retractor, etc.) for manipulating tissue during surgery. United States — (877) 529-1746 sible. The product’s sponsor should provide as much detail about the proposed product Class I. Subject to General Controls, no Outside U.S. — (845) 267-3065 as possible, so that the FDA can get a clear formal clearance or approval required from E-mail: picture of how the company intends the the FDA. [email protected] product to work. • Novel IOL design. All IOLs are classifi ed Website: www.reviewofophthalmology.com Each briefi ng package will be different, as Class III, requiring a PMA. Supplements based on the questions and insight the are submitted for modifi cations to existing sponsor is hoping to gain from the meeting, approved lenses. The nature of the modifi - but it should start with a robust description cations dictate the extent of clinical testing of the device. required. (Continued on page 8)

6 | Review of Ophthalmology | May 2019

003_rp0519_news.indd 6 4/16/19 2:11 PM NOW APPROVED. COMING SOON.

BIG TIME INNOVATION1 THE FIRST AND ONLY OPHTHALMIC STEROID INSERT DEXTENZA is an advancement in steroid treatment

• Resorbable, so no need for removal2 • Designed to deliver a tapered dose1 • Insert can be removed via saline irrigation • Contains fluorescein for visualization2 or manual expression, if necessary2 • No additional components or • Physicians rated DEXTENZA as easy assembly required2 to insert3*

VISIT BOOTH 1737 AT ASCRS

INDICATION Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections DEXTENZA is a corticosteroid indicated for the of the eye (including herpes simplex). treatment of ocular pain following ophthalmic surgery. Fungus invasion must be considered in any persistent IMPORTANT SAFETY INFORMATION corneal ulceration where a steroid has been used or is in CONTRAINDICATIONS use. Fungal culture should be taken when appropriate. Use of steroids after cataract surgery may delay DEXTENZA is contraindicated in patients with healing and increase the incidence of bleb formation active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic ADVERSE REACTIONS keratitis), vaccinia, varicella; mycobacterial infections; The most common ocular adverse reactions that fungal diseases of the eye, and dacryocystitis. occurred in patients treated with DEXTENZA were: WARNINGS AND PRECAUTIONS anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); Prolonged use of corticosteroids may result in glaucoma visual acuity reduced (2%); eye pain (1%); cystoid with damage to the optic nerve, defects in visual macular edema (1%); corneal edema (1%); and acuity and fields of vision. Steroids should be used conjunctival hyperemia (1%). with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment. The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was Corticosteroids may suppress the host response headache (1%). and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may Please see brief summary of full Prescribing mask infection and enhance existing infection. Information on adjacent page.

*73.6% of physicians in Study 1 and 76.4% in Study 2 rated DEXTENZA as easy to insert.

References: 1. Sawhney AS et al, inventors; Incept LLC, assignee. US patent 8,409,606 B2. April 2, 2013. 2. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2018. 3. Walters T et al. J Clin Exp Ophthalmol. 2016;7(4):1-11. © 2019 Ocular Therapeutix, Inc. All rights reserved. DEXTENZA is a registered trademark of Ocular Therapeutix, Inc. PP-US-DX-0071 02/2019

RP0319_Ocular Thera.indd 1 2/13/19 10:08 AM DEXTENZA was studied in three randomized, vehicle-controlled studies (n = 351). The mean age of the population was 68 years REVIEW (range 43 to 87 years), 62% were female, News and 85% were white. Forty-six percent had brown iris color and 31% had blue iris color. The most common ocular adverse (Continued from p. 3) BRIEF SUMMARY: Please see the reactions that occurred in patients treated DEXTENZA Package Insert for full with DEXTENZA were: anterior chamber prescribing information for DEXTENZA inflammation including iritis and iridocyclitis says Dr. Chew. “Now, we’re looking extensively at diets, (11/2018) (9%); intraocular pressure increased (5%); involvement of different nutrients and genetic interac- 1 INDICATIONS AND USAGE visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema tions. We’re planning to release that data very soon.” DEXTENZA® (dexamethasone ophthalmic (1%); and conjunctival hyperemia (1%). insert) is a corticosteroid indicated for the Overall, Dr. Chew says that the biggest accomplish- treatment of ocular pain following ophthalmic The most common non-ocular adverse surgery (1). reaction that occurred in patients treated with DEXTENZA was headache (1%). ment of the study is that it can allay any fears that taking 4 CONTRAINDICATIONS 8 USE IN SPECIFIC POPULATIONS calcium will worsen AMD, and that doctors can assure DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular 8.1 Pregnancy their patients that taking calcium is okay for their macu- infections, including epithelial herpes simplex Risk Summary keratitis (dendritic keratitis), vaccinia, lar degeneration. varicella; mycobacterial infections; fungal There are no adequate or well-controlled diseases of the eye, and dacryocystitis. studies with DEXTENZA in pregnant women to inform a drug-associated risk for major 1. Gopinath B, Flood VM, Louie JC, et al. Consumption of dairy products and the 15-year incidence 5 WARNINGS AND PRECAUTIONS birth defects and miscarriage. In animal of age-related macular degeneration. Br J Nutri 2014;111:9:1673-1679. 5.1 Intraocular Pressure Increase reproduction studies, administration of 2. Kakigi CL, Singh K, Wang SY, Enanoria WT, Lin SC. Self-reported calcium supplementation and topical ocular dexamethasone to pregnant Prolonged use of corticosteroids may result mice and rabbits during organogenesis age-related macular degeneration. JAMA Ophthalmol 2015;133:7:746-754. in glaucoma with damage to the optic nerve, produced embryofetal lethality, cleft palate defects in visual acuity and fields of vision. and multiple visceral malformations Steroids should be used with caution in the [see Animal Data]. presence of glaucoma. Intraocular pressure should be monitored during the course of Data the treatment. Animal Data 5.2 Bacterial Infection Topical ocular administration of 0.15% Corticosteroids may suppress the host dexamethasone (0.75 mg/kg/day) on response and thus increase the hazard gestational days 10 to 13 produced for secondary ocular infections. In acute embryofetal lethality and a high incidence purulent conditions, steroids may mask of cleft palate in a mouse study. A daily AkiOPDI Tobaru, Hiro Matsuda, PhD, & Matthew Chapin • Ora Inc., Andover, infection and enhance existing infection dose of 0.75 mg/kg/day in the mouse is REVIEW [see Contraindications (4)]. approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, 5.3 Viral Infections on a mg/m2 basis. In a rabbit study, topical ocular administration of 0.1% (Continued from page 6) Use of ocular steroids may prolong the dexamethasone throughout organogenesis course and may exacerbate the severity of (0.36 mg /day, on gestational day 6 followed many viral infections of the eye (including by 0.24 mg/day on gestational days 7-18) • Drug-eluting implant. Generally speaking, drug/device combi- herpes simplex) [see Contraindications (4)]. produced intestinal anomalies, intestinal nations with the primary purpose being the delivery of the drug, 5.4 Fungal Infections aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is are submitted and processed as a drug through CDER at the FDA Fungus invasion must be considered in any approximately 6 times the entire dose of persistent corneal ulceration where a steroid dexamethasone in the DEXTENZA product, (with appropriate input and review from the Device Division), and has been used or is in use. Fungal culture on a mg/m2 basis. should be taken when appropriate [see thus need to meet the clinical and preclinical requirements of a Contraindications (4)]. 8.2 Lactation drug as well. Generally, a separate device approval isn’t required 5.5 Delayed Healing Systemically administered corticosteroids for a drug/device combination. appear in human milk and could suppress The use of steroids after cataract surgery growth and interfere with endogenous • Contact lens rewetting drop. Class II device, submitted via may delay healing and increase the corticosteroid production; however the incidence of bleb formation. systemic concentration of dexamethasone 510k process. This is one of the only examples in which an eye- 6 ADVERSE REACTIONS following administration of DEXTENZA is low drop solution is treated as a device in the United States. There is [see Clinical Pharmacology (12.3)]. There The following serious adverse reactions are is no information regarding the presence of a detailed FDA Guidance Document on contact lens products, with described elsewhere in the labeling: DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects standard ISO preclinical testing and clinical requirements. Note • Intraocular Pressure Increase [see of the drug on milk production to inform risk that clinical testing on the range of lenses the product is intended Warnings and Precautions (5.1)] of DEXTENZA to an infant during lactation. • Bacterial Infection [see Warnings and The developmental and health benefits of to be used with is required for a new rewetting drop. Precautions (5.2)] breastfeeding should be considered along with the mother’s clinical need for DEXTENZA • iPad vision test. If the software itself won’t provide a diagnosis, • Viral Infection [see Warnings and and any potential adverse effects on the there’s still a consideration of how the results will impact a physi- Precautions (5.3)] breastfed child from DEXTENZA. cian’s decision making. Quality control and software validations • Fungal Infection [see Warnings and 8.4 Pediatric Use Precautions (5.4)] are based on the level of risk and need to be considered early in Safety and effectiveness in pediatric patients • Delayed Healing [see Warnings and have not been established. the process. Precautions (5.5)] 8.5 Geriatric Use 6.1 Clinical Trials Experience No overall differences in safety or Mr. Chapin is senior vice president of corporate development at Because clinical trials are conducted effectiveness have been observed between under widely varying conditions, adverse elderly and younger patients. Ora, which offers device and drug consulting, as well as conduct- reaction rates observed in the clinical trials ing clinical research and development. Mr. Bouchard is vice of a drug cannot be directly compared to 17 PATIENT COUNSELING INFORMATION rates in the clinical trials of another drug Advise patients to consult their surgeon if president for medical devices at Ora. The authors welcome your and may not reflect the rates observed pain, redness, or itching develops. in practice. Adverse reactions associated comments or questions regarding product development. Please with ophthalmic steroids include elevated send correspondence to [email protected] or rbouchard@ intraocular pressure, which may be associated with optic nerve damage, oraclinical.com, or visit www.oraclinical.com visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection MANUFACTURED FOR: For reference: from pathogens including herpes simplex, Ocular Therapeutix, Inc. • www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ and perforation of the globe where there default.htm Bedford, MA 01730 USA is thinning of the cornea or sclera [see • https://www.fda.gov/downloads/training/cdrhlearn/ucm421766.pdf Warnings and Precautions (5)]. PP-US-DX-0072 • www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm • https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/ generalandspecialcontrols/ucm055910.htm

003_rp0519_news.indd 8 4/16/19 2:13 PM The POWER of the PULSE Advanced Doctor Treatment for Anterior Blepharitis*

ASCRS Show Special - $1,495 for the AB Max™ Starter Kit

The advanced technology of the PATENT PENDING AB Max™GHOLYHUV38/6(DFWLRQIRUPRUHHƯFLHQWDQG rapid debridement. AB Max™RƪHUV • Treatment of the same conditions as a standard Algerbrush** PLUS Anterior Blepharitis • Removal of even the most tenacious scurf and debris • Advanced Anterior Blepharoexfoliation

The AB Max™ works seamlessly with your Algerbrush, transforming it into a multi-purpose device.

With AB Max™ you receive: • BETTER treatment outcomes with HIGHER PROFITS r$ƪRUGDEOH$QWHULRU%OHSKDURH[IROLDWLRQ • 5X faster return on your investment Visit us at ASCRS • Add $100,000 to your bottom line WITHOUT booth # 513 and a major investment ask about receiving a FREE anatomical eyelid model

*Anterior blepharitis means blepharitis on the outer eyelid margin, including the eyelashes.

$OJHUEUXVKLVDWUDGHPDUNRI7KH$OJHU&RPSDQLHV0\FR,QGXVWULHV,QFLVQRWDƯOLDWHGZLWK www.AB-Max.com • 800-721-8006 The Alger Companies. Patents pending Myco Industries, Inc. For use by medical professionals only.

RP0519_Myco.indd 1 4/15/19 3:37 PM Editorial

REVIEW Board

BUSINESS OFFICES 11 CAMPUS BOULEVARD, SUITE 100 NEWTOWN SQUARE, PA 19073 ONTRIBUTORS SUBSCRIPTION INQUIRIES (877) 529-1746 C (USA ONLY); OUTSIDE USA, CALL (847) 763-9630 CHIEF MEDICAL EDITOR PEDIATRIC PATIENT Mark H. Blecher, MD Wendy Huang, MD BUSINESS STAFF CONTACT LENSES PLASTIC POINTERS PUBLISHER Penny Asbell, MD Ann P. Murchison, MD, MPH JAMES HENNE (610) 492-1017 [email protected] CORNEA / ANTERIOR SEGMENT REFRACTIVE SURGERY Thomas John, MD Arturo S. Chayet, MD REGIONAL SALES MANAGER MICHELE BARRETT (610) 492-1014 [email protected] GLAUCOMA MANAGEMENT RETINAL INSIDER Peter Netland, MD, PHD Carl Regillo, MD, FACS REGIONAL SALES MANAGER Kuldev Singh, MD Yoshihiro Yonekawa, MD MICHAEL HOSTER (610) 492-1028 [email protected] MASTERS OF SURGERY TECHNOLOGY UPDATE Taliva D. Martin, MD Steven T. Charles, MD CLASSIFIED ADVERTISING Sara J. Haug, MD, PhD Michael Colvard, MD (888)-498-1460 MEDICARE Q & A WILLS RESIDENT CASE SERIES VICE PRESIDENT OF OPERATIONS Paul M. Larson, MBA Jason Flamendorf, MD. CASEY FOSTER (610) 492-1007 [email protected]

PRODUCTION MANAGER SCOTT TOBIN ADVISORY BOARD (610) 492-1011 [email protected] PENNY A. ASBELL, MD, MEMPHIS, TENN. MIKE S. MCFARLAND, MD, PINE BLUFF, ARK. SUBSCRIPTIONS $63 A YEAR, $99 (U.S.) IN CANADA, PEKIN, ILL. WILLIAM I. BOND, MD, JEFFREY B. MORRIS, MD, MPH, ENCINITAS, CALIF. $158 (U.S.) IN ALL OTHER COUNTRIES. SUBSCRIPTIONS E-MAIL: ALAN N. CARLSON, MD, DURHAM, N.C. MARLENE R. MOSTER, MD, PHILADELPHIA [email protected] Y. RALPH CHU, MD, EDINA, MINN. ROBERT J. NOECKER, MD, FAIRFIELD, CONN. ADAM J. COHEN, MD, DOWNERS GROVE, ILL. ROBERT OSHER, MD, CINCINNATI CIRCULATION UDAY DEVGAN, MD, FACS, LOS ANGELES MARK PACKER, MD, WEST PALM BEACH, FLA. PO BOX 71, CONGERS, NY 10920-0071 ERIC DONNENFELD, MD, ROCKVILLE CENTRE, N.Y. (877) 529-1746 STEPHEN PASCUCCI, MD, BONITA SPRINGS, FLA. OUTSIDE USA: (845) 267-3065 DANIEL S. DURRIE, MD, KANSAS CITY, MO. PAUL PENDER, MD, BEDFORD, N.H. ROBERT EPSTEIN, MD, MCHENRY, ILL. SENIOR CIRCULATION MANAGER CHRISTOPHER J. RAPUANO, MD, PHILADELPHIA HAMILTON MAHER ROBERT D. FECHTNER, MD, NEWARK, N.J. (212) 219-7870 [email protected] AUGUST READER III, MD, SAN FRANCISCO WILLIAM J. FISHKIND, MD, TUCSON, ARIZ.

JAMES P. GILLS, MD, TARPON SPRINGS, FLA. TONY REALINI, MD, MORGANTOWN, W.V.

HARRY GRABOW, MD, SARASOTA, FLA. KENNETH J. ROSENTHAL, MD, GREAT NECK, N.Y. CEO, INFORMATION GROUP SERVICES MARC FERRARA DOUGLAS K. GRAYSON, MD, NEW YORK CITY ERIC ROTHCHILD, MD, DELRAY BEACH, FLA.

THOMAS S. HARBIN, MD, MBA, ATLANTA SHERI ROWEN, MD, BALTIMORE SENIOR VICE PRESIDENT, OPERATIONS JEFF LEVITZ DAVID R. HARDTEN, MD, MINNEAPOLIS JAMES J. SALZ, MD, LOS ANGELES

KENNETH J. HOFFER, MD, SANTA MONICA, CALIF. INGRID U. SCOTT, MD, MPH, HERSHEY, PA. VICE PRESIDENT, HUMAN RESOURCES JACK T. HOLLADAY, MD, MSEE, HOUSTON TAMMY GARCIA JOEL SCHUMAN, MD, PITTSBURGH JOHN D. HUNKELER, MD, KANSAS CITY, MO. VICE PRESIDENT, CREATIVE SERVICES & PRODUCTION GAURAV SHAH, MD, ST. LOUIS THOMAS JOHN, MD, TINLEY PARK, ILL. MONICA TETTAMANZI DAVID R. STAGER JR., MD, DALLAS ROBERT M. KERSHNER, MD, MS, PALM BEACH GARDENS, FLA. CORPORATE PRODUCTION DIRECTOR KARL STONECIPHER, MD, GREENSBORO, N.C. GUY M. KEZIRIAN, MD, PARADISE VALLEY, ARIZ. JOHN ANTHONY CAGGIANO JAMES C. TSAI, MD, NEW YORK CITY TERRY KIM, MD, DURHAM, N.C. VICE PRESIDENT, CIRCULATION VANCE THOMPSON, MD, SIOUX FALLS, S.D. TOMMY KORN, MD, SAN DIEGO EMELDA BAREA FARRELL C. TYSON, MD, CAPE CORAL, FLA. DAVID A. LEE, MD, HOUSTON

FRANCIS S. MAH, MD, PITTSBURGH R. BRUCE WALLACE III, MD, ALEXANDRIA, LA. 440 Ninth Avenue, 14th Floor NICK MAMALIS, MD, SALT LAKE CITY ROBERT G. WILEY, MD, CLEVELAND New York, N.Y. 10001 WILLIAM G. MARTIN, MD, OREGON, OHIO FRANK WEINSTOCK, MD, CANTON, OHIO

REVIEW OF OPHTHALMOLOGY (ISSN 1081-0226; USPS No. 0012-345) is published monthly, 12 times per year by Jobson Medical Informa- tion. 440 Ninth Avenue, 14th Floor, New York, N.Y. 10001. Periodicals postage paid at New York, NY and additional mailing offi ces. Postmaster: Send address changes to Review of Ophthalmology, PO Box 71, Congers, NY 10929-0071. Subscription Prices: US One Year $63.00, US Two Year $112.00, Canada One Year $99.00, Canada Two Year $181.00, Int’l One Year $158.00, Int’l Two Year $274.00. For subscription information call (877) 529-1746 (USA only); outside USA, call (845-267-3065. Or email us at [email protected]. Canada Post: Publications Mail Agreement #40612608. Canada Returns to be sent to Bleuchip International, P.O. Box 25542, London, ON N6C 6B2.

10 | Review of Ophthalmology | May 2019

0003_rp0519_news.indd03_rp0519_news.indd 1100 44/16/19/16/19 2:142:14 PMPM SUBMICRON STRONG Engineered with SM Technology™ for effi cient penetration at a low BAK level (0.003%)1,2 GREATER PENETRATION ~2× to the aqueous humor2* * Compared to LOTEMAX® GEL (loteprednol etabonate ophthalmic gel) 0.5%. Clinical signifi cance of these preclinical data has not been established.

SMALL & MIGHTY SUBMICRON PARTICLES

PROVEN STRENGTH Important Safety Information (cont.) • The use of steroids after cataract surgery may delay healing and increase • 30% of LOTEMAX® SM patients had complete ACC resolution the incidence of bleb formation. In those with diseases causing thinning of vs vehicle (15%) at Day 8 (N=371, P<0.0001)1,3† the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order • 74% of LOTEMAX® SM patients were completely pain-free should be made by a physician only after examination of the patient with the 1,3‡ vs vehicle (49%) at Day 8 (N=371, P<0.0001) aid of magnifi cation such as slit lamp biomicroscopy and, where appropriate, fl uorescein staining. † Pooled analysis of Phase 3 clinical studies. 29% LOTEMAX® SM (N=171) vs Study 1: • Prolonged use of corticosteroids may suppress the host response and thus 9% vehicle (N=172). Study 2: 31% LOTEMAX® SM (N=200) vs 20% vehicle (N=199); P<0.05 for all. increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. ‡ Pooled analysis of Phase 3 clinical studies. Study 1: 73% LOTEMAX® SM (N=171) vs 48% vehicle (N=172). Study 2: 76% LOTEMAX® SM (N=200) vs 50% vehicle • Employment of a corticosteroid medication in the treatment of patients with (N=199); P<0.05 for all. a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Indication • Fungal infections of the cornea are particularly prone to develop LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid coincidentally with long-term local steroid application. Fungus invasion must indicated for the treatment of post-operative infl ammation and pain following be considered in any persistent corneal ulceration where a steroid has been ocular surgery. used or is in use. Fungal cultures should be taken when appropriate. • Contact lenses should not be worn when the eyes are infl amed. Important Safety Information • There were no treatment-emergent adverse drug reactions that occurred in • LOTEMAX® SM, as with other ophthalmic corticosteroids, is contraindicated in more than 1% of subjects in the three times daily group compared to vehicle. most viral diseases of the cornea and conjunctiva including epithelial herpes You are encouraged to report negative side eff ects of prescription drugs simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. mycobacterial infection of the eye and fungal diseases of ocular structures. • Prolonged use of corticosteroids may result in glaucoma with damage Please see brief summary of Prescribing Information on adjacent page. to the optic nerve, defects in visual acuity and fi elds of vision. If LOTEMAX® SM References: 1. LOTEMAX SM [prescribing information]. Bridgewater, NJ: Bausch & Lomb, Incorporated. 2. Cavet ME, Glogowski S, DiSalvo C, Richardson ME. Ocular pharmacokinetics of submicron loteprednol is used for 10 days or longer, IOP should be monitored. etabonate ophthalmic gel, 0.38% following topical administration in rabbits. Poster presented at 2015 ARVO • Use of corticosteroids may result in posterior subcapsular cataract formation. Annual Meeting; May 4, 2015; Denver, Colorado. 3. Data on fi le. Bausch & Lomb, Inc.

®/TM are trademarks of Bausch & Lomb Incorporated or its affi liates. © 2019 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. LSM.0118.USA.19 Visit www.LOTEMAXSM.com

RP0519_B & L Lotemax.indd 1 4/5/19 10:14 AM

BRIEF SUMMARY OF PRESCRIBING INFORMATION produced malformations when administered orally to pregnant rabbits at doses 4.2 times the recommended human ophthalmic dose (RHOD) and to This Brief Summary does not include all the information needed to use pregnant rats at doses 106 times the RHOD. In pregnant rats receiving oral LOTEMAX® SM safely and effectively. See full prescribing information ® doses of loteprednol etabonate during the period equivalent to the last for LOTEMAX SM. trimester of pregnancy through lactation in humans, survival of offspring was ® reduced at doses 10.6 times the RHOD. Maternal toxicity was observed in LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% rats at doses 1066 times the RHOD, and a maternal no observed adverse For topical ophthalmic use effect level (NOAEL) was established at 106 times the RHOD. The Initial U.S. Approval: 1998 background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general INDICATIONS AND USAGE ® population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, LOTEMAX SM is a corticosteroid indicated for the treatment of post- of clinically recognized pregnancies. Data: Animal Data. Embryofetal studies operative inflammation and pain following ocular surgery. were conducted in pregnant rabbits administered loteprednol etabonate by DOSAGE AND ADMINISTRATION oral gavage on gestation days 6 to 18, to target the period of organogenesis. Invert closed bottle and shake once to fill tip before instilling drops. Apply one Loteprednol etabonate produced fetal malformations at 0.1 mg/kg (4.2 times drop of LOTEMAX® SM into the conjunctival sac of the affected eye three the recommended human ophthalmic dose (RHOD) based on body surface times daily beginning the day after surgery and continuing throughout the first area, assuming 100% absorption). Spina bifida (including meningocele) was 2 weeks of the post-operative period. observed at 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at 0.4 mg/kg (17 times the RHOD). At 3 mg/kg (128 times the CONTRAINDICATIONS ® RHOD), loteprednol etabonate was associated with increased incidences of LOTEMAX SM, as with other ophthalmic corticosteroids, is contraindicated abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, in most viral diseases of the cornea and conjunctiva including epithelial and delayed ossification. Abortion and embryofetal lethality (resorption) herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in occurred at 6 mg/kg (256 times the RHOD). A NOAEL for developmental mycobacterial infection of the eye and fungal diseases of ocular structures. toxicity was not established in this study. The NOAEL for maternal toxicity in WARNINGS AND PRECAUTIONS rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may rats administered loteprednol etabonate by oral gavage on gestation days 6 result in glaucoma with damage to the optic nerve, defects in visual acuity to 15, to target the period of organogenesis. Loteprednol etabonate produced and fields of vision. Steroids should be used with caution in the presence of fetal malformations, including absent innominate artery at 5 mg/kg (106 times glaucoma. If this product is used for 10 days or longer, intraocular pressure the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical should be monitored. hernia, decreased fetal body weight and decreased skeletal ossification at 50 Cataracts: Use of corticosteroids may result in posterior subcapsular mg/kg (1066 times the RHOD). Embryofetal lethality (resorption) was cataract formation. observed at 100 mg/kg (2133 times the RHOD). The NOAEL for Delayed Healing: The use of steroids after cataract surgery may delay developmental toxicity in rats was 0.5 mg/kg (10.6 times the RHOD). healing and increase the incidence of bleb formation. In those diseases Loteprednol etabonate was maternally toxic (reduced body weight gain) at 50 causing thinning of the cornea or sclera, perforations have been known to mg/kg/day. The NOAEL for maternal toxicity was 5 mg/kg. A peri-/postnatal occur with the use of topical steroids. The initial prescription and renewal of study was conducted in rats administered loteprednol etabonate by oral the medication order should be made by a physician only after examination gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the of the patient with the aid of magnification such as slit lamp biomicroscopy end of lactation period). At 0.5 mg/kg (10.6 times the clinical dose), reduced and, where appropriate, fluorescein staining. survival was observed in live-ERUQRIIVSULQJ'RVHV•PJNJ WLPHVWKH Bacterial Infections: Prolonged use of corticosteroids may suppress the RHOD) FDXVHGXPELOLFDOKHUQLDLQFRPSOHWHJDVWURLQWHVWLQDOWUDFW'RVHV• host response and thus increase the hazard of secondary ocular infections. mg/kg (1066 times the RHOD) produced maternal toxicity (reduced body In acute purulent conditions of the eye, steroids may mask infection or weight gain, death), decreased number of live-born offspring, decreased birth enhance existing infection. weight, and delays in postnatal development. A developmental NOAEL was Viral infections: Employment of a corticosteroid medication in the treatment not established in this study. The NOAEL for maternal toxicity was 5 mg/kg. of patients with a history of herpes simplex requires great caution. Use of Lactation: There are no data on the presence of loteprednol etabonate in ocular steroids may prolong the course and may exacerbate the severity of human milk, the effects on the breastfed infant, or the effects on milk many viral infections of the eye (including herpes simplex). production. The developmental and health benefits of breastfeeding should Fungal Infections: Fungal infections of the cornea are particularly prone to EHFRQVLGHUHGDORQJZLWKWKHPRWKHU¶VFOLQLFDOQHHGIRU/27(0$;® SM and ® develop coincidentally with long-term local steroid application. Fungus any potential adverse effects on the breastfed infant from LOTEMAX SM. invasion must be considered in any persistent corneal ulceration where a Pediatric Use: Safety and effectiveness of LOTEMAX® SM in pediatric steroid has been used or is in use. Fungal cultures should be taken when patients have not been established. appropriate. Geriatric Use: No overall differences in safety and effectiveness have been Contact Lens Wear: Contact lenses should not be worn when the eyes are observed between elderly and younger patients. inflamed. NONCLINICAL TOXICOLOGY ADVERSE REACTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal Because clinical trials are conducted under widely varying conditions, studies have not been conducted to evaluate the carcinogenic potential of adverse reaction rates observed in the clinical trials of a drug cannot be loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in directly compared to rates in the clinical trials of another drug and may not the Ames test, the mouse lymphoma tk assay, or in the chromosomal reflect the rates observed in practice. Adverse reactions associated with aberration test in human lymphocytes, or in vivo in the mouse micronucleus ophthalmic steroids include elevated intraocular pressure, which may be assay. Treatment of male and female rats with 25 mg/kg/day of loteprednol associated with infrequent optic nerve damage, visual acuity and field etabonate (533 times the RHOD based on body surface area, assuming defects, posterior subcapsular cataract formation, delayed wound healing 100% absorption) prior to and during mating caused preimplantation loss and and secondary ocular infection from pathogens including herpes simplex, and decreased the number of live fetuses/live births. The NOAEL for fertility in perforation of the globe where there is thinning of the cornea or sclera. There rats was 5 mg/kg/day (106 times the RHOD). were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2019 Bausch & Lomb Incorporated USE IN SPECIAL POPULATIONS Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Pregnancy: Risk Summary: There are no adequate and well controlled Bridgewater, NJ 08807 USA studies with loteprednol etabonate in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit LSM.0091.USA.19 and rat when administered orally during pregnancy. Loteprednol etabonate Based on 9669600-9669700 Revised: 02/2019

RRP0519_BP0519_B & L LotemaxLotemax PI.inddPI.indd 1 44/5/19/5/19 110:160:16 AMAM May 2019 • Volume XXV No. 5 | reviewofophthalmology.com Cover Story 20 | Saving Private Practice: Is Solo Still Viable? Christopher Kent, Senior Editor Being on your own comes with many advantages and challenges—especially today.

Features

32 | EHR: Room for Improvement? Alexandra Skinner, Associate Editor Doctors discuss EHR issues that need attention, and suggest ways to improve current systems.

40 | The Questionable Cataract: Who Decides? Walter Bethke, Editor in Chief Surgeons share tips to help you navigate the sometimes murky waters of preop evaluations.

48 | How to Manage Uveitic Glaucoma Lama Al-Aswad, MD, MPH Tips and techniques for dealing with this unique subset of glaucoma patients.

54 | Strong Moves for Weak Zonules Michelle Stephenson, Contributing Editor Experts share their best tips for managing these difficult cases.

May 2019 | reviewofophthalmology.com | 13

013_rp0519_toc.indd 13 4/16/19 10:05 AM Departments

Review News 3 | 70

16 | Medicare Q & A The Medicare Appeals Process Appealing a claim can be daunting. Here’s how to navigate the process, should you need to make an appeal.

60 | Research Review Statins’ Value vs. Diabetic Retinopathy

62 | Glaucoma Management Managing Glaucoma with OCT Angiography This technology is showing promise as a clinical tool for diagnosing and monitoring glaucoma patients. 77 70 | Product News

76 | Classifieds

76 | Ad Index

77 | Wills Eye Resident Case Series

62

14 | Review of Ophthalmology | May 2019

013_rp0519_toc.indd 14 4/16/19 10:05 AM TRANSFORMING MIGS IN MORE WAYS THAN ONE.

Optimized Outflow: Two multi-directional stents designed to restore natural outflow Clinically Proven: Significant IOP reduction across a wide range of clinical studies1,2 Procedural Elegance: Predictability and precision to meet the needs of your practice Proven Safety: Safety profile similar to cataract surgery alone1

ASCRS BOOTH 3145

All with the exceptional customer support you’ve come to expect from Glaukos.

TransformMIGS.com | 800.GLAUKOS (452.8567)

INDICATION FOR USE. The iStent inject ® Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. CONTRAINDICATIONS. The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent inject is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. ADVERSE EVENTS. Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss * 2 lines * 3 months (2.6% vs. 4.2%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events. REFERENCES: 1. iStent inject ® Trabecular Micro-Bypass System: Directions for Use, Part #45-0176. 2. Hengerer FH. Personal experience with second-generation trabecular micro-bypass stents in combination with cataract surgery in patients with glaucoma: 3-year follow-up. ASCRS 2018 Presentation. © 2018 Glaukos Corporation. Glaukos and iStent inject are registered trademarks of Glaukos Corporation. PM-US-0026

RP0419_Glaukos.indd 1 3/26/19 6:02 PM 016_rp0519_mqa.indd 16 Q Appeals Process Appeals The Medicare A • Medical necessityconsider- • Diagnosis not onpayerlist number ofreasons: Medicare contractorcanhappenfora denied. Denialsafterareviewbyyour is reviewedbyapayerandformally however, apaidorsubmittedclaim without aformalappeal.Sometimes, rect processingandproperpayment opening theclaimmayresultincor- ing theissueandresubmittingorre- what wentawry. Inthatsituation,fi cases it’s obvioustoyourbillingstaff smoothly thefi 16 process work? Appeals Medicare the does How appeal. to Ineed now process, shouldyouneedtomakeanappeal. Appealing aclaimcanbedaunting.Here’s howtonavigatethe

occur whenthepayer’s pub- diagnosis. Mostoften,these ations—even withaproper considered non-covered. gery, diagnostictestorexam)is service youdelivered(e.g.sur- payer listforcoverage,thenthe and thatdiseaseisn’t onthe a patienthascertaindisease, chart documentationthatsays for coverage. REVIEW | ReviewofOphthalmology Paul M. Larson, MBA, MMSc, COMT, COE, CPC, CPMA Medicare Q&A claims was denied and myMedicare of One Medicare willgothrough Not everyclaimyoufilewith rst time,butinmany Ifadoctorhas | May2019 x- A with various levels of appeal. with variouslevelsofappeal. Medicare hasanoffi mentation requiremorework. cal necessityorlackofdocu- ered diagnosisinthefuture. requesting thisbeacov- Medicare Contractor you canwritetothe likely towin—although this isn’t anappealyou’re B orC”forpayment,then and thepayerallowsonly“A, noncovered diagnosis“X,” agnoses. Ifyourpatienthas ered forcertainspecifi are publishedasonlycov- diagnosis; someservices says youhaveanincorrect of the appeal process? process? appeal the of fi the What’s formally. Q can accesstheCMS-20027 form on

Formal denialsformedi- Check thechartwhenpayer lished guidance). used or properdocumentationisn’t lished guidanceisn’t followed, known asRedetermination. You The firstlevelofappeal is appeal something to Ihave out I found (even ifthereisn’t pub- cial process cial c di- c rst level This articlehasnocommercial sponsorship. are assumed to have received it—an are assumedtohavereceived it—an date ontheletterisnot you as describedabove.”Note that the 30 daysfromthedateofthisletter request forredeterminationwithin from occurringyouneedtofi “If youwishtoavoidrecoupment tice. Your MACwillalsoinformyou, the formbutitisn’t advisedsince ly fromCMS.(You cando it without Contractor’s websiteorgetitdirect- your localMedicareAdministrative after thedatelistedonno- you mightleavesome- thing out.)CMSnotes, “A redeterminationisa review oftheclaimby ceived theRAfi Advice, youhave120 Medicare Administra- ceive theRemittance days tofileaccord- ing totheRA’s date termination.” Once youre- sumed youre- of receipt.CMS notes thatit’s as- initial claimde- tive Contractor involved inthe sonnel not (MAC) per- ve days ve le your your le 4/15/19 12:04 PM Visit us at ASCRS Booth 1327 Less stress, pure success ...in your O.R. day1 ™

OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is added to ophthalmic irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

The data are compelling and consistent—OMIDRIA makes cataract surgery better for you and your patients Published and presented clinical studies and manuscripts in press and/or in preparation report that in post-launch (i.e., not included in current labeling), prospective and retrospective, double-masked and open-label, cohort and case-controlled, single- and multi-center analyses, the use of OMIDRIA, compared to the surgeons’ standard of care, statistically significantly: • Prevents Intraoperative Floppy Iris Syndrome (IFIS)2 • Delivers NSAID to the anterior chamber and related structures • Reduces complication rates (epinephrine comparator)3 better than routine preoperative topical drug administration, • Decreases use of pupil-expanding devices resulting in effectively complete postoperative inhibition of 10,11 (epinephrine comparator)3-8 COX-1 and COX-2 • Reduces surgical times (epinephrine comparator)3,5,7,8 • Reduces the incidence of rebound iritis, postoperative pain/ photophobia, and cystoid macular edema (CME) in patients without • Prevents miosis during femtosecond laser-assisted surgery preoperative vitreomacular traction (VMT), when used with a (epinephrine comparator)6,9 postoperative topical NSAID (compared to postoperative topical • Improves uncorrected visual acuity on day after surgery NSAID + corticosteroid without OMIDRIA)12 (epinephrine comparator)3 OMIDRIA inhibits prostaglandin release, reducing intraoperative inflammation, to prevent miosis and reduce postoperative pain13 OMIDRIA is separately reimbursed under Medicare Part B and by many Medicare Advantage and commercial payers.* Contact your OMIDRIA representative today or visit omidria.com to learn more.

*Based on currently available information and subject to change without notice. Individual plan coverage, policies, and procedures may vary and should be confirmed. Omeros does not guarantee coverage or payment.

IMPORTANT SAFETY INFORMATION OMIDRIA must be added to irrigating solution prior to intraocular use. OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Systemic exposure of phenylephrine may cause elevations in blood pressure. Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma. The most commonly reported adverse reactions at ≥2% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Please see the Full Prescribing Information for OMIDRIA at www.omidria.com/prescribinginformation. You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. Omeros survey data on file. 2. Silverstein SM, Rana V, Stephens R, Segars L, Pankratz J, Shivani R, et al. Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2018;44(9):1103-1108. 3. Rosenberg ED, Nattis AS, Alevi D, et al. Visual outcomes, efficacy, and surgical complications associated with intracameral phenylephrine 1.0%/ketorolac 0.3% administered during cataract surgery. Clin Ophthalmol. 2018;12:21-28. 4. Bucci FA Jr, Michalek B, Fluet AT. Comparison of the frequency of use of a pupil expansion device with and without an intracameral phenylephrine and ketorolac injection 1%/0.3% at the time of routine cataract surgery. Clin Ophthalmol. 2017;11:1039-1043. 5. Visco D. Effect of phenylephrine/ketorolac on iris fixation ring use and surgical times in patients at risk of intraoperative miosis. Clin Ophthalmol. 2018;12:301-305. 6. Walter K, Delwadia N. Miosis prevention in femtosecond cataract surgery using a continuous infusion of phenylephrine and ketorolac. Presented at: 2018 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC. 7. Matossian C. Clinical outcomes of phenylephrine/ketorolac vs. epinephrine in cataract surgery in a real-world setting. Presented at: American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC. 8. Al-Hashimi S, Donaldson K, Davidson R, et al. Medical and surgical management of the small pupil during cataract surgery. J Cataract Refract Surg. 2018;44:1032-1041. 9. Gayton JL. E-poster presented at: 15th International Congress on Vision Science and Eye; 2017 Aug 10-11; London, UK. 10. Katsev DA, Katsev CC, Pinnow J, Lockhart CM. Intracameral ketorolac concentration at the beginning and end of cataract surgery following preoperative topical ketorolac administration. Clin Ophthalmol. 2017;11:1897-1901. 11. Waterbury LD. Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model. J Ocul Pharmacol Ther. 2018;34:154-160. 12. Visco D. et al. Study to evaluate patient outcomes following cataract surgery when using OMIDRIA with postoperative topical NSAID administration versus a standard regimen of postoperative topical NSAIDs and steroids. Presented at: 28th Annual Meeting of the American College of Eye Surgeons (ACES), the American Board of Eye Surgery (ABES), and the Society for Excellence in Eyecare (SEE), Caribbean Eye Meeting; February 1-5, 2019; Cancún, Mexico. 13. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2017. OMIDRIA® and the OMIDRIA logo® are registered trademarks of Omeros Corporation. © Omeros Corporation 2019, all rights reserved. 2019-006

RP0519_Omeros.indd 1 4/5/19 10:12 AM Medicare

REVIEW Q&A

important distinction. 2019 Medicare Appeals Process Recoupment means that if you don’t pay the demand in full, the owed Process: Days for Time Limit for Re- Minimum Amount in money will be subtracted from other Level of Appeal Provider to File viewer to Respond Controversy (AIC) payments you’ll get. Importantly, in- Appeal terest begins accruing on any balance, Redetermination 120 days 60 days $0 even if you elect to stop recoupment, and it’ll continue to accrue until you Reconsideration 180 days 60 days $0 fi nally win (in which case it would go away in full), or lose (in which case Administrative Law 60 days 90 days $160 you would owe it all plus the interest). Judge The interest rate in effect is 10.75 Department Appeals 60 days 90 days $0 percent (simple, not compound). Board CMS adds that you should include Federal District Court 60 days N/A $1,630 “any and all documentation that sup- ports the argument against the pre- vious decision.” Leave out anything MAC can provide instructions and QIC notice to fi le. There must be that doesn’t help your argument. This forms, or you can download the doc- at least $160 in controversy and it’s information (chart, op note, test re- uments from CMS. unlikely that additional information sult, anything you write, etc.) is sent You have 180 days to file a can be submitted. with the form to the MAC that made Reconsideration based on the date There are fourth and fi fth levels the original determination. The send- listed on the notice received, but re- of appeal, but they are rarely re- ing address can be found on the MAC coupment will begin no earlier than quired. At the fi fth level, you must website, in the Redetermination pro- 60 days from the date on the letter, fi le within 60 days and have at least cess section. Keep a complete copy unless you notify them. This appeal $1,630 in controversy. The appeal of what you send. There isn’t a mini- doesn’t go to your MAC; instead is filed with the Federal District mum dollar amount regarding the it goes to a Qualifi ed Independent Court, and it’s a good idea to have a amount in controversy that’s needed Contractor (QIC). Again, there’s no lawyer represent you. to file. You can mail or send your minimum amount in controversy packet electronically, but regardless required to fi le an appeal, but this Can you summarize how of how it’s sent, be sure to get a return is likely your last chance to send Q to be successful when receipt so you know it was delivered. any new information that could help formally appealing? your case. CMS notes, “Any docu- I lost a first-level appeal. mentation not submitted at the re- Successful appeals require pay- Q What can I do next if I consideration level may be excluded A ing close attention to payer want to pursue it further? from consideration at subsequent guidance, if it exists, and meeting levels of appeal …” They add, “The medical necessity requirements. Your MAC will have notified reconsideration decision will con- Reasons for any denials are im- A you via a Redetermination No- tain detailed information on further portant to address, as subsequent tice as to whether or not the decision appeals rights, where applicable.” rounds of appeal might not be de- was in your favor. If the decision was nied or questioned for the same unfavorable, you can forgo the ap- I lost part of the second- reason(s). peal process and have it recouped Q level appeal. What’s next? The required timelines to return gradually, pay it in full, or go to a your information and (separately) second-level appeal known as Re- If your Reconsideration goes avoid recoupment require monitor- consideration. Again, CMS assumes A unfavorably, in full or part, you ing, as these change based on the you’ve received the notice fi ve days can proceed to a third level of ap- level of appeal. after the date listed. Be sure to see peal—an Administrative Law Judge if the denial is for the same rea- (ALJ) hearing—but recoupment be- Mr. Larson is a senior consul- son, and if not, address it carefully. gins immediately. A third form is tant at the Corcoran Consulting There’s a different form for second- needed, the OHMA-100, and you Group. Contact him at plarson@ level appeals—CMS-20033. Your have 60 days from the receipt of the corcoranccg.com.

18 | Review of Ophthalmology | May 2019

0016_rp0519_mqa.indd16_rp0519_mqa.indd 1818 44/15/19/15/19 12:0512:05 PMPM Experiencing zero-energy lens fragmentation. ZEISS miLOOP

Keep the zonules intact New The new miLOOP® from ZEISS is a micro-interventional device, developed to deliver zero-energy1 lens fragmentation and achieve full-thickness lens fragmentation. The dissecting action of ZEISS miLOOP is designed to reduce force on the delicate 1 without 1 the need apply to energy from phacoemulsification capsular bag and zonules.

Lens cracking Lens fragmentation with ZEISS miLOOP

Lens cracking Broken zonules Lens fragmentation Preserved zonules

More product information: www.zeiss.com/miloop

© Carl Zeiss Meditec, Inc. 2019. All rights reserved. SUR.10825

RP0319_Zeiss miloop.indd 1 2/14/19 2:18 PM Private Practice REVIEW Cover Story Saving Private Practice: Is Solo Still Viable?

Christopher Kent, Senior Editor

Being on your t’s no secret that practicing med- “Today, there are about 7,000 pri- icine “ain’t what it used to be.” vate ophthalmology practices in this own comes with IEscalating costs, reduced reim- country,” he adds. “That number may bursements, having to implement decline over time, but for those doc- many advantages electronic medical records, managing tors who want to be private practitio- relationships with insurance compa- ners, the opportunities are still there. and challenges— nies, keeping up with billing and cod- In fact, we’ve recently gotten an in- ing rules, and staying on top of gov- creasing number of calls from doctors especially today. ernment regulations are just some of in academic or institutional settings the challenges facing anyone in medi- who want to go out and hang a shingle. cine today. Many ophthalmologists So the interest in solo practice is still are dealing with these nonmedical very real.” matters by circling their wagons and joining with other doctors and/or insti- The Challenges tutions. The question is: Can a doctor in solo private practice survive in this It’s not hard to see why surgeons like environment? being in private practice. “The appeal “I’ve been consulting for ophthal- of being in private practice is the same mologists for 40 years, and every year as always—being in control,” says Mr. I’ve heard the tribal beat that small Pinto. Specifi cally, doctors in private private practice is moribund and will practice cite advantages that include: soon be unavailable as a professional getting to structure their practice the option,” says John Pinto, president way they want it to be; being able to of J. Pinto & Associates, an ophthal- make decisions without having to get mic practice management consulting approval from others; being able to fi rm. “Of course, private, independent decide how much responsibility they’ll practices continue to do just fi ne. This take on in the offi ce, potentially elimi- way of practicing has survived massive nating the need to hire technicians (a drops in fees, the encroachment of huge cost saving); and being able to health systems on a local and regional decide how many hours a week they basis, the 1990s encroachment of Wall want to work. Street, and the Great Recession. And On the other hand, the challenges it’s doing just fi ne in the midst of the faced by private, independent prac- latest industry shift—putting practices tices today—especially boutique-scale together in a private equity context. practices—are considerable. Those

20 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

0020_rp0519_f1.indd20_rp0519_f1.indd 2020 44/15/19/15/19 11:1411:14 AMAM INVELTYS The ƼVWXERHSRP] corticosteroid FDA approved for &-(XVIEXQIRX of post-operative inflammation and pain following ocular surgery

Powered by AMPPLIFY™ Drug Delivery Technology

Indication -2:)08=7 PSXITVIHRSPIXEFSREXISTLXLEPQMGWYWTIRWMSR  MWMRHMGEXIHJSVXLIXVIEXQIRXSJTSWXSTIVEXMZIMRƽEQQEXMSRERH pain following ocular surgery. Important Safety Information INVELTYS is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and ƼIPHWSJZMWMSR-JXLMWTVSHYGXMWYWIHJSVHE]WSVPSRKIV-34WLSYPHFIQSRMXSVIH Use of corticosteroids may result in posterior subcapsular cataract formation. Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and VIRI[EPSJXLIQIHMGEXMSRSVHIVWLSYPHFIQEHIF]ETL]WMGMERSRP]EJXIVI\EQMREXMSRSJXLITEXMIRX[MXLXLIEMHSJQEKRMƼGEXMSR WYGLEWWPMXPEQTFMSQMGVSWGST]ERH[LIVIETTVSTVMEXIƽYSVIWGIMRWXEMRMRK Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. In clinical trials, the most common adverse drug reactions were eye TEMR  ERHTSWXIVMSVGETWYPEVSTEGMƼGEXMSR  8LIWIVIEGXMSRW may have been the consequence of the surgical procedure. Please see Brief Summary of Prescribing Information for INVELTYS on the next page. (loteprednol etabonate ophthalmic suspension) 1%

US-INV-1800111

RP0319_Kala.indd 1 2/11/19 9:41 AM INVELTYSTM (loteprednol etabonate ophthalmic suspension) 1%, ADVERSE REACTIONS for topical ophthalmic use Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing INDICATIONS AND USAGE and secondary ocular infection from pathogens including herpes INVELTYS is a corticosteroid indicated for the treatment of simplex, and perforation of the globe where there is thinning of the post-operative inflammation and pain following ocular surgery. cornea or sclera.

CONTRAINDICATIONS Clinical Trial Experience—Because clinical trials are conducted INVELTYS is contraindicated in most viral diseases of the cornea and under widely varying conditions, adverse reaction rates observed conjunctiva including epithelial herpes simplex keratitis (dendritic in the clinical trials of a drug cannot be directly compared to rates keratitis), vaccinia, and varicella, and also in mycobacterial infection in the clinical trials of another drug and may not reflect the rates of the eye and fungal diseases of ocular structures. observed in practice. The most common adverse drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular WARNINGS AND PRECAUTIONS opacification, both reported in 1% of patients. These reactions may Intraocular Pressure (IOP) Increase—Prolonged use of corticosteroids have been the consequence of the surgical procedure. may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Steroids should be used USE IN SPECIFIC POPULATIONS with caution in the presence of glaucoma. If this product is used for Pregnancy—Risk Summary: INVELTYS is not absorbed systemically 10 days or longer, intraocular pressure should be monitored. following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug. Cataracts—Use of corticosteroids may result in posterior subcapsular cataract formation. Lactation—Risk Summary: INVELTYS is not absorbed systemically by the mother following topical ophthalmic administration, and Delayed Healing—Use of steroids after cataract surgery may delay breastfeeding is not expected to result in exposure of the child healing and increase the incidence of bleb formation. In those to INVELTYS. diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The Pediatric Use—Safety and effectiveness in pediatric patients have initial prescription and renewal of the medication order should be not been established. made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where Geriatric Use—No overall differences in safety and effectiveness appropriate, fluorescein staining. have been observed between elderly and younger patients.

Bacterial Infections—Prolonged use of corticosteroids may suppress NONCLINICAL TOXICOLOGY the host response and thus increase the hazard of secondary ocular Carcinogenesis, Mutagenesis, Impairment of Fertility— infections. In acute purulent conditions of the eye, steroids may Long-term animal studies have not been conducted to evaluate mask infection or enhance existing infection. the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse Viral Infections—Use of corticosteroid medication in the treatment lymphoma thymidine kinase (tk) assay, or in a chromosome of patients with a history of herpes simplex requires great aberration test in human lymphocytes, or in vivo in the single dose caution. Use of ocular steroids may prolong the course and mouse micronucleus assay. may exacerbate the severity of many viral infections of the eye (including herpes simplex). For a copy of the Full Prescribing Information, please visit www.INVELTYS.com. Fungal Infections—Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid Manufactured for: application. Fungus invasion must be considered in any persistent Kala Pharmaceuticals, Inc. Waltham, MA 02453 corneal ulceration where a steroid has been used or is in use. Marks designated by TM and ® are owned by Fungal cultures should be taken when appropriate. Kala Pharmaceuticals, Inc. Patented. See www.kalarx.com/patents Contact Lens Wear—The preservative in INVELTYS may be © 2018 Kala Pharmaceuticals, Inc. All rights reserved. absorbed by soft contact lenses. Contact lenses should be removed US-INV-1800055 December 2018 prior to instillation of INVELTYS and may be reinserted 15 minutes following administration.

RRP0319_KalaP0319_Kala PI.inddPI.indd 1 22/11/19/11/19 9:429:42 AMAM Cover Private Practice

REVIEW Story

First-hand Experience: Getting Started

Michael Stock, MD, recently opened a solo practice in St. Louis. been in solo practice as well. “I was in an academic group prac- Before that, he’d started out by joining another solo provider. “That tice for 10 years,” he explains. “Then, when I left the university, didn’t work out,” he explains. “We had very different philosophies I went into solo practice as an anterior segment surgeon doing about how to treat patients and manage a practice. So I decided cornea and cataract, refractive and glaucoma. I started with six to branch out on my own, and I started my own practice in May of employees and my own offi ce, which was small—1,500 square 2018.” feet—with four or fi ve lanes. I had two certifi ed ophthalmic medi- Dr. Stock says the fi rst practice situation was a useful learning cal technologists to work up patients, a fellow, one nurse, one experience. “I wasn’t sure from the outset whether or not it would person at the front desk, one business offi ce and an administrative work out, so I spent every minute learning as much as I could assistant. My practice was adjacent to the Phillips Eye Institute, about running a business,” he says. “Then, when it became clear so I was able to use all of their lasers and advanced diagnostic that it was time to go our separate ways, I realized I could try the equipment. same thing again and possibly end up with the same problem, or I “There were defi nitely some attractive things about being in could try going out on my own. solo private practice, and I stayed in solo practice for about two “Today, the reality is that ophthalmologists are in demand,” he years before I was joined by my fi rst associate,” he continues. continues. “The number of new doctors coming into practice is “Now, 30 years later, we have 30 doctors in our practice—18 smaller than the number of doctors who are retiring. So I realized ophthalmologists and 12 optometrists. We also have three physi- that even though I have a family and kids, I could try solo practice cian’s assistants and just over 300 employees manning fi ve for a year. If I ended up falling fl at on my face, I would have lost offi ces with adjacent ASCs, four of which we own. a year, but I could get hired by another practice in a second. So, I “My story is different from some solo doctors’, because I found a spot and set up my own practice.” always intended to build a larger group practice,” he adds. “But Richard L. Lindstrom, MD, managing partner at Minnesota Eye I’ve experienced all the models, in terms of practice size, and I can Consultants and an attending surgeon at the Phillips Eye Institute testify that being in solo practice can work and be enjoyable.” and Minnesota Eye Laser and Surgery Center in Minneapolis, has —CK

challenges include: der my belt, a well-established prac- manager who’s been with us for about • Financial challenges. “The tice and no debt. Today, many doctors 19 years,” she notes. “She stays up-to- cost of hiring qualified lay staff has are starting out with signifi cant debt; date on what every insurance com- been going up faster than infl ation,” they’ve had to borrow money to get pany needs, and that’s quite a chore. notes Mr. Pinto. “The cost of bring- through college and medical school.” In fact, she used to be able to handle ing in professional colleagues as part- He notes that it’s also harder to bor- all of the billing and payment issues ner-track associates is also going up, row that money from a bank than it by herself; now our office manager because we’re not training enough used to be. “Doctors are not as secure spends a good deal of time entering new ophthalmologists. Then there’s a risk as we once were,” he says. “That payments as well. Luckily, we have a the cost of technology, both in terms means that an individual may need computer system that helps us man- of advanced testing and treatment some family money or support to get age some of the details, such as letting equipment—a pretty heavy lift for a started. I’m sure that’s part of the rea- us know about a patient’s eligibility small practice—and the challenges son the majority of residents coming before the patient comes in. That tells inherent in adopting EHR.” into practice today are joining at least us what information we need to collect “Nowadays, to build a nice office a small group, and not just hanging from the patient, so we don’t spend and equip it well will cost you $600,000 out a shingle. I’d estimate that only 5 time collecting that after the fact.” to a million dollars,” says Richard L. percent of today’s young doctors can • Government regulations. Ms. Lindstrom, MD, managing partner manage the start-up expenses.” McKillop notes that increasing gov- at Minnesota Eye Consultants and an • Managing insurance claims. In ernment regulations also make things attending surgeon at the Phillips Eye terms of challenges, Kerry McKillop, tougher. “We have to keep up with all Institute and Minnesota Eye Laser COE and practice administrator at the MIPS things, of course, and they and Surgery Center in Minneapolis. the Kirk Eye Center, a solo practice change yearly,” she says. “That forces “When I went into solo practice 30 in Loveland, Colorado, says that bill- us to make changes periodically, which years ago, I had to borrow $60,000, ing continues to become more time- gets tiresome. On the other hand, but I had 10 years at the university un- consuming. “We have a great billing they’re not impossible to manage, and

May 2019 | reviewofophthalmology.com | 23

0020_rp0519_f1.indd20_rp0519_f1.indd 2323 44/15/19/15/19 11:1611:16 AMAM Monthly MACKOOL ONLINE CME CME SERIES | SURGICAL VIDEOS

MackoolOnlineCME.com MONTHLY Video Series We are excited to continue into our fourth year of Mackool Online CME. With the generous support of several ophthalmic companies, I am honored to have our To view CME video viewers join me in the operating room as I demonstrate go to: the technology and techniques that I have found to be www.MackoolOnlineCME.com most valuable, and that I hope are helpful to many of my colleagues. We continue to edit the videos only to either change camera perspective or to reduce down time – allowing you to observe every step of the procedure. Richard J. Mackool, MD Episode 41: As before, one new surgical video will be released monthly, “A Controlling Floppy Iris and physicians may earn CME credits or just observe the case. New viewers and Zonular Laxity with are able to obtain additional CME credit by reviewing previous videos that are Capsule Retractors” located in our archives. Surgical Video by: I thank the many surgeons who have told us that they have found our CME Richard J. Mackool, MD program to be interesting and instructive; I appreciate your comments, suggestions and questions. Thanks again for joining us on Mackool Online CME.

Video Overview: CME Accredited Surgical Training Videos Now An 80 year old Flomax patient with severe zonular laxity can Available Online: www.MackoolOnlineCME.com present a number of challenges during cataract surgery. Here Richard Mackool, MD, a world renowned anterior segment ophthalmic I demonstrate how the proper microsurgeon, has assembled a web-based video collection of surgical use of capsule retractors makes cases that encompass both routine and challenging cases, demonstrating both the case safer for the patient familiar and potentially unfamiliar surgical techniques using a variety and easier for the surgeon. of instrumentation and settings. This educational activity aims to present a series of Dr. Mackool’s surgical videos, carefully selected to address the specifi c learning objectives of this activity, with the goal of making surgical training available as needed online for surgeons motivated to improve or expand their surgical repertoire. Learning Objective: After completion of this educational activity, participants should be able to: • demonstrate the use of capsule retractors to simultaneously prevent severe pupil constriction and provide support for the capsule/lens complex during phacoemulsifi cation.

Satisfactory Completion - Learners must pass a post-test and complete an evaluation form to receive a certifi cate of completion. You must listen to/view the entire video as partial credit is not available. If you are seeking continuing education credit for a specialty not listed below, it is your responsibility to contact your licensing/certifi cation board to determine course eligibility for your licensing/certifi cation requirement.

Physicians - In support of improving patient care, this activity has been planned and implemented by Amedco LLC and Postgraduate Healthcare Education. Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team

JOINTLY ACCREDITED PROVIDERTM Credit Designation Statement - Amedco designates this enduring material activity for a maximum of .25 AMA PRA Category 1 INTERPROFESSIONAL CONTINUING EDUCATION CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Additionally Supported by: Endorsed by: Jointly provided by: Supported by an unrestricted independent Glaukos In Kind Support: Review of Ophthalmology® medical educational grant from: MST Sony Healthcare Video and Web Production by: REG (Review Education Group) Alcon Crestpoint Management Solutions JR Snowdon, Inc Carl Zeiss Meditec Cover Private Practice

REVIEW Story ANTARES

One advantage of owning a small private practice is being able to provide a more personal patient experience, which can be a real selling point for patients. This can include strategies such as providing cookies when wait times unexpectedly grow long, or passing Corneal Topography & More! out green carnations for St. Patrick’s Day. (Pictured above: The waiting area for Kirk Eye Center in Loveland, Colorado, a privately owned one-doctor practice.)

as a small practice we have some ad- that we need to stick to. So anybody Introducing the vantages. We’re not required to do all starting out in solo practice will have NEW Dry Eye Report the things that big practices are.” to be dedicated to working long hours. • Going without MD backup. Ms. You have to be devoted if you want to McKillop points out that despite hav- make this work.” ing greater fl exibility to create the kind Despite this impressive list of chal- of practice you want, being in solo lenges, Mr. Pinto notes that they can practice puts more pressure on the be overcome, as many practices have doctor and limits flexibility in other proven. However, he adds that the ways. “In a large practice, if you don’t challenges facing solo ophthalmolo- want to come in one day, it’s not a big gists aren’t likely to diminish any time deal to reschedule your patients with soon. “The macroeconomic and social another doctor,” she notes. “We’re a environment we’re heading into for little more restricted in that sense; if the next 20 or 25 years is one of pro- Dr. Kirk doesn’t show up, I have 45 pa- found challenge,” he says. “We have tients to reschedule. He’s the only MD debts in this country and other devel- here, and we’re booked a month out. oped countries that are unsustainable. “Some appointments are more We have levels of growth that have problematic to reschedule than oth- pushed the natural world to its limits. Comprehensive ers, of course,” she continues. “Com- We have political strife and energy prehensive eye exams can be resched- prices that are set to rise substantial- Diagnostic Imaging uled and it’s not a big deal. We have ly, and our country’s ability to pay for For Dry Eyes two optometrists here; they can take health care is reaching its limits. over many of the things that Dr. Kirk “All of these factors are not going to would do if he decides to be out for a leave ophthalmology untouched, even More Information: [email protected] day or two. But there are many medi- though the demand for ophthalmolog- cal things they can’t do. If you have ic care is increasing rapidly,” he says. a glaucoma patient who’s in big trou- “So plenty of challenges lie ahead. ble, that appointment won’t be easy Whether group practices will have an to postpone, and patients who need easier time dealing with them than injections are usually on a schedule solo practices remains to be seen.” 250 Cooper Ave., Suite 100 Tonawanda NY 14150 www.s4optik.com I 888-224-6012 Sensible equipment. Well made, well priced.

020_rp0519_f1.indd 25 4/15/19 11:22 AM Cover Private Practice

REVIEW Story

Is It Really That Hard? own private practice with a focus on cata- Michael Stock, MD, ract and refractive sur- recently opened a solo prac- gery three years ago in tice in St. Louis. He says he’s Miami, is in a hybrid heard many warnings about version of private prac- the diffi culty of being in solo tice that allows her to practice today, but his experi- maintain control of her ence has not supported that practice while working perspective. “Some people in concert with a num- make it sound like it’s ex- Access to the latest advanced equipment can be a challenge for solo ber of other private traordinarily difficult to go practitioners, especially when starting out. Alternatives to purchasing practices (and a few the equipment include joint purchases with nearby practices, buying out on your own—that it’s small group practices) refurbished equipment (from reliable sources) and partnering with local something that can’t be done institutions that will allow doctors access to their advanced equipment, to share some of the today,” he says. “But is it re- such as the Phillips Eye Institute in Minneapolis (above). burdens associated with ally that diffi cult? No. Cre- insurance and govern- dentialing is a pain in the butt, but you City might be different,” he admits. ment regulations. just do it once. Billing and insurance “However, I know of many solo eye “We’re a group of individual prac- companies are a burden, but if you doctors in southern California. The tices that have joined together to oper- have even one person to help you with reason they went into solo practice ate as one large mega-group,” she ex- that, it’s quite manageable. I know was that the area was so saturated plains. “We all bill under the same tax how to do the coding, and I keep up to that no practices wanted to hire them. ID. There’s a central business offi ce, date so I know I’m doing it correctly. They’ve done fi ne. I’ve seen many solo where all the billing, claims, denials If a claim is rejected, we treat it as a doctors get onto insurance plans, even and so forth are managed. However, learning experience. We figure out in densely populated areas. in terms of day-to-day operation, each why it was rejected and adjust. The “If you’re really concerned about practice is run and managed by an rejection rate we had the fi rst month taking on these challenges yourself, individual doctor. The doctor sets his was astronomically different from our you can hire a consultant to help you,” or her own schedule, is responsible for current rejection rate. he adds. “But after doing this myself, I recruiting patients and managing the “What about MIPS?” he continues. can tell you that managing these tasks employees, and the practice is its own “If you have the right EHR software, is signifi cantly easier than any of the profi t and loss center. it’s built into the system. You just click medical training we go through.” “Basically, the benefi t of being part on some buttons. Besides, if you’re Dr. Stock says he believes the real of this group is that we have some just starting a practice, you won’t even problem isn’t that these tasks are diffi - economy of scale in certain key areas,” be part of MIPS until you start gener- cult to do, but that doctors may not be she continues. “Most important, we ating some Medicare revenue.” up for dealing with another learning have the benefi t of being considered Dr. Stock says that although he’s curve. “I suspect that once doctors fi n- a large group for insurance purposes. heard horror stories about doctors ish their training, they want to just be Especially in an urban area like south having difficulty getting onto insur- doctors,” he says. “They’re not looking Florida, it’s almost impossible to get ance panels, that has not been his ex- for more learning curves—but that’s onto insurance panels as a solo doctor. perience. “I can’t say how hard it might not a good place to be if you want to Most insurance companies won’t even be in different parts of the country, but run your own practice. speak to you unless you’re part of a big I’ve gotten on every panel I’ve applied “I think many more doctors would group. I have a colleague who’s on his for,” he says. “A few needed a bit of ha- go out on their own in a second if it own; he started his own practice about rassment. One gave me the runaround didn’t seem like such a high barrier,” six months ago. He’s only been able to for months. But eventually, with per- he adds, “but the prospect of another get on two insurance plans, after trying sistent calling, I got through to the learning curve keeps them from going and trying and trying. right person. If you bug the right per- off on their own.” “Of course,” she adds, “if you’ve al- son enough, it’s less painful for them to ready been in practice for 20 or 30 let you onto the panel than give you a The Benefi ts of Teaming Up years, this isn’t an issue because you’re reason to continue bugging them. already on the insurance panels. But “Southern California or New York Jennifer Loh, MD, who started her if you’re a solo practice starting new,

26 | Review of Ophthalmology | May 2019

020_rp0519_f1.indd 26 4/15/19 11:15 AM ANTARES DRY EYE TESTING pretty much the only way to get in is to metropolitan center where big con- join a group practice—at least in this solidations are occurring,” notes Dr. part of the country.” Lindstrom. “I’m a fan of what I call Dr. Loh notes that the group also ‘exurbia’—the areas about 60 to 100 alleviates some of the paperwork bur- miles from the center of a metropol- den by managing some processes cen- itan area. In some of those smaller trally. “The group has a centralized communities you have a better op- billing department that handles all portunity to be successful as a solo claims and denials,” she explains. “We ophthalmologist. When you encoun- also have a human resources manager ter complex or specialty-care patients Non-Invasive Tear Film who oversees issues with individual you can send them to specialists in the Break-up Analysis employees. We’re able to use technol- nearby metropolitan area. I think this ogy like ADP to manage our payroll, creates a pretty ideal situation for a and we have a good EHR system and solo practitioner.” a group IT expert. As a solo doctor, I Ms. McKillop notes that being in wouldn’t be able to afford that level the small town of Loveland, Colorado, of personnel expertise. But because of has limited the competition they face. the way this arrangement works, I’m “The one competing ophthalmologist still able to control my own schedule in town joined a larger group to our and life, and the way I practice.” north,” she says. “The bigger practice Dr. Loh says one limitation of this has many MDs and several satellite particular arrangement is that the locations. They’d undoubtedly like to Tear Meniscus Height practices in the group don’t share dominate this market, but we’ve got equipment. “For one thing, we’re all our own niche, and we’re doing fi ne.” at different locations, pretty far apart,” She adds that the practice’s physical she says. “The other factor is that when location in town also works to their ad- the group was initially formed, most vantage. “We’re located on Highway of the practices already existed and 34, which is the main artery in and out owned their own equipment. I’m one of town,” she says. “Forty thousand of only two practices that came into cars drive past our big sign out front existence after the group was formed. every day. That helps remind everyone So, I’m responsible for buying all my that we’re here.” own capital equipment. But at least • Think about how to set your- MeibomianMMeibbomiian GlandGlland we share some of the overhead relat- self apart from other practices in Imaging & Analysis ing to human resource expenses.” the area. “It’s important that your practice stand out in some way,” says Strategies for Starting Out Ms. McKillop. “It’s not always easy to fi gure out how to do that, but as a Surgeons offer these tips for those small practice, offering personal ser- thinking about going solo: vice is a good place to start.” • Choose an auspicious location • Consider narrowing your fo- for your practice. Being in the right cus. Dr. Lindstrom notes that many of location can make an enormous differ- the larger, high-volume solo practices ence in terms of getting on insurance focus on one practice specialty, usually OcularOcullar SSurfaceurfface DiseaseDisease panels—which is much harder to do in cataract surgery; they refer most of the Index Questionnaire an area crowded with doctors offering other sophisticated subspecialty care the same services as you. The right out. “Often they do cataract surgery More Information: [email protected] location can also minimize competi- and refractive-cornea along with glau- tion and make you easily available to coma,” he says. “They refer out retina patients who need your services. and the like. That means they don’t Being in a small town can help. need all of the sophisticated equip- “It’s tough to compete inside a major ment that a glaucoma, cornea or retina 250 Cooper Ave., Suite 100 Tonawanda NY 14150 www.s4optik.com I 888-224-6012 Sensible equipment. Well made, well priced.

020_rp0519_f1.indd 27 4/15/19 11:22 AM 0020_rp0519_f1.indd 28 2 0 _ r p 0 5 1 9 _ f 1 28 affording expensiveequipment. solo doctor.” how likelyitisthatyou’llsucceedasa er. Soyoursubspecialtymayimpact gist, fi hand, ifyou’reageneralophthalmolo- cialists here,”hesays.“Ontheother there arelownumbersofthesespe- da, yourservicesareneededbecause neuro-ophthalmology inSouthFlori- practice specializesinglaucomaor a specialtythat’s indemand.“Ifyour practice increaseifyou’refocusedon that yourchancesofsuccessinsolo International University, pointsout heim CollegeofMedicineatFlorida faculty memberattheHerbertWert- Eye CareinMiami,andavolunteer cornea attheCenterforExcellencein William B.Trattler, MD,directorof by thepopulationinyourarea. specialist needs.” . i n d

• Don’t worrytoo muchabout • Offeraservicethat’s needed REVIEW d brought themin. The group’s websiteis hiredotherdoctorsand now them over;someweresolobuthave someboughtsolopracticesandtook practices fromscratch; practices.150 doctorswhoruntheirown startedtheirown Many called SoloEyeDocsGroup,” hesays. “It acollectiveofabout practice.mologists interestedinprivate “There’s anonlineforum Louis, sayshe’s usefulresourcesforophthal- foundsomevery solo-eye-docs-group/ Physician-CEO program, withSurgiVision presentedinassociation a practicewascompletingtheKelloggSchoolofManagement afairamountofcashforthefund.” ate Surgical ScopeFund, orOphthPAC. It’s $500ayear, andwegener- says. “There’s amembershipfeeofsorts;it’s tothe adonation on one, youreallyareasolodoctor,” andbasicallyprovethat he practice. “To join, alease, tohave youhave orbeabouttoexecute a niceresource.” asyou.reach outtopeoplewhoareinthesamesituation It’s been do youdealwiththiscodingorbillingissue?’Basically, youcan uplate?’ keepsshowing doyouwhenanemployee ‘How ‘What ‘What’s tobuyforthislaneequipment?’ thebestlightswitch ing awiderangeofquestionslike, doyougetcredentialed?’ ‘How | Resources forSoloPractitioners

Story Cover Review ofOphthalmology

2 Michael Stock, MD, whorecentlyopenedasolopracticeinSt. Dr. helpedhimlearntorun Stocksaysanotherresourcethat Dr. thegroupisonlyopentothoseinsolo Stocknotesthat nding patients maybeabithard- 8

Private Practice Private . forask- The sitegivesmembersaplatform | May2019 solobuildingblogs.com/ ogists accesstothebestequipment environment. Thatgivesophthalmol- struments andlasers,agreat OR with alltheadvanceddiagnosticin- The institutehasadiagnosticcenter individual ophthalmologistscanjoin. says. “It’s anopen-panelinstitutethat called thePhillipsEyeInstitute,”he in Minneapoliswehavesomething access toadvancedequipment.“Here settings thereareotherwaystogain slowly grow.” gadget intheworldatfi not havethebiggestoffi practice, youcanstartsmall.You may Besides, ifyou’regoingintoprivate table dealer, and itworksreallywell. furbished equipmentfromarepu- equipment. I’vepurchasedlotsofre- she notes.“Andyoucanbuyused business, youcantakeoutaloan,” this isn’t amajorhurdle.“Likeany Dr. Lohsaysthat, inherexperience, Dr. Lindstromaddsthatinsome control in the years ahead—than many suspect.” control intheyearsahead—thanmany willremainmorein professional andbusinessdestiny—and trend. It’s doctorsaremoreincontroloftheir anothersignthat two ago. Iseeitasakindofcounter-current equity totheprivate or wasmorecommonageneration or thebusinessbackingthat tally suitedtobeinsolopractice, therisktolerance butdon’thave will helpprovidealegupforyoungdoctorswhoaretemperamen- andexpertise,”capital hesays. “It’s adoctor-based enterprisethat willhelpyoungdoctorsgoingintosolopracticebyproviding that Ican’tname, that withaninterestingnewcompany conversations practice.young doctorsinterestedingoingintoprivate “We’ve had shouldhelp that newsupportsystemsareappearing adds that hasbeeninvaluable.” of thesecolleagues practices. Gettingtoheartheirexperiencesandbounceideasoff were highlysuccessfulphysiciansrunninglarge, prestigious oftheircareersandindiverseorganizations. allstages at Many likemyown,situations Physician-CEOexposedmetocolleagues Solo EyeDocsgroup, in withcolleagues whereI’mcommunicating sential tobeinganeffectivephysicianleader. Incontrastwiththe he says. “In thesemodules, arees- welearnedbusinessskillsthat fourintensivetrainingmodules,”the courseofayearIattended Consultants, NorthwesternUniversity’s at businessschool. “Over rst, but you can rst, butyoucan John Pinto, presidentofconsultingfi rm J. Pinto& Associates, ce, with every ce,withevery top down. pattern thatmakessense.” uses theOReachday. Ithinkthat’s a cent oftheASC.Then,onedoctor Ideally, everyoneowns10or20per- build anASCthathasoneortwoORs. ophthalmologists gettogetherand “Typically, agroupoffi surgical center,” saysDr. Lindstrom. who canaffordhisownambulatory portant, butit’s araresolopractitioner being onthefacilitysideisveryim- other solopractices. without havingtopurchaseit.” torney andagoodCPA,” hesuggests. quality advisor/consultant,a good at- es,” advisesMr. Pinto. company inchallengingcircumstanc- tor, workingtogethertooperatethe and anexceedinglystrongadministra- exceedingly strongmanagingpartner • Buildyourpracticefromthe • ConsidersharinganASCwith Dr. Lindstrom agrees.“Hireahigh- “Make sureyouhavean “In my opinion, “In myopinion, ve orsixsolo —CK 44/15/19 11:16 AM / 1 5 / 1 9

1 1 : 1 6

A M Better Nutrition to Support Healthy Vision

COMBATS DRY EYE SYMPTOMS AND PROMOTES HEALTHY TEARS

MaquiBright® Clinical trials show Maqui Berry increases tear production and improves dry eye symptoms.

Omega-3 Fatty Acids O3+Maqui contains 2420mg of highly refined omega-3 fish oil in a re-esterified triglyceride form.

Patented Unigel™ Technology The only patended technology that combines a liquid & powder tablet in one convenient softgel.

LEARN MORE & ORDER Visit O3Maqui.com or call (866) 752-6006

FocusLaboratories.com

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

FLM191-1218-01

RP0319_Focus.indd 1 2/26/19 3:17 PM 0020_rp0519_f1.indd 30 2 0 _ r p 0 5 1 9 _ f 1 30 does cataracts,”hesays.“He offers is anoculoplasticsspecialistwho also ments. “Onesolopractitioner Iknow a bulwarkagainstdecliningreimburse- self-pay procedurescanhelpprovide Dr. Trattler points outthatoffering says. “That’s oneofourbiggestassets.” of andreceivepersonalattention,”she sure thatourpatientsaretakencare cookies. Abigpracticecan’t dothat. longer thannormal,wegetthemsome up. Ifpatientsenduphavingtowait the techniciansthatareworkingthem desk, andpatientsknowthenamesof always someonesmilingatthefront it wastooimpersonal.Here,there’s to thebiggerpracticeintownbecause our patientsthattheydidn’t likegoing Ms. McKillop.“We oftenhearfrom offer thatthebigpracticescan’t,” notes sonalized serviceissomethingwecan offer personalizedattention. that yoursolopracticethrives: Once You’re UpandRunning… in thesamesituationyou’rein.” vice, trytogetitfromdoctorswhoare running abusiness.Soifyouneedad- them havelimitedknowledgeabout sive knowledgeandskills,butmostof are wonderfulpeoplewithimpres- Stock pointsout.“Academicdoctors they workintwodifferentworlds,”Dr. doctors thoughtwasquestionable,but community doctorsthatmyattending ence. may bebasedonlimitedexperi- ademic doctorsaboutpracticing as asolopractitioner,” shesays. you won’t haveachanceofsucceeding collect fortheminatimelymanner, “If youcan’t billforyourservicesand good billingdepartmentisessential. side isbecomingmoreimportant.” “Sophisticated helpwiththebusiness . i n d

• Offercash-payprocedures. ”The bottomlineisthatwemake • Makethemostofbeingableto These strategiescanhelpensure • Beawarethatadvicefromac- Ms. McKillopnotesthathavinga REVIEW d |

Story Cover Review ofOphthalmology

3 “I got a lot of good advice from “Igotalotofgoodadvicefrom 0

Private Practice Private | May2019 “Per- always beingused. gets withtheinsurancecompanies.” These helptooffsetthelowrateshe as Botoxandcosmeticlidsurgery. self-pay oculoplasticsproceduressuch ahead you’llhavetoworkharder at ogists areprettysmart,inthe years says Mr. Pinto. you havetoworkharderthantheydo,” you’re notsmarterthantheotherguys, gist JohnCorboyhasobserved,if practice thriving. time asisnecessarytokeepthe to you,doyourhomework.” Mr. Pintosays.“Ifareasareunfamiliar pening onthebusinesssideofthings,” formed abouteverythingthat’s hap- your practice,youhavetostayin- business details. with unforeseenchallenges.” to besettingasidereservesfordealing the practiceasyoursalary. You have “Don’t draweverylastpennyoutof greater volatility,” saysMr. Pinto. ing inabusinessenvironmentwith when youneedit. that you’llhaveaccesstocapital the ASCsitsempty.” economically iftheoffi really hardtomakesolopracticework can beseeingpatientsintheoffi OR oronvacation,theoptometrists Dr. Lindstrom.“Whenyou’reinthe or moreoptometricemployees,”notes titioners canbenefi private-practice type • Makesureyourfacilitiesare • Bewillingtoputinasmuch • Stayontopofyourpractice’s • Arrangeyouraffairstoensure “Patients appreciate that personalized, — JenniferLoh,MD of care.” “Since allophthalmol- t fromhavingone “Astheownerof “Asophthalmolo- “You’ll bepractic- “Most soloprac- ce isempty, or ce. It’s profession, whereverit’s heading.” right orrunforwardtostaywiththe have tobereadylungetheleftor have todoasanophthalmologist.You any direction,andthat’s whatyou preparing tobeablespringoffin to foot,”notesMr. Pinto.“They’re about toreceiveaservehopfromfoot spond tochanges. when necessary.” the clinicandworkinglongerhours all levels—focusingmoreintenselyin think it’s wellworthit.” dream, Ithinkit’s stillpossible,andI if beinginprivatepracticeistruly your ized, private-practicetypeofcare.So it. Patientsappreciatethatpersonal- think there’s aneedanddesirefor their ownpractice.Furthermore,I doctors arehappy;theylikehaving adds Dr. Loh.“Mostprivatepractice ally prefertobeinprivatepractice,” they’ll dojustfi and makewisechoices,butIthink of thefi they’ll continuetobeasignifi practitioners willshrinkovertime,but he says.“Isuspectthenumberofsolo to sixMDswhoowntheirASC,” towards agrouppractice,suchasfour think theidealmodelwillshiftmore unless you’refi ably nottheidealmodelgoingforward sees afutureforsolopractice,it’s prob- generations tocome.” able towritetheirownticketformany ophthalmologists willcontinuetobe fer tooperatein,”hesays.“Ithink the professionalcontextthey’dpre- the driversseat,intermsofchoosing flat. “Ophthalmologistsreallyarein ber ofophthalmologistsisremaining population isgrowing,whilethenum- four tofi for eye-careservicesisincreasingat Outlook: Positive • Remainfl “Ithinkmostdoctorswouldactu- Dr. Lindstromsaysthatwhilehe Mr. Pintonotesthatthedemand eld. They’ll need to be nimble eld. They’llneedtobenimble ve times the rate at which the ve timesthe rateatwhichthe exible soyoucanre- ercely independent. “I ne.” “Tennis players cant part 44/15/19 11:16 AM / 1 5 / 1 9

1 1 : 1 6

A M WHEN RELIABILITY COUNTS Visit BVI at ASCRS THE RIGHT BOOTH PACK 1206 MATTERS

Minimize your pack-building time

Expedite your OR experience

Treat more patients CustomEyes® your pack

bvimedical.com

BVI, BVI Logo and all other trademarks (unless noted otherwise) are property of Beaver-Visitec International, Inc. (“BVI”) © 2019 BVI. 1498237-02

RP0419_Beaver.indd 1 3/21/19 1:51 PM EHR REVIEW Feature EHR Systems: Room For Improvement?

Alexandra Skinner, Associate Editor

Doctors discuss lectronic medical records of- medical fi eld: the doctor-patient rela- fer many benefi ts, such as im- tionship. “You’re creating a new indus- EHR issues that Eproved documentation and ef- try that adds third party diversion from fi cient storage and recall of past data. the doctor-patient relationship, which need attention, However, as with most things, physi- just erodes it,” she contends. cians say there’s some room for im- • Preserving the doctor-patient and suggest ways provement in their records systems. relationship. Doctors say it’s crucial In this article, doctors are given a plat- to maintain rapport with the patient, to improve current form to not only discuss their EHR even if having the EHR system in the gripes but also address the “wish-list” exam lane makes it more challenging. systems. items they’d like to see included or im- Andrew Iwach, MD, executive proved upon in future EHR systems. director of the Glaucoma Center of San Francisco and board chair for the EHR Issues Glaucoma Research Foundation, says that when it comes to quality of care, The advent of EHRs changed the the primary concern is the patient- way physicians document patient in- doctor interaction. “My job is, number teractions and, in the process, also one, patient quality of care and happi- changed those interactions. Though ness, and number two, keeping doc- EHR innovations have had a positive tors happy,” he says. “We’re looking influence on some aspects of care, at the patient experience and how the Jamie Wells, MD, FAAP, a board- value of our practice is perceived be- certified physician and director of yond the technical skills that we have. medicine at the American Council on Patients appreciate me looking them Science and Health, a “pro-science in the eye versus looking at a terminal.” consumer advocacy organization,” Dr. Wells agrees that understanding says this isn’t necessarily so in all cases. the patient dialogue can be as valuable, “EHR disrupts medical practice, and if not more valuable, than structured it hasn’t been a positive disruptor,” she data. “Being a phenomenal physician says. Claiming that the dawn of EHR vs. being a so-so one, involves utilizing was the catalyst that caused the coding not just your expertise, knowledge and and billing industry to quickly grow, experience but also skills of observa- Dr. Wells says this has consequently tion,” she says. “Your sense of vision, shifted attention from what she feels smell, and hearing in combination with should be the highest priority in the your assessment of body language, and

32 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

0032_rp0519_f2.indd32_rp0519_f2.indd 3232 44/15/19/15/19 11:3611:36 AMAM The first and only FDA-approved, single-dose, NEW sustained-release, intracameral steroid for the treatment of postoperative inflammation1-3

For Post-Cataract Surgery Inflammation Target Within1-3

With a single injection at the end of cataract NOW AVAILABLE surgery, anti-inflammatory efficacy begins as early as day 1 and continues through day 301* • The percentage of patients who received DEXYCU (517 mcg) who had anterior chamber cell clearing on day 8 was 60% (n=94/156) vs 20% (n=16/80) in the placebo group1 • The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) at day 30 was significantly lower in the DEXYCU (517 mcg) treatment group (20%; n=31/156) compared to placebo (54%; n=43/80)1

*DEXYCU was studied in a randomized, double-masked, placebo-controlled trial. Patients received either DEXYCU or a vehicle administered by a physician at the end of the surgical procedure. The primary endpoint was the proportion of patients with anterior chamber cell clearing (cell score=0) on postoperative day 8.

INDICATION AND USAGE DEXYCU™ (dexamethasone intraocular suspension) 9% is indicated . Use of a corticosteroid in the treatment of patients with a history of for the treatment of postoperative inflammation. herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections IMPORTANT SAFETY INFORMATION . Fungal infections of the cornea are particularly prone to coincidentally CONTRAINDICATIONS develop with long-term local steroid application and must be None. considered in any persistent corneal ulceration where a steroid has WARNINGS AND PRECAUTIONS been used or is in use. Fungal culture should be taken when appropriate Increase in Intraocular Pressure . Prolonged use of corticosteroids may suppress the host response . Prolonged use of corticosteroids, including DEXYCU, may result in and thus increase the hazard of secondary ocular infections. In glaucoma with damage to the optic nerve, defects in visual acuity acute purulent conditions, steroids may mask infection or enhance and fields of vision . existing infection Steroids should be used with caution in the presence of glaucoma Cataract Progression Delayed Healing . The use of corticosteroids in phakic individuals may promote the . The use of steroids after cataract surgery may delay healing and development of posterior subcapsular cataracts increase the incidence of bleb formation ADVERSE REACTIONS . In those diseases causing thinning of the cornea or sclera, perforations . The most commonly reported adverse reactions occurred in 5-15% have been known to occur with the use of corticosteroids of subjects and included increases in intraocular pressure, corneal Exacerbation of Infection edema and iritis . The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the Please see brief summary of full Prescribing Information cornea and conjunctiva including epithelial herpes simplex keratitis on adjacent page. (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures

References: 1. DEXYCU™ (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018. 2. Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with cataract surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018;125(6):799-806. 3. Data on file. EyePoint Pharmaceuticals, Inc.

DEXYCU and the EyePoint logo are trademarks of EyePoint Pharmaceuticals, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 01/2019 480 Pleasant Street, Suite B300, Watertown, MA 02472 US-DEX-1900045

RP0319_Eyepoint.indd 1 2/13/19 9:59 AM DEXYCU (dexamethasone intraocular suspension) 9%, 6.1 Clinical Trials Experience for intraocular administration Because clinical studies are conducted under widely varying conditions, Initial U.S. Approval: 1958 adverse reaction rates observed in the clinical studies of a drug cannot BRIEF SUMMARY: Please see package insert for full prescribing information. be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. 1 INDICATIONS AND USAGE DEXYCU (dexamethasone intraocular suspension) 9% is indicated The following adverse events rates are derived from three clinical trials for the treatment of postoperative inflammation. in which 339 patients received the 517 microgram dose of DEXYCU. The most commonly reported adverse reactions occurred in 5-15% of subjects 4 CONTRAINDICATIONS and included increases in intraocular pressure, corneal edema and iritis. None. Other ocular adverse reactions occurring in 1-5% of subjects included, 5 WARNINGS AND PRECAUTIONS corneal endothelial cell loss, blepharitis, eye pain, cystoid macular edema, 5.1 Increase in Intraocular Pressure dry eye, ocular inflammation, posterior capsule opacification, blurred vision, Prolonged use of corticosteroids including DEXYCU may result in glaucoma reduced visual acuity, vitreous floaters, foreign body sensation, photophobia, with damage to the optic nerve, defects in visual acuity and fields of vision. and vitreous detachment. Steroids should be used with caution in the presence of glaucoma. 8 USE IN SPECIFIC POPULATIONS 5.2 Delayed Healing 8.1 Pregnancy The use of steroids after cataract surgery may delay healing and increase the Risk Summary incidence of bleb formation. In those diseases causing thinning of the cornea There are no adequate and well-controlled studies of DEXYCU or sclera, perforations have been known to occur with the use of corticosteroids. (dexamethasone intraocular suspension) in pregnant women. Topical ocular 5.3 Exacerbation of Infection administration of dexamethasone in mice and rabbits during the period The use of DEXYCU, as with other ophthalmic corticosteroids, of organogenesis produced cleft palate and embryofetal death in mice and is not recommended in the presence of most active viral diseases of the malformations of abdominal wall/intestines and kidneys in rabbits at doses cornea and conjunctiva including epithelial herpes simplex keratitis 7 and 5 times higher than the injected recommended human ophthalmic dose (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial (RHOD) of DEXYCU (517 micrograms dexamethasone), respectively infection of the eye and fungal disease of ocular structures. [see Data in the full prescribing information]. Employment of a corticosteroid medication in the treatment of patients In the US general population the estimated background risk of major birth with a history of herpes simplex requires caution. Use of ocular steroids may defects and miscarriage in clinically recognized pregnancies is 2 to 4% prolong the course and may exacerbate the severity of many viral infections and 15 to 20%, respectively. of the eye (including herpes simplex). Fungal infections of the cornea are 8.2 Lactation particularly prone to develop coincidentally with long-term local steroid Risk Summary application. Fungus invasion must be considered in any persistent corneal Systemically administered corticosteroids are present in human milk and ulceration where a steroid has been used or is in use. Fungal culture should can suppress growth, interfere with endogenous corticosteroid production, be taken when appropriate. or cause other unwanted effects. There is no information regarding the Prolonged use of corticosteroids may suppress the host response and presence of injected DEXYCU in human milk, the effects on breastfed infants, thus increase the hazard of secondary ocular infections. In acute purulent or the effects on milk production to inform risk of DEXYCU to an infant during conditions, steroids may mask infection or enhance existing infection. lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for DEXYCU and any 5.4 Cataract Progression potential adverse effects on the breastfed child from DEXYCU. The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts. 8.4 Pediatric Use Safety and effectiveness of DEXYCU in pediatric patients have not 6 ADVERSE REACTIONS been established. The following adverse reactions are described elsewhere in the labeling: 8.5 Geriatric Use ҹ Increase in Intraocular Pressure [see Warning and Precautions (5.1)] No overall differences in safety or effectiveness have been observed ҹ Delayed Healing [see Warnings and Precautions (5.2)] between older and younger patients. ҹ Infection Exacerbation [see Warnings and Precautions (5.3)] ҹ Cataract Progression [see Warnings and Precautions (5.4)] Manufactured for: EyePoint Pharmaceuticals US, Inc. Watertown, MA 02472

DEX0019

RRP0319_EyepointP0319_Eyepoint PI.inddPI.indd 1 22/13/19/13/19 9:579:57 AMAM Feature EHR REVIEW

the patient’s facial affect for human interac- can optimize diagnosis.” tion and to help peo- Though EHR has ple,” she says. brought new levels of Dr. Chiang says that

efficiency and docu- MD Boland, Michael box checking may con- mentation to medical tribute to a weakening practice, some doctors of the patient’s ability say the need to enter to convey important data during patient in- details about her com- teractions can put some plaint; the traditional distance between the patient dialogue is of- Some doctors are suffering from “alarm fatigue.” Here, EHR is displaying two ophthalmologist and the ten being replaced by warnings. Wilmer’s Michael Boland, MD, says the top one is relevant (an allergy patient. Dr. Wells ex- to a medication being prescribed) but the bottom one is less so (alerting Dr. check-boxes and pre- plains, “A busy practitio- Boland that the patient is on duplicate therapy for glaucoma). populated text phras- ner has a limited amount es, he says. Dr. Wells of time, and everything says that just checking that co-ops an offi ce visit erodes the ca- going to take a moment to type their a box doesn’t compel a patient to share pacity to have an informed discussion thoughts and background information her story. “There are many of these or a healing conversation,” she says. into the computer. Then, they turn yes/no boxes and just checking them “It’s crucial to watch [patients] as they back toward the patient and talk to him may not stimulate the memory of a answer so you can understand their or her while making eye contact, which patient interaction that would allow state of mind, and if your head is in a is very acceptable. you to recall a certain piece of relevant computer screen, you can entirely miss “The other end of the spectrum information,” she says. the nuances of a conversation.” would be a doctor who’s busy or in a Some doctors are also suffering from Michael F. Chiang, MD, the rush,” she adds. “There are so many “alarm fatigue.” Michael Boland MD, Knowles professor of ophthalmol- things to document and, usually, the PhD, associate professor at Wilmer ogy and medical informatics, as well computer is positioned so that your Eye and Health Sciences Informat- as clinical epidemiology, at Oregon back is to the patient, which can make ics, director of information technol- Health and Science University, and him or her feel like you aren’t paying ogy and residency program director at associate director of the OHSU Casey attention.” Johns Hopkins’ Wilmer Eye Institute, Eye Institute, says, “Most EHRs re- Dr. Iwach agrees that a lot of it is says alarm fatigue occurs when the quire the physician to direct attention intuitive, based on the doctor’s feel for EHR’s system alerts begin piling up toward a desktop computer—which the interaction. “Technology is won- as the physician checks boxes during may detract from patient-doctor com- derful,” he says, “but it has to be imple- the exam and history. “If you don’t pay munication.” However, the integration mented at the right time.” He says that careful attention to [reminders and of EHR doesn’t always take attention understanding whether the patient is pop-ups], you end up with way too away from the patient. Dr. Chiang says being helped is what counts, and he many alerts for medications that don’t that the degree to which an EHR de- urges doctors to ask themselves if the really make sense or apply,” he says. tracts from this interaction can depend way they’re using the EHR system is Dr. Lim has thoughts on what could on the specifi c doctor. really helping patients. be behind some of the alarm-fatigue Michele Lim, MD, professor of • System issues. When it comes irritation. She says that some doctors ophthalmology, vice chair and medical to EHR, there are many different are aggravated by EHR regulations, director at the University of California- systems and setups available. How- requirements and objectives set forth Davis Eye Center, agrees, adding that ever, physicians say that the issues by the Meaningful Use program—the the range of doctor aptitude is pretty that consistently crop up usually in- federal incentive for EHR adoption— wide on this count. “It depends on volve “box checking” and “alarm fa- which can contribute to the entering of how the doctor integrates the EHR tigue.” unnecessary information. “[There’s a] or computer when they’re seeing a Though many physicians got into feeling that EHR designers are design- patient,” she says. “There are two ends medicine for similar reasons, Dr. ing toward fulfi lling these regulations of the spectrum: On the good side, a Wells says, nobody goes into medi- more than they’re trying to meet the lot of doctors have learned to preface cine intending to check boxes. “The needs of actual clinicians,” she says. Dr. the visit by communicating that they’re majority of people go into medicine Wells acknowledges that while pop-up

May 2019 | reviewofophthalmology.com | 35

032_rp0519_f2.indd 35 4/15/19 11:36 AM Feature EHR REVIEW

reminders are well-intended, ten diffi cult, due to EHRs con- they can be frustrating and cre- taining so much—often redun- ate unnecessary steps that shift dant—data. “Findings can be

the physician’s focus to non- MD Lim, Michele imported, so it may be diffi cult clinical tasks. to know exactly what occurred Dr. Boland says you can mini- in the offi ce visit,” he says. mize alarm fatigue by taking the Users say this process can time to correctly implement an cause some confusion. “Once EHR system and ensure it’s cus- something is written incorrectly tomized to work as smoothly as in your record, it can follow you possible. “In general, the more forever,” Dr. Wells says. time you’re spending entering In terms of treatment op- data, the less time you’re spend- Davis Eye Center’s Michele Lim, MD, fi nds it helpful to use a tions, Dr. Chiang says critical ing interacting with patients,” scribe, which she says can help optimize the doctor-patient fi ndings can be missed in long he says. To minimize alarms and interaction. EHR notes containing standard reminders and make it easier to pre-populated text (e.g., “copy- document what’s necessary without institution, have been pretty meticu- forward” and “all-normal” functions in having to take as much time away from lous about trying to minimize [alarm the EHR system). “You end up with the doctor-patient relationship, Dr. Bo- fatigue],” he says. “You want to make a bunch of notes you can’t trust, and land suggests purposefully specifying sure you’re only showing very-high- you have to be very careful,” Dr. Lim the desired workfl ows and designing importance alerts; otherwise people adds. She says that errors can go unno- how the EHR will implement them just ignore them.” ticed—or worse, a doctor could read a before configuring the system. “We Dr. Boland feels that some doctors note containing a mistake and come to have a small group at Johns Hopkins are better off with EHRs and some the wrong conclusion. Medicine whose job is to review and are worse off, but that it’s related to Dr. Wells says that a ripple effect can approve all such decision-support tools the amount of time taken to adapt the take place because physicians some- before they can be implemented in system to their desired workfl ow. “If times make decisions based on what’s EHR,” he says. “The design and build you don’t take the time to understand in a record. As a member of the claims is done by our internal EHR team, but what will work best in your practice, committee for the Ophthalmic Mutual the vendor can help if the team runs [EHR] may not be equipped with Insurance Company, Dr. Iwach says into trouble with a particular project. the right set of processes for you, and one problem with medical errors is “If you don’t get the system designed you either end up trying to recreate a that when there’s litigation, profession- to satisfy your particular requirements, paper-based workfl ow using an elec- als turn to the medical record because you’re probably not going to be happy tronic system—which isn’t a good use it’s regarded as the legal record of what with it later,” Dr. Boland adds. He says of it—or you try to take an out-of-the- happened. “You add a whole additional that having someone internal who’s box electronic system and wedge it level of complexity to EMR if you have able to sit down and discuss design into your practice,” he says. a record that’s compromised, not be- steps to improve a practice’s current • Data errors. Dr. Iwach says there cause of any ill intent but as a result of workfl ow is crucial. “This job is best are other issues associated with EHR the demand, inconvenience and busy done by someone with both clinical beyond the changing doctor-patient clinical setting,” says Dr. Iwach. and EHR/IT experience,” he says. interaction. He says the process of col- To avoid errors based on the EHR “Such people aren’t common, so it lecting data includes a lot of cut-and- data, Drs. Chiang and Lim say that may require sending someone from paste that could contribute to errors. education is integral. Dr. Chiang ac- the practice to be trained on EHR “EHRs allow you to use a lot of tem- knowledges that medical errors oc- confi guration so they can translate be- plates, copy-forwards and shortcuts,” curred prior to EMRs. “[Paper] charts tween the clinical and IT worlds.” In Dr. Lim says. “People aren’t editing containing old records were often un- Dr. Boland’s case, he fi lled this role. the information they copy forward, available, missing or illegible at the Having an EHR team that works so outdated data that isn’t valid any- time of medical decision-making, so to customize parts of the EHR sys- more makes it into your current notes, they didn’t provide easy communica- tem, such as which drug interactions which is where errors come from.” Dr. tion among different providers,” he will pop an alarm, can decrease alarm Chiang adds that reviewing everything says. However, he adds that whether fatigue Dr. Boland says. “We, as an within a short patient encounter is of- records are paper or digital, it still falls

36 | Review of Ophthalmology | May 2019

032_rp0519_f2.indd 36 4/15/19 11:36 AM There’s used. And there’s ÕİļõţÕÑ|İÕʴcŖčÕÑʣ Unlimited peace-of-mind with high-qualityuality performance

ĆĔČʲİļõčĴļİŁČÕčļʣËĔČʩĭİÕʴĔŖčÕÑ ĆĔČʲİļõčĴļİŁČÕčļʣËĔČʩĭİÕʴĔŖčÕÑĆĔČʲİļõčĴļİŁČÕČ čļʣËĔČʩĭİÕİÕʴĔŖčÕÑ

RP0519_Lombart.indd 1 4/8/19 3:05 PM Feature EHR REVIEW

to the physician to provide the • Artificial intelligence. best care for the patient. AI could potentially be incor- Dr. Lim provides a few ex- porated into EHR systems in amples of how education has many different ways, from sim- helped avoid medical errors. “In ply helping the doctor retain my department, we talk about patient information to actually [avoiding medical errors] a lot, aiding in the diagnostic process. and from the time we fi rst start- Dr. Boland would like to see ed using EHR to now, people AI-assisted documentation to are more careful in how they help restore the doctor-patient enter data,” she says. “You only interaction. “People would like have to be a victim of bad data a better way to enter data into once—perhaps reading some- an EMR,” he says. “[Perhaps] Trying to recreate a paper-based system using EHR isn’t a good one else’s botched note—to through natural language pro- use of the technology, surgeons say. ensure you’re careful entering cessing where you just talk to your own data.” the patient in the exam lane and Dr. Lim adds that using a scribe can and one for imaging information,” she some sort of AI assistant documents the help avoid errors, though not every says. “That way, you wouldn’t have to conversation for you.” Dr. Wells says practice can afford to employ one. sift through 30 different tabs.” that companies are starting to test this “A few years ago we began adopting Dr. Boland agrees, emphasizing the idea using AI and voice recognition. scribes and that helps get the informa- need for computer-driven data synthe- AI may have the ability to go even tion down a bit more pristinely,” she sis. He says EHR should be better at further by potentially providing deci- says. Dr. Lim says using a scribe lets showing the doctor what he needs to sion-making assistance and guidance the doctor-patient conversation unfold see, when he needs to see it. “Systems toward possible treatment options. Dr. naturally, without the disruption of en- should be more context-dependent,” Lim says there’s a lot of talk surround- tering data into a computer. However he says. “If I’m seeing a patient with ing this topic. She wonders if, in the fu- Dr. Chiang urges doctors to implement glaucoma, I automatically want to see ture, a physician might be able to “take scribes properly and to ensure appro- IOPs and visual fi eld results, so ide- pieces of disparate data, like a patient’s priate training. He says documentation ally, [the system] would take advantage test results, and incorporate AI to help should still be reviewed by physicians, of the computer’s abilities in order to guide him or her toward a treatment.” emphasizing that it shouldn’t be out- show me the information graphically, • Improved interoperability. sourced to scribes. or in a more digestible way.” When it comes to sharing data be- In general, Dr. Lim would like en- tween different EHR systems, doctors An EHR Wish-List hanced customization in the form of agree signifi cant improvement is need- a more graphical representation. She ed. Dr. Boland calls for improved data Doctors acknowledge that EHR wants the user to be able to organize sharing. “In ophthalmology, we need systems are becoming a fact of life, information like visual fi elds and pres- standards that let us share ophthal- and the current systems have a lot of sure measurements more easily; hav- mology-specifi c data with each other,” potential, especially in ophthalmology, ing the ability to pull together informa- he says. “Otherwise, we’re going to be which is very data-driven. With many tion quickly would be a big advantage. stuck with these generic systems that different needs on doctor’s minds, here She says she essentially does that with were designed for primary care, which are a few of the top requests. her scribe, but in an audible way in- doesn’t really help us in a meaningful • An improved interface. In most stead of visually. When referring to way.” cases, EHR interfaces attempt to mim- the advantage of being able to ask her • Ophthalmic imaging integration. ic a paper chart, but Dr. Wells says that scribe to dictate patient-specifi c data, It’s a big undertaking, but many doc- the ease of paper was lost in the transi- like past IOL or OCT values, Dr. Lim tors feel that better integration of im- tion to technology. To review one pa- says, “We need an Alexa for EMR!” re- aging results would benefi t their prac- tient, she may have a dozen or so tabs ferring to the virtual-assistance device tice. Currently, companies employ to navigate, making her wish that there developed by Amazon that’s capable of picture archiving and communication were only a few tabs, each designated voice interaction and other functions systems. Dr. Lim says there may be for a particular use. “One for progress, that could potentially prove helpful for workarounds to incorporate imaging, one for medical testing information ophthalmologists. but it’s still not truly integrated. “Most

38 | Review of Ophthalmology | May 2019

032_rp0519_f2.indd 38 4/15/19 11:36 AM ophthalmologists have to use separate haps a modifi ed use of technology,” he list of options. I’m passionate about systems to capture all of their imag- says. “How about ‘effi cient’ medical the topic and I want people to be able ing results and look at them; but now records, instead of ‘electronic’? May- to think, ‘maybe there’s another way.’ you’re dealing with two different sys- be we utilize some paper for taking It’s good to have a message out there tems that you have to somehow link notes but then use computers, servers that gives people permission to ques- together,” she says. Dr. Boland agrees and scanners in conjunction to enable tion technology and its timing.” that it’d be better if images were inte- more effi cient data collection while Most doctors agree that EHRs, grated more tightly with EHR. In par- still promoting the doctor-patient re- while not perfect, have their benefi ts, ticular, he’d like more vendor-neutral lationship.” and they hope that, with time, the analysis of OCT images. “For retina Even though he hasn’t yet imple- systems will have more features that folks specifi cally, it’s currently a big mented EHR in his practice—and doctors find useful. Dr. Boland says struggle because, depending on what therefore incurs a penalty—Dr. this may be a ship that can’t be turned machine they’re using, to get images Iwach has a background in software around. “I think EHRs are likely here of the retina they have to launch all of and computer databases that has kept to stay, so we need to acknowledge the vendor-specifi c software to do the him from implementing what he feels that and focus on taking the time to review,” he says. “Using two or three are systems that wouldn’t quite fit consider how [EHR] can be used to different systems just to view the im- within his practice. With published make workfl ow better,” he says. “Take ages can become cumbersome.” papers on the subject going back to control of your EHR so that it doesn’t • A break from EHR? Sometimes, his residency in the 1980s, he feels it’s take control of you.” physicians will switch EHR systems in his background and interest in tech hopes of fi nding one that better suits that has made him more of a “cautious Drs. Wells, Lim and Boland report their practice. Dr. Iwach says instead consumer” of software. “All I suggest no relevant fi nancial disclosures. Dr. of switching EHR systems, maybe it is that we don’t forget there are alter- Iwach is a consultant for Bausch & should be more socially acceptable natives,” he says. “It may not be an Lomb and Dr. Chiang is a consultant to take a break from EHR. “I’m not option for all settings, but don’t take for Novartis and an equity owner of saying not to use technology, but per- [waiting to implement EHR] off the Inteleretina.

9LVLWXVDW $6&56 %RRWK 

032_rp0519_f2.indd 39 4/15/19 11:35 AM Cataract Patients REVIEW Feature The Questionable Cataract: Who Decides?

Walter Bethke, Editor in Chief

Surgeons share urgeons say that the success of dure, and they offer further advice on modern cataract surgery, both making sure the right patient gets the tips to help you Swith premium lenses and high- right procedure—or none at all. quality monofocal IOLs, can push navigate the some patients to visit their ophthal- “I Think I Have a Cataract” mologist to try to get cataract sur- sometimes murky gery—medically justifi ed or not—in Boulder, Colorado, ophthalmologist an effort to “get what my neighbor Mark Packer says that though malin- waters of preop got.” Some of these patients are even gering in most of medicine is usually savvy enough to work the system by done to qualify for some sort of dis- evaluations. claiming visual diffi culties. ability payment, it can take on a new To avoid committing insurance form in ophthalmology. fraud and exposing these individu- “There aren’t a lot of examples in als to unnecessary risks, surgeons say other fi elds where someone is malin- there are certain measures you can gering in order to get an operation, take. They’re quick to add, however, other than Munchausen’s syndrome,” that just because a patient’s attempt at he says. “But in ophthalmology, I’ve insurance- or Medicare-paid surgery definitely seen this. I guess it arose is rebuffed doesn’t mean he won’t even before the Medicare ruling in want to spring for it himself in the 2005 regarding presbyopic IOLs. Be- form of refractive lens-based proce- fore that, patients were aware that their friends went to see the ophthal- mologist for cataract surgery, and that they used to wear bifocals but now they don’t. This would lead them to my offi ce, saying something to the ef- fect, ‘I don’t have cataracts but I want that.’ But then they fi nd out it will cost $10,000 because they don’t have cata- racts. ‘But my neighbor didn’t pay any- thing—the insurance paid for it!’ You reply that that’s because the neighbor had cataracts. ‘So,’ he thinks, ‘what does it take to have a cataract? Maybe I can fi nd one.’”

40 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

040_rp0519_f3-updated.indd 40 4/16/19 10:12 AM POWERED DESIGNED WITH FOR PENETRATION1,2 COMFORT IN MIND1,2

® 1-3 #1 P THE 1 PRESCRIBED DELIVER THE PROLENSA EFFECT BRANDED Achieve POWERFUL CORNEAL PENETRATION with the OCULAR NSAID* #1 prescribed branded ocular NSAID, PROLENSA®.

The only branded formulation of bromfenac approved for once-daily use.1 *IQVIA NPA Monthly. November 2018 INDICATIONS AND USAGE PROLENSA® (bromfenac ophthalmic solution) 0.07% is a • Use of topical NSAIDs may result in keratitis. nonsteroidal anti-infl ammatory drug (NSAID) indicated Patients with evidence of corneal epithelial breakdown for the treatment of postoperative infl ammation and should immediately discontinue use of topical NSAIDs, reduction of ocular pain in patients who have undergone including bromfenac, and should be closely monitored cataract surgery. for corneal health. Patients with complicated ocular IMPORTANT SAFETY INFORMATION ABOUT PROLENSA® surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases • PROLENSA® contains sodium sulfi te, a sulfi te that may (e.g., dry eye syndrome), rheumatoid arthritis, or repeat cause allergic type reactions including anaphylactic ocular surgeries within a short period of time may be symptoms and life-threatening or less severe asthmatic at increased risk for corneal adverse events which may episodes in certain susceptible people. The overall become sight threatening. Topical NSAIDs should be used prevalence of sulfi te sensitivity in the general population is with caution in these patients. Post-marketing experience unknown and probably low. Sulfi te sensitivity is seen more with topical NSAIDs suggests that use more than 24 hours frequently in asthmatic than in non-asthmatic people. prior to surgery or use beyond 14 days post-surgery may • All topical nonsteroidal anti-infl ammatory drugs (NSAIDs), increase patient risk for the occurrence and severity of including bromfenac, may slow or delay healing. corneal adverse events. Concomitant use of topical NSAIDs and topical steroids • PROLENSA® should not be instilled while wearing contact may increase the potential for healing problems. lenses. The preservative in PROLENSA®, benzalkonium • There is the potential for cross-sensitivity to acetylsalicylic chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following acid, phenylacetic acid derivatives, and other NSAIDs, ® including bromfenac. Use with caution in patients who administration of PROLENSA . have previously exhibited sensitivities to these drugs. • The most commonly reported adverse reactions in 3%-8% • There have been reports that ocularly applied NSAIDs of patients were anterior chamber infl ammation, foreign may cause increased bleeding of ocular tissues (including body sensation, eye pain, photophobia, and blurred vision. hyphemas) in conjunction with ocular surgery. Use with Please see brief summary of full Prescribing Information caution in patients with known bleeding tendencies or for PROLENSA® on adjacent page. who are receiving other medications which may prolong bleeding time.

References: 1. PROLENSA Prescribing Information. 2. Baklayan GA, Patterson HM, Song CK, Gow JA, McNamara TR. 24-hour evaluation of the ocular distribution of (14)C-labeled bromfenac following topical instillation into the eyes of New Zealand white rabbits. J Ocul Pharmacol Ther. 2008;24(4):392-398. 3. Data on fi le, Bausch & Lomb Incorporated.

PROLENSA is a trademark of Bausch & Lomb Incorporated or its affi liates. © 2019 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. PRA.0017.USA.19

RP0319_BL Prolensa.indd 1 2/13/19 10:14 AM BRIEF SUMMARY OF PRESCRIBING INFORMATION rates in the clinical trials of another drug and may not reflect the rates observed in This Brief Summary does not include all the information needed to prescribe clinical practice. Prolensa safely and effectively. See full prescribing information for Prolensa. The most commonly reported adverse reactions following use of PROLENSA ophthalmic solution following cataract surgery include: anterior chamber PROLENSA (bromfenac opthalmic solution) 0.07% inflammation, foreign body sensation, eye pain, photophobia and vision blurred. These reactions were reported in 3 to 8% of patients. Rx only Initial Rx Approval: 1997 USE IN SPECIFIC POPULATIONS Pregnancy INDICATIONS AND USAGE Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the ® PROLENSA (bromfenac ophthalmic solution) 0.07% is indicated for the treatment systemic exposure predicted from the recommended human ophthalmic dose [RHOD] of postoperative inflammation and reduction of pain in patients who have undergone assuming the human systemic concentration is at the limit of quantification) and cataract surgery. rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic DOSAGE AND ADMINISTRATION exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and Recommended Dosing rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac One drop of PROLENSA ophthalmic solution should be applied to the affected eye treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, human exposure), and caused dystocia, increased neonatal mortality, and reduced and through the first 14 days of the postoperative period. postnatal growth at 0.9 mg/kg/day. Use with Other Topical Ophthalmic Medications There are no adequate and well-controlled studies in pregnant women. Because PROLENSA ophthalmic solution may be administered in conjunction with other topical animal reproduction studies are not always predictive of human response, this drug ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase should be used during pregnancy only if the potential benefit justifies the potential inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 risk to the fetus. minutes apart. Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the CONTRAINDICATIONS fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA ophthalmic solution during late pregnancy should be avoided. None Nursing Mothers WARNINGS AND PRECAUTIONS Caution should be exercised when PROLENSA is administered to a nursing woman. Sulfite Allergic Reactions Pediatric Use Contains sodium sulfite, a sulfite that may cause allergic-type reactions including Safety and efficacy in pediatric patients below the age of 18 have not been anaphylactic symptoms and life-threatening or less severe asthmatic episodes in established. certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in Geriatric Use asthmatic than in non-asthmatic people. There is no evidence that the efficacy or safety profiles for PROLENSA differ in patients 70 years of age and older compared to younger adult patients. Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may NONCLINICAL TOXICOLOGY slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Carcinogenesis, Mutagenesis and Impairment of Fertility Concomitant use of topical NSAIDs and topical steroids may increase the potential for Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up healing problems. to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from Potential for Cross-Sensitivity the recommended human ophthalmic dose [RHOD] assuming the human systemic There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid concentration is at the limit of quantification) and 5 mg/kg/day (340 times the derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be predicted human systemic exposure), respectively, revealed no significant increases used when treating individuals who have previously exhibited sensitivities to these in tumor incidence. drugs. Bromfenac did not show mutagenic potential in various mutagenicity studies, Increased Bleeding Time including the reverse mutation, chromosomal aberration, and micronucleus tests. With some NSAIDs, including bromfenac, there exists the potential for increased Bromfenac did not impair fertility when administered orally to male and female rats at bleeding time due to interference with platelet aggregation. There have been doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues and 30 times the predicted human exposure, respectively). (including hyphemas) in conjunction with ocular surgery. It is recommended that PROLENSA ophthalmic solution be used with caution in PATIENT COUNSELING INFORMATION patients with known bleeding tendencies or who are receiving other medications Slowed or Delayed Healing which may prolong bleeding time. Advise patients of the possibility that slow or delayed healing may occur while using Keratitis and Corneal Reactions NSAIDs. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued Sterility of Dropper Tip use of topical NSAIDs may result in epithelial breakdown, corneal thinning, Advise patients to replace bottle cap after using and to not touch dropper tip to any corneal erosion, corneal ulceration, or corneal perforation. These events may be surface, as this may contaminate the contents. Advise patients that a single bottle of sight threatening. Patients with evidence of corneal epithelial breakdown should PROLENSA be used to treat only one eye. immediately discontinue use of topical NSAIDs, including bromfenac, and should be Concomitant Use of Contact Lenses closely monitored for corneal health. Advise patients to remove contact lenses prior to instillation of PROLENSA. The Post-marketing experience with topical NSAIDs suggests that patients with preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact complicated ocular surgeries, corneal denervation, corneal epithelial defects, lenses. Lenses may be reinserted after 10 minutes following administration of diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid PROLENSA. arthritis, or repeat ocular surgeries within a short period of time may be at increased Concomitant Topical Ocular Therapy risk for corneal adverse events which may become sight threatening. Topical NSAIDs If more than one topical ophthalmic medication is being used, the medicines should should be used with caution in these patients. be administered at least 5 minutes apart. Post-marketing experience with topical NSAIDs also suggests that use more than 24 Rx Only hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. Manufactured by: Contact Lens Wear Bausch + Lomb, a division of Valeant Pharmaceuticals PROLENSA should not be instilled while wearing contact lenses. Remove North America LLC, Bridgewater, NJ 08807 USA contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, Product under license from: benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be Senju Pharmaceutical Co., Ltd., Osaka, Japan 541-0046 reinserted after 10 minutes following administration of PROLENSA. Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates. © Bausch & Lomb Incorporated ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse Revised: 06/2016 reaction rates observed in the clinical trials of a drug cannot be directly compared to Based on: 9306701/9306801 PRA.0119.USA.16

RRO0319_BLO0319_BL ProlensaProlensa PI.inddPI.indd 1 22/13/19/13/19 10:1610:16 AMAM Feature Cataract Patients REVIEW

It turns out, however, what a result is supposed that if a patient really to look like or anything else wants to say he has poor about it,” avers Dr. Packer. vision, this can be dif- “They don’t know how hard fi cult to disprove just by to try on it or how poorly using visual acuity charts. they’re supposed to do on “They can see the size of it, yet they can’t say ‘I don’t the letters,” Dr. Packer see anything,’ because that’s says. “They might know not plausible. It’s a subjec- what 20/40 looks like or, tive test, however, so a very if you’re using an older sophisticated patient might chart, it might say ‘20/40’ be able to fake it, but most right on the chart. While aren’t that sophisticated and today we have random- Scheimpfl ug imaging can provide an objective grading of a cataract won’t know how; they’ll get ized, digital charts that that can help in borderline cases, surgeons say. a score that’s either too good no one can memorize, if or too bad. Then, they’re someone’s motivated to lie to get the or what a realistic score would be for caught. This is the general method for surgery paid for by Medicare or insur- someone with the degree of visual dis- spotting a malingerer: Give him a test ance, it can still be hard to prove that ability that he’s claiming to have—but where a certain response would be someone is malingering, just by using I do. So, if the vision is 20/50, for in- physiologically impossible.” visual acuity.” stance, in general that correlates with Surgeons say that the advent of cer- At this point, if you simply don’t be- a VF-14 in the range of 60 to 75. If it’s tain instruments, such as the Penta- lieve what a patient is saying for some better than that, such as an 88, then cam, allows them to objectively evalu- reason, it would be easy enough to there’s no reason to have cataract sur- ate a cataract’s density, which can help smack the patient down as dissembling gery, because that’s the average score in cases such as this. “We do tests like and refuse to do the surgery. How- for individuals who’ve had the surgery. the iTrace or HD Analyzer to look at ever, surgeons say the effect of this In that case, there’d be no room for the quality of the optical system,” says is to alienate a member of your com- improvement.” Jeffersonville, Indiana, surgeon Asim munity, as well as all of that person’s Contrast sensitivity is another test Piracha. “We use these to see if we can family members and friends. “It’s help- about which patients have little un- objectively confirm their complaints ful to have some other workarounds derstanding, so they can’t easily ma- and say, ‘Yes, your vision is poor.’ If, that maybe patients aren’t as familiar nipulatepy its results. “They don’t know however, these tests show a per- with, but which can provide evievidencedence howhow it’s graded,graded, fectfect oopticalpt system, I wouldn’t that they’re not really a candidatedidate forfor recommendrecomm surgery, because I medically-reimbursed cat- don’tdon’t tthink the surgery would aract surgery,” Dr. Packer helphelp them.t We then get into says. “I’ve got a few of those why tthey’reh not seeing well. Is up my sleeve.” it amblyopia?am A retinal issue? Since physicians say visualal An optico nerve problem? Of- acuity can be “squishy” andnd ten,ten, we do a Pentacam exam easy to manipulate, one of thehe andand end up doing more test- first ways to weed out a less-ss- inging than we’d normally do; than-truthful patient is with thehe we perform topography and VF-14 visual function ques-es- anan OCT of the optic nerve tionnaire. “It has such ques-es- andan retina to make sure it’s tions as, ‘Do you drive?’ and ‘I‘Iff notn something I’m missing you drive, is it diffi cult?’” saysays ono exam. If there aren’t Dr. Packer. “A patient doesn’tn’t anya findings, however, know what they can complain but I the score on The VF-14 question- can’t do cataract surgery that is sup- naire can help weed because I’m not seeing posed to be, out malingerers. any findings on exam

May 2019 | reviewofophthalmology.com | 43

040_rp0519_f3-updated.indd 43 4/16/19 10:12 AM WE’RE SEEING AMAZING RESULTS. AND SO ARE THEY.

Foundation Fighting Blindness is shining a light in the darkness of Inherited Retinal Degenerations. We are the world’s leading organization searching for treatments and cures, and with many treatments already found, today’s innovations are illuminating a future of possibilities. Patients with Inherited Retinal Degenerations are urged to partner with us to accelerate the discovery of treatment and cures. We have robust disease information, a national network of local chapters and support groups, local educational events, and our My Retina Tracker patient registry helps to keep your patients connected with clinical and research advancements.

Visit ECPs4Cures.org to make a donation YTMJQUܪSIRTWJHZWJX

FightBlindness.org

RP1218_House Fight Stars.indd 1 11/13/18 11:02 AM Feature Cataract Patients REVIEW

that would justify it.” Determining that a patient is feigning worse vision is only half the battle, however. The fi nal challenge is inform- ing him that you’re not going to perform surgery in such a way that you don’t incite anger or resentment. “When you return to the exam room with the patient, and have such things as his questionnaire, contrast sensitivity and the objective measurement of the cataract’s densitometry,” says Dr. Packer, “you can say, ‘Look, even though your visual acuity is in line with Medicare or your insurance carrier’s defi nition of a cataract, based on this additional testing you’re functioning pretty well. I don’t believe that cataract surgery’s benefi ts will outweigh the risks for you. Please come back and see me in a year.” He says framing it in this way gives you an argument to fall back on, rather than just pointing your fi nger at him and saying that he’s faking it. Dr. Piracha says he’s seen patients seeking cataract sur- gery not because of malingering, but because of the effects of past corneal refractive surgery. “Some older patients come in and think, ‘I can’t see well, it must be a cataract,’ ” he says. “When I perform iTrace on these patients such as, for example, the post-RK patient who’s now hyperopic—+4 D and seeing maybe 20/30 best-corrected—and it shows the cornea isn’t right but the lens is pretty good, I tell them that cataract surgery probably won’t improve their quality of vision, it’ll just help reduce the hyperopia. Also, with the post-RK eye, cataract surgery’s not as predictable. I get patients referred in also, such as post-LASIK and post-RK, and they say they want cataract surgery. This testing helps me tell them that I don’t see a value in cataract surgery for them, since it’s not going to address their irregular astigma- tism. If you perform cataract surgery on these patients, they can be diffi cult to deal with postop, because they expected cataract surgery to fi x them but they still won’t see well.” For surgeons who don’t have an iTrace, Dr. Piracha says the time-honored RGP over-refraction will tell you if the irregular vision is from the cornea or not. “If it’s an RK patient, or a patient with ectasia, and you do the RGP over-refraction and they go from 20/40 to 20/20,” Dr. Pira- cha says, “you know the problem is the cornea. If we do it, however, and they’re still 20/40, then we know the problem isn’t the cornea, because the RGP covers up the irregular astigmatism.”

When the Talk Turns Elective

Surgeons say that a few of these patients who are exag- gerating their poor vision will actually be open to having an elective lens procedure when they’re eventually told that an insurance-paid cataract surgery isn’t advisable. Though this development may cause the surgeon to heave a sigh of relief—the patient isn’t going away mad and possibly em-

040_rp0519_f3-updated.indd 45 4/16/19 10:13 AM Feature Cataract Patients REVIEW

Legal Lookouts

Denver, Colorado, attorney C. Gregory Tiemeier has represented the patient could go to one of these doctors and the doctor will say, ophthalmologists in a number of malpractice cases, from lasers to “I can’t believe they did a clear lens extraction on you.” lenses. Here are his tips for covering yourself, whichever way the • Focus on the informed consent. Mr. Tiemeier says that any surgical discussion goes. time a patient is paying out of pocket for a procedure, the patient’s • Get it in writing. Mr. Tiemeier says if you go ahead with an insur- expectations go up dramatically. “You need to adjust your informed ance-covered procedure in which you have some objective proof consent process accordingly,” he warns. “I know most doctors tend of a cataract—it doesn’t need to be 3+—but the main complaints to view informed consent as a kind of ‘necessary evil,’ but I remind are subjective, make sure to have a record of it. “If you’re going them that if the patient is unhappy for some reason and you get to perform the procedure and want to cover yourself, make sure sued, it’s going to take more time to deal with that lawsuit than the the patient signs something to the effect of, ‘I have problems with fi ve minutes it would have taken to sit down with the patient and reading, low-light vision, driving at night, driving during the day, explain that this surgery is different from LASIK or PRK; you’re going etc.,’ ” he says. “Though brightness acuity testing can be a gamble, inside the eye, so the risks go up, especially the risk of endophthal- the critical question is how it’s affecting the patient subjectively, mitis. You also have to have something in the document that says, though some objective fi ndings need to be there. If you don’t want ‘You may need to wear glasses after the surgery.’ ” Though Mr. to perform the surgery, such as a case where you’ve done BAT and Tiemeier hasn’t been involved with any CLE lawsuits, he has had you think the patient is faking it, make a note to the effect that the suits involving multifocal IOLs. Based on that experience, he says patient’s subjective complaints and the BAT aren’t consistent with surgeons should also advise patients in the informed consent for the degree of cataract that’s observed objectively.” multifocal lenses that it might take up to six months to adjust to the • RLE is less common. “If you’re going to perform an elective multifocality effects. clear lens extraction on someone and he doesn’t have a cataract, • Check your malpractice coverage. This could be a hidden trap. be aware that you’re increasing your risk slightly in terms of legal “Though I’m not aware of any insurance companies that exclude exposure,” Mr. Tiemeier says. “When compared to more ‘main- clear lens extraction,” Mr. Tiemeier says, “it would probably be a stream’ procedures like PRK and LASIK, this is less common. This is good idea to make sure that it’s not excluded from your malpractice important to note because there are conservative doctors out there coverage before you do it.” who won’t remove a lens unless it has a cataract. Postoperatively, — WB

barrassed—experts remind that just If a patient isn’t a candidate, Los cursor to cataracts. “I personally don’t because the patient is ready and will- Angeles ophthalmologist Sam Masket do RLE on someone who’s younger ing to pay for the procedure doesn’t says the best thing is to be upfront and than 60 and has 20/30 or better dis- automatically mean that it should hap- honest about it. “I always say that if it’s tance vision,” Dr. Chayet says. “I’ve pen. good for the patient, it’s good for the found that the expectations of those “We have to consider a few major doctor—and the industry,” Dr. Masket patients are very high, and their satis- things,” says Arturo Chayet, MD, of says. “The patient’s interests must al- faction rate after RLE isn’t that good. Tijuana, Mexico’s, Codet Vision Insti- ways be front and center.” Most of the very unsatisfi ed patients tute. “The fi rst is the refractive error. Dr. Chayet says that the patient’s I’ve seen after RLE are these patients. In other words, myopes vs. hyperopes. age also plays a large role—especially Surgeons who perform RLE on them There’s very strong data from the past which side of age 60 they’re on. “I’ve are pushing the envelope. 20 years that’s made it well-known that found that there’s a big difference be- “Now, if the patient is older than 60, if a patient has an axial length of over tween someone younger than 60, and his distance vision is 20/40 or worse 25 mm, and undergoes uneventful someone older,” he says. “The crystal- and the axial length is shorter than cat aract surgery or refractive lens ex- line lens becomes very dysfunctional 25 mm, then I think the RLE conver- change, he’s in the highest incidence after age 60. In my practice, most of sation becomes more appropriate,” group for retinal detachment. the patients who request RLE start Dr. Chayet continues. “At that point, “And, there’s the knowledge that doing so at about age 52, right around you have to explain to the patient what high myopes are also at a higher risk the time they began wearing pro- to expect and the side effects of our for spontaneous bag dislocation 10 gressive lenses or using bifocals.” Dr. current IOLs, even if you go with mo- years after IOL implantation,” Dr. Chayet isn’t saying everyone should novision with monofocal IOLs. If the Chayet continues. “So these two is- universally accept “dysfunctional lens patient accepts the possibility of these sues, in my opinion, are defi nite exclu- syndrome” as a diagnostic term, but he side effects, then I feel comfortable sion criteria for RLE in high myopes.” is saying he thinks presbyopia is a pre- doing the procedure.”

46 | Review of Ophthalmology | May 2019

0040_rp0519_f3-updated.indd40_rp0519_f3-updated.indd 4646 44/16/19/16/19 10:1410:14 AMAM Lid Hygiene is important to Overall Eye Health

Dr. Chayet says categorizing patients based on their vi- sion also helps ensure a positive outcome. “If the distance vision is good, I wouldn’t recommend doing any RLE,” he says. “On the other hand, if the patient is +4 D with 20/200 uncorrected distance vision with an anterior chamber depth of 2 mm or less, I think that patient might benefi t PRESCRIPTION STRENGTH from surgery. That’s because not only will he be able to see well, but the surgery will increase the depth of the anterior WITHOUT A PRESCRIPTION chamber, and will increase the angle, which will reduce the risk of glaucoma in the future. These types of patients, however, are the least frequently encountered ones seeking RLE these days.” He says the only refractive procedure he’d perform on a high myope would be a phakic intra- ocular lens in the form of the Visian ICL. “Even if I know cataract is a risk for them,” he says, “I’d rather implant an INTRODUCING ICL [than perform RLE.]” There are also the patients who aren’t malingering, but have visual issues that don’t reach the level of an insurance- covered cataract. Dr. Piracha offers as an example the patient who has a best-corrected vision of 20/25 or 20/30, and inquires about a refractive option. “This happens a good bit,” he says. “We rule out all the causes for decreased night vision, all the issues associated with glare and halo, and examine the ocular surface and topography to make sure nothing else is going on, and if they say they’d like to CONTAINS have refractive surgery, we’ll discuss it with them. If they 0.02% PURE don’t meet the defi nition of cataract per insurance—which HYPOCHLOROUS ACID SOLUTION here in Indiana is 20/50 or worse with either best-corrected vision testing or testing with glare—we tell them, ‘You have (*VU]LUPLU[HUK,ќLJ[P]L(S[LYUH[P]L a mild cataract that doesn’t meet the offi cial criteria yet, so [V*VZ[S`7YLZJYPW[PVUVUS`:VS\[PVUZ you have two choices: Do an elective surgery now in order Safe for Daily Long-Term Use to get better vision without glasses, as well as improve your visual quality, or wait until you meet the criteria for insur- ance coverage, in which case we can see you back here in a year for another evaluation.’ I inform them that if they de- cide to wait, insurance will cover part of the procedure, but not the refractive-cataract surgery part—i.e., if they have VISIT BRUDER BOOTH #2352 astigmatism or want to see both near and far, then they’ll DURING ASCRS - SAN DIEGO TO LEARN MORE still need to pay for the laser AK, or a toric or multifocal lens.” He then follows this with a discussion of the risks out- lined by Dr. Chayet, especially with regard to high myopes. In the end, if a patient is trying to get surgery paid for but doesn’t really have a cataract, Dr. Packer says it often comes down to your estimate of his character, “as much as you can HELP YOUR PATIENTS ENHANCE THEIR OCULAR do that in the three minutes that you’re with him in the exam room,” he says. “Ask yourself, ‘Is this someone who’s HEALTH THROUGH AN IMPROVED HOME LID primary motivation is refractive but he’s trying to frame it as CLEANSING ROUTINE BY RECOMMENDING a medical procedure?’ That’s the main distinction.” BRUDER EYE CARE PRODUCTS.

Dr. Piracha has spoken for iTrace in the past. The other surgeons have no fi nancial interest in the products they Better. By Design. discuss.

bruder.com | 888-827-8337

040_rp0519_f3-updated.indd 47 4/16/19 10:35 AM Uveitic Glaucoma REVIEW Feature How to Manage Uveitic Glaucoma

Lama Al-Aswad, MD, MPH New York Tips and ne of the many pitfalls to deal management to keep in mind. with when a patient has two • Look at the medication regi- techniques for Oco-existing diseases is the con- men. This is one of the fi rst things the founding possibility that the treat- clinician will want to do. Is he cur- dealing with this ment for one will interfere with—or rently using steroids? If so, how often? even worsen—the other. Such is the Altering the steroid regimen is one unique subset case with uveitic glaucoma patients. of the simplest, most straightforward In these cases, one of the mainstays actions you can take in these cases. of glaucoma of uveitis treatment—steroids—can In addition to measuring the patient’s exacerbate the glaucoma while, at the visual acuity and IOP, be sure to per- patients. same time, the infl ammation can make form gonioscopy to check for anterior successful glaucoma surgery more synechiae, and make sure there are no diffi cult to achieve. In this article, I’ll posterior synechiae that might cause share my approach to managing these pupillary block. challenging cases. You may want to change the ste- roid regimen. Some patients arrive in Etiology your office from the uveitis special- ist and they have quiet eyes due to a Uveitic glaucoma occurs in about 20 strong steroid regimen. In these cas- percent of patients with uveitis. There es, it might be benefi cial to decrease are multiple reasons why it may occur: the frequency of the steroids to see if infl ammatory cells obstructing the tra- they’re steroid responders. In some becular meshwork; peripheral anterior cases, however, you may not be able to synechiae; pupillary block; trabeculitis; do this. If you do fi nd—or suspect— and as a response to the steroids being posterior synechiae, there’s a higher used to treat the uveitis. There can also chance, unfortunately, that manipulat- be instances of inflammation of the ing the frequency of the steroids might trabecular meshwork that results in not do anything for the patient, since elevated intraocular pressure. the trabecular meshwork is closed by the synechiae. Workup and Management • Consider an iridotomy. If you think pupillary block is the cause, a If a patient presents with a history laser iridotomy can open a passage of uveitis and elevated IOP, there are between the posterior and anterior several key aspects of diagnosis and chambers.

48 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

0048_rp0519_f4.indd48_rp0519_f4.indd 4848 44/15/19/15/19 5:215:21 PMPM T H E I N T E L L I G E N T T O N O M E T E R T H E A C C U R A T E T O N O M E T E R T H E C O N S I S T E N T T O N O M E T E R T H E O B J E C T I V E T O N O M E T E R T H E R E P E A T A B L E T O N O M E T E R T H E I N T E L L I G E N T T O N O M E T E R T H E A C C U R A T E T O N O M E T E R T H E C O N S I S T E N T T O N O M E T E R T H E O B J E C T I V E T O N O M E T E R T H E R E P E A T A B L E T O N O M E T E R T H E I N T E L L I G E N T T O N O M E T E R T H E A C C U R A T E T O N O M E T E R T H E C O N S I S T E N T T O N O M E T E R T H E O B J E C T I V E T O N O M E T E R T H E R E P E A T A B L E T O N O M E T E R T H E O B J E C T I V E T O N O M E T E R T H E R E P E A T A B L E T O N O M E T E R T H E I N T E L L I G E N T T O N O M E T E R

FOR FOR PATIENTS PROFESSIONALS

VISIT ASCRS BOOTH #827 FOR SHOW SPECIAL! For more information, scan, email [email protected] or visit www.icare-usa.com.

RP0519_Icare.indd 1 4/5/19 9:47 AM 048_rp0519_f4.indd 50 50 homatropine, dependingonthe sever- while awake,inadditiontoCyclogyl or Durezol foruseeveryonetotwo hours patient isprescribedPredForteor tially, iftheeyeisveryinfl anterior chamber, ifpossible. sure, andwon’t tolerateanycellsinthe fl tions. Idomybesttocontrolthein- specialist, Ifollowhisrecommenda- to controltheinfl other immunosuppressivemodalities ity oftheuveitisanditscause,switchto of steroidsor, dependingonthesever- need totakesomeuveitispatientsoff with thisperson,becauseyoumay It’s important toworkhand-in-hand uveitis specialist/rheumatologist. with thediagnosisandmanagement. but I’llneedlongitudinaldatatohelp doesn’t confi rm that,I’msuspicious, tentially glaucomatous,buttheOCT I seeacupthatappearslargeandpo- agree withyourexam.Forinstance,if your imagingandfunctionaltesting ter ideaofhisstatus.It’s importantthat low thepatientovertimetogetabet- your clinicaldiagnosisfi rst. Then,fol- nerve fi ber layershouldcorrelatewith nal informationisveryimportant.The with glaucoma;that’s whylongitudi- surements appearnormalinapatient it canbeinformativeinsomepatients. This laststepisn’t alwaysnecessary, but ment whetherthere’s synechiaeornot. in certainindividualsordertodocu- also performanteriorsegmentOCT follow himovertime.Iwillsometimes get abaselineforthepatientsoyoucan ence tomographyoftheopticnerve,to visual fi eld examsandopticalcoher- age. Useyourdiagnostictools,suchas and there’s alsoevidenceofnervedam- steroids haveincreasedthepressure no evidenceofglaucoma,orthatthe has elevatedIOPfromsteroidusebut tic tools.You mayfi nd thatthepatient ammationwhilecontrollingthepres-

• Managetheinfl When I’mworkingwiththeuveitis • Communicatewiththepatient’s Sometimes, nervefi ber layermea- • Useyourimaginganddiagnos- REVIEW |

Feature Review ofOphthalmology ammation. ammation. ammation.

Uveitic Glaucoma amed, the the amed, | May2019 Ini- you mayneedtoaltertheuveitistherapy. Working withauveitisspecialistiskey, as for controllingtheinfl switch thepatienttoanother modality to workwithauveitisspecialist tohelp a littleonthehighside,andIhavetime important toassessthepressure.Ifit’s the patientisasteroidresponder, it’s work.) (If it’s bad,though,thisapproachwon’t but whoseinflammation wasn’t severe. patients whoweresteroidresponders riod. Thisapproachhasalsoworkedin patient ontheNSAIDforalongerpe- I takeawaythesteroidandkeep it. Iftheeyeisthenquietforawhile, even once.Ithencanalsoslowlytaper day, thepatientcanuseitonlytwice,or men; insteadofusingitthreetimesa allows metodecreasethesteroidregi- to helpwiththeinflammation.This a non-steroidalanti-infl upward, I’llalternatethesteroidwith being quiet,buttheIOPistrending can behardtocontrol. developing reboundinfl er youtaper, thehigherchanceof that aslowtaperisimportant;thefast- pering thesteroid.Longago,Ilearned inflammation, Ieventuallybeginta- echiae. order todecreasethechanceofsyn- have thepupilmovingonandoffin ence ofalotinfl ammation. Iliketo pupil dilatedorconstrictedinthepres- once aday, whichdoesn’t keepthe alternating betweentwiceadayand ity. Forthelattertwodrugs,Iprefer If theinflammationissevereand If theeyeisveryquiet,orcloseto Depending ontheseverityof ammatory drop ammation, like like ammation, ammation that yet but,ifIneededsomething else, used Rhopressainuveitic patients low-grade inflammation.(I haven’t patients becausetheycaninducea usually avoidprostaglandinsinthese lution forahighpressure,butwe a prostaglandinastemporaryso- agonist. On drase inhibitor, betablockeroralpha physicians willuseacarbonicanhy- glaucoma drugsimmediately. Most patients, youshouldstarttreatingwith rally, ifthepressureishighinthese sure. implant tocontroltheintraocularpres- then you’llmostlikelyneedaglaucoma ment andtheinfl sure remainshighregardlessoftreat- therapy. Iftheherpetic patient’s pres- a waysimilartoconventionalherpes maintain treatment—withacyclovir, in use asteroidandbegintreatment—or is viral(i.e.,herpetic),you’relikelyto oral corticosteroids. therapy andgetthepatientoffof or uveitisspecialisttostartimmuno- need toworkwiththeimmunologist chosis fromtheoralsteroids,andI’ll can developcomplicationssuchaspsy- p.o. prednisone. inflammation withtheoptiontouse drops postoperativelytodecreasethe operative IVprednisoneandmore and p.o.prednisoneifneeded,intra- eye hardwithpreopprednisonedrops insert aglaucomaimplant,hittingthe the patienttooperatingroom the opticnerve.Insuchcases,Itake high andthere’s ariskofdamageto approach, becausethepressureisvery sive therapyisintroduced. of thesteroidsasimmunosuppres- specialist toslowlytakethepatientoff in thepatient.I’llworkwithuveitis months beforethey’refullyfunctional usually havealoadingtimeoffew issue isthattheseimmunomodulators methotrexate orCellCept,Iwill.The • Managetheglaucoma.Natu- If theetiologyofinfl In someofthesecases,thepatient Sometimes Idon’t havetimeforthis rare occasions,we’lluse ammation is chronic, ammationischronic, ammation ammation 4/15/19 5:22 PM 4&&
8)&3&
"
)""(453&*5 4-*5
-".1
$"/
5",&
:06.

(SPVOECSFBLJOH
PQUJDT
QPXFSFE
CZ
-&%
JMMVNJOBUJPO(SPVOE /PX
XJUI
B
:FBS
-JNJUFE
8BSSBOUZ/PX
X

5IF
TMJU
MBNQ
JT
UIF
FOHJOF
UIBU
LFFQT
ZPVS
QSBDUJDF
JO
NPUJPO
"OE
UIF
IBOETEPXO
JOEVTUSZ
MFBEFS
GPS
PWFS

ZFBST
)BBH4USFJU
PVUTIJOFT
UIF
DPNQFUJUJPO
XJUI
BO
-&%
JMMVNJOBUJPO
TZTUFN
UIBU
SFTVMUT
JO
PVS
TIBSQFTU
CSJHIUFTU
PQUJDT
FWFS
8JUI
B
MFWFM
PG
EJBHOPTUJD
EFUBJM
UIJT
BEWBODFE
UIF
SPBE
BIFBE
CFDPNFT
DMFBSFS
UIBO
FWFS

)BBH4USFJU
TMJU
MBNQT
OPX
DPNF
XJUI
B
:FBS
-JNJUFE
8BSSBOUZ
XIJDI
QSPWJEFT
ZPV
XJUI
UIF
QFBDF
PG
NJOE
ZPV
OFFE
GPS
UIF
QJFDF
PG
FRVJQNFOU
ZPVS
QSBDUJDF
EFQFOET
PO
NPTU

7JTJU
VT
BU
"4$34
#PPUI

PS
Mearn more at )4ESJWFO.com

DRIVEN TO EXCELLENCE 80.787.5426 haag-streit-usa.com © 201 Haag-Streit USA. All Rights Reserved.

RP0519_Haag.indd 1 4/11/19 9:58 AM 0048_rp0519_f4.indd 52 4 8 _ r p 0 5 1 9 _ f 4 52 will beatubeimplant. so yourfi trabeculectomy willmostlikelyfail, If there’s infl surgery tochooseforthesepatients. the degreeofinfl of thesteroidregimenisbasedon postoperative steroids.Theduration intraoperative IVsteroidsandthep.o. roid regimenandjustadministerthe though, I’llforgothepreoperativeste- it slowly. Insomeless-severecases, for longerthanaweek,andtaper the patientonp.o.prednisone of thissevereinfl and Ihadtooperateinthesetting If thepreopinfl pack p.o.foraweekpostoperatively. and thenprescribeaMedroldose ter IVsteroidsduringtheprocedure p.o. steroidpreoperatively, adminis- of thedisease,Istartpatienton surgery. Dependingontheseverity time andhavetoperformimmediate however, Idon’t havetheluxuryof as quietpossible.Insomecases, glaucoma, Iprefertohavetheeye patient willrequiresurgery. regimen won’t beenough,andthe Surgery move ontosurgery. management, orcan’t tolerateit,we’ll condition. Ifthepatientsfailmedical their bodyweightandoverallphysical fi amox 500mg,becausesomepatients mg, b.i.d.).I’llrarelyprescribeDi- some casesI’lluseDiamoxpills(250 prescribe themthreetimesdaily. In twice aday, thoughIwilloccasionally time IuseaCAIoralphaagonist I’d probablytryit.) in the anterior chamber in the uveitic in theanteriorchamber uveitic have zerotoleranceforcelland fl work insomecases,butonly ifyou showed thatatrabeculectomycan . nd ithardtotolerate,dependingon i n d

The otherconsiderationiswhich In casesthatneedsurgeryfortheir In somecases,modifyingthedrug In termsofdosages,mostthe REVIEW d |

Feature

Review ofOphthalmology

5 2 rst line of surgical treatment rstlineofsurgicaltreatment ammation intheeye,a ammation is severe, ammation. ammation, I’llkeep

Uveitic Glaucoma 1 Onestudy | May2019 are are the limitations,thoughis price. aren’t compliantwithdrops.Oneof for twotothreeyearsinpatients who implantation. TheRetisertcanwork my, cataractextractionandglaucoma implanted duringparsplanavitrecto- tained-release steroidimplant.Thisis cialist inimplantingtheRetisertsus- patients. rience withtheTrabectome insuch glaucoma too,butI’veonlyhadexpe- surgeries mightbeeffectiveinuveitic newer minimally-invasiveglaucoma Trabectome insteadofatube.Other, glaucoma I’vehadsuccessusingthe a gooduseofit. that Iexpectwillfaildoesn’t seemlike tate inordertoperformaprocedure ma procedure.Usingupthisreales- need touseitlaterforafutureglauco- limeter isimportant,sinceyoumight for theglaucomapatient,everymil- distinct “realestate”intheeyeand, approach, though;Ifeelthatthereis have startedworking.Idon’t likethis weeks, butbythatpointthetubewill that itwillmostlikelyfailafterafew trabeculectomy withtheknowledge because thesurgeonperforms glaucoma implant.It’s called“orphan” in additiontoanon-valvedBaerveldt known asan“orphan”trabeculectomy recurrence forafewyears. solved, andtherewasnoevidenceof years lateraftertheinfl coma tubeandthenatrabeculectomy few patientsinwhomIfi hypotony aswell.I’veoperatedona present. There’s alsoariskoflater early onwhenthere’s inflammation valve becauseoftheriskhypotony patients, IpreferusinganAhmed ally theprocedureofchoiceinthese without infl work, theeyehastobeverystableand erated; forthetrabeculectomyto however, especiallyifyou’vejustop- patient. Thisisdifficulttoachieve, I’ve alsoworkedwithauveitisspe- In somecasesofmilduveitisand Some surgeonswilldowhatis Since glaucomaimplantsareusu- ammation for a long time. ammation foralongtime. ammation re- ammation rst didaglau- results forthepatient. gether, youcanhelpguaranteebetter manage theglaucoma.Working to- mation, whichcanhelpyoubetter ist hastoolstohelpcontroltheinfl a teamapproach.Theuveitisspecial- tient canbechallenging,andrequires two hourspostop,andcyclopentolate. Pred ForteorDurezoleveryone oral prednisonebothpre-andpostop, is similartothatforglaucomasurgery: ter cataractsurgeryinthesepatients My infl ists areusedtothesecomplexcases.) ring oririshooks.(Glaucomaspecial- need toemployapupil-expansion branes youhavetocut.You might synechiae youhavetobreakormem- tle morecomplex,sincetheremaybe the positionoftube. have toadjustyourwoundbasedon The oneconsiderationisthatyoumay come backlaterifacataractdevelops. do theglaucomaprocedurealoneand evidence ofcataract,though,Imight cedure simultaneously. Ifthereisn’t coma surgeryandthecataractpro- many ofthesecases,I’lldotheglau- on chronicsteroidsforawhile.In cataract surgerybecausethey’vebeen gan) andYutiq (EyePoint). matory optionsareOzurdex(Aller- Other sustained-releaseanti-infl According tothe 2.Drugs.com Retisertpricing. valve implantation. 1999;106:11:2168-72. Ophthalmology CS. ofuveiticglaucomawith Management Ahmed glaucoma 1. DaMata A, BurkSE, Netland PA, S, Baltatzis Christen W, Foster ucts mentioned. has nofi the tele-ophthalmologyinitiative.She lowship directorandtheof serves astheInstitute’s glaucomafel- S. HarknessEyeInstitute.Shealso University MedicalCenter’s Edward fessor ofophthalmologyatColumbia guide/retisert guide, asingleRetisertcosts$19,871. Managing theuveiticglaucomapa- The cataractprocedureitselfisalit- A lotofthesepatientswillalsoneed Dr. Al-Aswadisanassociatepro- ammation controlregimenaf- . Accessed 2 April 2019. .2 April Accessed nancial interestinanyprod- drugs.com https://www.drugs.com/price- pricing am- am- 2 44/15/19 5:22 PM

/ 1 5 / 1 9

5 : 2 2

P M SMART is Better AI-DRIVEN EHR & PM FOR OPTIMAL EFFICIENCY

ophthalmology’s ALL-IN-1 SOLUTION

ENTERPRISE | EHR | PM | ASC | RCM | OPTICAL PATIENT ENGAGEMENT | WORKFLOW OPTIMIZATION

Powered by artifi cial intelligence, Advantage SMART Practice® uses real-time data to drive effi ciencies across your practice.

Our all-in-one system completely automates administrative tasks to maximize your time with patients and deliver better fi nancial results for your business. EHR & PM Leader for 34 Years

SEE IT LIVE. AScrs annual meeting. B00TH #3013

www.compulinkadvantage.com/oNETAB | 800.456.4522

RP0519_Compulink.indd 1 4/9/19 11:51 AM Weak Zonules REVIEW Feature Strong Moves for Weak Zonules

Michelle Stephenson, Contributing Editor

Experts share hen patients with weak zon- between doing a routine surgery and ules present for cataract sur- possibly placing a capsular tension their best tips for Wgery, surgeons will need to ring, which will take 10 minutes or get creative when implanting the IOL. less, versus doing a more complicated managing these According to Richard Hoffman, procedure in which I’ll have to suture MD, who is in practice in Eugene, in some type of support for the capsule diffi cult cases. Oregon, diagnosing zonular laxity is or suture the lens in place, which will fairly straightforward. “Preoperatively, take 20 to 30 minutes.” if patients have phacodonesis, a his- Dr. Hoffman agrees. “Everything tory of trauma or pseudoexfoliation, depends on how loose the zonules then you need to be prepared for weak are,” he says. “If the lens is frankly sub- zonules,” he explains. “And, if they luxed and moving around in the eye, don’t have phacodonesis, one very easy I will usually just coordinate that with way of diagnosing zonular laxity at the the retinal surgeon and have him do beginning of the procedure is to push a pars plana vitrectomy and lensecto- down on the lens to start the capsu- my. Then, I’ll scleral-fi xate a posterior lorhexis. If you see a whole bunch of chamber lens. The latest technique striae or folds, that usually implies that I’m using is the Yamane intrascleral you’ve got mild to moderate zonular haptic fi xation technique. However, it’s weakness. At that point, you have to rare to have a patient whose whole lens decide whether you want to place cap- is jiggling around. Some people try to sule hooks or place a capsular tension rescue the lens with the capsular bag, ring.” do a rhexis, support it with hooks, and then sew in capsular prosthetic devic- After the Diagnosis es. It’s just a lot of work, and I fi nd it’s a lot easier just to remove a very loose “The first thing to consider is the crystalline lens and scleral-fi xate a pos- severity of the weakness,” says Uday terior chamber lens in extreme cases.” Devgan, MD, who is in practice in Los In most cases, patients just have a Angeles. “Am I able to just insert the small amount of zonular laxity or weak- lens into the capsular bag or maybe ness. “Most of the time, we can get by even have a sulcus lens with optic cap- with just being very gentle during the ture? Or am I going to need to suture procedure. If there’s a lot of capsular in some sort of support for the lens laxity but the lens isn’t frankly moving, or the capsule? That’s the difference then I’ll use capsule hooks, sometimes

54 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

0054_rp0519_f554_rp0519_f5 nnew.inddew.indd 5544 44/15/19/15/19 11:3911:39 AMAM new!

Gentle on Tough on Eyelids. Bacteria.

RECOMMEND THE ONLY FDA-ACCEPTED ANTIMICROBIAL EYELID CLEANSER 3 Advanced Hypochlorous Acid (0.01%) formula for superior cleansing 3 Cleanses away bacteria and irritants 3 pH balanced formula is gentle on eyelids 3 Effective daily eyelid and eyelash hygiene 3 No rinse – soap free

Coming soon without a prescription at Walgreens, CVS Pharmacy®, Amazon, Rite Aid, and other retailers nationwide Visit theratears.com to learn more

Reference: 1. Results from an in vitro laboratory study. TheraTears® SteriLid® Antimicrobial Eyelid Cleanser and Facial Wash showed effi cacy in reduction of colony forming units for eight common eyelid organisms. Data was captured at 30 and 60 seconds. M18-069-00

RP0519_Akorn.indd 1 4/5/19 10:52 AM 054_rp0519_f5 new.indd56 56 how much zonulopathy currently exists. how muchzonulopathycurrently exists. dilate well.You’ll alsoneedtofi he notes.“Thesepatients’pupils don’t nomena, suchaspseudoexfoliation,” then, therearetheprogressivephe- itself willusuallystabilizethelens.“But clock hours,acapsulartensionringby by traumaandislessthanfourtofi versity ofUtah,ifthelaxitywascaused from theMoranEyeCenteratUni- ternative placementofthelens.” chamber lensorplansomeotheral- option wouldbetoputinananterior ing thecataract,”hesays.“Another plan onsewinginalensafterremov- severe zonularloss,youmayhaveto sular tensionring,andifthereisreally progressive disease,youmaydoacap- “However, iftheweaknessisduetoa capsular tensionringduringsurgery. typically supporttheweakareawitha zonules duetotrauma,surgeonscan for that.” in thefuture,andyou’llneedtoplan sive disease,thezonuleswillbeworse you willseeovertime.With progres- trauma, whatyouseetodayis syndrome,” Dr. Devgansays.“With such aspseudoexfoliationorMarfan left hook,versusaprogressivedisease, hit intheeyewithacarairbagor zonules willcontinuetodeteriorate. trauma, sothey’llknowwhetherthe gressive diseaseorwhetherit’s dueto whether theweaknessisduetoapro- geons willneedtoascertain verity oftheweakness,sur- What’s theCause? aract,” Dr. Hoffmanexplains. I’ve removedmostofthecat- capsular tensionringinafter hooks andthenputtingthe wards justusingthecapsule lately, I’vebeenmovingto- sular tensionring.However, in combinationwithacap-

According toAlanCrandall,MD, He addsthat,inpatientswithweak “There’s adifferencebetweenbeing After determiningthese- REVIEW |

Feature Review ofOphthalmology

Weak Zonules gure out | May2019 All images: Uday Devgan, MD to trauma. A capsulartensionringisvaluable incasesofweakening due ve ve sion segments.” tension segmentortwocapsular ten- place aCionnisegment, capsular you willneedtodecidewhether ract procedurehasbeenperformed, the rhexis,”hesays.“Oncecata- them ascounter-traction tocontinue shaber hooks(Alcon)inordertouse an irishook,acapsulehookorGrie- should starttherhexisandthenputin in loosepseudoexfoliation,surgeons tion. Iftheydon’t haveanystability, as use thegoodzonulesforcounter-trac- performing therhexis.“You wantto mends tearingtowardthedefectwhen due totrauma,Dr. Crandallrecom- thalmics), tosuture.” Cionni modifi ed segment(FCIOph- capsular tensionsegment,suchasa Additionally, youmayneedtousea going toputinacapsulartensionring. with anyzonularinstability, I’malways of thecataract.Inpseudoexfoliation, technique dependsonthehardness energy comesallthewayup.Thebest example, isgoodtousebecausethe The miLoop(CarlZeissMeditec),for bulking andcataractremovalsystem. or someformofzonular-friendly de- a 5.5-mmrhexis,andusepre-chop that wehaveagoodhydrodissection, ules duringsurgery, sowemakesure tion, wedon’t wanttostressthezon- ues. “Ifapatienthaspseudoexfolia- start therhexis,”Dr. Crandallcontin- kling intheanteriorcapsuleasyou If the patient has zonular weakness If thepatienthaszonularweakness “One ofthebiggestcluesiswrin- sutures forfour-point scleral fi scribed thatuses8-0polypropylene iris wouldbehelpful,aswell.” support, thenmaybesewingittothe are allscleral-based.Ifthereissome of thelenstosclera.Theseoptions mane techniquethatfi xes thehaptics the sclera.Additionally, there’s theYa- an IOL. chamber suturelessimplantationof talline lens,whounderwentposterior dislocated IOLorasubluxatedcrys- consecutive patientswithaphakia, spectively studiedin100eyesof97 fi for transconjunctivalintrascleral tions, suchaserosionorinfection. tion, tiltorsuture-relatedcomplica- with nosignsofsubluxation,disloca- IOL remainedstablefor10months nine cases,andtheposteriorchamber nique wasperformeduneventfullyin are sealedwithfi brin glue.Thistech- embedded inthescleralgrooveand The suturesandtheexposedknotsare tightened foroptimalIOLcentration. sutures arethenpulledabinternoand IOL isinsertedbehindtheiris.The haptics, andtheposteriorchamber tures arethenpassedthroughtheIOL tween. Two setsofpolypropylenesu- two scleralgroovesarecreatedinbe- sites 2.5mmfromthelimbus,and Surgeons fi rst markfoursclerotomy to the limbus using 30-gauge thin-wall to thelimbususing30-gaugethin-wall making twoangledincisions parallel xation ofan IOLwasrecentlypro- A newtechniquewasrecentlyde- Additionally, theYamane technique techniques, or it can be glued to techniques, oritcanbegluedto the sclerausingvarioussuture gan explains. “It can be sewn to gan explains.“Itcanbesewnto tach ittothesclera,”Dr. Dev- then wewillsewthelensorat- and thecapsuleisjustshot, solutely nocapsularsupport, for theirpatient.“Ifthere’s ab- need todeterminewhichisbest few options,andsurgeonswill cured intheeye,therearea Suturing/Gluing If thelensneedstobese- 2 Thistechniqueconsistsof xation. 4/15/19 11:39 AM 1

FROM CORNEAL HYSTERESIS TO IOP, SO ARE WE. Only Ocular Response Analyzer® G3 measures Corneal Hysteresis and Corneal Compensated IOP (IOPcc) using patented technology to assess the unique corneal biomechanical properties of your patient. Corneal Hysteresis has shown to be an independent risk factor and more predictive of glaucoma development and progression than CCT or IOP1-3. Using biomechanics, IOPcc is less influenced by corneal properties than Goldmann applanation tonometry4.

Only Tono-Pen AVIA® continues to advance handheld tonometry with the all-new Quick-Tap™ measurement mode. The same ready-to-use, calibration-free, and accurate operation, now with more confidence in fewer measurements. Trusted by clinicians for over 30 years. We share your passion for improving glaucoma care.

VISIT US AT ASCRS #907 OR REICHERT.COM/GLAUCOMACARE

PASSIONATE ABOUT EYE CARE

© 2019 AMETEK, Inc. & Reichert, Inc. (04-2019) · Ocular Response Analyzer and Tono-Pen are registered trademarks of Reichert, Inc. · Designed & assembled in USA ·

References: 1. Medeiros FA, Meira-Freitas D, Lisboa R, Kuang TM, Zangwill LM, Weinreb RN. Corneal hysteresis as a risk factor for glaucoma progression: a prospective longitudinal study. Ophthalmology. 2013 Aug;120(8):1533-40. 2. De Moraes CV, Hill V, Tello C, Liebmann JM, Ritch R. Lower corneal hysteresis is associated with more rapid glaucomatous visual field progression. J Glaucoma. 2012 Apr-May;21(4):209-13. 3. Susanna CN, Diniz-Filho A, Daga FB, Susanna BN, Zhu F, Ogata NG, Medeiros FA. Am J Ophthalmol. A Prospective Longitudinal Study to Investigate Corneal Hysteresis as a Risk Factor for Predicting Development of Glaucoma. 2018 Mar;187:148-152. doi: 10.1016/j.ajo.2017.12.018. 4. Felipe A. Medeiros, MD and Robert N. Weinreb, MD. Evaluation of the Influence of Corneal Biomechanical Properties on Intraocular Pressure Measurements Using the Ocular Response Analyzer. J Glaucoma 2006;15:364–370. CPT is registered trademark of the American Medical Association.

RP0519_Reichert.indd 1 4/10/19 11:48 AM 054_rp0519_f5 new.indd58 58 cells/mm or absentzonularsupport. exfoliation andpoorzonularintegrity fi glued surgerytobeagoodoptionfor in place.Arecentstudyfoundscleral- dislocation. endophthalmitis orintraocularlens postoperative retinaldetachment, percent). Nopatientsexperienced cystoid macularedemainoneeye(1 orrhage infi eight eyes(8percent),vitreoushem- cluded iriscapturebytheIOLin IOL tiltwas3.4±2.5degrees. 24 and36months,respectively. Mean cells/mm creased from2,341cells/mm corneal endothelialcelldensityde- (nearly 20/20)at36months.Mean months, 0.12at24monthsand0.04 0.09 (alittlebetterthan20/25)at12 to 0.11(around20/25)atsixmonths, signifi what worsethan20/32),which was 0.25logMARunits(some- best-corrected visualacuity axial stability. fi scleral tunnels.TheIOLswere pushed backandfi xed intothe haptics. Theflangewasthen ized tomakeaflangeofthe the needlesandwerecauter- IOL wereexternalizedwith needles. Thehapticsofthe operatively to2,313cells/mm percent) experiencedpostoperative scleral-glued surgery. Eight eyes(29 pre-existing glaucomaatthe timeof than halfofeyes(54percent)had cataract surgery(4percent).More cent) andaphakiaaftercomplicated cent), subluxedcrystallinelens(7per- IOL duetocomplications(14per- (75 percent),exchangeforiris-fi ed lateendocapsularIOLdislocation for scleral-gluedIOLfi included 28eyes,andtheindications xed with exact centration and xed withexactcentrationand xating anIOLineyeswithpseudo- Another optionistogluetheIOL Postoperative complicationsin- Preoperatively, themean REVIEW |

Feature Review ofOphthalmology cantly improved postoperatively cantly improvedpostoperatively 2 2 , 2,189cells/mm postoperatively atsix,12, ve eyes(5percent)and

xation includ- xation Weak Zonules 3 2 The study Thestudy and 2,244 and2,244 | 2 May2019 , 2,240 , 2,240 2 xated xated pre- zonules. A wrinkledanteriorcapsule(arrow) isasignofweak Decentered IOLs sion ring,becauseyoudon’t haveto easier ifthepatienthasacapsular ten- ian ofthesubluxation,and it’s even easier ifthehapticisinmerid- using alassotechnique.“Thisislot usually fi xates thehapticstosclera degraded withtime.” down theroad.Thezonuleshavejust the capsularbagsevenoreightyears up havingsubluxedlensesthatarein tain percentageofthesepatientsend any zonularweakness,becauseacer- even whentheredoesn’t appeartobe rings inpseudoexfoliationpatients, that peopleplacecapsulartension this 10yearsago,Irecommended man says.“WhenIlecturedabout to seemorecaseslikethis,”Dr. Hoff- is common,andIthinkwe’regoing can causetheirlenstodecenter. “This zonules aftercataractsurgery, which exfoliation patients,experienceweak cent ofeyes. than itwaspreoperativelyin89per- acuity wasequivalenttoorbetter follow-up, correcteddistancevisual pre-existing glaucoma.Atthefinal pseudoexfoliation, withorwithout can belesspredictableineyeswith control followingsurgery, becauseit cial attentiontointraocularpressure vestigators recommendpayingspe- calated medicalmanagement. ocular hypertensionthatrequiredes- In thesecases,Dr. Hoffmansayshe Some patients,especiallypseudo- The in- mentioned inthisarticle. related totheproducts/companies pseudoexfoliation. JGlaucoma. 2018;27:2:164-169. control afterscleral-glued intraocularlensinsertionineyeswith J, KangJ, SeedorJA. Clinicaloutcomes andintraocularpressure 3. Ragam A, RitterbandDC, Waisbren ED, Mathew-Padiyedathu Ophthalmology. 2017;124:8:1136-1142. intrascleral intraocularlensfi withdouble-needletechnique.xation 2. Yamane S, S, Sato M, Maruyama-Inoue KadonosonoK. Flanged intraocular lenses. RefractSurg. JCataract 2018;44:12:1421. polypropylene sutureforfour-point scleral fi ofsecondary xation 1. John T, Tighe S, HashemO, ShehaH. Newuseof8-0 Dr ly purchasedbyCarlZeissMeditec. sultant forIantech,whichwasrecent- ractcoach.com. Dr. Crandallisacon- much tougher,” hesays. vitreous, whichmakesthesituation the lenscanfallwaybackinto table, ifthelensisn’t well-supported, lie thepatientonoperatingroom ular tothefl oor. However, whenyou lamp, thelensineyeisperpendic- when yourpatientissittingattheslit retinal colleagues.Rememberthat ask fortheassistanceofyourvitreo- your comfortlevel,youmaywantto pars planaapproach.Dependingon you mayjusthavetotakeitoutviaa lens isveryfardislocatedintotheeye, in place,butitstillcanbedone.Ifthe piece lens,it’s alittletoughertosuture the scleraissuffi cient. Ifit’s asingle- sewing ittothebackofirisor and sewitinplace,”hesays.“Usually, you canjustkeepthatlensintheeye reach fromtheanteriorsegment,then it’s athree-piecelensthatyoucan of lensandhowdecentereditis.“If Dr. Devganownsandruns . Hoffmanhasnofi treatment depends on the type treatment dependsonthetype Gore-Tex makesalotofsense.” grade. Inayoungerpatient, more for9-0Prolenetode- going totake1520yearsor to beelderly, andit’s probably ally works.Thesepatientstend or CV8Gore-Tex, whichusu- sclera usingeither9-0Prolene the capsulartensionringto are,” hesays.“You justfixate worry aboutwherethehaptics Dr. Devganaddsthatthe nancial interests cata- 4/15/19 11:41 AM NuLids – transformational dry eye therapy Transforms your Transforms your practice

patients’ lives The NuLids System helps reduce patient out-of- Finally… A doctor directed pocket expenses while creating an additional at-home treatment for dry revenue stream for the practice – all without eye disease that is safe, impacting overhead costs or disrupting other effective and easy to use. in-office treatments. 1 A multi-center study1 showed: A multi-center study showed 95% were satisfied • 50% decrease in dry eye symptoms or very satisfied with the treatment. • 65% improvement in TBUT For more information visit www.NuSightMedical.com • 80% increase in meibomian glands yielding or call us at 833-468-5437 liquid secretions.

1 Schanzlin, Olkowski, Coble, Gross. NuLids II Study, April 2018

RP0319_NuSight Medical.indd 1 2/22/19 11:54 AM Research Review REVIEW

Statins’ Value vs. Diabetic Retinopathy

n a recent retrospective, population- preventing retinopathy in patients with and $1,904 ($1,904), respectively, for Ibased cohort study, researchers inves- diabetes remains uncertain. However, ranibizumab; and $2,074 ($1,961) tigated the association between statin fi ndings suggest that the therapy could and $1,956 ($1,956), respectively, for use and prevention of vision-threat- slow the progression of vision-threat- afl ibercept. ening diabetic retinopathy in patients ening DR. • The mean (Australian dollar pric- with type 2 diabetes and dyslipidemia. JAMA Ophthalmology es unadjusted for infl ation) 2013 and Studies have suggested that statins 2019;137:4:363-371. 2017 prices in Australia were $1,854 may reduce the risk of developing dia- Kang EY, Chen TH, Garg, S, et al. (A $1,797) and $1,206 (A $1,574), re- betic retinopathy, so the researchers spectively, for adalimumab; $2,157 (A wanted to see if there was, indeed, an Drug Prices in Australia $2,090) and $972 (A $1,268), respec- effect from the drugs. vs. the United States tively, for ranibizumab; and $2,030 The study collected data between ($1,967) and $996 ($1,300), respec- January 1, 1998, and December 31, Researchers from multiple centers tively, for afl ibercept. 2013, from 37,894 Taiwanese patients say that prices for certain drugs de- • The estimated annual change in (half in the statin group and half in the creased at a greater rate in Australia price for adalimumab was +12.8 per- nonstatin group) with type 2 diabetes. than in the States. cent in the U.S. compared with -11.1 There was a mean follow-up of 7.6 The retrospective price-comparison percent in Australia, a difference of years for the statin group and 7.3 years study looked at the prices paid by gov- 23.9 percent per year (p<0.001). The for the nonstatin group. ernment organizations in the United annual change for ranibizumab was Ultimately, 2,004 patients in the States (Medicare) and Australia (Phar- -2.6 percent in the U.S. compared with statin group (10.6 percent) and 2,269 maceuticals and Benefi ts Scheme) for -18.5 percent in Australia, a difference patients in the nonstatin group (12 per- the drugs adalimumab (Humira; Ab- of 15.9 percent per year (p=0.003). cent) developed diabetic retinopathy. bVie), ranibizumab (Lucentis; Genen- The annual change for afl ibercept was Researchers say there was a statisti- tech) and afl ibercept (Eylea; Regener- -1.5 percent in the U.S. compared with cally signifi cantly lower rate of diabetic on). They collected data on the initial, -16.9 percent in Australia, a difference retinopathy (NPDR, PDR, vitreous fi nal and change in medication price of 15.4 percent (p=0.001). hemorrhage, tractional retinal detach- annually from 2013 to 2017 in infla- The researchers say the data shows ment and macular edema) in the statin tion-adjusted, 2017 U.S. dollars. They that prices for the three drugs dropped group. Not only did those taking statins took steps to ensure “an accurate com- signifi cantly during the past fi ve years have a decreased risk of developing parison of prices between changes in in Australia compared with the United DR, but also a lower need for treat- infl ation and currency exchange rates.” States, though the study couldn’t de- ments. Even when treatment was The study reported the following: termine why such differences exist or needed, a smaller number of interven- • The mean prices (U.S.-dollar pric- what actions might affect future pric- tions was required than in patients not es unadjusted for inflation) in 2013 ing in the countries. taking statins. and 2017 in the U.S. were $1,114 JAMA Ophthalmol 2019;137:4:358- Researchers say that the effective- ($1,053) and $1,818 ($1,818), respec- 362. ness of statins as the primary means of tively, for adalimumab; $2,102 ($1,988) Parikh R, Feng PW, Tainsh L.

60 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

0060_rp0519_rr.indd60_rp0519_rr.indd 6060 44/15/19/15/19 12:3412:34 PMPM ADVERTORIAL

KENNETH A. BECKMAN, ® MD, FACS Director of Corneal Surgery at SYSTANE Complete Comprehensive Eyecare of Central Ohio Clinical Assistant Professor of Ophthalmology at The Ohio State University Columbus, Ohio Designed to Deliver

Dr Beckman was compensated by Alcon * for his participation in this advertorial. Better Coverage

Dry eye is one of the most frequent causes of patient visits to eye instillation.17 In contrast, osmolarity changes induced by care practitioners, affecting an estimated 30 million people in the hypotonic tear substitutes are reversed in 1-2 minutes.17,18 1 US. As many as 1 in 3 ophthalmic patients report experiencing at ® 2 SYSTANE Complete has a unique delivery system that helps least one symptom of dry eye. Dry eye symptoms adversely ® 11-12 3-6 provide better coverage versus SYSTANE Balance. affect vision-related quality of life and productivity. ® SYSTANE Complete’s patented formulation is comprised of Dry eye is recognized as a condition with a multifactorial nanosized droplets that have a greater surface area allowing for etiology that results in loss of homeostasis of the tear film.7-8 more lubricant particles per drop.13,16 This advanced lipid Determining the major etiology behind the dry eye is an nanodroplet technology allows rapid delivery of the lubricant essential step in its management. Published recommendations across the ocular surface resulting in better coverage* to provide such as those from the 2017 Tear Film and Ocular Surface fast hydration and locking in moisture for long-lasting relief.15,16,19

Smaller Total surface Total surface Total surface area = ® area = 6 cm2 area = 60 cm2 60,000,000 cm2 “SYSTANE Complete droplet size is a very versatile drop Lipid Droplet that can work in Greater total different types of dry surface area eye and can be used 1 cm cube as first-line or as an Better coverage all 1 mm cubes all 1 nm cubes adjuvant treatment” Illustration depicting the increased surface area of nano-sized materials.20

Society Dry Eye Workshop (DEWS) II and the Cornea, External Additionally, SYSTANE® Complete is designed to minimize blur Disease, and Refractive Society (CEDARS) describe a upon instillation due to its nanodroplet formulation.10,13 Patients systematic approach that includes a detailed patient history, often try different products seeking the formulation that works clinical assessments and diagnostic measures.8-9 This best for them. My patients diagnostic process can be further complicated by an overlap in describe SYSTANE® Complete as the etiology of dry eye that can be present in many cases.8-10 If easy to use and providing them only one of the underlying mechanisms of dry eye is addressed, long-lasting relief,15,16,19 thereby patients may be unable to derive meaningful relief. A simple satisfying their needs.

way to help relieve patient symptoms is to recommend an ® SYSTANE Complete simplifies artificial tear designed for every major type of dry eye, such as the choice for patients and SYSTANE ® Complete.7,11-15 practitioners because it is Dry eye management is focused on restoring tear film designed to provide symptom homeostasis. SYSTANE® Complete contains HP-guar, a non- relief for every major type of dry ionic polymer that becomes a gel upon instillation and is eye, supports all layers of the known to enhance the effect of the active demulcents.16 In a tear film and protects against prospective, open-label trial, administration of an HP-guar evaporation – it’s one simple containing lubricant four times daily for 3 weeks resulted in a choice for optimal relief from significant reduction in tear osmolarity 15 minutes after dry eye symptoms.7,11,13-16,19,21

*Compared to SYSTANE® Balance Lubricant Eye Drops.

References 1. TFOS. What Is DEWS II. Available at http://www.tearfilm.org/dettreports-tfos_dews_ii_report/32_30/eng/. Accessed May 16, 2018. 2. Martinez JD, Galor A, Ramos-Betancourt N, et al. Frequency and risk factors associated with dry eye in patients attending a tertiary care ophthalmology center in Mexico City. Clin Ophthalmol. 2016;10:1335-1342. 3. Mertzanis P, Abetz L, Rajagopalan K, et al. The relative burden of dry eye in patients’ lives: comparisons to a U.S. normative sample. Invest Ophthalmol Vis Sci. 2005;46:46-50. 4. Miljanovic B, Dana R, Sullivan DA, Schaumberg DA. Impact of dry eye syndrome on vision-related quality of life. Am J Ophthalmol. 2007;143:409-415. 5. Barabino S, Labetoulle M, Rolando M, Messmer EM. Understanding symptoms and quality of life in patients with dry eye syndrome. Ocular Surf. 2016;14:365-376. 6. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred practice pattern guidelines. Dry eye syndrome. San Francisco, CA: American Academy of Ophthalmology; 2013. 7. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15:276-283. 8. Milner MS, Beckman KA, Luchs JI, et al. Dysfunctional Tear Syndrome: Dry Eye Disease and Associated Tear Film Disorders - New Strategies for Diagnosis and Treatment. Curr Opin Ophthalmol. 2017 Jan;27 Suppl 1:3-47. 9. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II Diagnostic Methodology Report. Ocul Surf. 2017; 15:539-574. 10. Jones L, Downie LE, Korb D et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017; 15:575-628. 11. Korb D, Blackie C, Meadows D, Christensen M, Tudor M. Evaluation of extended tear stability by two emulsion based artificial tears. Poster presented at the 6th International Conference of the Tear Film and Ocular Surface: Basic Science and Clinical Relevance, September 22-25, 2010, Florence, IT. 12. Davitt, WF, Bloomenstein M, Christensen M, Martin AE. Efficacy in patients with dry eye after treatment with a new lubricant eye drop formulation. J Ocul Pharmacol Ther. 2010;26:347-353. 13. Ketelson H, Rangarajan R. Pre-clinical evaluation of a novel phospholipid nanoemulsion based lubricant eye drops. Invest Ophthalmol Vis Sci. 2017;58:3929. 14. Lane S, Paugh J, et al. An Evaluation of the in vivo Retention Time of a Novel Artificial Tear as Compared to a Placebo Control. Invest Ophthalmol Vis Sci. 2009;50:4679 15. Benelli U. SYSTANE® lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-790. 16. Data on file. Alcon; 2017. 17. Ng A, Keech A, Jones L. Tear osmolarity changes after use of hydroxypropyl-guar-based lubricating eye drops. Clin Ophthalmol. 2018;12 695-700. 18. Baudouin C, Aragona P, Messmer EM, et al. Role of hyperosmolarity in the pathogenesis and management of dry eye disease: proceedings of the OCEAN group meeting. Ocul Surf. 2013;11:246-258. 19. Data on file. Alcon. 20. United States National Nanotechnology Initiative. https://www.nano.gov/nanotech-101/special. Accessed April 5, 2018 21. Ogundele A, Ketelson H, et al. Preclinical evaluation of a novel hydroxypropyl-guar phospholipid nanoemulsion lubricant eye drop for dry eye disease. Poster presented at: The 36th World Ophthalmology Congress (WOC); June 16-19, 2018; Barcelona, Spain.

© 2018 Novartis 9/18 US-SYS-18-E-2129 Sponsored by

RP0519_Alcon Systane.indd 1 4/5/19 10:01 AM Glaucoma Management

REVIEW Edited by Kuldev Singh, MD, MPH, and Peter A. Netland, MD, PhD

Managing Glaucoma With OCT Angiography This technology is showing promise as a clinical tool for diagnosing and monitoring glaucoma patients.

David Huang, MD, PhD, Liang Liu, MD, Yali Jia, PhD, Portland, Oregon

hen it comes to managing making it impractical for the routine sels down to the capillary level is W glaucoma, we have plenty of clinical monitoring of glaucoma. straightforward. The OCTA soft- technologies to help us. Nevertheless, Several other imaging technologies, ware compares sequential cross- new options are always welcome— such as Doppler ultrasound, Doppler sectional OCT image frames at the especially if they increase our ability OCT, laser Doppler flowmetry, and same position, looking for signal to detect and monitor the disease, laser speckle flowgraphy have also fluctuations that indicate blood while making clinic visits a little less been used to show that retinal and flow. Our group has been heavily burdensome for patients. optic nerve blood flow are reduced involved in developing and testing I believe optical coherence tomog- in glaucoma patients. However, these this technology. Among other things, raphic angiography is exactly that kind instruments have high measurement we’ve developed an algorithm of technology. OCTA makes it easy to variability and are more suitable for called split-spectrum amplitude- monitor blood fl ow within the retina, detecting differences between groups decorrelation angiography—SSADA giving us a new way to evaluate the of research subjects than performing for short—that’s so effi cient that you health of the ganglion cells that can be diagnostic evaluation in individual just need two frames to accurately devastated by the disease. patients. identify capillaries.1 This efficient OCTA is different from these algorithm, along with improvements Blood Flow and Glaucoma previous instruments in two important in the speed of Fourier-domain OCT, ways. First, OCTA is noninvasive. made clinical OCTA feasible. The idea of evaluating glaucomatous Second, OCTA can measure vessel Since OCTA senses motion, it’s damage by measuring blood flow is density with high repeatability and susceptible to artifacts produced hardly new. Ophthalmologists who reproducibility. Since each OCTA by bulk eye motion such as micro- have been in the fi eld for many years scan takes just a few seconds, it can saccades, ocular pulsation and ocular point out that the correlation between easily be done at every glaucoma drift. Therefore high-speed, active blood flow and glaucomatous dam- patient visit. And because the mea- eye tracking, image registration age was clear decades ago. Using fl u- surements are precise, it can be used postprocessing and bulk motion sub- orescein angiography, they showed to make a diagnosis and monitor dis- traction algorithms are all needed to that glaucomatous damage was ac- ease progression. produce high-quality OCTA images. companied by reduced fl uorescence, These technical requirements have as well as delayed vascular filling. How Does OCTA Work? stimulated rapid advances in com- However, fl uorescein angiography is mercial OCT technology on both invasive and only semi-quantitative, The way OCTA detects blood ves- hardware and software fronts.

62 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

062_rp0519_gm.indd 62 4/15/19 11:24 AM The design is distinctive. The outcomes are clear. Aberration-free optic | Glistening-free performance | Predictable outcomes

Let’s be clear about enVista. enVistaIOL.com • 800.338.2020

RP0519_B & L Envista.indd 1 4/5/19 9:45 AM Glaucoma

REVIEW Management

Figure 1. 6 x 6-mm superfi cial vascular complex (SVC) OCT angiogram (left) and 6 x 6-mm ganglion cell complex thickness map (right) of a typical glaucomatous eye. The glaucoma damage (yellow dashed outline) was mostly outside the central 3 x 3-mm area (the red outline). Thus the larger scan area is needed for early detection of the pattern of damage common in glaucoma.

Where to Look for Glaucoma density provided excellent diagnostic OCT,5 then on measuring flow accuracy. Furthermore, vessel density index with OCTA.2 However, we We first used OCTA to study al- correlated well with visual fi eld pa- found the reproducibility of these tered blood fl ow in glaucoma patients rameters—better than with structural fl ow measurements to be poor. The in 2014.2 In that study, we scanned OCT parameters such as the overall fundamental reason may be that the optic nerve head. We found that retinal nerve fi ber layer thickness. the velocity and volumetric rate of glaucoma patients have reduced It’s worth noting that OCTA scans blood fl ow are affected by variations capillary density and fl ow index at the must cover suffi cient area to provide in the patient’s physiologic state. For level of superfi cial disc tissue and at accurate diagnostic information. For example, we’ve demonstrated that the plane of the lamina cribrosa. The the peripapillary region, we’ve found these measurements are affected by fl ow defi cit at the lamina cribrosa was that a 4.5 x 4.5-mm scan provides the oxygen concentration in inhaled intriguing because this is potentially the best diagnostic accuracy. For the gas mixture and by visual stimulation. the site where elevated intraocular macular region, a 6 x 6-mm scan is There may also be many other factors pressure could affect optic nerve per- needed (See Figure 1). There have that affect blood fl ow. fusion. However, for routine diag- been studies that used small macular In contrast, we’ve found that the nostic purposes, the optic nerve head OCTA scans of 3 or 4 mm areas that reproducibility of vessel density is not an ideal image target due to found poor diagnostic accuracy. That’s measurements by OCTA is excellent. shadowing of neural tissue from to be expected, because glaucoma Vessel density is measured on en face numerous large blood vessels and affects the peripheral portions of the OCTA images of the appropriate highly variable geometry of the disc macula fi rst. anatomic slabs. A “projection” oper- rim and vessels. ation is used to select the maximum So, when we turned our attention Flow Rate or Vessel Density? flow value within the slab’s depth to designing the ideal diagnostic range, so that the three-dimensional scans for glaucoma, we decided to When we began to investigate OCTA data is reduced to a two- focus on the peripapillary retina3 and functional imaging for glaucoma, dimensional en face angiogram. The macula.4 In both of these regions, we first focused on measuring vessel density can be defi ned by the we found that the retinal vessel volumetric flow rate with Doppler percent area occupied by vascular

64 | Review of Ophthalmology | May 2019

062_rp0519_gm.indd 64 4/15/19 11:25 AM OCULUS Pentacam® AXL The All-in-One Unit!

6ISITTHE/#5,53BOOTH AT!3#23IN3AN$IEGO Please note: The availability of the products and features may differ in your country. Please note: The availability of the products and features may differ in your country. Specifications and design are subject to change. Please contact your local distributor for details.

Optical biometry and built-in IOL formulas for any eye status

Use Total Corneal Refractive Power (TCRP) keratometry to account for individual total corneal astigmatism of every patient and select suitable aspheric, toric and multifocal IOL candidates more confidently. Perform swift IOL calculations using the built-in IOL Calculator, avoid manual transcription errors and optimize your personal constants. Included: Barrett IOL formulas and customized formulas for post-corneal refractive patients

www.pentacam.com Follow us!

RP0519_Oculus.indd 1 4/5/19 9:42 AM Glaucoma

REVIEW Management

Figure 2. En face projection-resolved OCT angiograms of four retinal vascular plexuses in the right eye of a normal human participant. NFLP = nerve fi ber layer plexus; GCLP = ganglion cell layer plexus; ICP = intermediate capillary plexus; DCP = deep capillary plexus. The NFLP and GCLP can be combined into the superfi cial vascular complex (SVC), which contain both large vessels and capillaries. The ICP and DCP can be combined into the deep vascular complex (DVC), which is primarily composed of capillary networks.

pixels (pixels with higher flow that could distinguish in-situ flow fields as the more frequently used signal relative to the nonvascular from projected fl ow. With projection- method for glaucoma evaluation. background) in the en face angiogram. resolved OCTA, it’s possible to resolve Structural OCT measurements of Large vessels can be excluded if one up to four vascular plexuses in the the peripapillary NFL and macula wishes to measure capillary density; retina6 (See Figure 2). ganglion cell complex are now part the latter may be useful in assessing In the peripapillary region, glau- of standard glaucoma management. perfusion in smaller sectors, so that coma primarily affects the nerve fi ber Since OCTA measurement of peri- variations in the course of large vessels layer plexus, which perfuses the NFL. papillary NFLP vessel density is don’t unduly bias the measurement. In the macula, glaucoma affects both highly correlated with NFL thickness, For glaucoma assessment, we the NFLP and the ganglion cell layer and macular SVC vessel density is believe that percent area vessel plexus, which perfuses the ganglion highly correlated with GCC thickness, density and capillary density are cell layer. Together, the NFLP and why do we need to invest in OCTA the ideal metrics for diagnosis and GCLP constitute the superfi cial vas- machines? Why not just stick with the monitoring. cular complex. Thus, focusing on the more familiar OCT technology we peripapillary NFLP and macular SVC already have? Which Plexuses are Affected? enhances the visualization of focal The answer is that OCTA has ad- glaucomatous defects and improves ditional value, both in the very early In the earlier OCTA studies, we diagnostic accuracy. For example, and late stages of glaucoma. looked at the retinal circulation as a we’ve shown that the macular SVC Two clinical studies have shown single slab, because blood fl ow in the vessel density has better diagnostic that OCTA can detect early pre- superfi cial plexuses cast time-varying accuracy than the all-plexus retinal perimetric glaucoma better than shadows onto deeper layers that are vessel density.4 structural OCT.7,8 Why would this also detected as flow by the OCTA be the case? I believe it’s because algorithms. Thus, flow signal in the Why Use OCT Angiography? OCTA detects both dysfunctional various retinal plexuses could not (sick) and lost (dead) ganglion cells, be cleanly separated. This limitation According to the American Acade- while structural OCT only detects lost was overcome when we developed a my of Ophthalmology’s IRIS Registry, ganglion cells. I speculate that in very projection-resolved OCTA algorithm OCT has already overtaken visual early glaucoma, sick, dysfunctional

66 | Review of Ophthalmology | May 2019

062_rp0519_gm.indd 66 4/15/19 11:25 AM )&"%
'03
5)&
46/ 5)&
4&"
"/%
5)&
4"7*/(4

Be sure you don’t miss out on exclusive 3FMJBODF
BOE
)BBH4USFJU deals at ASCRS booth 1845.

Now’s the time and ASCRS is the place to enjoy special deals on a wide range of industry-leading 3FMJBODF
.FEJDBM
BOE
)BBH4USFJU products. ForFor a preview, visit http://promo.haag-streit-usa.com/. But don’t wait – offersffers are only good through June 30, 2019.

FX920 Chair + 7900 IC Stand FX920 Chair + 7900 NC Standnd

Price: $21,315 with BI 900 Slit Lamp Price: $20,935 with BI 900 Slit Lamp Price: $25,785 with BI 900 + Imaging Price: $25,335 with BI 900 + Imaging Includes a 5346 Stool and tonometer. Includes a 5346 Stool and tonometer.

800.735.0357 | Builttosupport.com © 2019 Haag-Streit USA. All Rights Reserved.

RP0519_Reliance.indd 1 4/11/19 9:55 AM Glaucoma

REVIEW Management

Figure 3. A glaucomatous eye imaged by the AngioVue OCT angiography system (Optovue) using the 4.5 x 4.5-mm AngioDisc scan pattern. The focal capillary dropout (arrows) can be visualized more clearly in the nerve fi ber layer plexus slab than on the ganglion cell layer plexus and all-plexus retinal angiograms, while the deep vascular complex appears unaffected.

ganglion cells have lower metabolism Simulating Visual Fields glaucoma progression—in addition to that leads to reduced capillary density. being more painless and convenient. This reduced density is detectable Given that OCTA parameters cor- (We caution that this method of visual by OCTA, prior to the apoptosis relate well with visual fi eld data over fi eld simulation is not FDA-cleared these ganglion cells undergo and the a wider range of disease severities, it or commercially available, and a subsequent thinning of NFL and has the potential for simulating actual large longitudinal study is needed to GCC that can be detected by struc- visual fi eld results. This would be a validate its utility.) tural OCT. Thus, by adding OCTA to boon to the many patients who cannot The variability of visual field our diagnostic toolkit, we can detect reliably perform visual fi eld tests. And testing is not just inconvenient, it glaucoma earlier and intervene in a the fact is—your patients hate taking could result in unnecessary surgery, timelier fashion. visual fi eld tests. or delayed treatment and loss of Other studies have shown that vision. Statistical analyses11 have OCTA parameters correlate better shown that for a glaucomatous eye with visual field parameters than with MD worsening at a rate of -1 structural OCT parameters such as These metrics are now dB/year, testing every six months over NFL thickness.3,9 This is partly due becoming available four years is required for the trend to the lessening of the “fl oor effect” to become statistically signifi cant (90 with OCTA measurements. The fl oor on commercial OCT percent power, p<0.05), at which time effect describes the fact that while machines as well. the mean deviation would already be NFL thickness is correlated with 4 dB worse. This represents a 60- visual field mean deviation in early percent loss of retinal sensitivity be- glaucoma, it reaches a fl oor value in fore a clinician has fi rm evidence to moderate glaucoma, and then doesn’t We’ve developed a method of sec- support intensifying treatment! A decrease any further in advanced torwise visual fi eld simulation using more reproducible, objective method glaucoma. This limits the utility of peripapillary NFLP OCTA results for monitoring glaucoma progression NFL thickness for monitoring glau- (See Figure 4, p. 75). The results could detect significant progression coma progression in the moderate show good correlation in the early and sooner, thus allowing more timely and advanced stages.10 While vessel moderate stages of the disease. The intervention to save vision. density also eventually reaches a fl oor, simulated visual field sectors could it appears to do so only in advanced also be summed into a mean deviation OCTA Availability glaucoma. Thus OCTA has the po- parameter: NFLP_MD. NFLP_MD tential to improve the monitoring is highly correlated with VF_MD, but The results we’ve published were of glaucoma in the moderate to ad- has better diagnostic accuracy and achieved using capillary and vessel- vanced stages. (A large longitudinal reproducibility. Thus, the simulated density algorithms developed in study is needed to demonstrate this visual fi eld might perform better than potential.) an actual visual fi eld for monitoring (Continued on page 75)

68 | Review of Ophthalmology | May 2019

062_rp0519_gm.indd 68 4/15/19 11:25 AM COMING 2019 Open your eyes to what’s on the horizon in dry eye.

Sign up for updates at TearCare.com

TearCare is indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.

©2018 Sight Sciences. All rights reserved. 06221.A

RP0119_Sight Sciences.indd 1 12/27/18 3:16 PM REVIEW Product News EyePoint Launches New Treatment Option

yePoint Pharmaceuticals has are avoided, as the implant contains generation visual fi eld test, HFA3. E released Yutiq, a new treatment 0.18 mg of the steroid, which it consis- The new system uses technological option for chronic non-infectious pos- tently releases for 36 months. advancements to accelerate clinic terior uveitis. fl ow while still delivering the same testing strategies and test pat- terns as prior generations of HFA, the company says. They add that HFA3’s new features increase confi - dence in test results, save time and make test administration simpler. Yutiq is the first FDA-approved Additionally, for those eligible to Zeiss says HFA3 provides faster fluocinolone acetonide micro-insert receive fi nancial assistance, the com- initialization, works on a wider that delivers continuous fluocino- pany has launched EyePoint Assist, a spectrum of patients than earlier lone acetonide for up to three years. program that bolsters patient access models and keeps test results equal It can be administered in a physi- to Yutiq. For more information, call and interchangeable with data from cian’s office through a single-dose (646) 368-8014. prior generations of HFA. Visit preloaded applicator. The company zeiss.com/meditec/us/home. says that peaks and valleys associ- Humphrey Field Analyzer 3 ated with typical treatment options Zeiss has announced its next- AngioWellness Scan Doctors can now assess and di- agnose new pathologies using the AngioWellness scan, a new pa- tient-monitoring tool in Optovue’s AngioVue OCTA unit, says the com- pany. Optovue says that the scan was designed to help eye-care profes- sionals offer a more comprehensive assessment of diabetic patients and glaucoma suspects. The scan com- bines structural information about retinal and ganglion cell layer thick- ness with objective metrics on reti- nal vasculature into one report, to identify those who may need moni- toring or treatment. Visit optovue. com for more information. The AngioWellness Scan can assess and diagnose new pathologies, says Optovue.

70 | Review of Ophthalmology | May 2019 This article has no commercial sponsorship.

070_rp0519_products.indd 70 4/15/19 12:28 PM DISCOVER LOTEMAX® SM: SUBMICRON STRONG

Join your peers for a webinar presentation introducing the exciting new advancements of LOTEMAX® SM, the newest loteprednol etabonate formulation from Bausch + Lomb

REGISTER FOR ONE OF THE FOLLOWING WEBINAR SESSIONS:

MARGUERITE MCDONALD, MD MITCHELL JACKSON, MD Tuesday, April 9th• 6:00 PM ET | 3:00 PM PT Wednesday, April 24th• 8:00 PM ET | 5:00 PM PT

AUDREY TALLEY ROSTOV, MD RAJESH RAJPAL, MD Thursday, April 25th• 9:00 PM ET | 6:00 PM PT Wednesday, May 15th• 6:00 PM ET | 3:00 PM PT

Dates and speakers are subject to change or substitution.

THIS LIVE WEBINAR PRESENTATION WILL COVER: • OVERCOMING CHALLENGES of ocular drug delivery • NEW SM TECHNOLOGY™ in LOTEMAX® SM • LOTEMAX® SM FORMULATION features designed • THE PROVEN EFFICACY AND SAFETY of LOTEMAX® SM with the patient in mind

This promotional webinar is sponsored by Bausch + Lomb. No CME/CE or food will be provided for this program. Only physicians and healthcare professionals involved in providing patient care or product recommendations may attend this educational program.

REGISTER NOW AT www.reviewofophthalmology.com/LotemaxSMWebinar2019

INDICATION IMPORTANT SAFETY INFORMATION (CON'T) LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% • Prolonged use of corticosteroids may suppress the host is a corticosteroid indicated for the treatment of post-operative response and thus increase the hazard of secondary ocular infl ammation and pain following ocular surgery. infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. IMPORTANT SAFETY INFORMATION • Employment of a corticosteroid medication in the treatment of • LOTEMAX® SM, as with other ophthalmic corticosteroids, patients with a history of herpes simplex requires great caution. is contraindicated in most viral diseases of the cornea and Use of ocular steroids may prolong the course and may conjunctiva including epithelial herpes simplex keratitis exacerbate the severity of many viral infections of the eye (dendritic keratitis), vaccinia, and varicella, and also in (including herpes simplex). mycobacterial infection of the eye and fungal diseases of • Fungal infections of the cornea are particularly prone to develop ocular structures. coincidentally with long-term local steroid application. Fungus • Prolonged use of corticosteroids may result in glaucoma with invasion must be considered in any persistent corneal ulceration damage to the optic nerve, defects in visual acuity and fi elds of where a steroid has been used or is in use. Fungal cultures should vision. If LOTEMAX® SM is used for 10 days or longer, IOP should be taken when appropriate. be monitored. • Contact lenses should not be worn when the eyes are infl amed. • Use of corticosteroids may result in posterior subcapsular • There were no treatment-emergent adverse drug reactions that cataract formation. occurred in more than 1% of subjects in the three times daily • The use of steroids after cataract surgery may delay healing and group compared to vehicle. increase the incidence of bleb formation. In those with diseases causing thinning of the cornea or sclera, perforations have You are encouraged to report negative side eff ects of been known to occur with the use of topical steroids. The initial prescription drugs to the FDA. Visit www.fda.gov.medwatch prescription and renewal of the medication order should be made or call 1-800-FDA-1088. by a physician only after examination of the patient with the aid Please see Brief Summary of full Prescribing Information on of magnifi cation such as slit lamp biomicroscopy and, where adjacent page. appropriate, fl uorescein staining.

®/TM are trademarks of Bausch & Lomb Incorporated or its affi liates. © 2019 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. LSM.0056.USA.19

RP0419_BL Lotemax house.indd 1 3/19/19 11:00 AM

BRIEF SUMMARY OF PRESCRIBING INFORMATION produced malformations when administered orally to pregnant rabbits at doses 4.2 times the recommended human ophthalmic dose (RHOD) and to This Brief Summary does not include all the information needed to use pregnant rats at doses 106 times the RHOD. In pregnant rats receiving oral LOTEMAX® SM safely and effectively. See full prescribing information ® doses of loteprednol etabonate during the period equivalent to the last for LOTEMAX SM. trimester of pregnancy through lactation in humans, survival of offspring was ® reduced at doses 10.6 times the RHOD. Maternal toxicity was observed in LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% rats at doses 1066 times the RHOD, and a maternal no observed adverse For topical ophthalmic use effect level (NOAEL) was established at 106 times the RHOD. The Initial U.S. Approval: 1998 background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general INDICATIONS AND USAGE ® population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, LOTEMAX SM is a corticosteroid indicated for the treatment of post- of clinically recognized pregnancies. Data: Animal Data. Embryofetal studies operative inflammation and pain following ocular surgery. were conducted in pregnant rabbits administered loteprednol etabonate by DOSAGE AND ADMINISTRATION oral gavage on gestation days 6 to 18, to target the period of organogenesis. Invert closed bottle and shake once to fill tip before instilling drops. Apply one Loteprednol etabonate produced fetal malformations at 0.1 mg/kg (4.2 times drop of LOTEMAX® SM into the conjunctival sac of the affected eye three the recommended human ophthalmic dose (RHOD) based on body surface times daily beginning the day after surgery and continuing throughout the first area, assuming 100% absorption). Spina bifida (including meningocele) was 2 weeks of the post-operative period. observed at 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at 0.4 mg/kg (17 times the RHOD). At 3 mg/kg (128 times the CONTRAINDICATIONS ® RHOD), loteprednol etabonate was associated with increased incidences of LOTEMAX SM, as with other ophthalmic corticosteroids, is contraindicated abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, in most viral diseases of the cornea and conjunctiva including epithelial and delayed ossification. Abortion and embryofetal lethality (resorption) herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in occurred at 6 mg/kg (256 times the RHOD). A NOAEL for developmental mycobacterial infection of the eye and fungal diseases of ocular structures. toxicity was not established in this study. The NOAEL for maternal toxicity in WARNINGS AND PRECAUTIONS rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may rats administered loteprednol etabonate by oral gavage on gestation days 6 result in glaucoma with damage to the optic nerve, defects in visual acuity to 15, to target the period of organogenesis. Loteprednol etabonate produced and fields of vision. Steroids should be used with caution in the presence of fetal malformations, including absent innominate artery at 5 mg/kg (106 times glaucoma. If this product is used for 10 days or longer, intraocular pressure the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical should be monitored. hernia, decreased fetal body weight and decreased skeletal ossification at 50 Cataracts: Use of corticosteroids may result in posterior subcapsular mg/kg (1066 times the RHOD). Embryofetal lethality (resorption) was cataract formation. observed at 100 mg/kg (2133 times the RHOD). The NOAEL for Delayed Healing: The use of steroids after cataract surgery may delay developmental toxicity in rats was 0.5 mg/kg (10.6 times the RHOD). healing and increase the incidence of bleb formation. In those diseases Loteprednol etabonate was maternally toxic (reduced body weight gain) at 50 causing thinning of the cornea or sclera, perforations have been known to mg/kg/day. The NOAEL for maternal toxicity was 5 mg/kg. A peri-/postnatal occur with the use of topical steroids. The initial prescription and renewal of study was conducted in rats administered loteprednol etabonate by oral the medication order should be made by a physician only after examination gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the of the patient with the aid of magnification such as slit lamp biomicroscopy end of lactation period). At 0.5 mg/kg (10.6 times the clinical dose), reduced and, where appropriate, fluorescein staining. survival was observed in live-ERUQRIIVSULQJ'RVHV•PJNJ WLPHVWKH Bacterial Infections: Prolonged use of corticosteroids may suppress the RHOD) FDXVHGXPELOLFDOKHUQLDLQFRPSOHWHJDVWURLQWHVWLQDOWUDFW'RVHV• host response and thus increase the hazard of secondary ocular infections. mg/kg (1066 times the RHOD) produced maternal toxicity (reduced body In acute purulent conditions of the eye, steroids may mask infection or weight gain, death), decreased number of live-born offspring, decreased birth enhance existing infection. weight, and delays in postnatal development. A developmental NOAEL was Viral infections: Employment of a corticosteroid medication in the treatment not established in this study. The NOAEL for maternal toxicity was 5 mg/kg. of patients with a history of herpes simplex requires great caution. Use of Lactation: There are no data on the presence of loteprednol etabonate in ocular steroids may prolong the course and may exacerbate the severity of human milk, the effects on the breastfed infant, or the effects on milk many viral infections of the eye (including herpes simplex). production. The developmental and health benefits of breastfeeding should Fungal Infections: Fungal infections of the cornea are particularly prone to EHFRQVLGHUHGDORQJZLWKWKHPRWKHU¶VFOLQLFDOQHHGIRU/27(0$;® SM and ® develop coincidentally with long-term local steroid application. Fungus any potential adverse effects on the breastfed infant from LOTEMAX SM. invasion must be considered in any persistent corneal ulceration where a Pediatric Use: Safety and effectiveness of LOTEMAX® SM in pediatric steroid has been used or is in use. Fungal cultures should be taken when patients have not been established. appropriate. Geriatric Use: No overall differences in safety and effectiveness have been Contact Lens Wear: Contact lenses should not be worn when the eyes are observed between elderly and younger patients. inflamed. NONCLINICAL TOXICOLOGY ADVERSE REACTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal Because clinical trials are conducted under widely varying conditions, studies have not been conducted to evaluate the carcinogenic potential of adverse reaction rates observed in the clinical trials of a drug cannot be loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in directly compared to rates in the clinical trials of another drug and may not the Ames test, the mouse lymphoma tk assay, or in the chromosomal reflect the rates observed in practice. Adverse reactions associated with aberration test in human lymphocytes, or in vivo in the mouse micronucleus ophthalmic steroids include elevated intraocular pressure, which may be assay. Treatment of male and female rats with 25 mg/kg/day of loteprednol associated with infrequent optic nerve damage, visual acuity and field etabonate (533 times the RHOD based on body surface area, assuming defects, posterior subcapsular cataract formation, delayed wound healing 100% absorption) prior to and during mating caused preimplantation loss and and secondary ocular infection from pathogens including herpes simplex, and decreased the number of live fetuses/live births. The NOAEL for fertility in perforation of the globe where there is thinning of the cornea or sclera. There rats was 5 mg/kg/day (106 times the RHOD). were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2019 Bausch & Lomb Incorporated USE IN SPECIAL POPULATIONS Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Pregnancy: Risk Summary: There are no adequate and well controlled Bridgewater, NJ 08807 USA studies with loteprednol etabonate in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit LSM.0091.USA.19 and rat when administered orally during pregnancy. Loteprednol etabonate Based on 9669600-9669700 Revised: 02/2019

RRP0419_BLP0419_BL LotemaxLotemax PIPI house.inddhouse.indd 1 33/19/19/19/19 10:5710:57 AMAM Product

REVIEW News

but with the incorporation of a dual Hartmann-Shack aberrometer and a digital phoropter, the measure- ment can be taken in just one step. In three minutes, the company says that autorefraction and subjective refi nement can be done using Eye Refract. Go to visionixusa.com/ecp- products/refraction-instruments/ eye-refract-automatic-refraction- system for more information. New Antiviral Option Arrives Doctors now have an additional option when managing herpes kera- titis, as Fera Pharmaceuticals has announced that the FDA has ap- proved its new drug Avaclyr. The product is an ophthalmic ointment containing acyclovir 3%. The company describes Avaclyr GMPE Software Update Eyes 1Day, a daily disposable contact as a herpes simplex virus nucleo- Heidelberg Engineering has an- lens. The company says the lenses side analog DNA polymerase in- nounced that the Hood Glaucoma include a new technology called Dual hibitor, indicated for the treatment Report will be available as a new Tangible Polymers, from Tangible Sci- of acute herpetic keratitis (dendritic feature in the Spectralis OCT ence. SimplifEyes 1Day uses a tangi- ulcers) in patients with herpes sim- Glaucoma Module Premium Edi- ble polymer coating on lens surfaces, plex (HSV-1 and HSV-2) virus. The tion (GMPE). The software can along with another tangible polymer most common adverse reactions, aid in diagnosis and management in the solution, which it says discour- which occurred in 2 to 10 percent of of glaucoma, the company says, by ages debris build-up while provid- subjects, were eye pain (stinging), highlighting essential diagnostic in- ing comfort and enhanced wettable punctate keratitis and follicular con- formation in an intuitive layout, al- surfaces. Through a partnership with junctivitis. lowing for quick and comprehensive MyContactLens Online Ordering Fera says it’s in the process of fi - assessment. System the lens-ordering process can nalizing selection of a commercial- The report lets doctors visual- potentially be simplifi ed with direct ization partner to provide doctors ize high resolution OCT B-scans delivery to the patient’s home. Call and patients access to Avaclyr. Call alongside functional and structural (619) 855-4522 for more information. (516) 277-1449. measurements so that information can be related to 10-2 and 24-2 vi- Refraction System Moist-Heat Mask sual fi eld points. OCT B-scans and Luneau Technology has recently Bruder recently announced the the unique anatomy of each eye are announced the availability of release of Eyeleve, a moist- emphasized in the report. Taking the Visionix Eye Refract, a heat mask that can provide advantage of the Anatomic Position- refraction system designed a solution to patient dis- ing System in GMPE, which tailors with space, speed and con- comfort caused by all-day scan placement and orientation to sistency in mind, says contact lens use. The mask each patient’s individual anatomy, the company. The increases comfortable Heidelberg says the report serves system provides contact lens wear-time by as an intuitive diagnostic aid. Visit an automated up to three hours daily, heidelbergengineering.com. wavefront re- the company says, and fraction measure- with anti-microbial New Daily Disposables ment, which is usu- threads woven into SynergEyes has launched Simplif- ally a two-step process, its fabric, the mask

May 2019 | reviewofophthalmology.com | 73

070_rp0519_products.indd 73 4/15/19 12:28 PM VisiPlug Product

is the only REVIEW News one for me… decreases the level of certain bacteria and helps to No pop-out! address eyelid hygiene while reducing the risk of cor- neal infection. Delivering consistent and therapeutic moist heat, Eyeleve stimulates glands and increases oil production in an effort to stabilize the ocular surface, the company says, and this may alleviate symptoms of meibomian gland dysfunction and dry eye related to contact lens use. For more information, visit www. eyeleve.com.

Lacrimedics’ VisiPlug is not like VisoPocket Folding Magnifi er “other” punctum plugs. We have no reported “pop-outs” since VisiPlug’s Eschenbach’s new folding magnifi er, VisoPocket, can help improve daily visual activities, says the company. introduction in 2003… and it’s Its ultrathin lens can provide 2.5X magnifi cation, and distributed in over forty countries! while its lightweight design makes it discreet, the mag- nifi er still features a large lens that provides a wide fi eld FDA approved for the treatment of the of view, Eschenbach says. Dry Eye components of varying Ocular Surface Diseases (OSD), after surgery to prevent complications due to Dry Eye Disease, and to enhance the efficacy of topical medications. VisiPlug® – a visibly better plug to treat dry eye! $PNF
TFF
VT
BU
"4$34
A cutout tab on the corner of the magnifi er’s built- JO
#PPUI
 in leather case provides easy access when it comes to viewing a menu, map, bills or prescriptions, the company adds. Since VisoPocket is compact, it can be carried in a pocket or purse, and it’s available in three (800) 367-8327 colors, including black, brown and Bordeaux. Call E-mail: [email protected]
(800) 487-5389 for more information. www.lacrimedics.com

1Dramatization. Not a real patient. ©2017 Lacrimedics, Inc.

070_rp0519_products.indd 74 4/15/19 12:29 PM Figure 4. In an eye with moderate glaucoma, the en face OCT angiogram of the nerve fi ber layer plexus and the visual fi eld map were divided into eight corresponding sectors according to a modifi ed Garway-Heath scheme. The nerve fi ber layer plexus angiogram showed a superotemporal area of capillary dropout. In the OCTA-based simulated visual fi eld total deviation map, sectors 3 and 5 had moderate to advanced defects matching those found in the actual visual fi eld.

(Continued from page 68) software. You can use the AngioPlex Health and Science University in 6-mm macular scan to evaluate Portland. Dr. Jia is the Weeks Pro- our laboratory and reading center. glaucoma. That system can analyze fessor of Ophthalmology and an However, these metrics are now superficial retinal vessel density, associate professor of biomedical becoming available on commercial which they call perfusion density. engineering at OHSU. They report OCT machines as well, so it’s possible To the best of my knowledge, that fi nancial interests in Optovue. Dr. Liu to get peripapillary disc scans and system currently doesn’t have specifi c is a research associate at OHSU. macular scans using commercially software to analyze the peripapillary 1. Jia Y, Tan O, Tokayer J, et al. Split-spectrum amplitude- available OCT angiography systems. NFLP around the disc, but I believe decorrelation angiography with optical coherence tomography. That means that this isn’t limited to it’s possible to export the images Opt Express 2012;20:4:4710-4725. 2. Jia Y, Wei E, Wang X, et al. Optical coherence tomography the laboratory; glaucoma specialists and process them for this purpose. angiography of optic disc perfusion in glaucoma. Ophthalmology can now use these scans to monitor Heidelberg has an OCT angiography 2014;121:7:1322-1332. 3. Liu L, Jia Y, Takusagawa HL, et al. Optical coherence their glaucoma patients. module for Spectralis that was in- tomography angiography of the peripapillary retina in glaucoma. For example, the AngioVue, which troduced at the American Academy JAMA ophthalmology 2015;133:9:1045-1052. 4. Takusagawa HL, Liu L, Ma KN, et al. Projection-resolved optical runs on the Avanti OCT system from of Ophthalmology meeting in 2018, coherence tomography angiography of macular retinal circulation Optovue, has a good set of metrics and Topcon has developed swept- in glaucoma. Ophthalmology 2017;124:11:1589-1599. for quantifying the peripapillary source OCT angiography software 5. Wang Y, Bower BA, Izatt JA, Tan O, Huang D. In vivo total retinal blood fl ow measurement by Fourier domain Doppler optical NFLP and the macular SVC. On called OCTARA (pending FDA coherence tomography. J Biomed Opt 2007;12:4:041215. the AngioVue peripapillary scan, the clearance) that works with its Triton 6. Campbell JP, Zhang M, Hwang TS, et al. Detailed vascular anatomy of the human retina by projection-resolved optical NFLP is called the radial peripapil- OCT platform. coherence tomography angiography. Sci Rep 2017;7:42201. lary capillary, or RPC. We recommend Thus, the OCTA options for the 7. Akil H, Huang AS, Francis BA, Sadda SR, Chopra V. Retinal vessel density from optical coherence tomography angiography using the 4.5 x 4.5-mm high-defi nition glaucoma specialist will expand in to differentiate early glaucoma, pre-perimetric glaucoma and OCTA scan for the disc region, and the the near future. As the possibility of normal eyes. PLoS One 2017;12:2:e0170476. 8. Yarmohammadi A, Zangwill LM, Manalastas PIC, et al. RPC density, to evaluate glaucoma. detecting and monitoring glaucoma Peripapillary and macular vessel density in patients with For the AngioVue macular scans, with this technology becomes ap- primary open-angle glaucoma and unilateral visual fi eld loss. Ophthalmology 2018;125:4:578-587. you should use the larger, 6 x 6-mm parent, all of these systems will un- 9. Yarmohammadi A, Zangwill LM, Diniz-Filho A, et al. Relationship HD scan pattern and look at what doubtedly offer software updates, between optical coherence tomography angiography vessel density and severity of visual fi eld loss in glaucoma. they call the superfi cial retinal vessel allowing clinicians to perform these Ophthalmology 2016;123:12:2498-2508. density. The current AngioVue super- types of analyses. 10. Zhang X, Dastiridou A, Francis BA, et al. Comparison of glaucoma progression detection by optical coherence fi cial retinal slab corresponds exactly tomography and visual fi eld. Am J Ophthalmol. 2017;184:63-74. to the SVC. Dr. Huang is the Peterson Professor 11. Wu Z, Saunders LJ, Daga FB, Diniz-Filho A, Medeiros FA. Frequency of testing to detect visual fi eld progression derived Zeiss’s Cirrus HD-OCT platform of Ophthalmology and a professor using a longitudinal cohort of glaucoma patients. Ophthalmology has the AngioPlex OCT angiography of biomedical engineering at Oregon 2017;124:6:786-792.

May 2019 | reviewofophthalmology.com | 75

062_rp0519_gm.indd 75 4/15/19 11:25 AM REVIEW Classifi eds

Career Opportunities

KW,d,>DK>K'/^d^ ĂŶďƵƌLJ͕d KƉŚƚŚĂůŵŽůŽŐŝƐƚƐƚŽƐŚĂƌĞŽĸĐĞ ǁŝƚŚůŽŶŐƐƚĂŶĚŝŶŐKƉŚƚŚĂůŵŽůŽͲ Targeting ŐŝƐƚŝŶĂŶďƵƌLJ͕d͘,ŝŐŚƋƵĂůŝƚLJ ĞƋƵŝƉŵĞŶƚ͘ΨϮ͕ϮϱϬƉĞƌŵŽŶƚŚŽƌ Ophthalmologists? ĂĚũŽŝŶŝŶŐŽĸĐĞǁŝƚŚŽƵƚ ĞƋƵŝƉŵĞŶƚͲΨϭ͕ϳϱϬƉĞƌŵŽŶƚŚ͘ CLASSIFIED ADVERTISING ϮϬϯͲϱϰϱͲϯϱϯϵŽƌ WORKS ĞŵĂŝůŵĞŚƌŝŵĚΛĂŽů͘ĐŽŵ

Contact us today for classified advertising: Toll free: 888-498-1460 Do you have Products E-mail: [email protected] and Services for sale? CONTACT US TODAY FOR CLASSIFIED ADVERTISING Toll free: 888-498-1460 E-mail: [email protected]

EyeVance Pharmaceuticals 81 Myco Industries, Inc./AB MaxTM 9 Phone (817) 677-6120 Phone (800) 721-8006 Advertising eyevance.com [email protected] www.AB-Max.com Focus Laboratories, Inc. 29 REVIEW Index Phone (866) 752-6006 NuSight Medical Operations 59 Fax (501) 753-6021 Phone (833) 468-5437 Alcon Laboratories 61 www.focuslaboratories.com www.NuSightMedical.com Phone (800) 451-3937 Fax (817) 551-4352 Glaukos 15 Ocular Therapeutix, Inc. 7, 8 Phone (800) 452-8567 Phone (877) 628-8998 Akorn Consumer Health 55 www.glaukos.com www.ocutx.com Phone (800) 579-8327 Fax www.akornconsumerhealth.com Haag-Streit 51 Oculus, Inc. 65 Phone (800) 627-6286 Phone (888) 284-8004 Bausch + Lomb 11, 12, 41, 42, 63, 71, 72 Fax (603) 742-7217 Fax (425) 867-1881 Phone (800) 323-0000 Fax (813) 975-7762 Icare USA 49 Omeros 17 Phone (888) 389-4022 Phone (206) 676-5000 Beaver-Visitec International, Inc. 31 www.icare-usa.com Fax (206) 676-5005 Phone (866) 906-8080 Fax (866) 906-4304 Johnson & Johnson Surgical Vision, Inc. 2 Reichert Technologies 57 www.beaver-visitec.com https://surgical.jnjvision.com Phone (888) 849-8955 Fax (716) 686-4545 Bruder Ophthalmic Products 45. 47 Kala Pharmaceuticals 21, 22 www.reichert.com Phone (888) 827-8337 Phone (781) 996-5252 [email protected] Fax (781) 642-0399 Reliance Medical 67 [email protected] Phone (800) 735-0357 Carl Zeiss Meditec Inc. 19 www.kalarx.com Fax (513) 398-0256 Phone (877) 486-7473 Fax (925) 557-4101 Keeler Instruments 5 S4OPTIK 25. 27 Phone (800) 523-5620 Phone (888) 224-6012 Compulink 53 Fax (610) 353-7814 Phone (800) 456-4522 Shire Ophthalmics 83. 84 www.shire.com www.compulinkadvantage.com Lacrimedics, Inc 74 Phone (800) 367-8327 Sight Sciences 69 Dry Eye Doctor 39 Fax (253) 964-2699 Phone (877) 266-1144 Phone (833) 4DRYEYE [email protected] [email protected] [email protected] www.lacrimedics.com www.sightsciences.com www.thedryeyedoctor.net Lombart Instruments 37 This advertiser index is published as a convenience EyePoint Pharmaceutical 33, 34 Phone (800) 446-8092 and not as part of the advertising contract. Every Phone (617) 926-5000 Fax (757) 855-1232 care will be taken to index correctly. No allowance Fax (617) 926-5050 will be made for errors due to spelling, incorrect eyepointpharma.com page number, or failure to insert.

76 | Review of Ophthalmology | May 2019

ROPH0519.indd 76 4/10/19 10:03 PM

076_rp0519_class.indd 76 4/16/19 10:39 AM 077_rp0519_wills.indd 77 What isyourdiagnosis? furtherworkupwouldyoupursue?Thediagnosis appearsonp. 79 1 and2). showed symmetric,circumferentialscallopedareasofdepigmentationwithscatteredpigmentclumping didn’t blanchwithphenylephrineandtracenuclearsclerosiscataractsOU. Extraocular motilitywasfullbilaterally. Anteriorsegmentexaminationrevealedfocaltemporalinjectionintherighteyethat sures were15mmHgODand16OS.Confrontationvisualfi elds werecircumferentiallyconstrictedinbotheyes. Examination ritonavir, rilpivirine,darunavir, dolutegravirandemtricitabine. pack-per-day cigaretteuseand unprotectedsame-sexintercourse;hedeniedanydruguse.Currentmedicationsincluded hepatitis BandCinfection;hypertension.Familyhistorywasnon-contributory. Socialhistorywassignifi times previouslywithintramuscularpenicillinarapidplasmareagin(RPR)titerof1:4threemonthsprior;sarcoidosis; included: HIVinfectionwithanundetectableviralloadandarecentCD4+countof450/mL;syphilisthatwastreatedthree Medical History cough, sinusitis,neurologicdysfunction,arthralgias,andgenitalulcersorpain. and fl oaters. Thesesymptomshadbeenslowlyprogressingformonthstoyears.Reviewofsystemswasnegativefevers, that hadbeenpresentforthreedays.Onfurtherquestioning,thepatientreportedpoornightvisionandoccasionalfl Presentation Travis Peck, MD, JamesP. Dunn, MD room withpoornightvision,fl ashes andfl oaters. A 47-year-old EyeHospitalemergency malepresentstotheWills fovea canalsobeseen. vascular arcades. An area ofretinal atrophy temporal tothe showing circumferential retinal atrophy extending tothe Figure 1.Montagefundusphotograph ofthelefteye

Dilated fundus examination demonstrated petalloid macular edema in the left eye. The peripheral retina of both eyes Dilated fundusexaminationdemonstratedpetalloidmacularedemainthelefteye.Theperipheralretinaofbotheyes Ocular examinationdemonstratedvisualacuityof20/20ODand20/30OS.Pupilswerenormal,intraocularpres- Past ocularhistoryincludedcentralserouschorioretinopathysecondarytosystemicsteroidtherapy. Pastmedicalhistory A 47-year-old African-AmericanmalepresentedtotheWills Eyeemergencyroomforacute,severe,boringrighteyepain REVIEW Wills Eye Wills Eye Resident CaseSeries Edited byJasonFlamendorf, MD gyrate-like atrophy withpigmentdeposition. Figure 2.Enlarged colorphotooftheperipheral retinal May 2019 | reviewofophthalmology.com cantforone- (Figures (Figures ashes ashes |

77 4/15/19 12:38 PM

SAVE THESE DATES 3RD YEAR RESIDENTS CONTINUING SPECIALIZED EDUCATION 3RD YEAR RESIDENT PROGRAMS & WET LAB Dear CSE 3rd-Year Resident Program Director and Coordinator, We would like to invite you to review the upcoming 3rd-Year Ophthalmology Resident Programs and Wet Lab for 2019 in Fort Worth, Texas. The programs offer a unique educational opportunity for third-year residents by providing the chance to meet and exchange ideas with some of the most respected thought leaders in ophthalmology. The programs are designed to provide your residents with a state-of-the-art didactic and wet lab experience. The programs also serve as an opportunity for your residents to network with residents from other programs. After reviewing the material, it is our hope that you will select and encourage your residents to attend one of these educational activities, which are CME accredited to ensure fair balance. Best regards, Kendall Donaldson, MD, Yousuf Khalifa, MD, Anjali Tannan, MD, & Mitch Weikert, MD, MS

Third-Year Resident Wet Lab Programs 2019:

August 2-3 August 16-17 August 23-24 September 20-21 Fort Worth, TX Fort Worth, TX Fort Worth, TX Fort Worth, TX Course Director: Course Director: Course Director: Course Director: Mitch Weikert, MD, MS Yousuf Khalifa, MD Anjali Tannan, MD Kendall Donaldson, MD

Register Now: www.revophth.com/ResEdu2019

For more information: Visit the registration site above or Email: [email protected] • Call: Denette Holmes 866-627-0714

Courses are restricted to US-based 3rd-year residents enrolled in a US-based ophthalmology resident program and within their third year at the time of the course. There is no registration fee for these activities. Air, ground transportation in Forth Worth, hotel accommodations and modest meals will be provided through an educational scholarship for qualified participants.

Satisfactory Completion - Learners must complete an evaluation form to receive a certifi cate of completion. Your chosen sessions must be attended in their entirety. Partial credit of individual sessions is not available. If you are seeking continuing education credit for a specialty not listed below, it is your responsibility to contact your licensing/certifi cation board to determine course eligibility for your licensing/certifi cation requirement. Physicians - In support of improving patient care, this activity has been planned and implemented by Amedco LLC and Postgraduate Healthcare Education. Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team

TM JOINTLY ACCREDITED PROVIDERTM Credit Designation Statement - Amedco designates this live activity for AMA PRA Category 1 Credits . Physicians should claim only the INTERPROFESSIONAL CONTINUING EDUCATION credit commensurate with the extent of their participation in the activity.

Endorsed by: Jointly provided by: Supported by an independent medical education grant from: ® REG Review of Ophthalmology (Review Education Group) Alcon Workup, Diagnosis and Treatment

Ancillary imaging, including fl uo- characteristic pat- rescein angiography (Figure 3) and tern of perifoveal OCT (Figure 4), was obtained. The whitening and late former showed late leakage in the bull’s-eye macular superior macula of the left eye. OCT atrophy. No asso- demonstrated cystoid macular ede- ciation with macular ma in both eyes. Goldmann visual edema or periph- fi elds showed mild, scalloped, con- eral atrophy has centric peripheral visual field loss, been made with this most prominent superiorly. medication. Further The work-up of this patient with a review of his previ- history of HIV, syphilis and sarcoid- ous highly active an- osis, presenting with bilateral insidi- tiretroviral therapy ous peripheral vision loss and nycta- revealed that he had lopia due to wide-spread peripheral, been treated with pigmentary RPE atrophy, began by didanosine, the use excluding infectious etiologies. of which has been Given the patient’s history of syphi- associated with a gy- Figure 3. Fluorescein angiography of the left eye at one minute lis, an RPR and Venereal Disease rate-like peripheral and thirty seconds demonstrates leakage in the temporal Research Laboratory (VDRL) titer retinopathy. Given macula as well as peripheral window defects. were drawn. (Fluorescent trepone- the low suspicion mal antibody-absorption [FTA-ABS] for other diagnoses and the similarity macular edema, he also received one remains reactive from an initial in- of previous case reports of didano- week of oral ibuprofen that success- fection, so it’s not useful in monitor- sine toxicity to this case, a presumed fully treated his scleritis, which was ing for recurrence.) The RPR titer diagnosis of didanosine toxicity was the cause of his presentation to the was 1:4, decreased from 1:16 previ- made. However, didanosine has nev- Wills ER, but incidental to the reti- ously. A computed tomography scan er been reported to cause macular nal fi ndings. of the chest showed hilar lymphade- edema, as was seen in this patient. He was followed closely for three nopathy and interstitial lung disease The patient was started on topi- years without any progression of the consistent with known sarcoidosis. cal dorzolamide to treat the macu- peripheral retinal fi ndings. The mac- The patient’s medication list was lar edema, to limit interactions with ular edema fl uctuated in severity, de- reviewed, and only ritonavir was as- his other medications and to avoid spite continuing topical dorzolamide. sociated with a retinopathy. Rito- steroids, given his history of CSCR. navir toxicity is reported to have a In addition to the dorzolamide for

Figure 4. Optical coherence tomography of the left eye shows cystoid macular edema, as well as outer retinal atrophy temporally.

May 2019 | reviewofophthalmology.com | 79

077_rp0519_wills.indd 79 4/15/19 12:38 PM Resident Case Series REVIEW

Discussion

Didanosine is a nucleoside reverse alone or is associated with the entire the most likely possible infectious pro- transcriptase inhibitor (NRTI) most class of NRTIs. There are no docu- cess, especially given the patient’s his- well-known for its role as a component mented cases of this pattern of retinal tory of syphilis treated multiple times of HAART used in the management toxicity in patients on HAART not tak- with only intramuscular penicillin. of HIV. It’s an adenosine analogue that ing didanosine, but it’s possible that Ocular manifestations of syphilis in- terminates viral transcription when it’s the use of other medications that af- clude anterior or intermediate uveitis, incorporated into a growing nucleic fect mitochondrial function may in- optic neuritis and posterior subretinal acid chain. Introduced in 1991, the crease the risk of didanosine toxicity.3 placoid lesions. Pertinent to this case, drug was the second HIV medication In our patient, didanosine had already syphilis leading to a non-necrotizing bi- approved by the Food and Drug Ad- been discontinued at the time of di- lateral process resulting in large areas ministration, preceded only by zidovu- agnosis, but he didn’t know when it of retinal atrophy followed by RPE hy- dine.1 It became the fi rst generic HIV was stopped. Fortunately, the toxicity perplasia has been described. Infl am- medication in 2001. The most well- didn’t progress in our patient. matory fi ndings are typically present, known adverse effect of didanosine is The cystoid macular edema in this including retinal vasculitis or vitritis. acute pancreatitis, which has resulted case remains something of a diagnostic Decreasing RPR titers, the gyrate-like in a black-box warning. Other gastroin- mystery. The patient was taking ritona- appearance and lack of progression testinal symptoms can also occur, such vir, which is known to cause a macu- weren’t consistent with syphilis or oth- as nausea, vomiting, diarrhea and ab- lopathy. However, this has a charac- er infectious processes. dominal pain. Peripheral neuropathy teristic pattern described as perifoveal In conclusion, this is a case of bilat- is reported in a quarter of patients, and whitening, telangiectasias, intraretinal eral pigmentary retinopathy in an HIV- case reports of optic neuritis have been crystals and RPE disruption with late positive patient with a history of syphi- described.1 retinal atrophy. Progression leads to lis and sarcoidosis. After infectious, There are 22 case reports of didan- a bull’s eye maculopathy due to reti- infl ammatory and neoplastic processes osine-related ophthalmic toxicity, all nal atrophy, but no reports document were ruled out, a diagnosis of didano- of which include a peripheral retinal macular edema.4 Macular edema is sine toxicity was presumed. An impor- atrophy with pigmentary deposition.2 not associated with any other HAART tant point is that patients, especially The pigmentary changes often take medications, including didanosine.5 As those with HIV and autoimmune dis- on a gyrate-like pattern, as described the patient had no other conditions as- eases, may have numerous simultane- in this case, and never involve the sociated with cystoid macular edema, ous ocular processes. While Occam’s macula. For this reason, symptoms are it seems possible that this could be a razor states that a single underlying limited to nyctalopia and photopsias, novel presentation of didanosine toxic- diagnosis may explain numerous seem- with central visual acuity remaining ity. ingly unrelated fi ndings, this may not largely unaffected.2 It’s believed that This case illustrates the importance be the case in HIV patients. This case the process primarily affects rods, due of a broad differential diagnosis in presented a management dilemma in to their high mitochondrial activity, HIV-positive patients. The most im- balancing medication side effects with as didanosine inhibits mitochondrial portant fi rst step is to rule out an infec- the necessity of steroid therapy and function in vitro.1 tious process. Pathogens affecting the HAART. Co-management with infec- Signs and symptoms in these pa- retina include syphilis, toxoplasmosis, tious disease and other specialties is tients are typically stable or slowly cytomegalovirus, herpes simplex and critical in proper management of these worsen. There are no cases where the the varicella-zoster virus. The Herpes medically complex patients.

retinal fi ndings or symptoms resolved. viridae have characteristic presenta- 1. Kakuda TN. Pharmacology of nucleoside and nucleotide The most important step in manage- tions that aren’t consistent with the ret- reverse transcriptase inhibitor-induced mitochondrial toxicity. Clin Ther 2000;22:685-708. ment is to diagnose didanosine as the inopathy or insidious time-course seen 2. Haug SJ, Wong RW, Day S, et al. Didanosine retinal toxicity. Retina 2016;36 Suppl 1:S159-S167. offending medication and discontinue in this case. Toxoplasmosis can cause a 3. Gabrielian A, MacCumber MM, Kukuyev A, et al. Didanosine- its use, although case reports have doc- bilateral necrotizing chorioretinitis in associated retinal toxicity in adults infected with human immu- nodefi ciency virus. JAMA Ophthalmol 2013;131:255-259. umented progression of retinal atro- HIV patients, but the mid-peripheral 4. Pinto R, Vila-Franca M, Oliveira Afonso C, et al. Ritonavir and 3 bull’s eye maculopathy: Case report. GMS Ophthalmol Cases phy despite cessation of therapy. atrophic appearance of the fundus in 2013;3:Doc01. This raises the question of whether this patient didn’t appear compatible 5. Whitcup SM, Butler KM, Caruso R, et al. Retinal toxicity in human immunodefi ciency virus-infected children treated with the retinopathy is due to didanosine with toxoplasmosis scars. Syphilis was 2’,3’-dideoxyinosine. Am J Ophthalmol 1992;113:1-7.

80 | Review of Ophthalmology | May 2019

0077_rp0519_wills.indd77_rp0519_wills.indd 8800 44/15/19/15/19 12:3812:38 PMPM (fluorometholone acetate ophthalmic suspension) 0.1%

NOW JOINING THE EYEVANCE™ FAMILY of ophthalmic treatment options

© 2019 Eyevance Pharmaceuticals LLC. All rights reserved. FLAREX® is a registered trademark of Eyevance Pharmaceuticals LLC. FLA-004 01/2019

RRO0419_Eyevance.inddO0419_Eyevance.indd 1 33/26/19/26/19 10:3310:33 AMAM Save the Date

ASRS AAO

JULY 25 OCT 10 2019 2019

SAN CHICAGO FRANCISCO

FACILITATING MEANINGFUL INTERACTIONS AND THE EXCHANGE OF INFORMATION BETWEEN INDUSTRY AND CLINICAL LEADERS SINCE 2009. Register Today! The Ophthalmology Innovation Summit at ASRS* and AAO unites industry, entrepreneurial and clinical leaders to collaborate on the development and commercialization of innovative drugs and devices to address unmet clinical needs.

FOR MORE INFORMATION, VISIT WWW.OIS.NET

*OIS@ASRS is not affiliated with ASRS.

RP0519_House OIS.indd 1 4/11/19 3:16 PM VGUVGFOIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV the recommended human ophthalmic dose [RHOD], based on VJGCTGCWPFGTVJGEWTXG=#7%?NGXGN 5KPEGJWOCPU[UVGOKE GZRQUWTGVQNKƂVGITCUVHQNNQYKPIQEWNCTCFOKPKUVTCVKQPQH:KKFTC Rx Only CVVJG4*1&KUNQYVJGCRRNKECDKNKV[QHCPKOCNƂPFKPIUVQVJG risk of Xiidra use in humans during pregnancy is unclear. Animal Data BRIEF SUMMARY: .KƂVGITCUVCFOKPKUVGTGFFCKN[D[KPVTCXGPQWU +8 KPLGEVKQP Consult the Full Prescribing Information for complete product VQTCVUHTQORTGOCVKPIVJTQWIJIGUVCVKQPFC[ECWUGF information. an increase in mean preimplantation loss and an increased INDICATIONS AND USAGE KPEKFGPEGQHUGXGTCNOKPQTUMGNGVCNCPQOCNKGUCVOIMI Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGFHQTVJG FC[TGRTGUGPVKPIHQNFVJGJWOCPRNCUOCGZRQUWTGCV VTGCVOGPVQHVJGUKIPUCPFU[ORVQOUQHFT[G[GFKUGCUG &'&  the RHOD of Xiidra, based on AUC. No teratogenicity was QDUGTXGFKPVJGTCVCVOIMIFC[ HQNFVJGJWOCP DOSAGE AND ADMINISTRATION RNCUOCGZRQUWTGCVVJG4*1&DCUGFQP#7% +PVJGTCDDKV Instill one drop of Xiidra twice daily (approximately 12 hours an increased incidence of omphalocele was observed at the CRCTV KPVQGCEJG[GWUKPICUKPINGWUGEQPVCKPGT&KUECTF NQYGUVFQUGVGUVGFOIMIFC[ HQNFVJGJWOCPRNCUOC VJGUKPINGWUGEQPVCKPGTKOOGFKCVGN[CHVGTWUKPIKPGCEJG[G GZRQUWTGCVVJG4*1&DCUGFQP#7% YJGPCFOKPKUVGTGFD[ Contact lenses should be removed prior to the administration +8KPLGEVKQPFCKN[HTQOIGUVCVKQPFC[UVJTQWIJ#HGVCN0Q QH:KKFTCCPFOC[DGTGKPUGTVGFOKPWVGUHQNNQYKPI 1DUGTXGF#FXGTUG'HHGEV.GXGN 01#'. YCUPQVKFGPVKƂGFKP administration. the rabbit. CONTRAINDICATIONS Lactation 6JGTGCTGPQFCVCQPVJGRTGUGPEGQHNKƂVGITCUVKPJWOCP Xiidra is contraindicated in patients with known hypersensitivity VQNKƂVGITCUVQTVQCP[QHVJGQVJGTKPITGFKGPVUKPVJG milk, the effects on the breastfed infant, or the effects on milk RTQFWEVKQP*QYGXGTU[UVGOKEGZRQUWTGVQNKƂVGITCUVHTQO formulation. ocular administration is low. The developmental and health ADVERSE REACTIONS DGPGƂVUQHDTGCUVHGGFKPIUJQWNFDGEQPUKFGTGFCNQPIYKVJ Clinical Trials Experience the mother’s clinical need for Xiidra and any potential adverse Because clinical studies are conducted under widely varying effects on the breastfed child from Xiidra. conditions, adverse reaction rates observed in clinical studies Pediatric Use of a drug cannot be directly compared to rates in the clinical 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH VTKCNUQHCPQVJGTFTWICPFOC[PQVTGƃGEVVJGTCVGUQDUGTXGF years have not been established. KPRTCEVKEG+PƂXGENKPKECNUVWFKGUQHFT[G[GFKUGCUGEQPFWEVGF YKVJNKƂVGITCUVQRJVJCNOKEUQNWVKQPRCVKGPVUTGEGKXGFCV Geriatric Use NGCUVFQUGQHNKƂVGITCUV QHYJKEJTGEGKXGFNKƂVGITCUV  No overall differences in safety or effectiveness have been 6JGOCLQTKV[QHRCVKGPVU  JCFŰOQPVJUQHVTGCVOGPV observed between elderly and younger adult patients. GZRQUWTGRCVKGPVUYGTGGZRQUGFVQNKƂVGITCUVHQT NONCLINICAL TOXICOLOGY approximately 12 months. The majority of the treated patients Carcinogenesis, Mutagenesis, Impairment of Fertility YGTGHGOCNG  6JGOQUVEQOOQPCFXGTUGTGCEVKQPU Carcinogenesis: Animal studies have not been conducted TGRQTVGFKPQHRCVKGPVUYGTGKPUVKNNCVKQPUKVGKTTKVCVKQP VQFGVGTOKPGVJGECTEKPQIGPKERQVGPVKCNQHNKƂVGITCUV dysgeusia and reduced visual acuity. Other adverse reactions Mutagenesis: .KƂVGITCUVYCUPQVOWVCIGPKEKPVJGin vitro TGRQTVGFKPVQQHVJGRCVKGPVUYGTGDNWTTGFXKUKQP #OGUCUUC[.KƂVGITCUVYCUPQVENCUVQIGPKEKPVJGin vivo conjunctival hyperemia, eye irritation, headache, increased mouse micronucleus assay. In an in vitro chromosomal lacrimation, eye discharge, eye discomfort, eye pruritus and aberration assay using mammalian cells (Chinese sinusitis. JCOUVGTQXCT[EGNNU NKƂVGITCUVYCURQUKVKXGCVVJGJKIJGUV Postmarketing Experience concentration tested, without metabolic activation. 6JGHQNNQYKPICFXGTUGTGCEVKQPUJCXGDGGPKFGPVKƂGFFWTKPI Impairment of fertility: .KƂVGITCUVCFOKPKUVGTGFCV postapproval use of Xiidra. Because these reactions are KPVTCXGPQWU +8 FQUGUQHWRVQOIMIFC[ reported voluntarily from a population of uncertain size, it is not HQNFVJGJWOCPRNCUOCGZRQUWTGCVVJG always possible to reliably estimate their frequency or establish TGEQOOGPFGFJWOCPQRJVJCNOKEFQUG 4*1& QH a causal relationship to drug exposure. NKƂVGITCUVQRJVJCNOKEUQNWVKQP JCFPQGHHGEVQP Rare cases of hypersensitivity, including anaphylactic reaction, fertility and reproductive performance in male and bronchospasm, respiratory distress, pharyngeal edema, swollen female treated rats. tongue, and urticaria have been reported. Eye swelling and rash have been reported. USE IN SPECIFIC POPULATIONS Pregnancy /CPWHCEVWTGFHQT5JKTG75+PE5JKTG9C[.GZKPIVQP/# There are no available data on Xiidra use in pregnant women to (QTOQTGKPHQTOCVKQPIQVQYYY:KKFTCEQOQTECNN KPHQTOCP[FTWICUUQEKCVGFTKUMU+PVTCXGPQWU +8 CFOKPKUVTCVKQP Marks designated ®CPFvCTGQYPGFD[5JKTGQTCPCHƂNKCVGFEQORCP[ QHNKƂVGITCUVVQRTGIPCPVTCVUHTQORTGOCVKPIVJTQWIJ 5JKTG75+PE5*+4'CPFVJG5JKTG.QIQCTGVTCFGOCTMUQT IGUVCVKQPFC[FKFPQVRTQFWEGVGTCVQIGPKEKV[CVENKPKECNN[ TGIKUVGTGFVTCFGOCTMUQH5JKTG2JCTOCEGWVKECN*QNFKPIU+TGNCPF relevant systemic exposures. Intravenous administration of .KOKVGFQTKVUCHƂNKCVGU NKƂVGITCUVVQRTGIPCPVTCDDKVUFWTKPIQTICPQIGPGUKURTQFWEGF Patented: please see JVVRUYYYUJKTGEQONGICNPQVKEGRTQFWEVRCVGPVU an increased incidence of omphalocele at the lowest dose .CUV/QFKƂGF5

RRO0519_ShireO0519_Shire PI.inddPI.indd 1 44/5/19/5/19 110:030:03 AMAM :KKFTCOC[RTQXKFG .#56+0)4'.++'( UVCTVKPICUGCTN[CUYGGMU

1PGFTQRKPGCEJG[GVYKEGFCKN[CDQWVJQWTUCRCTV &KUECTFVJGUKPINGWUGEQPVCKPGTKOOGFKCVGN[CHVGTWUG

Indication Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGFHQTVJG %JQQUG:KKFTCƂTUVHQTRCVKGPVU VTGCVOGPVQHUKIPUCPFU[ORVQOUQHFT[G[GFKUGCUG &'&  YKVJUKIPUCPFU[ORVQOUQH Important Safety Information &T['[G&KUGCUG :KKFTCKUEQPVTCKPFKECVGFKPRCVKGPVUYKVJMPQYPJ[RGTUGPUKVKXKV[ VQNKƂVGITCUVQTVQCP[QHVJGQVJGTKPITGFKGPVU :KKFTCTGFWEGFU[ORVQOUQHG[GFT[PGUUCV +PENKPKECNVTKCNUVJGOQUVEQOOQPCFXGTUGTGCEVKQPUTGRQTVGF YGGMUKPQWVQHUVWFKGUCPFKPCNNUVWFKGU KPQHRCVKGPVUYGTGKPUVKNNCVKQPUKVGKTTKVCVKQPF[UIGWUKC CVCPFYGGMU:KKFTCCNUQKORTQXGFUKIPU CPFTGFWEGFXKUWCNCEWKV[1VJGTCFXGTUGTGCEVKQPUTGRQTVGF QHKPHGTKQTEQTPGCNUVCKPKPICVYGGMUKPQWV KPVQQHVJGRCVKGPVUYGTGDNWTTGFXKUKQPEQPLWPEVKXCN QHUVWFKGU1 J[RGTGOKCG[GKTTKVCVKQPJGCFCEJGKPETGCUGFNCETKOCVKQP 6JGUCHGV[CPFGHƂECE[QH:KKFTCEQORCTGF G[GFKUEJCTIGG[GFKUEQOHQTVG[GRTWTKVWUCPFUKPWUKVKU VQXGJKENGYGTGUVWFKGFKPRCVKGPVUKP 6QCXQKFVJGRQVGPVKCNHQTG[GKPLWT[QTEQPVCOKPCVKQPQHVJG YGNNEQPVTQNNGFYGGMVTKCNU1 UQNWVKQPRCVKGPVUUJQWNFPQVVQWEJVJGVKRQHVJGUKPINGWUG EQPVCKPGTVQVJGKTG[GQTVQCP[UWTHCEG %QPVCEVNGPUGUUJQWNFDGTGOQXGFRTKQTVQVJGCFOKPKUVTCVKQP %JGEMKVQWVCV:KKFTC'%2EQO QH:KKFTCCPFOC[DGTGKPUGTVGFOKPWVGUHQNNQYKPI administration. 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH [GCTUJCXGPQVDGGPGUVCDNKUJGF

For additional safety information, see accompanying Brief Summary of Safety Information on the adjacent page and Full Prescribing Information on Xiidra-ECP.com.

Reference: 1. Xiidra [Prescribing Information]. Lexington, MA: Shire US.

©2018 Shire US Inc., Lexington, MA 02421. 1-800-828-2088. All rights reserved. SHIRE and the Shire Logo are trademarks or registered trademarks of - ˆÀi* >À“>ViṎV>œ`ˆ˜}ÃÀi>˜`ˆ“ˆÌi`œÀˆÌÃ>vwˆ>Ìið >ÀŽÃ`iÈ}˜>Ìi`® >˜`Ò>ÀiœÜ˜i`LÞ- ˆÀiœÀ>˜>vwˆ>Ìi`Vœ“«>˜Þ°-{ÓÓÇä£äÉ£n

RP0519_Shire.indd 1 4/5/19 10:05 AM