• Pros/Cons of the Newly-Approved Light-Adjustable IOL P. 12 • Choose Patients Wisely for Presbyopic Iols P

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FIRST RETINAL GENE THERAPY APPROVED P. 3 • GONIOSYNECHIALYSIS AND CATARACT P. 47 EMERGING TREATMENTS FOR UVEITIS P. 52 • RESEARCH ON TORIC ALIGNMENT P. 57

Review of Ophthalmology Vol. XXV, Tough No. 1 • January 2018 Answering Formula Questions • How IOL to Choose Presbyopic Preferences Lens Patients • Survey on IOL A RUNDOWN OF NEW PRODUCTS P. 59 • WILLS EYE RESIDENT CASE P. 61

JanuaryJanuary 20182018

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• Pros/Cons of the Newly-approved Light-adjustable IOL P. 12 • Choose Patients Wisely for Presbyopic IOLs P. 30 • Premium IOLs: Spotting Poor Candidates P. 38 • Survey on IOL Preferences P. 42

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RP0118_Alcon Acrysof.indd 1 12/19/17 2:32 PM REVIEW NEWS Volume XXV • No. 1 • January 2018 FDA Approves First-ever Retinal Gene Therapy

On December 19, 2017, the U.S. Food and Drug Administration binant DNA techniques, to deliver a healthy RPE65 gene approved a new gene therapy, voretigene neparvovec- to the retinal cells via a subretinal injection to restore vision. rzyl (Luxturna), manufactured by Spark Therapeutics in Treatment is followed by a short course of oral prednisolone Philadelphia. Luxturna is the fi rst gene therapy approved in to limit any potential immune reaction. (Each eye must be the United States that’s directly administered into the eye, treated on separate days, at least six days apart.) In the piv- targeting diseases caused by mutations in the gene RPE65. otal study, the most common adverse reactions to treatment Mutations in this gene can produce Leber’s congenital included conjunctival hyperemia, cataract, increased intra- amaurosis or retinitis pigmentosa, both rare but potentially ocular pressure and retinal tear. blinding diseases. The safety and effi cacy of Luxturna were established in The RPE65 gene provides genetic instructions for making a clinical development program involving 41 patients with an enzyme that converts light to an electrical signal in the confi rmed RPE65 mutations between the ages of 4 and 44 retina; mutations in the gene cause reduced or no enzyme years. A Phase III study with 31 participants measured the activity, resulting in impaired vision. Luxturna uses a natural- change in a subject’s ability to navigate an obstacle course at ly occurring adeno-associated virus, modifi ed using recom- various light levels, from baseline to one year. Patients that received Luxturna demonstrated signifi cant improvements IMPORTANT PRODUCT INFORMATION FOR THE in their ability to complete the obstacle course at low light ACRYSOF® IQ RESTOR® FAMILY OF IOLs levels, compared to the control group. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. Jean Bennett, MD, PhD, is a professor of ophthalmology INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Multi- and director of the Center for Advanced Retinal and Ocular focal IOLs include AcrySof® IQ ReSTOR® and AcrySof® IQ ReSTOR® Toric and are intended for primary implantation for the visual correction of aphakia secondary Therapeutics at the University of Pennsylvania in Philadel- to removal of a cataractous lens in adult patients with and without presbyopia, phia. She’s also scientifi c co-founder of Spark, and was the who desire near, intermediate and distance vision with increased spectacle independence. In addition, the AcrySof® IQ ReSTOR® Toric IOL is intended to scientifi c director for the RPE65 defi ciency clinical trials. correct pre-existing astigmatism. The lenses are intended to be placed in the capsular bag. “This is the second gene therapy approved by the FDA,” WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound she notes, “but it’s the fi rst one to target a genetic disease, clinical judgment should be used by the surgeon to decide the risk/benefit ratio and the fi rst in which the gene is delivered directly into the before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling for each IOL. Physicians should target emmetropia, person, rather than fi rst being delivered into a cell in a dish. and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. It’s also the fi rst gene therapy approved worldwide for a reti- The ReSTOR Toric IOL should not be implanted if the posterior capsule is nal disease. Seventeen years ago, our team demonstrated ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens reposition- that we could reverse blindness in a dog born with the same ing should occur as early as possible prior to lens encapsulation. mutation that causes blindness in children, Leber’s congeni- Some patients may experience visual disturbances and/or discomfort due to tal amaurosis. Since then we’ve been moving this through multifocality, especially under dim light conditions. A reduction in contrast sensitivity may occur in low light conditions. Visual symptoms may be significant clinical trials. The approval comes upon fi nishing a Phase enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary; some patients may need glasses when reading small III study, which was the fi rst controlled, randomized gene print or looking at small objects. therapy clinical trial for a genetic disease.” Posterior capsule opacification (PCO), when present, may develop earlier into As for availability of the treatment, Dr. Bennett says Spark clinically significant PCO with multifocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure Therapeutics is establishing centers of excellence that will available from Alcon informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. be set up to deliver the drug to qualifi ed candidates. “This Do not resterilize; do not store over 45° C; use only sterile irrigating solutions involves surgical delivery and a training plan for retinal sur- such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. geons at these centers,” she explains. “The estimate I’ve ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions. been given for availability is six months from now. We’ll be setting up a center here at the University of Pennsylvania,

0003_rp0118_news.indd03_rp0118_news.indd 3 112/22/172/22/17 2:162:16 PMPM ®

E DITORIAL STAFF REVIEW News Editor in Chief and Refractive Surgery recently issued Walter C. Bethke a clinical alert to warn surgeons that (610) 492-1024 PAR Pharmaceutical (Chestnut Ridge, [email protected] N.Y.) has updated its epinephrine for- Senior Editor mula, rendering it inappropriate for Christopher Kent intraocular use: ASCRS recommends (814) 861-5559 that surgeons make sure their centers [email protected] are not ordering the new epinephrine for ophthalmic use, and offers advice and that matches our time estimate.” Senior Associate Editor on how to safely use epinephrine from Current estimates of the cost of the Kristine Brennan alternative sources. procedure are very high, ranging up (610) 492-1008 Last January, PAR started making to $500,000 per eye. Dr. Bennett says [email protected] and shipping epinephrine containing pricing issues are outside of her pur- 0.457 mg/ml of sodium metabisulfi te view. “I’ve been assured by Spark Ther- Associate Editor (bisulfi tes can damage the corneal epi- apeutics that they’ll do their best to ac- Liam Jordan commodate people who could benefi t thelium at concentrations of 0.1%) and (610) 492-1025 from the procedure,” she says. “Part of 2.25 mg/ml of tartaric acid (no pub- [email protected] the challenge of pricing this is that it’s lished data or reports exist regarding unusual for a drug company to be sell- intracameral tartaric acid). Although Chief Medical Editor ing a one-shot drug treatment, rather PAR has disseminated new prescriber Mark H. Blecher, MD than something that requires repeated information and its 30-ml bottles of the dosing over time, and it’s a procedure new epinephrine are labeled “Not for Art Director that will have ramifi cations for the per- Ophthalmic Use,” its single-dose, 1-ml Jared Araujo son’s life and career and reduce the vials don’t have this warning. ASCRS (610) 492-1032 need for family and caregivers to help would like to avoid inducing TASS as a [email protected] the person. We certainly hope it will get result of using the product. less expensive over time.” Senior Graphic Designer ASCRS adds that even “preserva- Dr. Bennett notes that one benefi t Matt Egger tive-free” epinephrine from alterna- of this FDA approval is that there was (610) 492-1029 tive sources is likely to contain bi- previously no FDA pathway for the de- [email protected] sulfi te as a stabilizer, but that studies velopment of a gene therapy. “I hope have demonstrated that corneas ex- that having that pathway will expedite International coordinator, Japan posed to sodium bisulfi te 0.05% show the development of other drugs for Mitz Kaminuma no endothelial changes. Therefore, diseases for which we don’t have good [email protected] diluting preservative-free epineph- treatments now,” she says. In that vein, rine containing bisulfi te 0.1% 1:4 with the FDA plans to begin issuing guid- Business Offi ces BSS should be safe for intracameral ance documents to help with the devel- 11 Campus Boulevard, Suite 100 use, as should mixing epi-Shugarcaine opment of specifi c gene therapy prod- Newtown Square, PA 19073 (9 cc BSS Plus; 4 cc 1:1000 epineph- ucts for high-priority diseases next year. (610) 492-1000 rine; and 3 cc nonpreserved lidocaine Meanwhile, the manufacturer plans to Fax: (610) 492-1039 conduct a post-marketing observational 4%). ASCRS also says that diluting study of patients treated with Luxturna bisulfi te-containing epinephrine in Subscription inquiries: to further evaluate its long-term safety. the irrigating bottle is safe, but recom- United States — (877) 529-1746 mends avoiding epinephrine with tar- Outside U.S. — (845) 267-3065 taric acid, regardless of concentration, E-mail: Clinical Alert Issued until more data becomes available. [email protected] The full ASCRS clinical alert can be Website: www.reviewofophthalmology.com On Intracameral found at: http://www.ascrs.org/about- ascrs/news-about/clinical-alert-intraoc- Epinephrine ular-use-epinephrine-maintain-mydri- The American Society of Cataract asis-during-cataract-surgery.

4 | Review of Ophthalmology | January 2018

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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 Emmett T. Cunningham Jr., MD, PHD, MPH 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 Thomas Jenkins, MD. CASEY FOSTER (610) 492-1007 [email protected]

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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.

6 | Review of Ophthalmology | January 2018

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For more information about VYZULTA, visit vyzultanow.com INDICATION For more information about VYZULTA,• Macular visit edema, vyzultanow.com including cystoid macular VYZULTA™ (latanoprostene bunod ophthalmic edema, has been reported during treatment with solution), 0.024% is indicated for the reduction of prostaglandin analogs. Use with caution in aphakic INDICATION • Macular edema, including cystoid macular intraocular pressure (IOP) in patients with open-angle patients, in pseudophakic patients with a torn VYZULTA™ (latanoprostene bunod ophthalmic edema, has been reported during treatment with glaucoma or ocular hypertension. posterior lens capsule, or in patients with known solution), 0.024% is indicated for the reduction of prostaglandin analogs. Use with caution in aphakic risk factors for macular edema intraocularIMPORTANT pressure SAFETY (IOP) INFORMATION in patients with open-angle patients, in pseudophakic patients with a torn glaucoma• Increased or pigmentation ocular hypertension. of the iris and periorbital • posterior There have lens been capsule, reports or in of patients bacterial with keratitis known tissue (eyelid) can occur. Iris pigmentation is likely riskassociated factors with for macularthe use of edema multiple-dose containers of IMPORTANT SAFETY INFORMATION risk factors for macular edema to be permanent topical ophthalmic products that were inadvertently • Increased pigmentation of the iris and periorbital • There have been reports of bacterial keratitis contaminated by patients • tissueGradual (eyelid) changes can to occur. eyelashes, Iris pigmentation including increased is likely associated with the use of multiple-dose containers of tolength, be permanent increased thickness, and number of • Contact topical ophthalmic lenses should products be removed that were prior inadvertently to the eyelashes, may occur. These changes are usually administrationcontaminated by of patientsVYZULTA and may be reinserted • Gradual changes to eyelashes, including increased contaminated by patients reversible upon treatment discontinuation 15 minutes after administration length, increased thickness, and number of • Contact lenses should be removed prior to the • eyelashes,Use with caution may occur. in patients These with changes a history are usually of • administrationMost common ocularof VYZULTA adverse and reactions may be withreinserted reversibleintraocular upon infl ammation treatment (iritis/uveitis). discontinuation VYZULTA 15incidence minutes after2% are administration conjunctival hyperemia (6%), should generally not be used in patients with active eye irritation (4%), eye pain (3%), and instillation • Use with caution in patients with a history of • Most common ocular adverse reactions with intraocular infl ammation site pain (2%) intraocular infl ammation (iritis/uveitis). VYZULTA incidence 2% are conjunctival hyperemia (6%), should generally not be used in patients with active REFERENCEeye irritation (4%), eye pain (3%), and instillation intraocular infl ammation 1. siteVYZULTA pain Prescribing (2%) Information. Bausch & Lomb Incorporated. 2017.

ForREFERENCE more information, please see Brief Summary VYZULTA and the V design are trademarks of Bausch & Lomb Incorporated or its afﬁ liates. 1. VYZULTA Prescribing Information. Bausch & Lomb Incorporated. 2017. ©2017 Bausch & Lomb Incorporated. All rights reserved. VYZ.0351.USA.17 of1. VYZULTA Prescribing Prescribing Information Information. Bausch on next & Lomb page. Incorporated. 2017. For more information, please see Brief Summary VYZULTA and the V design are trademarks of Bausch & Lomb Incorporated or its afﬁ liates. ©2017 Bausch & Lomb Incorporated. All rights reserved. VYZ.0351.USA.17 of Prescribing Information on next page.

RP0118_BauschVyzulta.indd 1 12/22/17 11:55 AM BRIEF SUMMARY OF PRESCRIBING INFORMATION Doses ≥ 20 μg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality. Structural abnormalities observed in rabbit fetuses included anomalies of the great This Brief Summary does not include all the information needed to use VYZULTA vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, safely and effectively. See full Prescribing Information for VYZULTA. limb hyperextension and malrotation, abdominal distension and edema. Latanoprostene ™ VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, for topical bunod was not teratogenic in the rat when administered IV at 150 mcg/kg/day (87 times ophthalmic use. the clinical dose) [see Data]. Initial U.S. Approval: 2017 The background risk of major birth defects and miscarriage for the indicated population 1 INDICATIONS AND USAGE is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. VYZULTA™ (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Data 4 CONTRAINDICATIONS Animal Data None Embryofetal studies were conducted in pregnant rabbits administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 19, to target the period 5 WARNINGS AND PRECAUTIONS of organogenesis. The doses administered ranged from 0.24 to 80 mcg/kg/day. Abortion 5.1 Pigmentation occurred at doses ≥ 0.24 mcg/kg/day latanoprostene bunod (0.28 times the clinical VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% may cause changes to dose, on a body surface area basis, assuming 100% absorption). Embryofetal lethality pigmented tissues. The most frequently reported changes with prostaglandin analogs (resorption) was increased in latanoprostene bunod treatment groups, as evidenced have been increased pigmentation of the iris and periorbital tissue (eyelid). by increases in early resorptions at doses ≥ 0.24 mcg/kg/day and late resorptions at doses ≥ 6 mcg/kg/day (approximately 7 times the clinical dose). No fetuses survived Pigmentation is expected to increase as long as latanoprostene bunod ophthalmic in any rabbit pregnancy at doses of 20 mcg/kg/day (23 times the clinical dose) or greater. solution is administered. The pigmentation change is due to increased melanin content Latanoprostene bunod produced structural abnormalities at doses ≥ 0.24 mcg/kg/day in the melanocytes rather than to an increase in the number of melanocytes. After (0.28 times the clinical dose). Malformations included anomalies of sternum, coarctation discontinuation of VYZULTA, pigmentation of the iris is likely to be permanent, while of the aorta with pulmonary trunk dilation, retroesophageal subclavian artery with pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in absent brachiocephalic artery, domed head, forepaw hyperextension and hindlimb most patients. Patients who receive prostaglandin analogs, including VYZULTA, should be malrotation, abdominal distention/edema, and missing/fused caudal vertebrae. informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known. An embryofetal study was conducted in pregnant rats administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 17, to target the Iris color change may not be noticeable for several months to years. Typically, the period of organogenesis. The doses administered ranged from 150 to 1500 mcg/kg/day. brown pigmentation around the pupil spreads concentrically towards the periphery of Maternal toxicity was produced at 1500 mcg/kg/day (870 times the clinical dose, on the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor a body surface area basis, assuming 100% absorption), as evidenced by reduced freckles of the iris appear to be affected by treatment. While treatment with VYZULTA™ maternal weight gain. Embryofetal lethality (resorption and fetal death) and structural (latanoprostene bunod ophthalmic solution), 0.024% can be continued in patients who anomalies were produced at doses ≥ 300 mcg/kg/day (174 times the clinical dose). develop noticeably increased iris pigmentation, these patients should be examined Malformations included anomalies of the sternum, domed head, forepaw hyperextension regularly [see Patient Counseling Information (17) in full Prescribing Information]. and hindlimb malrotation, vertebral anomalies and delayed ossification of distal limb 5.2 Eyelash Changes bones. A no observed adverse effect level (NOAEL) was established at 150 mcg/kg/day (87 times the clinical dose) in this study. VYZULTA may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and the number of lashes or hairs. Eyelash 8.2 Lactation changes are usually reversible upon discontinuation of treatment. Risk Summary 5.3 Intraocular Inflammation There are no data on the presence of VYZULTA in human milk, the effects on the VYZULTA should be used with caution in patients with a history of intraocular breastfed infant, or the effects on milk production. The developmental and health inflammation (iritis/uveitis) and should generally not be used in patients with active benefits of breastfeeding should be considered, along with the mother’s clinical need intraocular inflammation as it may exacerbate this condition. for VYZULTA, and any potential adverse effects on the breastfed infant from VYZULTA. 5.4 Macular Edema 8.4 Pediatric Use Macular edema, including cystoid macular edema, has been reported during treatment Use in pediatric patients aged 16 years and younger is not recommended because of potential with prostaglandin analogs. VYZULTA should be used with caution in aphakic patients, in safety concerns related to increased pigmentation following long-term chronic use. pseudophakic patients with a torn posterior lens capsule, or in patients with known risk 8.5 Geriatric Use factors for macular edema. No overall clinical differences in safety or effectiveness have been observed between 5.5 Bacterial Keratitis elderly and other adult patients. There have been reports of bacterial keratitis associated with the use of multiple-dose 13 NONCLINICAL TOXICOLOGY containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility disruption of the ocular epithelial surface. Latanoprostene bunod was not mutagenic in bacteria and did not induce micronuclei 5.6 Use with Contact Lens formation in the in vivo rat bone marrow micronucleus assay. Chromosomal aberrations were observed in vitro with human lymphocytes in the absence of metabolic activation. Contact lenses should be removed prior to the administration of VYZULTA because this product contains benzalkonium chloride. Lenses may be reinserted 15 minutes after Latanoprostene bunod has not been tested for carcinogenic activity in long-term animal administration. studies. Latanoprost acid is a main metabolite of latanoprostene bunod. Exposure of rats and mice to latanoprost acid, resulting from oral dosing with latanoprost in lifetime 6 ADVERSE REACTIONS rodent bioassays, was not carcinogenic. The following adverse reactions are described in the Warnings and Precautions section: Fertility studies have not been conducted with latanoprostene bunod. The potential to pigmentation (5.1), eyelash changes (5.2), intraocular inflammation (5.3), macular impact fertility can be partially characterized by exposure to latanoprost acid, a common edema (5.4), bacterial keratitis (5.5), use with contact lens (5.6). metabolite of both latanoprostene bunod and latanoprost. Latanoprost acid has not been 6.1 Clinical Trials Experience found to have any effect on male or female fertility in animal studies. Because clinical trials are conducted under widely varying conditions, adverse reaction 13.2 Animal Toxicology and/or Pharmacology rates observed in the clinical trials of a drug cannot be directly compared to rates in the A 9-month toxicology study administered topical ocular doses of latanoprostene bunod clinical trials of another drug and may not reflect the rates observed in practice. to one eye of cynomolgus monkeys: control (vehicle only), one drop of 0.024% bid, one VYZULTA was evaluated in 811 patients in 2 controlled clinical trials of up to 12 months drop of 0.04% bid and two drops of 0.04% per dose, bid. The systemic exposures are duration. The most common ocular adverse reactions observed in patients treated equivalent to 4.2-fold, 7.9-fold, and 13.5-fold the clinical dose, respectively, on a body with latanoprostene bunod were: conjunctival hyperemia (6%), eye irritation (4%), eye surface area basis (assuming 100% absorption). Microscopic evaluation of the lungs pain (3%), and instillation site pain (2%). Approximately 0.6% of patients discontinued after 9 months observed pleural/subpleural chronic fibrosis/inflammation in the 0.04% therapy due to ocular adverse reactions including ocular hyperemia, conjunctival dose male groups, with increasing incidence and severity compared to controls. Lung irritation, eye irritation, eye pain, conjunctival edema, vision blurred, punctate keratitis toxicity was not observed at the 0.024% dose. and foreign body sensation. Distributed by: 8 USE IN SPECIFIC POPULATIONS Bausch + Lomb, a division of 8.1 Pregnancy Valeant Pharmaceuticals North America LLC Risk Summary Bridgewater, NJ 08807 USA There are no available human data for the use of VYZULTA during pregnancy to inform U.S. Patent Numbers: 6,211,233; 7,273,946; 7,629,345; 7,910,767; 8,058,467. any drug associated risks. VYZULTA is a trademark of Bausch & Lomb Incorporated or its affiliates. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. Latanoprostene bunod was shown to be abortifacient and teratogenic when administered © Bausch & Lomb Incorporated intravenously (IV) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. Based on 9464800 11/2017 VYZ.0055.USA.16 Issued: 11/2017

RRP0118_BauschVyzultaPI.inddP0118_BauschVyzultaPI.indd 1 112/22/172/22/17 11:5811:58 AMAM | 16 January 2018 • Volume XXV No. 1 reviewofophthalmology.com Cover Focus 16 | IOL Power Formulas: 10 Questions Answered Christopher Kent, Senior Editor Help ensure optimum outcomes through a better understanding of lens power calculations.

30 | Presbyopic IOLs: Choosing Wisely Kristine Brennan, Senior Associate Editor 30 How to watch and listen to your patients to enhance your success rate. 38 | Premium IOLs: How to Spot Poor Candidates Liam Jordan, Associate Editor How to weed out candidates who will be dissatisfied with these IOLs. 42 | Surgeons Share Their Views on IOLs Walter Bethke, Editor in Chief Opinions on monofocals, multifocals, torics and handling lens complications.

January 2018 | reviewofophthalmology.com | 9

009_rp0118_toc.indd 9 12/22/17 1:07 PM Departments

3 | Review News 12 12 | Refractive/Cataract Rundown RxLAL: Say Goodbye to Postop Surprise? A first look at the safety, efficacy and potential usage of the newly approved light-adjustable lens.

47 | Glaucoma Management Goniosynechialysis and Cataract Surgery An often underused procedure, GSL can be a significant contributor to pressure control.

52 | Retinal Insider A Look at Emerging Treatments for Uveitis Companies and researchers are hard at work on new drugs as well as innovative delivery systems. 52 57 | Research Review Corneal Marking for Toric IOLs

59 | Product News

60 | Classifieds

61 | Wills Eye Resident Case Series

65 | Ad Index 61

10 | Review of Ophthalmology | January 2018

009_rp0118_toc.indd 10 12/22/17 1:10 PM The Rick Bay Foundation for Excellence in Eyecare Education www.rickbayfoundation.org Support the Education of Future Healthcare & Eyecare Professionals

About Rick Scholarships are awarded to advance the education Rick Bay served as the publisher of students in both Optometry and Ophthalmology, of The Review Group for more than 20 years. and are chosen by their school based on qualities that embody Rick’s commitment to the profession, including To those who worked for him, he was integrity, compassion, partnership and dedication to the a leader whose essence was based greater good. in a ﬁ erce and boundless loyalty. Interested in being a partner with us?

To those in the industry and the Visit www.rickbayfoundation.org professions he served, he will be (Contributions are tax-deductible in accordance with section 170 of the Internal Revenue Code.) remembered for his unique array of skills and for his dedication to exceeding the expectations of his customers, making many of them fast friends.

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2015_rickbay_housead.indd 1 7/5/17 3:00 PM Refractive/Cataract

REVIEW Rundown Edited by Arturo Chayet, MD

RxLAL: Say Goodbye to Postop Surprise? A ﬁ rst look at the safety, efﬁ cacy and potential implementation of the newly approved light-adjustable lens. Walter Bethke, Editor in Chief

n the fall of 2017, the Food and through various studies, so it probably refraction is where the patient wants I Drug Administration approved helps to have a refresher on how the it, the surgeon then uses the Light RxSight’s (formerly Calhoun Vision) lens works: Delivery Device to perform a “lock- Light Adjustable Lens (RxLAL), in” exposure to the light energy which opening the fl oodgates for speculation stabilizes the fi nal lens power. on just how effective—and disrup- Sioux Falls, South Dakota, surgeon tive—this technology might prove to Vance Thompson, who participated in be. With the lens offering the abil- the study, explains the adjustment and ity to adjust a patient’s spherical and lock-in process further. After the UV cylindrical refractions post-implanta- light spatially polymerizes the pho- tion, would this mean obsessing over toreactive silicone, over the next two intraocular lens calculations, intra- days, through the process of diffusion operative aberrometry pros and cons the lens changes shape, he says. “So, and the myriad ways to mark the to- if you want an increase in curvature, ric axis would be quaint curiosities you illuminate the central portion of of the past? Though it’s a little early the lens, polymerizing more of the to pass judgment on those counts, in material,” he explains. “Then, there this article, surgeons who worked with will be an increase in thickness in that the lens in the clinical trial discuss its The RxLAL is a three-piece, fold- area. It does this very specifi cally, with performance, advantages and disad- able lens with a squared posterior very specifi c mathematics. If you want vantages, and the ways it might be optic edge; it’s made out of “photo- to take away power, you would expose integrated into ophthalmic practice. reactive silicone.” The last part of the the peripheral part of the optic, and description is key to the lens’s unique the unpolymerized material would The Technology operation: When it undergoes selec- diffuse to that area. This causes an in- tive exposure to UV light from Rx- crease in the peripheral curvature and Though the Light Adjustable Lens Sight’s proprietary Light Delivery takes away power from the optic. This has been available in Europe and Device, exposure produces modifi ca- can be done in a toric fashion, too— Mexico since 2008, information about tions in the lens curvature that result basically in whatever pattern you can the lens and interest in it the Unit- in spherical and/or spherocylindrical describe mathematically. You have ed States have waxed and waned for power changes postoperatively as the your shape change after two days, at more than a decade, as it made its way lens sits in the patient’s eye. When the which point you can schedule patients

12 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

012_rp0118_rcr.indd 12 12/22/17 1:49 PM MAKE XIIDRA YOUR FIIRST CHOICE 7 i>ÀÌwV>Ìi>ÀÃ>Ài½ÌiÕ} ]VÃ`iÀ«ÀiÃVÀL} 8`À>vÀÃÞ«Ì>ÌV ÀÞ Þi«>ÌiÌÃ°

Proven to treat the signs of inferior corneal Indication Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGFHQTVJGVTGCVOGPV staining in 12 weeks and symptoms of eye of signs and symptoms of dry eye disease (DED). dryness in 12, 6, and as little as 2. Xiidra helped provide symptom relief from Important Safety Information +PENKPKECNVTKCNUVJGOQUVEQOOQPCFXGTUGTGCEVKQPUTGRQTVGFKP eye dryness in some patients at week 2—and of patients were instillation site irritation, dysgeusia and reduced visual a measurable reduction in signs of inferior CEWKV[1VJGTCFXGTUGTGCEVKQPUTGRQTVGFKPVQQHVJGRCVKGPVUYGTG corneal staining in just 12 weeks. Consider blurred vision, conjunctival hyperemia, eye irritation, headache, increased :KKFTCVQJGNR[QWT&T['[GRCVKGPVUƂPFVJG lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis. relief they’ve been waiting for. To avoid the potential for eye injury or contamination of the solution, Check it out at Xiidra-ECP.com patients should not touch the tip of the single-use container to their eye or to any surface. Four randomized, double-masked, 12-week trials GXCNWCVGFVJGGHƂECE[CPFUCHGV[QH:KKFTCXGTUWU Contact lenses should be removed prior to the administration of Xiidra vehicle as assessed by improvement in the signs CPFOC[DGTGKPUGTVGFOKPWVGUHQNNQYKPICFOKPKUVTCVKQP (measured by Inferior Corneal Staining Score) and symptoms (measured by Eye Dryness Score) of Dry 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH[GCTUJCXG Eye Disease (N=2133). not been established.

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

Marks designated ® and ™>ÀiÜi`LÞ- ÀiÀ>>vw>Ìi`V«>Þ° ^Óä£Ç- Ài1-V°iÝ}Ì] ƂäÓ{Ó£-ÓnÇn{ 01/17

RP0118_Shire.indd 1 12/19/17 3:03 PM Animal Data .KƂVGITCUVCFOKPKUVGTGFFCKN[D[KPVTCXGPQWU +8 KPLGEVKQPVQTCVUHTQORTGOCVKPIVJTQWIJIGUVCVKQPFC[ ECWUGFCPKPETGCUGKPOGCPRTGKORNCPVCVKQPNQUU and an increased incidence of several minor skeletal CPQOCNKGUCVOIMIFC[TGRTGUGPVKPIHQNF Rx Only the human plasma exposure at the RHOD of Xiidra, based BRIEF SUMMARY: on AUC. No teratogenicity was observed in the rat at OIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV Consult the Full Prescribing Information for complete VJG4*1&DCUGFQP#7% +PVJGTCDDKVCPKPETGCUGF product information. incidence of omphalocele was observed at the lowest FQUGVGUVGFOIMIFC[ HQNFVJGJWOCP INDICATIONS AND USAGE RNCUOCGZRQUWTGCVVJG4*1&DCUGFQP#7% YJGP ® Xiidra NKƂVGITCUVQRJVJCNOKEUQNWVKQP KUKPFKECVGF CFOKPKUVGTGFD[+8KPLGEVKQPFCKN[HTQOIGUVCVKQPFC[U for the treatment of the signs and symptoms of dry eye through 19. A fetal No Observed Adverse Effect Level FKUGCUG &'& 01#'. YCUPQVKFGPVKƂGFKPVJGTCDDKV

DOSAGE AND ADMINISTRATION Lactation Instill one drop of Xiidra twice daily (approximately 12 6JGTGCTGPQFCVCQPVJGRTGUGPEGQHNKƂVGITCUVKPJWOCP JQWTUCRCTV KPVQGCEJG[GWUKPICUKPINGWUGEQPVCKPGT milk, the effects on the breastfed infant, or the effects on Discard the single use container immediately after using OKNMRTQFWEVKQP*QYGXGTU[UVGOKEGZRQUWTGVQNKƂVGITCUV in each eye. Contact lenses should be removed prior to HTQOQEWNCTCFOKPKUVTCVKQPKUNQY6JGFGXGNQROGPVCNCPF VJGCFOKPKUVTCVKQPQH:KKFTCCPFOC[DGTGKPUGTVGF JGCNVJDGPGƂVUQHDTGCUVHGGFKPIUJQWNFDGEQPUKFGTGF minutes following administration. along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from ADVERSE REACTIONS Xiidra. Clinical Trials Experience Pediatric Use Because clinical studies are conducted under widely 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH varying conditions, adverse reaction rates observed in [GCTUJCXGPQVDGGPGUVCDNKUJGF clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may Geriatric Use PQVTGƃGEVVJGTCVGUQDUGTXGFKPRTCEVKEG+PƂXGENKPKECN No overall differences in safety or effectiveness have been UVWFKGUQHFT[G[GFKUGCUGEQPFWEVGFYKVJNKƂVGITCUV observed between elderly and younger adult patients. ophthalmic solution, 1401 patients received at least FQUGQHNKƂVGITCUV QHYJKEJTGEGKXGFNKƂVGITCUV 6JGOCLQTKV[QHRCVKGPVU JCFŰOQPVJUQH NONCLINICAL TOXICOLOGY VTGCVOGPVGZRQUWTGRCVKGPVUYGTGGZRQUGFVQ Carcinogenesis, Mutagenesis, Impairment of Fertility NKƂVGITCUVHQTCRRTQZKOCVGN[OQPVJU6JGOCLQTKV[ Carcinogenesis: Animal studies have not been conducted QHVJGVTGCVGFRCVKGPVUYGTGHGOCNG 6JGOQUV VQFGVGTOKPGVJGECTEKPQIGPKERQVGPVKCNQHNKƂVGITCUV EQOOQPCFXGTUGTGCEVKQPUTGRQTVGFKPQHRCVKGPVU Mutagenesis: .KƂVGITCUVYCUPQVOWVCIGPKEKPVJGin vitro #OGUCUUC[.KƂVGITCUVYCUPQVENCUVQIGPKEKPVJG were instillation site irritation, dysgeusia and reduced in vivo XKUWCNCEWKV[1VJGTCFXGTUGTGCEVKQPUTGRQTVGFKP mouse micronucleus assay. In an in vitro chromosomal VQQHVJGRCVKGPVUYGTGDNWTTGFXKUKQPEQPLWPEVKXCN aberration assay using mammalian cells (Chinese JCOUVGTQXCT[EGNNU NKƂVGITCUVYCURQUKVKXGCVVJGJKIJGUV hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus concentration tested, without metabolic activation. .KƂVGITCUVCFOKPKUVGTGFCV and sinusitis. Impairment of fertility: KPVTCXGPQWU +8 FQUGUQHWRVQOIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCVVJG USE IN SPECIFIC POPULATIONS TGEQOOGPFGFJWOCPQRJVJCNOKEFQUG 4*1& QH Pregnancy NKƂVGITCUVQRJVJCNOKEUQNWVKQP JCFPQGHHGEVQP 6JGTGCTGPQCXCKNCDNGFCVCQP:KKFTCWUGKPRTGIPCPV fertility and reproductive performance in male and women to inform any drug associated risks. Intravenous female treated rats. +8 CFOKPKUVTCVKQPQHNKƂVGITCUVVQRTGIPCPVTCVUHTQO RTGOCVKPIVJTQWIJIGUVCVKQPFC[FKFPQVRTQFWEG teratogenicity at clinically relevant systemic exposures. +PVTCXGPQWUCFOKPKUVTCVKQPQHNKƂVGITCUVVQRTGIPCPV /CPWHCEVWTGFHQT5JKTG75+PE5JKTG9C[.GZKPIVQP/# rabbits during organogenesis produced an increased (QTOQTGKPHQTOCVKQPIQVQYYY:KKFTCEQOQTECNN incidence of omphalocele at the lowest dose tested, OIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV Marks designated ®CPFvCTGQYPGFD[5JKTG the recommended human ophthalmic dose [RHOD], QTCPCHƂNKCVGFEQORCP[ DCUGFQPVJGCTGCWPFGTVJGEWTXG=#7%?NGXGN 5KPEG 5JKTG75+PE JWOCPU[UVGOKEGZRQUWTGVQNKƂVGITCUVHQNNQYKPI 752CVGPVU ocular administration of Xiidra at the RHOD is low, the CRRNKECDKNKV[QHCPKOCNƂPFKPIUVQVJGTKUMQH:KKFTCWUGKP CPFRGPFKPIRCVGPVCRRNKECVKQPU humans during pregnancy is unclear. .CUV/QFKƂGF5

RRP0118_ShireP0118_Shire PPI.inddI.indd 1 112/19/172/19/17 3:063:06 PMPM Refractive/Cataract

REVIEW Rundown

for the lock-in, which we did at three says that 99.7 percent of the patients tremely stable,” Dr. Thompson says. days postop in the clinical trial. At saw 20/40 or better uncorrected post- “Even though other lenses can ro- that three-day postop point, you can op, and 91.6 percent were 20/25 with- tate in the early postop period, they’re do the lock-in or another adjustment, out glasses. “Getting 91.6 percent of typically stable by three weeks due to if necessary [two adjustments were patients to 20/25 or better has never capsular contraction. But with this, allowed in the trial]. The lock-in step happened before in cataract surgery we’re not adjusting it until the three- involves illuminating the entire lens. in any FDA-monitored study,” Dr. week mark, so it’s not only very stable, After the lock-in, the whole lens is Thompson avers. “These are LASIK- it’s locked in [place].” polymerized.” like results. The lens has some potential pitfalls, To decrease the chances of ambient “After the adjustment, 92 percent as well, though. “The primary prob- UV light affecting the lens before the of the patients were within 0.5 D of in- lem we had in the study was getting lock-in step, the protocol requires the tended, and 99.5 percent were within patients’ pupils large enough to do the patients to wear UV-blocking glasses, 1 D,” Dr. Thompson continues. “On light adjustments,” recalls Dr. Miller. mostly while outdoors. “We had zero average, there were 1.65 adjustments “You have to be able to see the full issues with patients complying with required. If I wanted to perform post- 6-mm diameter of the lens in order that requirement,” Dr. Thompson op PRK or LASIK, in comparison, to do them. That means the patient says. “When you tell a patient that, I’d need to wait three months for the has to dilate to a minimum of 6.5 to for the fi rst time ever, we can custom- wound to stabilize. With this, since 7 mm. But some patients can’t dilate ize the implant in his eye to his visual we’re adjusting the power of the optic, very well—they only dilate to about needs, but in order to do that we need we can start at three weeks postop.” 5 mm. So, for them, if there’s a 6-mm a little bit of healing, and a little bit of In terms of the toric adjustment, 82 lens in there, there will be a portion light adjustment until we fully lock in percent of subjects had no more than of the lens that you can’t treat; some the lens, and he needs to protect his 0.5 D of astigmatism at six months, of the molecules are hiding out in the eyes from the sun, the patient usually and 98.5 percent had no more than periphery and you can’t treat them. says that it’s no problem.” 1 D. There were zero postop rotations due to axis misalignment. “It’s ex- (Continued on page 66) Lens Performance Light-Adjustable Lens Specifi cations1 In the FDA study of the lens, 390 eyes were implanted with the Rx- LAL, while 195 received a traditional Lens Optic monofocal lens and acted as a control • Material: Photoreactive UV-absorbing group. The RxLAL group was actually silicone targeted for slight hyperopia. • Light transmission: UV cut-off at 10 percent T 385 ±2 nm for all lens “The FDA wanted to see if the tech- powers nology actually worked,” says Kevin • Index of refraction: 1.43 Miller, MD, professor and chair of • Power: +10 to +15.0 D and +25.0 to ophthalmology at UCLA’s David Gef- +30.0 D in 1-D increments; fen School of Medicine. Dr. Miller +16.0 to +24.0 D in 0.5-D increments also participated in the RxLAL trial. • Optic type: Biconvex “In the clinical trial, we were forced to • Optic edge: Square on posterior surface leave the patients with some hypero- and round on anterior surface pia—+0.5 or +0.75 D or so—because • Overall diameter: 13 mm • Optic diameter: 6 mm it’s easier to take them in the myopic direction than the hyperopic direc- Haptics tion. So, the patient’s impression of his • Confi guration: Modifi ed C vision in the fi rst three weeks would • Material: Blue core polymethylmetha- be, ‘It’s OK, but it’s not great.’ Then, crylate (PMMA) monofi lament when we’d do the first adjustment, • Haptic angle: 10 degrees three or five days later they’d say, ‘Whoa! My vision’s so much better!’ ” Citing the study, Dr. Thompson

January 2018 | reviewofophthalmology.com | 15

012_rp0118_rcr.indd 15 12/22/17 1:49 PM IOL Power Formulas REVIEW Cover Story IOL Power Formulas: 10 Questions Answered

By Christopher Kent, Senior Editor

Understanding ew subjects in the ﬁ eld of oph- yet many surgeons continue to use thalmology are as complex the older ones. To understand how how formulas Fas the formulas surgeons use much difference switching to a more to predict the best intraocular lens advanced formula can make, it’s im- calculate the power for a given patient. As at least portant to look at outcomes. one expert has noted, creating and Warren E. Hill, MD, medical di- optimum lens improving upon these formulas is a rector of East Valley Ophthalmology job best managed with the help of in Mesa, Arizona, and creator of the power can help physicists, mathematicians and optical Hill-RBF formula, is in a unique posi- engineers. Nevertheless, these formu- tion to compare the outcomes of sur- ensure good las are an essential part of performing geons using old or new formulas, since outcomes. cataract surgery. he’s reviewed data from more than Understandably, most surgeons like a quarter-million surgeries (mostly being able to simply plug numbers calculated using the older formulas). into a machine or an online calculator “After the removal of outliers, and fol- that does the work and produces an lowing lens-constant optimization, the answer, without the surgeon having to average ophthalmologist gets about worry about the details. Nevertheless, 78 percent of patients within ±0.5 D the better we understand something, of the target refraction,” he says. “Six the more likely we are to use it to its percent of surgeons are at 84 percent best advantage. With that in mind, or better. Fewer than 1 percent of four experts in this area, all known for surgeons in that database are at 92 their work developing IOL power for- percent or better. Different studies mulas, share their answers to 10 ques- around the world have found rates tions a clinician might ask about these ranging from 55 to 80 percent. So 71 formulas, covering issues such as how to 80 percent is sort of the accept- they work; how best to use them; and able range. That’s what most people what the future may hold. achieve using the older formulas. “Now, as we begin to see the newer Is it so bad to just keep using biometers and newer formulas, like 1 the older formulas? the Barrett and Hill-RBF, being used Most surgeons today are aware that by surgeons who also take their time the more recent formulas are capable making the measurements and then of producing more accurate power apply validation criteria, that’s chang- predictions than the older formulas, ing,” he continues. “We’re starting

16 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

0016_rp0118_f1.indd16_rp0118_f1.indd 1616 112/22/172/22/17 1:171:17 PMPM Uday Devgan, MD, FACS to see physician databases in las that you have a lot of confi - the 90-percent range. Two or dence in, but there’s really no three years ago, only 1 or 2 reason to plug your numbers percent of surgeons achieved into four or fi ve formulas and that; now everybody can po- try to average them,” he says. tentially reach that level. He notes, however, that “This is a huge sea change he sometimes finds it useful in the accuracy of lens-power to compare the predictions calculation,” he notes. “We’re of his own formula and the all creatures of habit, but for- Hill-RBF formula. “Mine is tunately, surgeons are begin- basically a theoretical, par- ning to switch to the newer axial ray-tracing formula—al- formulas—what we jokingly though there is an element refer to as ‘formulas from of data-driven enhancement this century.’ An 80-percent as well, so in that sense it’s a ±0.50 D accuracy level is Post-refractive-surgery eyes are particularly challenging in hybrid,” he explains. “War- acceptable, but 90-percent terms of predicting ideal IOL power because the alterations to ren’s formula, the Hill-RBF, ±0.50 D accuracy is now the cornea created by the refractive surgery disrupt the anterior is purely data-driven, using achievable. We should always corneal curvature and invalidate correlations that would artificial intelligence. These otherwise help the surgeon estimate posterior corneal curvature strive for what’s achievable.” and effective lens position. two formulas tackle the same Graham D. Barrett, MD, a problem from very different clinical professor of ophthalmology at improved our outcomes. However, we directions. So it’s quite nice to com- the Lions Eye Institute and the Uni- still don’t have one formula that we pare those two distinctive method- versity of Western Australia, consul- can always rely upon in every case. You ologies when you look at a particular tant to the ophthalmology department can choose to use just one formula, patient. It’s fascinating how often they at Sir Charles Gardiner Hospital, in like the Barrett or Hill formulas, and come up with a similar prediction, Perth, Australia, and creator of the you’ll get great results. But at least for when they couldn’t be more different Barrett Universal II formula, agrees. the time being, there are certain eyes in how they go about doing the job.” “There’s good data to show that the that remain problematic, even using Dr. Hill agrees that if you’re deter- latest generation of formulae, wheth- the most advanced formulas. And the mined to compare two formulas in a er it’s mine, the Olsen, Hill-RBF or predictions made by those formulas given situation, the Barrett Universal Holladay II, outperform the earlier can still be off, even in ‘normal’ eyes.” II and Hill-RBF might be good choic- generation of formulae,” he says. “Sur- Dr. Koch says that’s why he still plugs es. “That’s true for several reasons,” geons who are still using the earlier- his numbers into multiple formulas, he notes. “First, they’re both current. generation formulae can certainly do even in unexceptional eyes. “I’ve been Second, they’re far more sophisticat- better for their patients.” burned by all of the formulas, in terms ed than anything that’s come before. of errors,” he says. “Postoperative sur- Third, they use completely differ- Should I plug my numbers prises are not the exclusive territory ent premises. Dr. Barrett’s formula is 2 into multiple formulas and of one formula; I’ve seen it with ev- based on Gaussian optics; the predic- compare the results? ery single one of them. So in routine tions made by Hill-RBF are derived This question is one of the few that eyes I typically run the Holladay I, the using artifi cial intelligence. What’s re- evokes a range of opinions from the Barrett and the Hill. If one of them markable is that both of these methods experts. Douglas D. Koch, MD, pro- differs from the others, I tend to lean often give recommendations that are fessor and Allen, Mosbacher, and Law toward the other two in my IOL selec- within 0.25 D of each other. What this Chair in Ophthalmology at the Cul- tion. Some may think this is no longer suggests is a convergence of technolo- len Eye Institute, Baylor College of necessary, but we keep track of our gies. We’re arriving at something that’s Medicine in Houston, employs mul- surgical outcomes: We’re getting 90 very close to the right answer using tiple formulas. “Today we have some percent of our patients within ±0.5 D.” completely different approaches.” formulas that often do much better on Dr. Barrett says he doesn’t believe Dr. Hill adds an important point all kinds of eyes than in the past,” he that averaging the predictions of mul- regarding the use of multiple formulas says. “That’s a really fantastic advance tiple formulas is necessary anymore. for comparison. “If you’re in a situa- for us. They’ve all raised the bar and “It may be worth looking at two formu- tion in which every formula might run

January 2018 | reviewofophthalmology.com | 17

016_rp0118_f1.indd 17 12/22/17 1:17 PM Cover IOL Power Formulas

REVIEW Story

into trouble and you want to compare is based on big data. Finally, there are In fact, a recent article in Ophthalmol- the results, at least make sure the for- formulas based on ray-tracing. These ogy showed that the Barrett formula, mulas you’re using are well-suited to include the Olsen formula and one on average, ends up producing the the task,” he says. “For example, take from Germany called Okulix, which best outcomes.”1 the extreme axial myope. There are has not been as well distributed. Other Dr. Hill explains how his formula, three formulas that do very well with ray-tracing-based formulas exist, but which bases its predictions on the those eyes: the Wang-Koch modifi ca- to the best of my knowledge they’re analysis of hundreds of thousands of tion of Holladay I; the Barrett Uni- not commercially available. actual outcomes, differs from the al- versal II formula; and the expanded ternatives. “With the theoretical for- version of Hill-RBF. Comparing the mulas, you enter your numbers and predictions made by those three for- get a power prediction,” he notes. mulas makes sense because all three “If you’re going to “Then, you implant the lens and hope of them are uniquely suited to this for the best. My method is different. particular task. You wouldn’t use an switch to a more First of all, it’s not actually a formula; uncorrected version of SRK/T with an advanced formula, it’s an artifi cial intelligence algorithm. extreme axial myope—or an extreme “Because it works in this way, it can hyperope—because it doesn’t do a make sure you have a generate an internal validation process good job in those situations. If you add device that can take based in multiple pair-wise boundary formulas that don’t do well into the models,” he continues. “Stated differ- mix, all you’re doing is adding math- advantage of it.” ently, this calculation method is self- ematical noise.” — Douglas Koch, MD validating; you not only get an IOL power, you also get an indication of the How are the newer formulas calculation’s accuracy. Using boundary 3 different from each other? models, the Hill-RBF can estimate With an ever-increasing number of “The advantage of a ray-tracing for- the likelihood of ending up within formulas appearing over time, it’s be- mula over a standard vergence for- ±0.5 D of your target. (See examples, come common practice to categorize mula is that it takes into account the p. 20 and 21.) them by order of appearance: first- asphericities and other aberrations “For example, if you go to the on- generation; second-generation; and of the cornea and the lens implant,” line calculator at RBFCalculator.com so forth. However, Dr. Koch says he he explains. “Vergence formulas use and put in a sample case, you’ll either believes this isn’t very useful. “I think an average value for those factors. get an ‘in bounds’ or ‘out of bounds’ we should label formulas in terms of As a result, a ray-tracing formula will indication,” he explains. “ ‘Out of how they calculate the IOL power,” have some advantages in terms of bounds’ means that, at present, the he says. “For example, there are re- understanding the power of the IOL artifi cial intelligence database doesn’t gression formulas, such as the SRK/T. and cornea that you’re not going to have enough data paralleling your Then there are vergence formulas, get with a vergence formula. How- specific case to support the calcula- based on regular optics. The most ever, ray-tracing formulas have not tion at a 90-percent accuracy level. commonly used vergence formulas in- achieved their full potential because On the other hand, if you get an ‘in clude the two Holladay formulas; the they still depend on an accurate esti- bounds’ indication, that means the Hoffer Q; the SRK/T; the Haigis; and mate of effective lens position. Until system has enough data and experi- the Barrett formulas. That group can we do a better job of knowing where ence to support a 90-percent ±0.50 D be further classifi ed by the number of the implant is going to sit in the eye, level of accuracy. It’s the fi rst time in variables they incorporate. The ones we’re not going to achieve better than ophthalmology that something like that most doctors use—the Holladay 85- or 90-percent accuracy. this has been offered.” Dr. Hill notes I, SRK/T and Hoffer Q—only use two “Despite that limitation, the ray- that validating boundary models are variables. The Haigis uses three vari- tracing approach is very promising for frequently used in other fi elds. “We’re ables. Barrett uses fi ve, and the Hol- the future,” he concludes. “That’s what combining ophthalmology with math- laday II uses seven. I believe we’ll end up using in the long ematical tools that are commonly used “A third category is formulas based run. However, at their current level of in engineering,” he explains. on artifi cial intelligence,” he contin- development those formulas are not Dr. Hill says it took seven years to ues. “Currently, the only formula in outperforming the standard ones, so develop the Hill-RBF method in its that category is the Hill-RBF, which people don’t have a reason to switch. present form. “This was a team ef-

18 | Review of Ophthalmology | January 2018

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RP0118_Oculus.indd 1 12/19/17 2:39 PM Cover IOL Power Formulas

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fort involving 39 investigators in 19 countries, with Doug Koch, MD, and Li Wang, MD, PhD, at Baylor Uni- versity; Adi Abulaﬁ a, MD, in Tel Aviv, Israel; David Goldblum, MD, at the University of Basel in Switzerland; and the engineers and mathematicians at MathWorks as our core investigators,” he says. “The engineers and mathematicians at MathWorks did the heavy lifting for algorithm development.”

If I want to switch to a better 4 formula, how do I choose? Dr. Hill says the first thing to do when choosing a new formula is to listen to people who have experience in this area. “Surgeons shouldn’t make these kinds of decisions in a vacuum,” The Hill-RBF method is an artifi cial intelligence algorithm that bases its predictions on he says. “Go to meetings. Take CME. large amounts of previous surgical data. It’s self-validating, using six data pairings to rate the probable accuracy of its lens-power prediction. The label “in bounds” means its Join the ASCRS discussion group—a database has suffi cient data to confi rm that its prediction is likely to be accurate; the label very good way to stay current in this “out of bounds” indicates that it cannot make that guarantee. (Continued on facing page) area. Reading the literature is helpful too, but be careful: Some of what’s he says. “The IOLMaster 500 doesn’t selection of the appropriate power been published isn’t grounded in good measure lens thickness, for example, and result in better alignment of toric data. Studies need to have a large, so you can’t avail yourself of the more IOLs. The newest generation swept- clean database, with standards for re- sophisticated aspects of the Barrett source OCT devices also do a pretty fraction and validation criteria applied or Olsen formulas. You can use the remarkable job of penetrating through to the measurements.” Hill-RBF formula, because it doesn’t dense cataracts. That means you won’t Dr. Barrett points out that several require lens thickness. But if you want need to rely as much on ultrasound recently published papers have com- to make the best use of the Barrett when dealing with a posterior subcap- pared almost every formula that’s out and Olsen formulas you need to up- sular or dense cortical cataract. That’s there in a comprehensive fashion. grade to either the Lenstar or the new a double plus. Using a more advanced “Doctors can discern from the pub- swept-source devices: the IOLMaster instrument can make a big difference lished data which formulae tend to 700, Tomey’s OA-2000 optical biom- in outcomes.” be most accurate,” he says. “As you eter, the Argos from Movu, or, in the might expect, I prefer to use my own, future, the new Lenstar. All of these What’s the best way to deal but it’s up to the ophthalmologist to be devices are very fast and effi cient, and 5 with very short or long eyes? familiar with what’s been published they measure lens thickness in addi- Unusual eyes are still problematic and combine that with his or her own tion to the other parameters. when it comes to predicting the best experience to make a decision.” “This practical concern means that IOL power, and extreme axial lengths Dr. Hill adds that if a surgeon wants moving to a better formula is a two- are among the more challenging cases. to use only one formula, he recom- part process,” he continues. “You also “In the past it was common practice mends the Barrett Universal II. “In need to move forward with the devices to use specifi c formulae for different my opinion, it’s the best theoretical you’re using. Of course, doing so will axial lengths, because some formulae formula currently available,” he says. have other benefi ts as well: By tran- seemed to produce better outcomes “I believe it’s the standard.” sitioning from the IOLMaster 500 to in these subgroups,” says Dr. Barrett. Dr. Koch raises an important practi- one of the newer devices, for example, “And it’s not just axial length that can cal point. “If you’re going to switch to a you’re going to increase the accuracy challenge formulae; a very fl at or steep more advanced formula, the fi rst thing of your corneal power measurements, K can be a source of prediction error you need to do is make sure you have particularly with regard to astigma- if a formula is not really designed to a device that can take advantage of it,” tism. That will help to improve your manage those situations. However,

20 | Review of Ophthalmology | January 2018

016_rp0118_f1.indd 20 12/22/17 1:18 PM Warren E. Hill, MD

Over time, as the data bank grows larger, cases that would have been “out of bounds” become “in bounds.” For the case shown above, when the database contains 3,445 eyes (facing page), two of the six data pairs fall out of bounds (circled red dots). But when more eyes are added to the database (above), all six data pairs now fall within the boundaries covered by the larger database, meaning the new prediction is very likely to be accurate. most of the latest-generation formu- sition, and none of our formulas have lae, which some refer to as fourth- or enough data to do a great job of pre- fifth-generation, perform quite uni- dicting this. In fact, in my experience, formly, even when dealing with short these eyes produce the least accurate or long eyes or fl at or steep Ks. As a outcomes, regardless of which formula result, I don’t believe the practice of you use. We’ve actually found the Hol- using a different formula for differ- laday I to be just as good in these eyes ent types of eyes is as prevalent today. as any of the so-called advanced for- Most surgeons select their preferred mulas. up-to-date formula and are quite hap- “The typical error that I see in a py to use it throughout the full range short eye is an unexpectedly myopic of axial lengths.” outcome,” he continues. “The result However, Dr. Barrett admits that could be off in either direction, but the even the best formula can run into big surprises are usually on the myopic trouble with very short eyes. “There side, where the IOL ends up sitting are reasons for this,” he points out. more anteriorly than anticipated. In “For one thing, small errors in mea- fact, this outcome occurs primarily— surement have a much greater impact though not predictably—in those eyes in short eyes. Also, we still don’t know that have a shallow anterior chamber for certain the exact parameters of a preoperatively. One issue is that we given manufactured lens, and small still don’t know whether the anterior differences have a greater impact in a chamber shallowness is an anatomical short eye because the lens has a much feature of the eye, or whether it has higher power than in an average or something to do with increased lens long eye.” thickness that has occurred with aging Dr. Koch agrees. “Short eyes still and the development of the cataract. remain a major source of diffi culty,” he All of the formulas try to fi gure this says. “These eyes are very susceptible out; particularly the Holladay II, Bar- to small variations in effective lens po- rett and Olsen. But errors are com-

016_rp0118_f1.indd 21 12/22/17 1:18 PM Cover IOL Power Formulas

REVIEW Story

The Importance of Correcting Astigmatism

Graham D. Barrett, MD, a clinical professor of ophthalmology T2-equivalent toric lenses—lenses that can address less than 1 D at the Lions Eye Institute and the University of Western Australia, of astigmatism—are not yet approved. In the U.S., surgeons still and creator of the Barrett Universal II formula, says that in today’s utilize limbal relaxing incisions for those low levels of astigmatism. world, it’s preferable not to leave patients with signiﬁ cant residual “In reality,” he continues, “low-level toric IOLs are a much more astigmatism. “Here in Australia about 50 percent of the lenses we effective way to deal with low levels of astigmatism—although implant are toric IOLs,” he notes. “In my own practice, about 80 using those lenses means that your measurements and predic- percent of the lenses I implant are torics. It’s a paradigm shift. Just tions and formulae have to be quite sophisticated.” as you care about ensuring that patients have a spherical outcome Jack T. Holladay, MD, MSEE, FACS, the developer of the Holla- that’s as close to plano as possible, you also want your patients to day I, II and Refractive formulas, agrees that astigmatism needs to end up with less than 0.5 D of astigmatism. That’s the threshold be addressed. “Seventy-two percent of eyes having cataract sur- at which astigmatism becomes symptomatic. If you accept this gery have 0.5 D or more corneal astigmatism and would beneﬁ t premise, then using toric IOLs will be required in about 80 percent from a toric IOL,” he notes. “The toric calculators we recommend of patients undergoing cataract surgery.” are the AMO online calculator, the open-access toric calculator Dr. Barrett notes that while this philosophy is fairly well-accept- at hicsoap.com under the Calculator tab, and the Holladay IOL ed in Australia, it has stalled somewhat in Europe and the United Consultant software. These are based on vergence formulas and States. “That’s partly because of cost issues,” he says. “Here in have equally good toric results for long or short eyes, and for low Australia, toric lenses are reimbursed by private insurance, which or high IOL powers.” isn’t always true in other countries. Also, in the United States, —CK

mon. So in that kind of situation, I actually is in these eyes. Jack T. Holla- erage, a myopic error, and confi rming believe it’s still good to plug your num- day, MD, MSEE, FACS, the develop- that it is rather aggressive,”4 he notes. bers into more than one formula and er of the Holladay I, II and Refractive “I then used the 14,000 cases in the compare the results.” formulas, notes that there’s a tendency study to generate nonlinear equations Dr. Koch says that when he’s work- to end up with a hyperopic surprise for both the Holladay I and II formu- ing with a short eye, he plugs the num- when dealing with eyes deeper than 24 las in long eyes. “The results are less bers into fi ve different formulas. “I use mm. “Factors such as optical biometry aggressive than the 1-center study, the Holladay I, Holladay II, Barrett, using an average index of refraction producing equal myopic and hyper- Olsen and Hill formulas,” he says. “I for the entire eye, or the shape of the opic errors. The regression begins at look at all of their predictions and se- IOL, still can’t account for the eye be- 24 mm—the arithmetic mean of the lect a median value among those fi ve.” ing measured as longer than it actually axial lengths—and has no upper limit. Long eyes can also be challenging. is,” he says. “So far, no one has been Therefore, in long eyes, we recom- “In terms of long eyes, results have able to explain this error, but whatever mend using the Holladay II formula vastly improved with recent advances, the cause is, we can compensate for it with the Holladay nonlinear regres- beginning with the Wang-Koch for- by using regressions, fudge factors and sion. This combination can be found, mula, and, more recently, Hill and adjustments to our formulas. open-access, at hicsoap.com under Barrett,” notes Dr. Koch. “Studies “Doug Koch and Li Wang were the the Calculator tab. It’s also part of the have shown mixed outcomes with re- first to report the axial length mea- Holladay IOL Consultant software gard to which of the three is better surement problem in long eyes,” he and is being implemented in the IOL- in this situation. Fram and Masket continues. “They published a study Master. found the Wang-Koch formula to be presenting two regressions [to help “Eventually,” he concludes, “this more accurate;2 it is a bit more aggres- compensate for this], referred to as type of adjustment will evolve to com- sive in that it’s less likely to leave eyes the ‘1-center’ and ‘2-center’ regres- pensate for variations in all of the vari- hyperopic, but it’s a bit more likely to sions.3 They recommend using the ables—axial length, K-readings, an- produce mild postoperative myopia. It 1-center regression, which is the more terior chamber depth, lens thickness is still our go-to.” aggressive of the two. and white-to-white length—to further The problem appears to have a lot “We recently published an article reduce outcome errors.” to do with biometry tending to mea- in Ophthalmology demonstrating that Dr. Hill adds that there’s a lot of sure the axial length as longer than it using this regression produces, on av- “conventional wisdom” that comes

22 | Review of Ophthalmology | January 2018

0016_rp0118_f1.indd16_rp0118_f1.indd 2222 112/22/172/22/17 1:181:18 PMPM with the older formulas regarding prediction in post-refractive-surgery which one should be used with a given eyes challenging,” he says. “First of all, type of eye—much of which is incor- these are usually long eyes, so the axial rect. “For example, many surgeons length must be adjusted using a re- use the Hoffer Q formula for short gression formula. Second, the cornea eyes, when actually Holladay I may has been altered, so standard kera- do a better job,” he says. “For some tometry is no longer accurate. Third, reason it got stuck in everybody’s head the current K can’t be used to estimate that you’re supposed to use Hoffer the effective lens position. Instead, we Q. In any case, the newer calculation need to use the K that was measured methods like Barrett and Hill-RBF do before the cornea was altered, often much better in those eyes.” referred to as the Double K method.” Dr. Koch says that if you’re faced What’s the best way to man- with a post-refractive-surgery eye, he 6 age post-refractive-surgery recommends getting as many mea- eyes? surements as you can and using for- “The post-refractive-surgery eye re- mulas found on the ASCRS website. mains a disappointing proposition, in “We like several formulas,” he notes. the sense that we’re still only getting “We use the Masket formula if we 70 to 75 percent of these eyes within know the change in refraction caused ±0.5 D,” says Dr. Koch. “I think that by the previous refractive surgery. We will improve in the future as we see like the Barrett and the Haigis formu- more patients who’ve had more uni- las, and we often use the RTVue OCT form ablations, making it a little easier formula. If you have two or three for- to measure corneal power.” mulas whose results cluster together, Why are post-refractive surgery those are more likely to be accurate. Extremely Fast with eyes so problematic? Dr. Koch notes We also use intraoperative aberrom- Accurate Measurements three challenges. “The ﬁ rst challenge etry.” He notes, however, that despite is knowing what anterior corneal cur- having all of these options, he’s seen Variable Target Illumination vature to select, due to variability in signiﬁ cant errors with every formula. with Automatic Dimming this dimension,” he says. “Second, it’s “When faced with eyes that have very difficult to accurately measure undergone prior refractive surgery, I’d for Small Pupil posterior corneal curvature in these recommend using the online ASCRS eyes. In a normal eye you can fairly ac- calculator that Doug Koch, Li Wang Central and Peripheral curately predict the posterior corneal and I created,” says Dr. Hill. “That’s Keratometry (3.2 and 6.8) curvature from the anterior curvature, become a very popular tool for this but those assumptions break down purpose. In addition, surgeons should after you change the anterior corneal stay current with the literature. There 5.7” Touch Panel with curvature with refractive surgery. That have been a series of recent articles 45° Tilt Function same caveat also applies to using a discussing how to get the best results toric lens in a post-LASIK eye. Fi- with these eyes.” Cornea Diameter nally, the effective lens position calcu- Dr. Barrett notes that there are a Measurement (0-16mm) lation is more challenging, since most multitude of formulas that can be formulas use corneal power in their applied with these patients. “Once equations to estimate ELP.” again, you have to look at the pub- Retro Illumination for Dr. Holladay agrees that the prob- lished data,” he says. “Some formu- Cataract Observation lem is not the IOL formula itself, but lae do better than others with these the axial length and corneal power eyes. What a lot of people do is look at measurements that are being used, the online ASCRS calculator, because as well as the estimate of the effective the authors of that—Doug Koch, Li lens position. “As a result, there are Wang and Warren Hill—critically ex- three factors that make lens-power amine the formulae they include and

016_rp0118_f1.indd 23 12/22/17 1:18 PM Cover IOL Power Formulas

REVIEW Story

limit them to the ones that Rachel Trussart, MD, FRCSC the fi rst question to ask is: they’ve found provide bet- Will the silicone eventu- ter outcomes, so you don’t ally be removed? “I usu- have to choose between 15 ally assume the patient is or more different formulae. going to have the silicone “Personally, I tend to use oil removed, but I verify my own formula because this with the retinal sur- it can be used for myopic, geon,” he says. “Also, most hyperopic and radial kera- of these eyes have limited totomy eyes,” he contin- visual potential, which ues. “Also, it can be used must be discussed with the with or without the history patient. of the change in refraction “Fortunately, most op- that was produced by the tical biometers measure refractive procedure. If you eyes with silicone oil with do know the pre- and post- minimal difficulty,” he Eyes containing silicone oil are problematic because the oil has a LASIK, -PRK or -RK re- different refractive index that must be accounted for in the power continues. “If you use ul- fractions, the outcomes will calculation—unless the surgeon is certain that the silicone oil will be trasound, then you have to tend to be even more ac- removed soon after the cataract surgery. use immersion ultrasound curate; but if you don’t, the and segment the eye, in- True K formula still gives you a pretty from the procedure, often referred to serting the refractive index for that good prediction.” as the historical method, is still the gold particular silicone oil when you’re cal- “The most robust method for esti- standard for estimating the current culating the axial length. Of course, if mating the effective corneal power is corneal power. “If the pre-refractive you leave the silicone oil in and put in with topography/tomography where Ks were accurate and the refractive a standard IOL, the patient is going to one uses thousands of points on the change is stable—which is normally be very hyperopic until the silicone oil front and back of the cornea to es- true for LASIK, though not for RK— is removed. But being hyperopic for timate the ELP,” says Dr. Holladay. then this method works well,” he says. a brief period will be worth it for the “Our group prefers the EKR65 mea- “However, if the refraction has been patient in the long run.” surement in the Pentacam’s Holladay affected by lenticular changes caused “Luckily,” notes Dr. Barrett, “en- report. This uses more than 10,000 by the cataract, it doesn’t work.” countering an eye with silicone oil is points on the front and back of the cor- not a common occurrence, and re- nea to determine the effective power What’s the best way to man- moving the oil prior to cataract surgery over a 4.5-mm zone. Results have 7 age an eye with silicone oil? will avoid the complexities of formulae demonstrated a standard deviation Dr. Barrett notes that predicting prediction.” of ±0.56 D for LASIK and ±0.96 D the correct IOL power in an eye that for RK. Sixty-seven percent of the cas- contains silicone oil is challenging. Does using a toric lens alter es will be within this tolerance.” “The problem with optical biometry 8 the spherical correction? Dr. Holladay notes that different in this situation is that the refractive “An astigmatism correction [in the post-refractive formulas take the cor- index is different for a lens facing a IOL] shouldn’t affect the spherical neal refractive error caused by various medium of silicone oil, resulting in calculation signifi cantly,” says Dr. Bar- amounts of treatment and generate inaccurate predictions,” he says. “That rett. “In theory this could be an issue, a formula to compensate for that er- makes determining the required lens because an astigmatism correction ror. “The results will depend on the power quite complex. Using a convex could potentially alter the lens struc- specifi c laser used for the treatment, plano lens, in which the back surface ture and the principal planes, impact- since that will affect the postoperative of the lens is plano, will help because ing the spherical correction. However, shape of the cornea,” he points out. the silicone oil won’t impact the cal- the manufacturer can compensate for “Those formulas can work well for a culation of required IOL power to that. The more sophisticated compa- specifi c laser.” the same extent. Unfortunately, those nies utilize optic designs that ensure Dr. Holladay adds that using the K lenses are hard to fi nd.” that the principal planes of the lens that was measured before the cornea Dr. Koch suggests that when you remain equivalent for a given spheri- was altered and the refractive change encounter an eye with silicone oil, cal-equivalent lens power, regardless

24 | Review of Ophthalmology | January 2018

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Indications and Usage BromSite® (bromfenac ophthalmic solution) 0.075% is a perforation. Patients with evidence of corneal epithelial nonsteroidal anti-infl ammatory drug (NSAID) indicated for the breakdown should immediately discontinue use of topical treatment of postoperative infl ammation and prevention of ocular NSAIDs, including BromSite®, and should be closely monitored pain in patients undergoing cataract surgery. for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, Recommended Dosing ocular surface diseases (e.g., dry eye syndrome), rheumatoid ® One drop of BromSite should be applied to the affected eye arthritis, or repeat ocular surgeries within a short period of time twice daily (morning and evening) 1 day prior to surgery, the day may be at increased risk for corneal adverse events which may of surgery, and 14 days postsurgery. become sight threatening. Topical NSAIDs should be used with Important Safety Information caution in these patients. Post-marketing experience with topical • Slow or Delayed Healing: All topical nonsteroidal anti- NSAIDs also suggests that use more than 24 hours prior to infl ammatory drugs (NSAIDs), including BromSite®, may slow or surgery or use beyond 14 days postsurgery may increase patient delay healing. Topical corticosteroids are also known to slow or risk for the occurrence and severity of corneal adverse events. delay healing. Concomitant use of topical NSAIDs and topical • Contact Lens Wear: BromSite® should not be administered steroids may increase the potential for healing problems. while wearing contact lenses. The preservative in BromSite®, • Potential for Cross-Sensitivity: There is the potential for benzalkonium chloride, may be absorbed by soft contact lenses. cross-sensitivity to acetylsalicylic acid, phenylacetic acid • Adverse Reactions: The most commonly reported adverse derivatives, and other NSAIDs, including BromSite®. Therefore, reactions in 1% to 8% of patients were anterior chamber caution should be used when treating individuals who have infl ammation, headache, vitreous fl oaters, iritis, eye pain, and previously exhibited sensitivities to these drugs. ocular hypertension. • Increased Bleeding Time of Ocular Tissue: With some Please see brief summary of Full Prescribing Information NSAIDs, including BromSite®, there exists the potential for on the adjacent page. increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAID=nonsteroidal anti-infl ammatory drug. NSAIDs may cause increased bleeding of ocular tissues

(including hyphemas) in conjunction with ocular surgery. It is ® ® Reference: 1. BromSite [package insert]. Cranbury, NJ: Sun Pharmaceutical recommended that BromSite be used with caution in patients Industries, Inc.; 2016. with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Sun Ophthalmics is a division of Sun Pharmaceutical Industries, Inc. • Keratitis and Corneal Effects: Use of topical NSAIDs may © 2017 Sun Pharmaceutical Industries, Inc. All rights reserved. result in keratitis. In some susceptible patients, continued BromSite and DuraSite are registered trademarks of Sun use of topical NSAIDs may result in epithelial breakdown, Pharma Global FZE. SUN-OPH-BRO-365 11/2017 corneal thinning, corneal erosion, corneal ulceration or corneal

RP0118_Sun.indd 1 12/20/17 2:30 PM BromSite® (bromfenac ophthalmic solution) 0.075% Brief Summary

INDICATIONS AND USAGE USE IN SPECIFIC POPULATIONS BromSite® (bromfenac ophthalmic solution) 0.075% is indicated for the Pregnancy treatment of postoperative inflammation and prevention of ocular pain in Risk Summary patients undergoing cataract surgery. There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral CONTRAINDICATIONS bromfenac did not produce teratogenic effects at clinically relevant doses. None Clinical Considerations WARNINGS AND PRECAUTIONS Because of the known effects of prostaglandin biosynthesis-inhibiting drugs Slow or Delayed Healing on the fetal cardiovascular system (closure of ductus arteriosus), the use of All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite® during late pregnancy should be avoided. BromSite® (bromfenac ophthalmic solution) 0.075%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Data Concomitant use of topical NSAIDs and topical steroids may increase the Animal Data potential for healing problems. Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m2 basis, assuming 100% Potential for Cross-Sensitivity absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic daily dose on a mg/m2 basis) produced no structural teratogenicity in reproduction ® acid derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal solution) 0.075%. Therefore, caution should be used when treating individuals growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was who have previously exhibited sensitivities to these drugs. produced in rabbits at 7.5 mg/kg/day. Because animal reproduction studies Increased Bleeding Time of Ocular Tissue are not always predictive of human response, this drug should be used during With some NSAIDs, including BromSite® (bromfenac ophthalmic solution) pregnancy only if the potential benefit justifies the potential risk to the fetus. 0.075%, there exists the potential for increased bleeding time due to Lactation interference with platelet aggregation. There have been reports that There are no data on the presence of bromfenac in human milk, the effects on the ocularly applied NSAIDs may cause increased bleeding of ocular tissues breastfed infant, or the effects on milk production; however, systemic exposure (including hyphemas) in conjunction with ocular surgery. to bromfenac from ocular administration is low. The developmental and health It is recommended that BromSite® be used with caution in patients with benefits of breastfeeding should be considered along with the mother’s clinical known bleeding tendencies or who are receiving other medications which need for bromfenac and any potential adverse effects on the breast-fed child from may prolong bleeding time. bromfenac or from the underlying maternal condition. Keratitis and Corneal Reactions Pediatric Use Use of topical NSAIDs may result in keratitis. In some susceptible patients, Safety and efficacy in pediatric patients below the age of 18 years have not continued use of topical NSAIDs may result in epithelial breakdown, corneal been established. thinning, corneal erosion, corneal ulceration or corneal perforation. These Geriatric Use events may be sight threatening. Patients with evidence of corneal epithelial There is no evidence that the efficacy or safety profiles for BromSite® differ in breakdown should immediately discontinue use of topical NSAIDs, including patients 65 years of age and older compared to younger adult patients. BromSite® (bromfenac ophthalmic solution) 0.075%, and should be closely monitored for corneal health. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis and Impairment of Fertility Post-marketing experience with topical NSAIDs suggests that patients with Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac complicated ocular surgeries, corneal denervation, corneal epithelial defects, up to 0.6 mg/kg/day (129 times a unilateral daily dose assuming 100% absorbed, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid on a mg/m2 basis) and 5 mg/kg/day (540 times a unilateral daily dose on a mg/m2 arthritis, or repeat ocular surgeries within a short period of time may be at basis), respectively revealed no significant increases in tumor incidence. increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the bacterial reverse mutation, chromosomal aberration, and Post-marketing experience with topical NSAIDs also suggests that use more micronucleus tests. than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (195 and Contact Lens Wear 65 times a unilateral daily dose, respectively, on a mg/m2 basis). BromSite® should not be administered while wearing contact lenses. The ® preservative in BromSite , benzalkonium chloride, may be absorbed by soft Rx Only contact lenses. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the Brief Summary: • Slow or Delayed Healing • Potential for Cross-Sensitivity • Increased Bleeding Time of Ocular Tissue • Keratitis and Corneal Reactions • Contact Lens Wear Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most commonly reported adverse reactions in 1–8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain BromSite is a registered trademark of Sun Pharma Global FZE. and ocular hypertension. SUN-OPH-BRO-017-1 03/2017

RRP0118_SunP0118_Sun PPI.inddI.indd 1 112/20/172/20/17 2:312:31 PMPM 0016_rp0118_f1.indd 27 1 6 _ r p 0 1 1 8 _ f 1 9 a toricvs.non-toriclens.” difference insphericaloutcomesusing mon toriclenses—Ihaven’t foundany my experience—usingthemorecom- may notalwaysbeaddressed.Butin ently, soit’s possiblethatthisconcern manufacture theirtoriclensesdiffer- lent. Ofcourse,differentcompanies of whetherit’s aT2orT9toricequiva- before lettingthepatientgo.The phy- ments andapplythevalidation criteria technician shouldtakethemeasure- and theLenStar, respectively, sothe criteria availablefortheIOLMaster Zeiss andHaag-Streithavevalidation validation criteria,”henotes.“Both racy ofyourmeasurementsisbyusing physician. issue orbringsittotheattentionof picks uponthisandeitherresolvesthe the ordinary. Hopefullythetechnician perhaps there’s somethingelseoutof from onemeasurementtothenext,or haps there’s aseriousinconsistency tient getsupandleavestheofﬁ measurement validity, beforethepa- staff shouldbefirstinlinetocheck and makesurethey’recorrect.The to lookcarefullyatyourmeasurements things cangoofftherails,soyouhave he says.“Therearemanyplaceswhere to timethebiometermaybewrong,” come fromabiometer, andfromtime generate inthepreoperativeprocess refractive surprises.“Thenumberswe surements areacommonsourceof Dr. Hillnotesthatinaccuratemea- is essential,”hesays. outcomes, lensconstantoptimization stants. “Ifyouwanttoimproveyour ent fromasurgeon’s ownlenscon- be morethanahalf-diopterdiffer- provided bythemanufacturercan Dr. Hillnotesthatthelensconstants better outcomes? . i n d

“The bestwaytochecktheaccu- • • These strategieswillhelp: REVIEW d Story Cover

Optimize your lens constants. Optimize yourlensconstants. Validate yourmeasurements.

2 mize the likelihood of getting mize thelikelihoodofgetting What stepscanItaketomaxi- 7

IOL Power Formulas ce. Per-

and carefulsurgeons.Zeiss’new surgi- manner asthemostknowledgeable planning softwareinmuchthe same the validationiscarriedoutby planning isnowemerging,inwhich Fortunately, anewformofsurgical to getlostusingthiskindofprotocol. surements betweeneyes—it’s likely chamber, orabigdifferenceinmea- steep orfl usual—let’s saythepatienthasvery “However, ifthere’s somethingun- most ofthetime,”hecontinues. a pieceofpaper. and thephysicianjustselectsalenson of themeasurementsandcalculations practices, akeystaffmemberdoesall is automatedordelegated.Insome lead toascenarioinwhicheverything erything iscorrect.However, thatcan ders ofourstaffandmakesureev- don’t havetimetolookovertheshoul- cally runningbehindschedule,sowe Dr. Hill.“We’re allverybusyandtypi- geons lettheirstaffruntheshow,” says process. issue of reading hiseditorialintheJuly2017 about usingthevalidationcriteriaby (Dr. Hillnotesthatyoucanlearnmore stop untiltheproblemisresolved.” look right,thewholeprocessshould something onthefi she reviewsthemeasurements,andif sician shoulddothesamewhenheor Refractive Surgery 0.5-D goalisbecoming the 90-percent-within- — “With goodbiometry “That won’t leadtoabadoutcome • and agoodformula, Graham Barrett,MD Don’t removeyourselffromthe The Journal of Cataract and The JournalofCataractand achievable.” at Ks, or an unusual anterior at Ks,oranunusualanterior “Unfortunately, manysur- . nal reviewdoesn’t 5 ) January 2018 “This isafi about thelatestdevelopments. you’ve alwaysdone:Stayinformed would be.” modifi glasses orsomeformofpostoperative ready forthepossibilityofneeding be off.Also,Itellthepatientto one toimplant,buttheoutcomecould I’ll usemybestjudgmentaboutwhich not besurewhichisbest.Iexplainthat lenses tochoosefrom,andthatIcan- sheet topointoutthatIhavemany always showthepatientcalculation possibility ofatwo-stageprocedure.I pared tocounselthepatientabout come,” hesays.“Onehastobepre- difficult toguaranteeaperfectout- eyes fallintoacategoryinwhichit’s patients needtounderstandthattheir ly tohavearefractivesurprise.“These notes thatthesepatientsaremostlike- ous refractivesurgery. patients withshorteyesorprevi- charge.” The surgeonhastobethepersonin doing thesamethingyearafteryear. current sothestaffdoesn’t justkeep guidance andkeepstheentireprocess tion, andoverall,heorshealsooffers process oflens-constantoptimiza- he adds.“Thesurgeoninitiatesthe producing thedesiredlevelofresults,” comes, toensurethatthepracticeis oversees theprocessoftrackingout- be thephysician. regarding IOLcalculationsneedsto fi and makesurethey’reright,butthe needs tolookatthemeasurements on theirrefractiveoutcomes.Thestaff their patientsandpeersbased more, physiciansarebeingjudgedby on theteam,”hecontinues.“Further- cian isthemostknowledgeableperson surgeon. of beingabletomanagethisforthe cal plannerVeracity holdsthepromise nal arbitermakingthefi • • “After thesurgery, thedoctoralso “The bottomlineisthatthephysi- Spend extratimecounseling Don’t justkeepdoingwhat | cation, and what the cost of that cation, andwhatthecostofthat reviewofophthalmology.com eld thatchanges quickly,” nal decision decision nal Dr. Koch |

27 112/22/17 1:19 PM 2

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P M 0016_rp0118_f1.indd 28 1 6 _ r p 0 1 1 8 _ f 1 lieves that one day it will be possible lieves thatonedayitwillbe possible probably theceilingforaccuracy.” within ±0.5Dofthetargetoutcomeis to ophthalmologists,90or92percent the wayintraocularlensesareoffered measurement technologies,andgiven we’re startingtoseethatusingcurrent As JackHolladayrecentlypointedout, in thefaceoftechnologylimitations. means thatwecanonlybesoaccurate we haveacalculationceiling,which we’re measuringlivingtissue.Second, limit tohowaccuratewecanbewhen ment ﬂ problems. First,wehaveameasure- observes Dr. Hill.“Therearetwo technology asformulashortcomings,” are asmuchaboutmeasurement “The limitationswehaverightnow off, however—ifit’s evenpossible. they workwellforalleyesisourgoal.” Holladay. “Improvingformulassothat vary withtheformulas,”notesDr. time-consuming, andthebreakpoints usual axiallengths,Ks,andsoforthis eye? 10 to compete.” be keepingup,andyouwon’t beable petition. Theguydownthestreetwill inevitably you’llfallbehindthecom- simply dowhatyou’vealwaysdone, challenging lenscalculations.Ifyou the toolboxtohelpyouwithmore That wayyou’llknowwhattoolsarein attend webinars;readthejournals. current,” hesays.“Gotomeetings; short eyes. by theadditionof1,000exceptionally for theveryshorteyewasincreased and therangeofin-boundsindications the rangeofcalculationdownto-5D, online Hill-RBFcalculator, extending intervals. LastmonthIupdatedthe to be‘bestpractice’shiftsatregular notes Dr. Hill.“What’s considered 28 . i n d

Nevertheless, Dr. Hillsayshebe- Reaching thatgoalmaybeaways “Running differentformulasforun- “The pointisthatyouneedtostay REVIEW d |

Story Cover

Review ofOphthalmology

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mula that works for every mula thatworksforevery Will weeverhaveonefor-

IOL Power Formulas | January2018 effective lensposition.That’s often dict wherethelenswillend up—the The issue,however, istryingtopre- think they’dalltellusthesamething. cal physicsandoptics,soyoumight most formulaearebasedontheoreti- doubt it,”saysDr. Barrett.“Ofcourse, formula thatworksforeveryeye?“I comes inaverageeyes.” refractive eyes,butevensphericalout- of segments,notjustintoricorpost- enhance ouroutcomesinavariety that newinformation.Ithinkwill that willallowtheusertoincorporate tive Surgeons)andASCRSwebsites, Association ofCataractandRefrac- is onlineattheAPACRS (Asia-Paciﬁ an optiontomytoriccalculator, which “Just inthepastfewweeksI’veadded this newinformation,”hecontinues. mulae thatarecustomizedtoutilize but oursphericaloutcomesaswell. impact notonlyourtoricpredictions rior corneaquiteaccurately. Thatcan source OCTcanmeasuretheposte- as Scheimpflugdevicesandswept- will dothat.Newtechnologiessuch a newgenerationofbiometersthat he pointsout.“We’re onthe vergeof ion shouldimproveourpredictions,” the eyeinamoresophisticatedfash- is evolving.“Beingabletomeasure measure theposteriorcornealsurface power oftheIOLpostoperatively.) p. 12]enablingsurgeonstomodifythe Light-adjustable Lens[discussedon lenses suchastherecentlyapproved prove thesenumbersaswell,with (Adjustable lenstechnologymayim- power aspartofthelabelingprocess.” IOLs thathavetheexact,measured try mayonedaybeabletodeliverus ments,” hesays.“Inaddition,indus- work withtheseimprovedmeasure- methods willhavetobeoptimized surement technology, andcalculation will requireanimprovementinmea- cess of95percentpatients.“This to achievea±0.50Daccuracyinex- But willweendupwithasingle “Now, we’rebeginningtohavefor- Dr. Barrettnotesthatourabilityto c able.” within-0.5-D goalisbecomingachiev- and agoodformula,the90-percent- manufacture. Butwithgoodbiometry racy) andissuessuchasimperfectlens tion (whichhelpsusdetermineaccu- including thepostoperativerefrac- it’s theresultofenteringnoisydata, isn’t asignthattheformulaiswrong; tend tohitevenwithagreatformula precise outcomes.Theceilingthatwe mulae aregettingclosertoproducing he adds.“Thelatestgenerationoffor- to change. crafting, andIdon’t thinkthat’s going but therearealsoelementsofhand- on fundamentalopticsandphysics, it anotherway, theformulaearebased based ondifferenteyemodels.To put algorithms aredata-driven,some mula usesadifferentalgorithm;some where theauthorofaparticularfor- Refract Surgery 2017:43;7;869-70. Refract Surgery criteria,validation IOLconstants, andlanelength. J Cataract IOL calculations. II. Measurementfoibles: Measurementerrors, 5. Hill WE, Abulaﬁ a A, Wang L, Koch DD. Pursuingperfectionin ahead ofprint] 6420(17)31428-8. doi: 10.1016/j.ophtha.2017.08.027. [Epub formulas.calculation 2017;Sep23. Ophthalmology pii: S0161- 4. MellesRB, HolladayJT, Chang WJ. Accuracy ofintraocularlens RefractSurg2011;37:11:2018–27. Cataract ineyeswithaxiallengthsabove25.0mm. calculations power J 3. Wang L, M, Shirayama MaXJ, etal. Optimizingintraocularlens 2015;122:1096-101. Ophthalmology afterlaservisioncorrection. calculation formulae forIOLpower aberrometry, OCT-based IOLformula, Haigis-l, andMasket 2. Fram NR, Masket S, Wang L. Comparison ofintraoperative ahead ofprint] 6420(17)31428-8. doi: 10.1016/j.ophtha.2017.08.027. [Epub formulas.calculation 2017Sep23. Ophthalmology pii: S0161- 1. MellesRB, HolladayJT, Chang WJ. Accuracy ofintraocularlens ( Holladay IOLConsultantSoftware sulting, whichisthedistributorof las andispresidentofHolladayCon- Holladay 1,2andRefractiveFormu- Dr. Holladay isthedeveloperof thalmics, OptosandVeracity Surgical. Zeiss, Haag-Streit,Alcon,OmegaOp- Vision. Dr. Hillisaconsultantfor Zeiss, AlconandJohnson&Johnson to allonline. but notesthattheyarefreelyavailable his formulastomultiplecompanies, hicsoap.com “However, thereisaconvergence,” Dr. KochisaconsultantforCarl ). Dr. Barretthaslicensed 112/22/17 3:59 PM 2 / 2 2 / 1 7

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P M RRP0118_SightP0118_Sight LLife.inddife.indd 1 112/19/172/19/17 3:273:27 PMPM IOLs REVIEW Cover Focus Presbyopic IOLS: Choosing Wisely

By Kristine Brennan, Senior Associate Editor

How to watch ince presbyopia-correcting IOLS to affect the patient’s outcome, and if hit the U.S. market, starting with there’s some treatable pathology, such and listen to Sthe AMO Array (Allergan; Ir- as dry eye, treat it right away. That’s vine, Calif.), they’ve helped patients number one,” she says. your patients to achieve at least partial freedom from “I’m a big believer in repeating tests: glasses or contacts. According to the Measure twice, cut once,” adds Dr. enhance your International Society of Refractive Loh, who doesn’t limit her screening Surgery’s 2015 U.S. Trends in Refrac- to covered services. “You can do an success rate. tive Surgery Survey1, presbyopic IOL OCT of the macula to rule out reti- implantation is not a high-volume sur- nal pathology. If a patient actually has gery, although new lenses keep emerg- macular degeneration, for example, ing on the American market. then it’s a covered service, but not as The additional patient costs for a screening test. Corneal topography presbyopic IOLs and the risk of night- and OCT of the macula are not cov- time visual symptoms may be barriers ered services. Patients have to have to their adoption, and suitable candi- a problem like keratoconus or retinal dates require care and attention when pathology to get these paid; insurance choosing the best lenses to meet their won’t cover either as a screening tool. visual goals. Below, experienced sur- But they’re important because you can geons discuss lens planning for presby- pick up so many things that will affect opic IOL patients. outcomes,” she says. Stephen V. Scoper, MD, vice presi- Eye Health dent of Virginia Eye Consultants in Norfolk and a consultant to Alcon, Ocular health makes presbyopic evaluates testing performed by his lens selection possible. “Obviously, do staff to see if his patients meet the cri- all the testing, including topography, teria for a multifocal. “I examine the and make sure the patient doesn’t have patient, of course, and I look at all of dry eye. I think the topography and the testing,” he says. He offers suit- the health of the cornea and the retina able patients the AcrySof IQ ReSTOR are the most important things,” says +2.5 multifocal IOL with Activefocus Jennifer Loh, MD, of Loh Ophthal- (Alcon; Fort Worth, Texas) or the toric mology Associates in Coral Gables, version. “If I know the patient is inter- Florida. “You really have to make sure ested in an Activefocus, I’ll look at the there’s no other pathology that’s going topography and the keratometry to see

30 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

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REVIEW Focus

how much astigmatism they have. I’ll and drive. The second thing it will do look at their higher-order aberrations. is bring the distance vision’s clarity in to I’ll look at the angle kappa. I’ll look at arm’s-length vision. An example of this the macular OCT to make sure their would be that when driving, you’ll be macula is completely normal, and I’ll able to see street signs and other cars at put fluorescein in their eye to make distance, but you’ll also be able to see sure they don’t have signifi cant ocular the dashboard of the car. You’ll be able surface disease,” he says. to see the kitchen counter when you’re cutting up vegetables. You’ll be able to Patient Expectations see the peas on your plate when you’re eating. You’ll be able to see your com- Once screening is complete, Dr. Loh puter and your desktop. Arm’s-length starts talking to her patients to help vision will be very good. What it will them select the best presbyopic IOLs. not do is allow you to see small print “Assuming you have a person who is up very close, nor medicine bottles or physically a suitable candidate for pres- The toric version of the Tecnis Symfony price tags. If you’re going to read a nov- byopic lenses, really trying to under- extended-depth-of-focus IOL is designed to el for an hour, you’re going to be more offer good vision across all distances while stand what they want by listening to remediating astigmatism. comfortable with a light pair of reading what they say is critical,” she says. “I’ll glasses. Does that sound good to you?’ repeat some of my questions for them They usually say, ‘I understand. Let’s a few times, just to make sure that they ing of near, mid-range, and distance do it.’ ” understand.” Dr. Loh also uses a short vision. “There’s a wide range of near written questionnaire for prospective tasks, so someone telling me that they Visual Goals refractive surgery patients to learn want to see ‘up close’ may have a totally more about their visual priorities, and different concept of what means from Although newer presbyopia-cor- the CheckedUp system (Cirle; Miami, anyone else,” she says. recting IOLs offer satisfactory visual Fla.) to educate them about refrac- Dr. Scoper relies on his technicians results at more than one focal point, tive cataract surgery and IOL selec- and counselors to screen for suitability surgeons and their patients still need tion. “Using a little iPad, really well- for a presbyopic lens. “We do all the to prioritize. “I think there’s been a developed, cartoonlike videos explain testing and counseling before the pa- paradigm shift regarding what doctors the basic concepts of cataract surgery tient sees the doctor. I’m a big believer think is important to patients,” says Dr. and the different types of lenses to the in the idea that the doctor should do Scoper. “Early on, I and other surgeons patient,” she says. “You still need to talk only what only a doctor can do. So I focused heavily on near vision. With to your patients a lot, of course, but it don’t do things like explaining to a pa- some of the early generations of mul- helps to introduce the topic.” tient what cataracts are, what astigma- tifocals, patients’ distance vision wasn’t Dr. Loh handles the lens-selection tism is, or the types of lenses that are as clear as it would be with a monofocal talks with her patients. “I want to fi nd available. I’m lucky to have a great staff lens, but we had never talked about out about any hobbies, occupations that does that before the patient comes good distance vision and patients just and preferences they have for their vi- to me,” he explains. assumed that they would end up with sion. Some people just want to do com- Dr. Scoper spends a few minutes good distance vision. The number one puter work and have distance vision to making sure patients know what to thing that patients want but don’t know play golf and sail. Other people really expect once he has confi rmed that they to ask for is good distance vision. As want to read up close.” She notes that are good candidates for the Activefo- surgeons, our primary goal should be some presbyopic IOL candidates have cus IOL. “I have a little speech,” he good distance vision no matter what. surprisingly specifi c visual goals. “For says, “and it goes like this: ‘I can’t give That’s what patients really need and example, I saw an attorney who told you everything, but I can give you a lot. want.” me point-blank that he expected to Let me tell you what I can do for you Multifocal and accommodative lens- see without glasses at exactly 12 inches and what I cannot do for you. Number es emerged and developed roughly from his face,” she recalls. More often, one, this lens will give you great dis- in tandem with the growing ubiquity however, it takes careful listening and tance vision without any glasses. You’ll of screens. This has implications for questioning to make sure that surgeon be able to get up in the morning and presbyopic IOL selection, according and patient have a mutual understand- not need glasses to watch television to Dr Loh. “I think for most people

32 | Review of Ophthalmology | January 2018

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REVIEW Focus

mid-range is very important, but still, letting them know the pros and cons satisfaction with presbyopia-correcting I’d never assume that. I always ask. of each option, I get a little more feed- lenses. You still fi nd some people who never back from them before I offer my rec- While interacting with her patients, use a computer. I think most people ommendation of what I think would be Dr. Loh is also assessing how their want to see their cell phone and their best, but I still talk to them about ev- body type may infl uence their concept computer without glasses, though.” erything. I’ve found that everyone has of near or intermediate distance. “If When Dr. Scoper discusses visual a different idea of what they’ll be get- someone is really tall and has longer goals with his patients, he emphasizes ting. You can’t assume anything about arms, they’re going to have a differ- other activities of daily living to clue people’s expectations,” she says. ent focal point than a petite female them into the focal point he deems Once a patient settles on a presby- with shorter arms, for example” she second in importance to distance vi- opic IOL, Dr. Loh uses her chair time says. “The distance they’ll want to read sion: arm’s-length vision. “I used to talk with him or her to manage expecta- from is very different, and that is a key mainly about computer vision when tions one more time. She emphasizes point.” Dr. Loh cautions against relying I described this to them, but now that perfect spectacle independence on observations alone or just the pa- ‘computer’ is about the fourth or fi fth is not assured. “I do tell patients that tient’s questionnaire answers, however. word I use. The fi rst example I give is there is a really high likelihood that “You really have to look at the patient, seeing the dashboard of your car, and they will need light readers. I almost but you also have to ask them where then seeing the kitchen counter when exaggerate that point a little bit, be- they like to read,” she stresses. “Obvi- you’re cooking and cutting up small cause I fi nd that it’s better to put that ously, you can look at body type and vegetables,” he says. “So much of your out there from the beginning than to make some assumptions, but you’d still world is at arm’s length. When you’re let them think that they’re not going to better ask, because you don’t know sitting and having a conversation with wear glasses,” she says. people’s true preferences.” somebody and you can see their face Regarding the possible need for a For Dr. Scoper, body type deter- and their eyes, that’s so much more im- postop enhancement, Dr. Loh says, mines whether he can mix and match portant than being able to read small “I do warn patients ahead of time that lenses for a select group of patients, print. But I also tell patients that if sometimes it can take more than one placing a mid-range-power multifocal they’re going to sit down and read a surgery to get everything correct.” She in the dominant eye and one with a book or magazine for an hour, they’ll adds that it’s not a big topic of conver- stronger add in the nondominant fel- have to put on a light pair of dollar- sation, however, except on the rare low eye. “I do it if they’re fi ve-foot-zero store cheaters and turn on some good occasion that a patient is truly unhappy and their arms are just too short to light to be comfortable.” postop. really be able to use their intermediate Although he is acutely concerned Dr. Scoper says he will do a touch- vision,” he says. “I can give them more about creating unrealistic expectations, up at no charge if necessary, but also by adding that in.” Dr. Scoper says that in some cases he emphasizes that it’s a rare occurrence. Observing the patient’s near read- can, in fact, give patients good near “I use the expanded version of the Hill ing behavior preoperatively is also key, vision by putting an Activefocus in the RBF formula, and the last time Dr. says Dr. Loh. “Someone who’s already dominant eye, and then a ReSTOR 3.0 Hill ran my numbers, the percentage doing monovision naturally or with in the nondominant eye. “But I don’t of patients I hit ±0.5 D was 97 percent contact lenses, or who happens to be promise that,” he stresses. “I don’t of all the patients I did. So I don’t even a moderate to high myope may say, even hint. I try to under-promise and talk about enhancements in advance. ‘Well, I still take my glasses off to read.’ over-deliver on that.” The counselors may mention it, but That really alerts me to the fact that I Dr. Scoper also tries to avoid over- I’m doing very few enhancements.” have to take extra care when offering whelming patients with presbyopic presbyopic lenses,” she says. “One of lens options. “I think it’s important for Observation the biggest pearls ever taught to me a doctor to give one recommendation is to fi nd out what the patient’s vision to the patient. They don’t want fi ve dif- Sometimes a patient’s response on a is without their glasses. It sounds kind ferent things to choose from. They just preoperative questionnaire or even the of simple, but if you can’t make them want to know what’s best for them,” verbal feedback they give in discussion better than they are now without their he says. fails to fully clarify what they really glasses, they’re not going to be hap- Dr. Loh says that she doesn’t try to want. Both doctors say it’s important py. If someone is a moderate to high limit patients’ IOL options initially. to carefully observe patients to spot myope, if they can already read well “When I discuss the lenses with them, factors that can strongly affect their without their glasses, say at J2 even

34 | Review of Ophthalmology | January 2018

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IN THE COMPASS STUDY AT TWO YEARS1,2: • 72.5% of patients achieved a ≥20% reduction in IOP (n=374) • 93% of patients were medication free* • Safety proﬁ le similar to cataract surgery alone

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*Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared to baseline in the absence of IOP-aff ecting surgery during the study. References: 1. CyPass® Micro-Stent Instructions for Use. 2. Vold S, Ahmed IIK, Craven ER, et al. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsiﬁ cation in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10):2103-2112.

RP0118_Alcon Cypass.indd 1 12/19/17 2:22 PM 0030_rp0118_f2.indd 36 3 0 _ r p 0 1 1 8 WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS. _ postoperatively forpropermaintenanceofintraocular angle glaucoma(POAG). primaryopen- pressure (IOP)inadultpatientswithmildtomoderate contraindicated inthefollowingcircumstancesor conjunction withcataractsurgeryforthereductionof the anteriorchamberangle. uveitic, orneovascularglaucoma with angle-closureglaucoma;and(2)ineyestraumatic,malignant, a hazard. of theanglethatcouldleadtoimproperplacementstentandpose abnormalities orconditionsthatwouldprohibitadequatevisualization exclude peripheralanteriorsynechiae(PAS), rubeosis,andother angle hazards inallmagneticresonanceimagingenvironments. conducting, non-metallic,non-magneticpolymerthatposesnoknown (MR) Safe:theimplantisconstructedofpolyimidematerial,anon- The safetyandeffectivenessofthe days aftersurgery, orsevereinnature(3.5%vs.1.5%). or moredaysaftersurgery(4.3%vs.2.3%);andcornealedema30 or moredecibels(6.7%vs.9.9%);IOPincreaseof10mmHg30 surgery (8.6%vs.3.8%);worseningofvisualfieldmeandeviationby2.5 chamber cellandflarerequiringsteroidtreatment30ormoredaysafter the BCVA lossof10or moreletters surgery alone,themostcommonpostoperativeadverseeventsincluded: comparing cataractsurgerywiththe single significant cataract.Thesafetyandeffectivenessofusemorethana without concomitantcataractsurgerywithIOLimplantationforvisually injury totheanteriororposteriorsegment,andwhenimplantationis 25 mmHg,inthesettingofcomplicatedcataractsurgerywithiatrogenic mmHg orgreaterthan33mmHg,eyeswithmedicatedIOP to thesurgicalscreeningvisit,eyeswithunmedicatedIOPlessthan21 procedures, eyeswithlasertrabeculoplastyperformed≤3monthsprior that haveundergonepriorincisionalgla glaucoma, eyeswithothersecondaryopen-angleglaucomas, eyes withuveiticglaucoma,pseudoexfoliativeor associated withvasculardisorders,pseudophakiceyesglaucoma, anterior segment,eyeswithchronicinflammation,glaucoma significant priortrauma,chronicinflammation,eyeswithanabnormal with medications,inpatients21yearsoryounger, ineyeswith established asanalternativetotheprimarytreatmentofglaucoma INDICATION: CONTRAINDICATIONS: MRI INFORMATION: PRECAUTIONS: WARNINGS: ADVERSE EVENTS: FOR A COMPLETE LIST ATTENTION: PLEASE REFER TO THE INSTRUCTIONS f 2 IMPORTANT PRODUCT INFORMATION . i CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE n d CyPass d

CyPass

TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

3 CyPass 6 Micro-Stent Micro-Stenthasnotbeenestablished. Gonioscopyshouldbeperformedpriortosurgery The Thesurgeonshouldmonitorthepatient Inarandomized,multicenterclinicaltrial CyPass The vs. 15.3%forcataractsurgeryonly);anterior ® Useofthe CyPass Micro-Stent ® Micro-Stentisindicatedforusein OF CONTRAINDICATIONS, or at 3months Micro-Stentis CyPass discernible congenitalanomaliesof CyPass © 2017Novartis 9/17US-CYP-17-E-2272 ucoma surgeryorcilioablative Micro-Stent Micro-Stent CyPass after surgery (8.8%for conditions: magnetic resonance Micro-Stentis has notbeen pigmentary to cataract intraocular (1) ineyes pressure. pay attention to this.” pay attentiontothis.” jealous ofmebecauseIdon’t haveto.’I’vereallylearned to of myfriendshavetowearreadingglasses,andthey’reall recognize itiftheysaysomethinglike,‘I’mreallylucky. All take yourglassesoffandreadthiscardforme?’Oryoumay like, ‘Areyoureadingwithoutyourglasses?’and‘Can glasses. Butifthey’reamyope,you’dbetteraskthemthings a +3.50D,they’renotgoingtobeablereadatallwithout someone’s refraction:Ifsomeone’s ahyperope,forexample, they justthinkit’s normal.You cantellsomewhatbased on it’s anythingspecial.Theywon’t reportittoyoubecause strange, butthey’rejustsousedtoitthattheydon’t think don’t evenrealizeit,”saysDr. Loh. “Iknowthatsounds a littleintermediateblendedwithnear.” -2.25 Dandtheothereye-1.5to-1.75givethem used tothatuncorrectednearvision.Imaymakeoneeye to leavethemnearsighted,becausetheirbrainhasgotten astigmatism I’llcorrectitwithatoricorthelaser. I’mgoing -2 Dwithamonofocallens,”hesays.“Ifthey’vegotsome a -2Dwearshisorherglasses,I’mgoingtoleavethemat have togooddistancevision.Ifthat’s theonlytimethat blur atdistance.Theyjustputtheirglassesonwhenthey They canlookacrosstheroomandtheirbrainisusedto drive,’ Iknowtheyreallylovethatuncorrectednearvision. The onlytimeIputthembackonistowatchtelevisionor I walkintothehouse,leavemyglassesoffwholetime. maybe intermediatevision.Butifasa-2D,theysay, ‘Once look atnear,’ thenI’mgoingtogoforgooddistanceand on alldaylong,andInevertakethemoffwhenwantto glasses offalotfornear?Iftheyanswer, ‘Ileavemyglasses things throughyourbifocalatnear, ordoyoutakeyour is, ‘Doyouwearyourglassesalldaylongandjustlookat who’s a-2D,-2.5or-3theﬁ trope, likeanybodyelse,”hesays.“ButifI’vegotsomeone too closetobeverypractical.I’lltreatthemlikeanemme- who isa-5Dorabove,Iknowthattheirnearfocalpoint tients whentheyweartheirglasses.“IfI’vegotsomeone from iscritical,”shesays. J2 withoutmyglasses!’Soknowingwherethey’restarting case. Butthey’regoingtosay, ‘That’s notbetter!Icouldsee and thenthey’reJ4,youmightthinkhaveasuccessful with acataract,ifyouputinanEDOFormultifocallens done this for 20 years and they love it. When I hear that, I done thisfor20yearsandthey loveit.WhenIhearthat, get patientsthatusecontacts formonovision,andthey’ve caution themaboutattempting toﬁ patients who’vebeenhappywithmonovision,butshedoes Evolving Lenses “A lot of these patients who read well without glasses “A lotofthesepatientswhoreadwellwithoutglasses Dr. Scoperalsomakesapointofaskinghismyopicpa- Dr. Lohdoesn’t ruleoutpresbyopia-correctingIOLsfor REVIEW Focus Cover

IOLs rst question I ask them rst questionIaskthem x what’s notbroken.“I 112/22/17 2:10 PM 2 / 2 2 / 1 7

2 : 1 0

P M Francesco Carones, MD Dr. Scoper notes many patients experienced troubling nighttime symptoms and blurry distance vision with earlier generations of multifocal IOLs, and notes that visual outcomes are improving as the technology evolves. “I think that many surgeons felt like they were burned with some of the original multifocals because there was a small group of patients who really didn’t do well,” he says. “I have the most familiarity right now with the Symfony (Johnson & Johnson Vision; Santa Ana, Calif.) A 2013 study4 comparing the visual acuity of patients bilaterally implanted with ReSTOR 2.5 and I have used the new Activefocus IOLs to patients with a ReSTOR 2.5 in the dominant eye and a ReSTOR 3.0 in the nondominant from Alcon as well,” says Dr. Loh. eye at six months showed that the blended-vision patients gained signifi cantly greater near “Both feature improvements over UCVA, with only slightly lower intermediate and distance UCVA. the earlier presbyopic lenses in that they give more intermediate vision, usually tell them that I think we should Studies suggest that one way to which is becoming more important recreate that surgically. They like it, improve near vision and thereby to a growing number of patients than they’re used to it, and I’ve found that increase patient satisfaction with the reading of fi ne print. They do that changing it can be a problem. So in EDOF lenses like the Tecnis Sym- at a cost sometimes to book-reading that case, I’ll usually say, ‘Look. There fony is to employ a blended-vision ap- near vision and other up-close read- are these other lenses out there, mul- proach by targeting the dominant eye ing, though.” Dr. Loh adds that as tifocals or EDOF, that will give good for emmetropia and the nondominant the lenses improve to provide better distance and intermediate vision and for slight myopia.2,3 vision across a wider range of vision, some near vision binocularly, and that Both doctors say their presbyopic talking to your patients remains criti- may be benefi cial to you, but you’re lens patients have few complaints cal to their satisfaction. “What I’ve really used to your monovision and you about night vision. “I usually don’t learned is that everyone has a differ- seem very happy with it. I think keep- get too many complaints about it, but ent idea of great vision, and I think ing it would be in your best interest.’ I do warn them ahead of time,” says that in order to really make someone So sometimes I’ll steer people away Dr. Loh. “I have had some patients happy, you have to fi nd out what they from the multifocal or EDOF lenses who’ve had some glare and halos: really want,” she says. because of that. But if they want to try Luckily, I haven’t had anyone tell me them, that’s fi ne. It’s important to really it’s been horrible or debilitating. But Dr. Loh is a consultant for Johnson make them understand the pros and they’ll comment on it sometimes.” & Johnson Vision, Allergan and Sun cons of each situation.” Dr. Scoper reports essentially the Ophthalmics, and a speaker for Shire. Dr. Scoper will try placing a pres- same thing. “I may hear just a com- Dr. Scoper is on the speakers’ bureau byopic IOL in the dominant eye to ment or an observation that rings and and consults for Alcon, and is on the give good distance and intermedi- halos and glare are present, but it’s speakers’ bureau of its parent com- ate, with a monofocal targeted for really not a problem,” he says. He pany, Novartis. near vision in the nondominant eye in also advises his patients to expect 1. International Society of Refractive Surgery. ISRS 2015 U.S. those patients who are well-adapted some postoperative nighttime visual trends survey. https://isrs.aao.org/resources/2015-isrs-u-s- to monovision. “In their nondomi- symptoms. “I tell them that they’ll see trends-survey. Accessed 6 December 2017. 2. Cochener B, Concerto Study Group. Clinical outcomes of a new nant eye, I’ll place a monofocal lens some glare and rings around head- extended range of vision intraocular lens: International multicenter focused exactly to where they’re used lights and streetlights at night, simply Concerto Study. J Cataract Refract Surg 2016;42;9:1268-1275. 3. Breyer DRH, Kaymak H, Ax T, et al. Multifocal intraocular lenses to, whether it’s -2 D, -2.25 D or -2.5 because the implant actually has rings and extended depth of focus intraocular lenses. Asia-Pacifi c J D,” he explains. “We’re then able to in it. But I also tell them that it gets Ophthalmol 2017;6;4:339-349. 4. Carones, F. (2013 October). Six-month results from an aspheric give them more with intermediate better within three or four months to apodized diffractive multifocal IOL with a +2.5 D add power. Poster vision in the dominant eye, and they the point that usually, they’ll hardly presented at the 31st Congress of the European Society of Cataract love that,” he reports. notice it,” he adds. and Refractive Surgeons, Amsterdam, the Netherlands.

January 2018 | reviewofophthalmology.com | 37

030_rp0118_f2.indd 37 12/22/17 2:10 PM IOLs REVIEW Cover Focus Premium IOLs: How to Spot Poor Candidates

By Liam Jordan, Associate Editor

How to weed out f you choose to offer presbyopia- tions for the presbyopia-correcting correcting intraocular lenses, lens, then most patients are happy candidates who Iyou’re quickly faced with the regardless of their personality.” problem of matching the IOL to James Loden, MD, an ophthal- will be dissatisfi ed each patient’s lifestyle, which isn’t al- mologist based in Nashville, Tenn., ways easy. In this article, we’ll take a also discusses the importance of with these IOLs, look at who isn’t a suitable candidate managing expectations preopera- for premium IOLs like the Symfo- tively. “Sometimes, you’re going to even after a ny, ReSTOR, Tecnis Multifocal and have patients who set the bar so high Crystalens, and how to successfully that even with a perfect surgery and perfect surgery. avoid creating unhappy postop pa- implant, they’ll be disappointed with tients. their visual results,” he says. “So it’s important to manage these expecta- The Perfect Candidate tions preoperatively so they know what they’re getting themselves into. In an ideal world, all patients could It’s a big-time management of expec- get the procedures they want. For tations if pathology is present.” presbyopic IOLs, however, the per- Dr. Loden also describes his ideal fect patient can be diffi cult to come candidate for these premium IOLs. by. Zaina Al-Mohtaseb, MD, an as- “In terms of personality type, you’re sistant professor of ophthalmology at going to want to look for some- Baylor College of Medicine, discuss- one who can manage their expec- es her ideal candidate. “Patients with tations—they’re a realist. There is excellent ocular surfaces are the fi rst likely going to be some follow-up indication of a great candidate,” she that they’ll have to be on board for, says. “They should also have no co- and that’s important to identify from existing ocular pathology and would the get-go. like to be glasses-independent for “You can’t be too careful,” he con- most things, but understand they tinues. “With age, dry eye becomes might need glasses for small print. more and more prevalent, which ab- “Even if a patient is a good candi- solutely needs to be addressed be- date, the most important thing is the fore surgery. And this is true with preoperative discussion,” she contin- both a standard and premium IOL. ues. “If the surgeon and his team take You need to make sure the ocular the time to discuss realistic expecta- surface is pristine. As with most sur-

38 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

0038_rp0118_f3.indd38_rp0118_f3.indd 3838 112/22/172/22/17 12:4812:48 PMPM James Loden, MD James Loden,

A 71-year old man presented with a history of cataract. Scans showed dry eye, and the physician prescribed Xiidra before considering IOL implantation.

geries, this will help with faster visual result in decreased contrast sensitiv- • Weak zonules. “There’s also an recovery and better postop results.” ity, decreased visual acuity, and glare/ issue with implanting lenses in eyes (For speciﬁ c tips on matching a lens halos,” she continues. “You should with weak zonular support because to a patient’s visual needs, see “Pres- take at look at the retina with a slit they could dislocate,” Dr. Loden byopic IOLs: Choosing Wisely,” on lamp or OCT. The lens might actu- continues. “If you’re dead set on im- pg. 30.) ally make the patient’s vision worse planting though, you can put in a because of their AMD.” capsular tension ring, which should Medical Pathology • Anterior basement membrane make it a bit easier to reposition the dystrophy. “This will just kill you IOL. It just might be a pain for the Because not every patient will be on chair time,” Dr. Loden notes, patient to have issues with decentra- an ideal candidate for these premium because of the necessity to address tion, but that’s something you should lenses, surgeons describe who might the ABMD as well as the cataract. be transparent about preop.” not be a great ﬁ t for the lenses and “You’ll spend more time operating, • Glaucoma. “The earlier the why. The most obvious indication even though these patients with an- disease, the more options you can that a patient will not be a great can- terior membrane dystrophy won’t explore regarding some multifocal, didate comes from any medical pa- see well with the lenses implanted. premium IOLs,” Dr. Loden says. thology. Here are a few indications of They won’t be satisfied with their “However, there are ocular refractive a bad candidate to look out for: outcomes, and you’ll have to bring changes that occur after glaucoma • Fuchs’ dystrophy. “Most pa- them back in to either correct the surgery which would be a good rea- tients with co-existing corneal pa- lens or explant it.” son to advise against these lenses. thology won’t be an ideal candidate,” • Post-refractive surgery pa- It’s especially bad to implant one of Dr. Mohtaseb says. tients. “Any patient who has had these lenses if the patient’s glaucoma • Advanced dry eye. “Any pre- prior refractive surgeries is likely not is progressing or poorly controlled.” existing conditions need to be treat- going to get great results,” Dr. Loden To help catch patients such as ed prior to surgery to ensure good claims. “If they’ve had previous sur- those described above, Dr. Mohtaseb outcomes,” she adds. geries that have altered their refrac- recommends, “getting topography • Advanced macular degeneration, there can be residual refractive (look at the mires) and macular OCT tion. “These patients would also not errors. The patient might be left with on patients to evaluate if a patient is be good candidates since this would blurry vision and dysphotopsias.” a good candidate or not.”

January 2018 | reviewofophthalmology.com | 39

038_rp0118_f3.indd 39 12/22/17 12:49 PM Cover IOLs

REVIEW Focus

“Ignoring these signs of bad can- eratively. It all goes back to managing crisp distance vision, such as pilots, didates will cost you too much chair expectations and your instinct about were not good candidates because time for suboptimal results,” accord- whether or not they’ll adjust to the of the compromise of the distance ing to Dr. Loden. “Any ocular surface lens.” vision. We looked at our surgical in- disease has to be corrected preopera- Dr. Loden also shares his experi- dications for removing these pres- tively. These patients won’t be satis- ences with evaluating the personal- byopia-correcting IOLs and found fi ed with their outcomes otherwise, ities of his patients to see if they’ll that distance vision and glare, halos no matter how perfect the surgery be a fit for these lenses. “There and dysphotopsias were the most and implantation is. You have to be are definitely some psychological common issues that patients had. cautious and judicious with those signs to keep an eye out for, and I would also recommend avoiding outcomes. you’ll learn most of it from just implanting these lenses in very par- “It doesn’t matter if you’re charg- talking with your patients. Evalu- ticular people, such as an engineer ing them $500 or $1,000,” Dr. ate their visual needs. Ask if they who asks how the optics of the lens Loden continues. “Once you charge mind wearing glasses. Do they con- work.” them, they expect perfection, and sider themselves to be obsessive “There are definitely some ob- they don’t always understand that or a perfectionist? What are they vious indications for these lenses pathology is a limiting factor, so hoping to gain from this procedure based on patient careers,” Dr. they’re dissatisfied with their in terms of visual acuity? Would Loden says, “but as I said, you can results even if you do a perfect they prefer distance or near visual fi gure all this out if you talk to your procedure. We need to make sure acuity? It’s also important to evalu- patients and evaluate their needs we talk about these things preop. ate their state of mind as best you based on their lifestyles, and make With pathology present, you have can, too. If you have a depressed a judgment call. If the patient has to manage expectations.” patient, you probably shouldn’t im- a profession that calls for distance plant one of these lenses, as adjust- visual acuity, then you’re probably Psychological Mismatch ing to the new, imperfect visual best served looking elsewhere for a acuity might be stressful. It’s im- nonpremium lens.” Along with the obvious medical portant to take the time to talk with signs of a bad candidate for these them, and use your gut to make Looking Ahead premium IOLs, there are other red the call. There are plenty of other flags that visual tests won’t detect. options that might better suit your Despite the many benefits of The personality types of your pa- patient. It’s okay to go in a different premium IOLs, there are plenty tients can also be a good indication direction,” he says. of patients who just aren’t suited of whether or not a premium IOL is for them. Surgeons advise explor- right for them. Careers ing other lens options. Even with “I recommend avoiding the older- perfect surgery and implantation, a generation, high-add models in ob- Along with a patient’s psychologi- patient not fi t for these lenses will sessive/compulsive people or very cal makeup, his or her career should still be dissatisfi ed, leaving you and particular people, given the risk also be taken into account when look- him frustrated. Beyond the medical for postop glares and halos,” Dr. ing at implanting a premium IOL. contraindications, make sure your Mohtaseb says. “More often than For example, say your patient is an patient’s psychological makeup can not, they’ll be back to have the lens editor who needs closer visual acuity adapt to these lenses. explanted. There are plenty of alter- to edit his work. You’ll defi nitely want “Taking the time to understand natives to these high-add premium to keep that in mind while evaluating your patient’s needs makes the differ- IOLs, and I am much more comfort- whether or not to implant a premium ence between a satisfi ed patient and able placing the low-add multifocals IOL. a frustrated one,” Dr. Loden says. and extended-depth-of-focus lenses “In the older models of presbyopia- “It’s on you to recommend the lenses in these patients now. I think the correcting lenses with significant that are best for them.” most diffi cult patient is still the low add-power, some patients in certain myope (-2 D) who had crisp reading occupations were not happy with the Dr. Loden is a consultant for LEN- vision for years, because they’ll take a results of the lenses,” Dr. Mohtaseb SAR, J & J vision and Lenstec. Dr. long time to adjust to their vision and says. “For example, night drivers or Mohtaseb is a consultant for Alcon probably won’t be satisfi ed postop- patients who required excellent and and Allergan.

40 | Review of Ophthalmology | January 2018

0038_rp0118_f3.indd38_rp0118_f3.indd 4040 112/22/172/22/17 12:4912:49 PMPM ONLY

RP0118_AkornAzasite.indd 1 12/19/17 3:00 PM IOLs REVIEW Cover Focus Surgeons Share Their Views on IOLs

By Walter Bethke, Editor in Chief

Opinions on f surgical technique is the art that Monofocal Lenses helps ensure that cataract proce- monofocals, Idures go smoothly and yield great These are the lenses that surgeons visual results, then the intraocular say they use for most of their cases. multifocals, torics lenses are the science. This month, When choosing them, they look for cataract surgeons provided their opin- things like ease of use, consistency and and handling lens ions on IOL technology, from mono- a reliable lens material. focal and multifocal/extended-depth- Fifty-four percent of the surgeons complications. of-focus lenses to toric IOLs. They say they use the Alcon IQ Aspheric also shared their thoughts on which IOL for most of their cases, while 31 lens features, such as toricity and percent prefer the J&J Vision Tec- blue-light blocking, they found to be nis one-piece lens. Six percent use most useful in their practices. the B+L enVista, 4 percent like the This month, the e-mailed survey B+L SofPort AO, 2 percent prefer the was opened by 992 of 7,605 subscrib- B+L Akreos AO and 2 percent like the ers to Review’s e-mail service (13 per- Hoya iSymm/iSert. cent open rate); of those, 57 shared “I like that the Alcon IQ unfolds their responses. slowly,” says Connecticut surgeon To get a sense of where you stand in Kevin Dinowitz. “Acrylic is less likely the IOL landscape, read on. to cause inflammation or interfere with silicone oil retinal procedures. Surgeons’ Likelihood of Using It gives consistently excellent out- a Presbyopic IOL in Two Years comes.” “The lens is very quiet in the eye,” 50 avers an AcrySof IQ surgeon from Nevada. “Glistening and reflections are a little bothersome to patients.” A California surgeon also uses the Alcon 33 % lens for most of his surgeries, saying, “Cons: yellow color; glistening. Pro: 17 It’s very easy to insert.” On the Tecnis side, Bruce Cohen, MD, of St. Louis says he prefers it Very likely Somewhat likely Unlikely because it “works well, has no glisten- ings, is easy to load and inject and

42 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

0042_rp0118_f4.indd42_rp0118_f4.indd 4242 112/22/172/22/17 3:453:45 PMPM has great optics.” Lee Yasgur, MD, Surgeon Satisfaction with Presbyopic IOLs of Cherry Hill/Voorhees, New Jer- sey, agrees, saying, “The Tecnis offers ease-of-insertion, and it’s pre-loaded 39 to avoid twists, kinks and minimize 30 hand motion: KISS [Keep It Simple, 27 Stupid].” Rishi Kumar, MD, of Louis- % ville, Kentucky, says he likes the Tecnis best because it’s “pre-loaded, clear, one-piece and has no vacuoles.” 3 “The Bausch + Lomb enVista uses a high-quality optic and has no glis- Very satisfi ed Satisfi ed Somewhat satisfi ed Unsatisfi ed tenings,” argues another surgeon. A surgeon from Ohio prefers the B+L SofPort AO partly due to its versatility: percent (avg. no. implanted: 2; avg. “but not zero.” A surgeon from Cali- “It’s aspheric, compatible with use in charge: $2,769); fornia says he likes the Symfony, but the sulcus, with minimal dysphotop- • Tecnis 2.75 D Multifocal: 5 per- is a bit disappointed in its near vision. sia,” he says. “It allows me to order one cent (avg. no. implanted: 2.75; avg. “Make a higher-add component, if fea- lens, as it is also my sulcus backup.” charge: $1,899); sible,” he says. • Tecnis 3.25 D Multifocal: 5 Baltimore surgeon Ismail Shalaby Presbyopic Lenses percent (avg. no. implanted: 4; avg. uses the Alcon Aspheric ReSTOR charge: $2,300); 2.5 a lot, commenting, “Results are Surgeons also discussed the presby- • AcrySof ReSTOR Toric 3 D: 5 good with the Alcon lens, and the toric opic lenses they use, how many they percent (avg. no. implanted: 2; avg. platform is excellent with minimal or implant per month and what the aver- charge: $2,761); and no rotation. Patients haven’t reported age charge is. Some surgeons chose • Crystalens AO: 3 percent (avg. no. nighttime issues.” Dr. Dinowitz often more than one lens, leading to 78 re- implanted: 2.7; avg. charge: $2,167). uses the Aspheric ReSTOR 2.5, but sponses in all. Surgeons shared the reasons they says there’s always room for improve- The option chosen by most surgeons like certain presbyopic lenses, as well ment. “There’s still a learning curve was the Symfony, at 23 percent (aver- as what areas could use some improve- involved,” he says, “and needing the age number implanted per month: 2.7; ment. perfect candidate limits the number of average charge: $2,262). The AcrySof Louisville’s Dr. Kumar explains why candidates. The need to implant both aspheric ReSTOR 2.5 D was next, he likes the Symfony: “It has fewer ha- eyes to even know how it will work is a at 22 percent (average number im- los,” he says, “and you don’t have to be risk.” Cherry Hill’s Dr. Yasgur says that, planted: 2.6; average charge: $2,505). so exact with the refractive outcome. in his experience, “Any minus correc- The third most popular option was the However, refraction adjustment after tion left in the the Symfony causes AcrySof aspheric ReSTOR 3 D, at 8 surgery like that used by the light- spiderweb haloes, and all Alcon lenses percent (average number implanted: adjustable IOL would be great.” Ron cause ‘diamond-eye’ light refl exes that 3.2; average charge: $2,607). The rest Glassman, MD, of Teaneck, New Jer- patients’ family members do not like of the fi eld broke down as follows: sey, agrees up to a point. “It has less to look at.” Jonathan Adler, MD, of • AcrySof ReSTOR Toric 2.5: 6 glare than older multifocals,” he says, Bradenton, Florida, who says he often uses the Alcon Aspheric ReSTOR 3 D, shares his lens wish list: “A lens Surgeons Rank the Features of IOLs that could incorporate the ReSTOR Asphericity/neutral asphericity 4.4 2.5 D’s benefi ts with the reading vi- Toric design 4.3 sion of the ReSTOR 3 D, without the Edge design to decrease PCO 3.9 added side effects of the 3 D,” he says. Multifocality 3.9 Blue-light blocking 3.0 Toric Lenses Pseudo-accommodative motion 2.7

Surgeons on the survey ranked IOL features in terms of their usefulness using a numerical Fifty-eight percent of surgeons say scale that ran from 1 (least useful) to 6 (most useful). The average scores are shown. they regularly use toric lenses, and

January 2018 | reviewofophthalmology.com | 43

0042_rp0118_f4.indd42_rp0118_f4.indd 4343 112/22/172/22/17 3:453:45 PMPM Cover IOLs

REVIEW Focus

Toric IOL Used the Most scleral fi xation.” St. Louis’ Dr. Cohen says, “I used to suture IOLs when there was reduced capsule support, 67 but enough support that one suture would do the job. I have not had to do that for several years.” Dr. Yasgur % says he’ll suture it if “the eye presents as aphakic or with a traumatically dis- 18 located crystalline lens, or in cases of 66 3 a subluxated IOL.” In terms of explantations, surgeons’ AcrySof Tecnis Symfony AcrySof Trulign reasons for doing it in the past 12 monofocal toric toric ReSTOR toric months vary. Steven Stiles, MD, of toric Tarzana, California, says he explanted a lens because the “lens power was shared their views on these lenses’ on suturing and explanting IOLs. way off.” Baltimore’s Dr. Shalaby ex- pros and cons. Most respondents (62 percent) say plants lenses due to “nyctalopia in the In terms of the toric IOL the sur- they don’t fi nd themselves suturing an older multifocal IOLs.” Dr. Dinowitz geons say they use the most, 67 per- IOL in order to properly fi xate it; 28 had to take a lens out because the cent say they use the AcrySof monofo- percent say they have to suture-fi xate patient was a challenging case, citing cal toric. Eighteen percent prefer the a lens 1-3 times throughout the year; “the wrong IOL power in a kerato- Tecnis toric. (The popularity of the and 3 percent each say they have to conus patient.” In 2017, Dr. Yasgur other choices appears in the graph suture a lens 4-6 times, 7-10, or more had to explant a lens 15 years after above.) They provided several reasons than 10 times in a year. it was fi rst implanted, the culprit be- why they like the lenses they do, as Surgeons explained why this suture ing “subluxation due to pseudoexfo- well as thoughts on some things the fi xation was necessary. “Dislocation/ liation.” Dr. Cohen says he explanted lenses could do better. decentration of the IOL within the lenses on two occasions. “One was “The [AcrySof monofocal toric] is capsular bag,” says a surgeon from for the wrong power in an extended- easy to implant and rotate, but the Utah. “Also, poor zonular/capsular depth-of-focus lens, and the other was translucent markings are diffi cult to support. I use a ciliary sulcus suture.” a multifocal case in which the patient visualize and align in larger myopic An ophthalmologist from Virginia didn’t tolerate glare.” eyes,” says Dr. Dinowitz. “You can’t says the reason is often “lack of good Other reasons that respondents focus the cornea and the markings at capsule or iris support,” and that he provided for explants on this year’s the same time in the larger myopic usually uses a pars plana suture. One survey include: uveitis; multifocal is- eyes and have to focus on one plane.” surgeon, who says he sutures IOLs sues; instability; dysphotopsias; glare/ A New York surgeon likes using the more than 10 times a year, says the halo and positive photopsias; and pa- AcrySof monofocal toric, saying, “I most common reason is “subluxation tient dissatisfaction with a multifocal like the stability and refractive pre- after years of pseudoexfoliation; I use or EDOF lens. dictability.” He adds, however, “Its maker could improve the ease of insertion at the proper axis.” A surgeon Surgeons’ Annual Frequency of Suturing an IOL from Michigan says he likes the “larger range of options for astigmatism,” of- 62 fered by the AcrySof toric, but says it could use “improvement in prevention of lens rotation.” % 28 Lens Complications 33 3 Unfortunately, lens implantations don’t always go as smoothly as hoped, Zero times 1-3 times 4-6 times 7-10 times > 10 times so surgeons also shared their thoughts

44 | Review of Ophthalmology | January 2018

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MackoolOnlineCME.com MONTHLY Video Series

Welcome to the third year of Mackool Online CME! With the generous support of several ophthalmic companies, I am honored to have our viewers join me in the operating room To view CME video as I demonstrate the technology and techniques that I have go to: found to be most valuable, and that I hope are helpful to www.MackoolOnlineCME.com 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 25: As before, one new surgical video will be released monthly, “The Divide and and physicians may earn CME credits or just observe the case. New viewers are able to obtain additional CME credit by reviewing previous videos that are Conquer Technique” located in our archives. Surgical Video by: Richard J. Mackool, MD I thank the many surgeons who have told us that they have found our CME program to be interesting and instructive; I appreciate your comments, suggestions and questions. Thanks again for joining us on Mackool Online CME. Video Overview: In response to viewer requests, CME Accredited Surgical Training Videos Now this video demonstrates the Divide and Conquer procedure Available Online: www.MackoolOnlineCME.com using a curved ultrasonic needle. A useful method of Richard Mackool, MD, a world renowned anterior segment ophthalmic eyelash isolation is also shown. microsurgeon, has assembled a web-based video collection of surgical cases that encompass both routine and challenging cases, demonstrating both familiar and potentially unfamiliar surgical techniques using a variety 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 Divide and Conquer technique, including the use of a non-angulated, curved phaco needle, during the procedure • Incorporate a method of eyelash draping

Accreditation Statement This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Amedco and Postgraduate Healthcare Education, LLC (PHE). Amedco is accredited by the ACCME to provide continuing medical education for physicians. Credit Designation Statement Amedco designates this live activity for a maximum of .25 AMA PRA Category 1 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 medical educational grant from: Glaukos Review of Ophthalmology® MST Video and Web Production by: Alcon Crestpoint Management JR Snowdon, Inc & Carl Zeiss Meditec Glaucoma Management

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

GSL and Cataract Surgery: Low Risk, High Reward An often underutilized procedure, goniosynechialysis can be a signiﬁ cant contributor to pressure control in angle-closure patients.

Carla J. Siegfried, MD, St. Louis

oniosynechialysis is the lens extraction is both more effi cacious dialysis spatula was used to separate G process of physically separating and more cost-effective than doing the synechiae from the peripheral peripheral anterior synechiae (PAS), laser iridotomy in patients presenting cornea via anterior to posterior move- which can develop in the trabecular with primary angle closure. ment of the iris. meshwork when the angle is appo- Given these two developments, if Interestingly, these surgeons noted sitionally closed, contributing to the you’re going in to remove the lens in a a high rate of success (80 percent) in blockage of aqueous outflow. It’s patient in whom there’s a preoperative patients who had had angle closure for particularly useful as an adjunct to concern of angle closure, I believe it’s less than one year, because synechiae cataract surgery, and it can be done a good idea to perform intraoperative that have been in place longer than through a small corneal incision— gonioscopy after the IOL has been a year are not easily separated. the same incision you’re using for the placed. That will allow you to deter- (There’s also the issue of whether the cataract extraction. The procedure mine whether there are lingering trabecular outflow behind the syn- is accomplished by grasping the synechiae in the angle, or signifi cant echiae is still functional when the peripheral iris and gently pulling it areas of synechial closure that could angle has been closed for a signifi cant away from the angle, using any one of be opened relatively easily. If you do time.) However, I would point out a number of handheld instruments— fi nd synechiae in the angle, cataract that we usually don’t know how long most commonly microsurgical for- surgery provides a perfect opportunity synechiae have been present—unless ceps—under either direct or indirect to perform goniosynechialysis to open there was a clear attack of angle visualization by gonioscopy. the angle, improve trabecular outfl ow closure or a surgical intervention—so Goniosynechialysis has signifi cant and potentially lower the patient’s this procedure is usually worth a try. potential for increased utilization, for pressure. In terms of instrumentation, there two reasons: First, more surgeons are are a variety of techniques, but many becoming comfortable performing Performing the Procedure surgeons use microsurgical forceps gonioscopy in the offi ce and the OR, rather than a cyclodialysis spatula. thanks to the growing popularity of The classic description of gonio- When the procedure was first per- minimally invasive glaucoma sur- synechialysis in patients with acute formed, it was done with an irrigating geries, or MIGS. Second, the Effec- or subacute angle-closure glaucoma spatula because they didn’t have tiveness of Early Lens Extraction for appeared in 1984.2 Viscoelastic was good-quality viscoelastics. Fluid irri- the Treatment of Primary ACG study used to deepen the anterior chamber; gation into the eye kept it formed; (EAGLE), published in The Lancet then the angle was directly visualized then one could use the instrument in October 2016,1 indicated that clear by gonioscopy. An irrigating cyclo- to manipulate the tissue. This

This article has no commercial sponsorship. January 2018 | reviewofophthalmology.com | 47

047_rp0118_gm.indd 47 12/22/17 3:48 PM Glaucoma

REVIEW Management Robert Ritch, MD

An example of a narrow angle before (left) and after goniosynechialysis was performed.

works—I’ve performed it in the past procedure, you’re much less likely to 20-s (the “s” referring to a steep ap- with a spatula—but I fi nd it easier to cause a dialysis of either the iris or the proach). Cupping was 0.6 and 0.8 with perform with microforceps that allow ciliary body. some pallor of both optic nerves. She me to grasp the tissue. • Corneal endothelial damage. had an inferior arcuate defect in both The postoperative protocol is In my experience, corneal endotheli- eyes, as well as a nasal step in her left straightforward. Treat any inflam- al damage is uncommon as long as eye. The angle had 1 to 2+ pigment, mation with steroids and NSAIDs. one is careful to use viscoelastic and but I noted no PAS at that time. Pressure control is essential, especially exercise caution near the cornea. I followed her for the next several in the early postoperative period, • Problems resulting from re- years; her pressures, optic nerves because a pressure spike can result tained viscoelastic. This can be and visual fields remained stable. from a release of pigment, blood or avoided by carefully removing visco- Nevertheless, I continued to perform retained viscoelastic. I routinely inject elastic at the end of the procedure. annual gonioscopy, which is very im- a miotic intraoperatively after the portant in these patients, and her procedure to try to keep the angle GSL or Trabeculectomy? angles gradually became narrower open; some surgeons advocate longer- with appositional closure. For that term use of miotics as well. In a primary angle-closure glauco- reason, I performed an argon laser Possible complications of gonio- ma patient, performing cataract iridoplasty, which opened up her synechialysis include: extraction with goniosynechialysis angles again. • Mild to moderate postopera- instead of trabeculectomy often pro- After that, her pressure and visual tive infl ammation. This is probably vides an acceptable outcome without fi elds remained stable for a while, but the most common event. associated risks. In my experience, two years later at the age of 54, her • Hemorrhage. Hemorrhages are it makes sense to simply remove the pressures were 17 and 26 mmHg and relatively uncommon and usually self- lens, perform goniosynechialysis and she was starting to develop peripheral limiting; they can be minimized by then reassess the pressure. You may anterior synechiae. (During those exercising care during the procedure. be pleasantly surprised with the long- fi ve years her lens likely increased its If a hemorrhage does occur, it’s most term results. (You can always go back anterior-posterior diameter, pushing likely a tear in a very focal area, so later and do a trabeculectomy.) the iris forward and shallowing the the first thing to do is to stop pull- Consider a patient of mine who anterior chamber. This is a signifi cant ing in that location. I inject a little presented at the age of 49 with a one- component in progressive angle more viscoelastic to decrease the year history of primary angle-closure closure.) Even though she didn’t have hemorrhage by increasing the pres- glaucoma. She had a T-max in the low a visually signifi cant cataract, it was sure in that location. I’ve never had 40s in both eyes and she’d undergone “glaucoma significant” and I per- a serious hemorrhage—one that re- iridotomies in both eyes. When I formed cataract extraction along with curred or lasted for a long period of fi rst saw her, she had excellent visual goniosynechialysis in both eyes. time—during this procedure. acuity and was on brimonidine and She is now seven years postop. • Iridodialysis or cyclodialysis. travoprost, with pressures of 16 and She remains 20/20 and is off of all If you perform direct or indirect 18 mmHg. Gonioscopy at that time glaucoma medications; she has open visualization of the angle during the revealed angle closure of grade B(C) angles, IOPs in the low teens, and

48 | Review of Ophthalmology | January 2018

047_rp0118_gm.indd 48 12/22/17 3:48 PM RETINA ONLINE E-NEWSLETTER

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2016_Retina Online house Ad.indd 1 2/18/16 1:46 PM Glaucoma

REVIEW Management

stable visual fi elds and optic nerves. a patient has 90 to 180 degrees of to the feel of what you’re doing is All of this was accomplished without synechiae. equally important. If you have to pull resorting to trabeculectomy, which — Any level of angle closure is forcefully and the tissue is still not meant a shorter recovery time and acceptable, in my opinion, including releasing, it’s probably wise to leave lower risk of complications. acute, subacute and “chronic” angle that area alone to avoid causing a tear. Since Campbell and Vela’s initial closure, as well as angle closure in the The concept behind goniosyn- description, a review was published presence of plateau iris. echialysis is simple and straight- of 81 patients with primary ACG — GSL can be performed in com- forward, but as with many surgical with uncontrolled IOP and more bination with endocycloplasty. procedures, you don’t want to cause than six clock hours of synechiae that — GSL can be used to address re- a bigger problem than the initial underwent phaco/GSL. Eighty-nine sidual angle closure after iridotomy or problem you’re attempting to treat. percent had reduction of PAS and argon laser iridoplasty. • Avoid working with the pupil controlled IOP without medications,3 dilated. Constricting the pupil with consistent with the case described Miochol or Miostat after cataract above. More recent literature also surgery is helpful; you have the pupil supports this alternative to trabec- If you open six clock slightly more on stretch. If the pupil is ulectomy. One study found that hours, you may totally widely dilated, it’s much more diffi cult patients had shorter recovery times to see if you’ve broken the synechiae. and fewer complications with GSL change the outfl ow • Using viscoelastic is crucial. compared to trabeculectomy;4 another and improve IOP Viscoelastic helps keep the chamber found similar postoperative IOP formed throughout the procedure. and medication use, but decreased control. It also helps with hemostasis and complications with GSL;5 and another the initial viscodissection. Injecting found no difference in postop IOP, viscoelastic directly into the angle can but improved visual acuity and a help to “hyper-deepen” the peripheral deeper anterior chamber with PAS Contraindications, in my view, chamber, making it easier to identify resolution.6 include patients with neovasculari- the synechiae. A fourth study7 found that when zation in the angle or the iris, as well Whether you can open up some the glaucoma in angle-closure pa- as patients with chronic or recurrent of the synechiae just by using the tients was already well-controlled, uveitis, or ICE syndrome. viscoelastic to stretch the angle is there was no benefit to performing • Perform gonioscopy on your questionable, but viscoelastic will goniosynechialysis while undergoing angle-closure patients regularly. definitely allow you to differentiate cataract extraction. However, if you Angle closure may progress, and syn- appositional from synechial closure. can minimize your patient’s use of echiae may develop over time. • If necessary, make a second medications long-term without the • Aim for IOP control during incision to reach all of the syn- risks associated with trabeculectomy, the procedure to minimize corneal echiae. A two-site entry may be that’s a winning combination. For edema and optimize visualization. necessary, depending on where the that reason, I think it’s appropriate Having a clear cornea for visualization synechiae are located. If some are to consider GSL in primary angle- is crucial. If your patient has markedly subincisional or on the temporal side closure glaucoma patients who have elevated pressure prior to the surgery, of the eye, then you’ll need to make well-controlled pressure, if they’re that requires treatment, including the an incision on the opposite side to dependent on several medications. use of IV mannitol preoperatively. open those up. • If possible, perform goniosyn- • Remember that you don’t have Strategies for Success echialysis under direct visuali- to separate every synechia to im- zation. It’s important to be able to prove outfl ow. If you only open up These suggestions will help ensure see what you’re doing during the a signifi cant portion of the angle and the best possible outcome when procedure, in order to avoid tearing leave some synechiae untouched, performing GSL in conjunction with tissue, potentially causing signifi cant that doesn’t mean the procedure has cataract surgery: bleeding or something worse than been a failure. Freeing up all 12 clock • Choose appropriate candi- the synechiae. (A small amount of hours doesn’t have to be your ultimate dates. Considerations include: bleeding, however, isn’t unusual or goal; if you open six clock hours, you — Goniosynechialysis is ideal when harmful.) Of course, being sensitive may totally change the outflow and

50 | Review of Ophthalmology | January 2018

0047_rp0118_gm.indd47_rp0118_gm.indd 5050 112/22/172/22/17 3:483:48 PMPM improve IOP control. An Option Worth Considering mology at Washington University • When performing a MIGS School of Medicine in St. Louis. She procedure, consider doing gonio- Performing goniosynechialysis in has no fi nancial ties to any product synechialysis first. Combining combination with phaco may be an mentioned. goniosynechialysis and a MIGS effective and safe treatment option 1. Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, procedure could increase flow into for many patients with primary angle- Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie the anterior chamber angle and then closure glaucoma. The technique J; EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): A distal to the potentially less-functional isn’t highly complex, especially if randomised controlled trial. Lancet 2016;388:10052:1389-1397. trabecular meshwork. Other angle you’re performing MIGS procedures, 2. Campbell DG, Vela A. Modern goniosynechialysis for the treatment of synechial angle-closure glaucoma. Ophthalmology procedures may also be performed at many of which require you to be 1984;91:9:1052-60. these locations in the future. comfortable visualizing and working 3. Teekhasaenee C, Ritch R. Combined phaco-goniosynechialysis If you can’t ensure good vi- for uncontrolled chronic angle-closure glaucoma after acute • in the anterior chamber angle. angle-closure glaucoma. Ophthalmology 1999;106:669-75. sualization through the cornea, By opening the angle, helping to 4. Lai JS, Tham CC, Lam DS. The effi cacy and safety of combined endoscopy can be used. Gonio- re-establish trabecular meshwork phacoemulsifi cation, intraocular lens implantation, and limited goniosynechialysis, followed by diode laser peripheral iridoplasty, synechialysis can be performed fl ow and improving pressure control, in the treatment of cataract and chronic angle-closure glaucoma. with an endoscope using a 19- or goniosynechialysis may decrease the J Glaucoma 2001;10:4:309-15. 5. Zhao X, Yang X, et al. Comparison of combined 23-ga. probe if you don’t have good need for medication use, as well as phacoemulsifi cation, intraocular lens implantation, and visualization through the cornea, but saving the patient from undergoing goniosynechialysis with phacotrabeculectomy in the treatment of primary angle-closure glaucoma and cataract. The Asia-Pacifi c this is a more challenging technique. more invasive and higher-risk pro- Journal of Ophthalmology 2013;2:5:286–290. • Be sure to carefully remove the cedures. 6. Zhang H, Tang G, Liu J. Effects of phacoemulsifi cation combined with goniosynechialysis on primary angle-closure viscoelastic after the procedure. glaucoma. J Glaucoma 2016;25:5:e499-503. As with any intraocular surgery, Carla J. Siegfried, MD, is the Jac- 7. Lee CK, Rho SS, Sung GJ, et al. Effect of goniosynechialysis during phacoemulsifi cation on IOP in patients with medically viscoelastic left behind can cause quelyn E. and Allan E. Kolker MD well-controlled chronic angle-closure glaucoma. J Glaucoma pressure spikes. Distinguished Professor of Ophthal- 2015;24:6:405-9.

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047_rp0118_gm.indd 51 12/22/17 3:47 PM Retinal Insider

REVIEW Edited by Carl Regillo, MD, and Emmett T. Cunningham Jr., MD, PhD, MPH

A Look at Emerging Treatments for Uveitis Companies and researchers are hard at work on new drugs as well as innovative delivery systems.

Elizabeth A. Atchison, MD, and Pauline T. Merrill, MD, Chicago

on-infectious uveitis affecting the injection (sub-Tenon’s or intravitreal) may provide control of uveitic macu- Nposterior segment (NIU-PS, in- and implants (the dexamethasone lar edema with fewer side effects cluding intermediate, posterior and intravitreal implant [Ozurdex, Aller- than sub-Tenon’s or intravitreal ste- panuveitis) is a relatively uncommon gan] and the fl uocinolone acetonide roid injections. condition, with an incidence of about intravitreal implant [Retisert, Bausch Iontophoresis is the use of an elec- 4.6 per 100,000 person-years.1 How- + Lomb]). In addition to risks from tric current to help propel molecules ever, for those affected, NIU-PS can the individual form of administra- across the hydrophilic cornea epi- lead to a multitude of ocular prob- tion (such as globe perforation for thelium, classically the largest bar- lems. Compared to age-matched sub-Tenon’s injection and endo- rier to drug penetration into the eye. patients, those with NIU-PS are 10 phthalmitis for intravitreal injection), This would theoretically increase the times more likely to have blindness side effects of local ophthalmic cor- bioavailability of the steroid medica- or low vision, twice as likely to have ticosteroids include a high rate of tion, allowing greatly reduced dosing glaucoma, three times as likely to cataract and complications due to frequency and increased effi cacy as have a cataract and 12 times more increased intraocular pressure.4 compared to topical corticosteroids. likely to have a retinal detachment.2 This method has the advantage of Improved control of inflammation New Delivery Systems not being associated with many of can lead to decreased ocular compli- the needle-related risks of other local cations, better vision and increased Currently, there are two studies treatments. EyeGate Pharmaceuti- quality of life.3 In addition to current looking at novel delivery approaches cals is currently examining iontopho- therapeutic options, a number of for corticosteroids to treat non-in- resis for the delivery of dexametha- new treatment approaches for NIU- fectious uveitis. The PEACHTREE sone into the eye to treat anterior PS are on the horizon. (Clearside Biomedical) study is a non-infectious uveitis. Phase III, randomized, masked, mul- Traditional Local Treatment ticenter, controlled clinical trial to Intravitreal Sirolimus study the safety and effi cacy of a tri- In most cases, the initial treatment amcinolone acetonide suspension in- Sirolimus is an immunomodulat- for NIU-PS is corticosteroids. For jected into the suprachoroidal space ing agent that works via the mTOR uveitis, these may be administered of subjects with macular edema as- pathway, reducing the number of locally or systemically. Current local sociated with non-infectious uveitis. active T-cells and the amount of in- options for corticosteroid administra- This study is designed to evaluate flammatory cytokines. Oral siroli- tion include ophthalmic drops, local whether injections every 12 weeks mus has been shown to be effective

52 | Review of Ophthalmology | January 2018 This article has no commercial sponsorship.

052_rp0117_retinal.indd 52 12/22/17 2:56 PM Quan Dong Nguyen, MD

Figure 1. An intravitreal depot of sirolimus 14 days after injection.

for treating non-infectious poste- lished in 2016. This study examined pering success and best-corrected rior uveitis, but its side-effect profi le 347 patients who received 44, 440 visual acuity. For the zero to 0.5+ and need for laboratory monitoring or 880 micrograms of sirolimus in- vitreous haze outcome, 53 percent make it a less desirable treatment travitreally. Patients were required in the 440-microgram, 43 percent in choice.5 A hydrophobic intravitre- to be off of all systemic immuno- the 880-microgram and 35 percent al formulation of sirolimus, which modulatory medications, except for in the 44-microgram group met this forms a depot lasting approximate- oral steroids, which were rapidly ta- broader vitreous haze outcome. Of ly two months in the vitreous (See pered at the start of the study per the 69 patients on systemic corti- Figure 1) has been evaluated in the protocol. The main study outcome costeroids at the start of the study, SAKURA (Sirolimus study Assessing was the proportion of patients with the proportion able to wean off of double-masKed Uveitis tReAtment) no vitreous haze at the end of the corticosteroids was 77 percent in I and II studies (Santen Pharmaceu- study. Overall, 22.8 percent in the the 440-microgram, 67 percent in ticals). In December of last year, the 440-microgram group, 16.4 percent the 880-microgram and 64 percent FDA informed Santen that its intra- in the 880-microgram group and in the 44-microgram groups. Mean vitreal sirolimus application wasn’t 10.3 percent in the 44-microgram visual acuity was maintained in each approvable in its current form, and group met this outcome at the fi ve- group.6 the agency would need additional month endpoint. Secondary out- What is potentially exciting about evidence of effi cacy. comes were vitreous haze amounts intravitreal sirolimus is the lower rate The SAKURA I results were pub- of zero or 0.5+, corticosteroid ta- of ocular side effects compared to

January 2018 | reviewofophthalmology.com | 53

052_rp0117_retinal.indd 53 12/22/17 2:56 PM Retinal

REVIEW Insider

intravitreal corticosteroids. In the cantly higher rates of complications In conclusion, though NIU-PS study, there was a low rate of cataract related to IOP and cataracts, while continues to be a challenging condi- and IOP change. The most common the systemic therapy group had a tion to treat, there continue to be ocular adverse events were infl amma- signifi cantly higher rate of infections more therapeutic options. For lo- tory, and there were some instances requiring treatment.4,7 cal treatment, intravitreal Sirolimus of opaque drug depot in the visual may become available soon and, sys- axis. There were no systemic serious New Systemic Options temically, adalimumab is a newly ap- adverse events related to the drug. proved FDA option. Also, there are Adalimumab (Humira, AbbVie) many therapeutics in the pipeline Systemic Treatments is a tumor necrosis factor alpha in- that offer novel agents and new ways hibitor given by subcutaneous injec- to use traditional drugs. Oral prednisone is very effective tion. It has been used for more than for the treatment and prevention of a decade for infl ammatory conditions Dr. Atchison is a fellow at Illinois recurrence in NIU-PS. In addition such as rheumatoid arthritis, psoria- Retina Associates and Rush Univer- to the ophthalmic side effects men- sis and Crohn’s disease. The VISU- sity, Chicago. Dr. Merrill is a partner tioned above, however, oral pred- AL I and II trials showed benefi t of at Illinois Retina Associates and an nisone can lead to a multitude of adalimumab for patients with active assistant professor in ophthalmology systemic side effects, including hy- and inactive NIU-PS, respectively, at Rush. Dr. Atchison may be reached perglycemia, dyslipidemia, hyperten- requiring systemic prednisone.8,9 Pa- at [email protected]. Dr. sion; osteoporosis and fractures; im- tients receiving adalimumab (80 mg Merrill may be contacted at pauline. munosuppression and gastric refl ux. loading dose followed by 40 mg every [email protected]. They’d like to In addition to corticosteroids, oth- other week) were half as likely to thank Quan Dong Nguyen, MD, for er traditional options for systemic fail steroid taper than those receiv- his contributions to the article. treatment include antimetabolites, T- ing placebo. Use of adalimumab was 1. Acharya NR, Tham VM, Esterberg E, et al. Incidence cell inhibitors and alkylating agents. also associated with an approximately and prevalence of uveitis: Results from the pacifi c ocular The antimetabolites include metho- doubled time to treatment failure infl ammation study. JAMA Ophthalmol 2013;131:11:1405-12. 2. Dick AD, Tundia N, Sorg R, et al. Risk of ocular complications trexate and mycophenolate mofetil as compared to placebo. Based on in patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Ophthalmology 2016;123:3:655-62. and tend to be the fi rst-line agents VISUAL I and II, in 2016 the FDA 3. Frick KD, Drye LT, Kempen JH, et al. Associations among for steroid-sparing systemic treat- expanded the indications of adalim- visual acuity and vision- and health-related quality of life among patients in the multicenter uveitis steroid treatment trial. Invest ments due to their relatively favor- umab to include NIU-PS. Ophthalmol Vis Sci 2012;53:3:1169-76. 4. Multicenter Uveitis Steroid Treatment (MUST) Trial Research able side-effect profi le. Cyclosporine Group, Kempen JH, Altaweel MM, et al. Randomized comparison and tacrolimus are T-cell inhibitors of systemic anti-infl ammatory therapy versus fl uocinolone Other Biologics acetonide implant for intermediate, posterior, and panuveitis: that that can be associated with hy- The multicenter uveitis steroid treatment trial. Ophthalmology 2011;118:10:1916-26. pertension and nephrotoxicity. Cy- The STOP-UVEITIS study is cur- 5. Shanmuganathan VA, Casely EM, Raj D, et al. The effi cacy of clophosphamide and chlorambucil rently evaluating tocilizumab (an anti- sirolimus in the treatment of patients with refractory uveitis. Br J Ophthalmol 2005;89:6:666-9. are alkylating agents that are used interleukin-6 antibody) for patients 6. Nguyen QD, Merrill PT, Clark WL, et al. Intravitreal sirolimus for noninfectious uveitis: A phase III sirolimus study assessing for uveitis associated with severe sys- with non-infectious uveitis. This study double-masKed uveitis TReAtment (SAKURA). Ophthalmology temic disease, such as granulomato- looks at monthly IV infusions of tocili- 2016;123:11:2413-23. 7. Writing Committee for the Multicenter Uveitis Steroid sis with polyangitis. Their side effects zumab in two doses and is scheduled Treatment (MUST) Trial and Follow-up Study Research Group, Kempen JH, Altaweel MM, et al. Association between long- include pancytopenia, hemorrhagic to conclude in December of 2017 lasting intravitreous fl uocinolone acetonide implant vs. systemic cystitis and malignancies. (https://clinicaltrials.gov/ct2/show/ anti-infl ammatory therapy and visual acuity at 7 years among patients with intermediate, posterior, or panuveitis. JAMA The Multicenter Uveitis Steroid NCT01717170). Secukinumab is an 2017;317:19:1993-2005. Treatment (MUST) trial compared anti-interleukin 17A antibody that 8. Jaffe GJ, Dick AD, Brezin AP, et al. Adalimumab in patients with active noninfectious uveitis. N Engl J Med 2016;375:10:932-43. systemic anti-infl ammatory therapy was shown to be effective in quieting 9. Nguyen QD, Merrill PT, Jaffe GJ, et al. Adalimumab for prevention of uveitic fl are in patients with inactive non- to sustained-release corticosteroid posterior uveitis and improving remis- infectious uveitis controlled by corticosteroids (VISUAL II): A implants for NIU-PS. This longitudi- sion rates.10 Intravenous treatment multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet 2016;388:10050:1183-92. nal study showed that although local was more effective than subcutane- 10. Letko E, Yeh S, Foster CS, et al. Effi cacy and safety of intravenous secukinumab in noninfectious uveitis requiring therapy led to faster control of in- ous treatment. Sarilumab is another steroid-sparing immunosuppressive therapy. Ophthalmology fl ammation, after seven years the sys- anti-IL-6 antibody that resulted in de- 2015;122:5:939-48. 11. de Smet m, Sundaram P, Erickson K, et al. Variability in temic medication group had better creased vitreous haze and decreased vitreous haze grading technique using a 9-step logarithmic scale in patients enrolled in the sarilumab in noninfectious visual acuity outcomes. The implant oral steroid dosing when given subcu- uveitis (SARIL-NIU), the SATURN study. In ARVO Proceedings; therapy eyes had statistically signifi - taneously every two weeks.11 2016.

54 | Review of Ophthalmology | January 2018

0052_rp0117_retinal.indd52_rp0117_retinal.indd 5544 112/22/172/22/17 3:063:06 PMPM SAVE THE DATE OphthalmologyUpdate FEBRUARY 17-18, 2018 • CARLSBAD, CALIFORNIA An interdisciplinary faculty of ophthalmic subspecialists will review the continuing progress in Cataract and Refractive Surgery, Glaucoma, Retina, Neuro-Ophthalmology, Pediatric Ophthalmology, Ocular Surface Disease, Cornea and Oculoplastics.

LOCATION KEYNOTE SPEAKER Cape Rey Carlsbad, A Hilton Hotel Larry Smarr, PhD 1 Ponto Road, Carlsbad, CA P: (760) 602-0800 UCSD SPEAKERS Limited rooms reserved at $209/night. Natalie Afshari, MD Please visit registration site for PROGRAM TIMES Andrew S. Camp, MD reservation information. Saturday, February 17 Daniel L. Chao, MD, PhD PROGRAM CHAIRS 8:00am — 5:00pm William R. Freeman, MD Reception to follow Michael H. Goldbaum, MD Don O. Kikkawa, MD, FACS Weldon W. Haw, MD Robert N. Weinreb, MD Sunday, February 18 8:00am — 12:15pm Chris W. Heichel, MD DISTINGUISHED Bobby S. Korn, MD, PhD INVITED SPEAKERS Eric D. Nudleman, MD, PhD C. Gustavo De Moraes, MD Shira L. Robbins, MD Audrey Ko, MD Peter J. Savino, MD Dan Schwartz, MD Derek S. Welsbie, MD, PhD Jonathan Song, MD, MBA Kang Zhang, MD, PhD Benjamin Xu, MD, PhD EARLY BIRD SPECIAL: $95* FOR MORE INFORMATION www.reviewofophthalmology.com/Update2018 Email: [email protected] Phone: 855-851-9964 *See event website for additional information. Accreditation Statement This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Amedco and Postgraduate Health Education, LLC (PHE). Amedco is accredited by the ACCME to provide continuing medical education for physicians. Credit Designation Statement This meeting is approved for AMA PRA Category 1 Credits™

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2017_opg_ad_fullpge_rp.indd 1 9/27/17 2:15 PM Research Review REVIEW

Corneal Marking For Toric IOLs

esearchers from the Univer- 59.4 ±15.3 seconds; p=0.003). In domain optical coherence tomog- Rsity Eye Hospital in Munich, addition, the mean overall time re- raphy. Data collected included Germany, designed a prospective quired to perform the surgery was spherical equivalent, central cor- case series to compare the visual significantly shorter in the digital neal thickness, axial length, intra- outcomes, alignment accuracy and group (727.2 ±198.4 vs. 1,110.0 ocular pressure and keratometry. surgical time between two meth- ±382.2 seconds; p<0.001). Eyes with keratoconus had sig- ods of implanting toric intraocular Based on the results of this nificantly thinner LC (174.9 ±11.4 lenses. study, the researchers say that vs. 249.1 ±4.9 µm, p<0.001) com- The study included 29 patients the digital tracking approach for pared with control-group eyes. (57 eyes) having cataract surgery toric IOL alignment is an efficient There was no statistically signif- with implantation of a toric IOL and safe way to improve refractive icant difference in the depth of (Torbi 709 M). They were random- outcomes. Furthermore, they say LC between the keratoconus and ly assigned to one of two groups that image-guided surgery helps control groups (p=0.3). Multivari- based on the marking system used streamline the workflow in refrac- able analysis, controlled for age (manual or digital). Patients were tive cataract surgery. and sex, showed that the thick- included if they had age-related J Cataract Refract Surg ness of LC significantly correlat- cataract and regular corneal astig- 2017;43:1281-1286 ed with central corneal thickness matism of 1.25 D or higher. Visual Mayer WJ, Kreutzer T, Dirisamer M, et al. (p<0.001). This association per- and refractive outcomes, as well as sisted (p<0.001) after controlling rotational stability, were evaluated. Lamina Cribrosa Thickness in for intraocular pressure, in addi- Vector analysis was performed to Patients with Keratoconus tion to age and sex. There were no evaluate total astigmatic changes. n a cross-sectional, observation- significant correlations with other There were 28 eyes in the manu- Ial study comprising 45 patients factors, including the spherical al group and 29 eyes in the digital with keratoconus and 56 healthy equivalent (p=0.93) and keratom- group. The mean toric IOL mis- subjects, researchers from the etry (p=0.46). alignment was significantly lower department of ophthalmology at The researchers note that the in the digital group than in the the Kayseri Training and Research study showed that optical coher- manual group (2.0 ±1.86 vs. 3.4 Hospital in Kayseri, Turkey, evalu- ence tomography measurement ±2.37 degrees; p=0.026). The mean ated the thickness and depth of the of LC revealed thinner LC for pa- deviation from the target induced lamina cribrosa in the optic nerve tients with keratoconus compared astigmatism was significantly low- head region of the eyes in patients with healthy controls, and specu- er in the digital group (0.10 ±0.08 with nonglaucomatous keratoco- late that the structural properties vs. 0.22 ±0.14 D; p=0.008). During nus to compare the thickness and of the cornea may be related to the surgery, the mean toric IOL align- depth with those of age-matched optic nerve. ment time was significantly shorter controls. Analysis of LC imaging Cornea 2017;36:1509-1513 in the digital group (37.2 ±11.9 vs. was performed using spectral- Akkaya S, Küçük B.

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0057_rp0118_rr.indd57_rp0118_rr.indd 5757 112/22/172/22/17 10:3010:30 AMAM ENRICH YOUR PRACTICE

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2017_rp_tsrad.indd 90 12/21/17 11:37 AM REVIEW Product News Aerie’s Rhopressa Recieves FDA Approval

erie Pharmaceuticals recently Expanded Parameters for A announced FDA approval for Avaira Vitality Toric Rhopressa 0.02% for lowering intra- n mid-December, CooperVision ocular pressure in patients with open- I announced the nationwide avail- angle glaucoma or ocular hyperten- ability of expanded parameters for its sion. Avaira Vitality toric two-week contact Rhopressa is a once-daily eye drop lenses, which now include plus pow- that the company says reduces IOP ers, high minus powers and a -2.25-D by increasing the outﬂ ow of aqueous cylinder. humor through the trabecular mesh- The toric is made from a new sili- work. cone hydrogel material (fanfilcon The three clinical trials for Rho- A) and has a high water content and pressa demonstrated up to 5 mmHg high level of oxygen permeability and reductions in IOP for subjects transmissibility, the company says. treated once daily in the evening. CooperVision adds that the UV pro- of its classic case design. For patients with baseline IOP <25 tection has also been improved to The case has a design that has mmHg, the IOP reductions with Class I, which means that the lenses been engineered to withstand 50,000 Rhopressa dosed once daily were now block more than 90 percent of openings without hinge breakage, similar to those with timolol 0.5% UVA and 99 percent of UVB rays. Volk says. There is a thermoplastic dosed twice daily. For patients with Avaira Vitality toric is now available rubber insert cushion in the case and baseline IOP equal to or above 25 in a power range of +8 to -10 D, with a magnetic closure that holds the mmHg, however, Rhopressa re- cylinder options of -0.75, -1.25, -1.75 case shut. sulted in smaller mean IOP reduc- and -2.25 D in axes from 10 to 180 Volk says that its digital series, tions at the morning time points degrees in 10-degree steps. The base BIO, slit lamp, laser, surgical and than timolol 0.5% for study visits curve is 8.5 mm and the diameter is specialty treatment lenses are all on days 43 and 90; the difference in 14.5 mm. available with the new case. The case mean IOP reduction between the For more information, visit cooper- exteriors are color-coordinated by two treatment groups was as high as vision.com/contact-lenses/avaira-vi- lens family and clearly labeled with 3 mmHg, favoring timolol. tality. the lens name. The cover plate can The most common ocular adverse also be custom engraved with doctor reaction observed in controlled clini- Volk Optical’s Next-Gen or practice name. Volk adds that the cal studies with Rhopressa dosed once Lens Cases molded plastic exterior and interior daily was conjunctival hyperemia, olk Optical has announced the insert are easy to wipe clean. Addi- which was reported in 53 percent of V launch of a new case design for tionally, the nonslip stabilizing feet patients. its line of diagnostic and therapeu- hold the case ﬁ rmly in place. For more information on Rhopres- tic ophthalmic lenses. It says that the For more information on Volk’s lens sa, visit aeriepharma.com. case enhances the durability and look cases, visit volk.com.

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60 | Review of Ophthalmology | January 2018

ROPH0118.indd 60 12/21/17 8:29 PM 061_rp0118_wills.indd 61 What isyourdiagnosis? furtherworkupwouldyoupursue?Thediagnosis appearsonp. 63. RPE detachment(Figure1). surrounding retinalpigmentepithelialalterationsandalarge mm indiameterandassociatedwithshallowsubretinalfl ill-defi ratio of0.6.However, intheinferiorquadrant,therewasan left funduswassimilar, withanormalmaculaandcup/disc ratio of0.6andevidentposteriorvitreousdetachment.The normal macula,disc,vesselsandperiphery, withacup/disc Dilated fundusexaminationoftherighteyedemonstrated eye hadmildnuclearsclerosisandanteriorcorticalchanges. revealed aposteriorchamberintraocularlens,andtheleft ally andconfrontationvisualfi elds werefullinbotheyes. mmHg intheleft.Extraocularmovementswerefullbilater- Intraocular pressureswere13mmHgintherighteyeand14 pils weresymmetricandwithoutafferentpupillarydefect. Examination father. Socialhistorywasrelevantforsubstantialsecondhandsmokeexposurebutnopersonalofsmoking. one, montelukast,fl uticasone nasalinhalationandsumatriptan.Familyhistorywasrelevantforlungcolon cancerinthe tension andhyperlipidemia.Systemicmedicationsincludedaspirin,simvastatin,metoprololtartrate,famotidine,progester- primary openangleglaucomaofbotheyesthathadbeenmanagedwithlatanoprost.Pastmedicalhistoryincludedhyper- Medical History quently referredthepatienttoanocularoncologyspecialistruleoutchoroidalmalignantmelanoma. saw asuspiciouschoroidallesionondilatedexaminationofthelefteyeandreferredhertoretinalspecialist,whosubse- well. Sheinitiallydescribedhersymptomstoprimarycareproviderwhoreferredanoptometrist.Theoptometrist presented forophthalmicevaluation.Shehadaworseningofchronicheadachesandnewonsetfl oaters in thelefteye,as Presentation Austin R.Meeker, MDandCarolL.Shields, MD something else? Amelanotic fundusmassina73-year-old woman:metastasisor

On examinationoftheanteriorsegment,righteye On examination,visualacuitywas20/20ineacheye.Pu- Past ocularhistoryincludedcataractextractionwithplacementofanintraocularlensintherighteyeoneyearpriorand A 73-year-old Caucasianwomanwithgradualonsetofblurredvisionandpressuresensationinherlefteyefortwomonths REVIEW ned yellow mass deep in the retina, measuring 16 x 14 nedyellowmassdeepintheretina,measuring16x14 Wills Eye Wills Eye uid, uid, Resident CaseSeries Edited by Thomas Jenkins, MD disrupting theretinal pigmentepithelium. 14-mm amelanoticmassispresent inferiortothearcade, patient’s ﬁrst visittotheocularoncologyclinic. An ill-deﬁned, 16x Figure 1.Montagecolorfundusphotoofthelefteye atthe January 2018 | reviewofophthalmology.com |

61 12/22/17 10:41 AM 061_rp0118_wills.indd 62 mass andadecrease insub-Tenon’s fluid. decrease insizeandthickness oftheechodense fundus after initiatingatrialofsystemicsteroids. There isinterval Figure 5.B-scanultrasonography ofthelefteye two weeks suspicion forchoroidalmetastasisoramelanotic ment (Figure4). suggestive ofRPEmottlingandperhapslipofuscinpig- nating hyper- andhypofl uorescence overlying themass, (Figure 3).Fundusautofluorescence demonstratedalter- epithelium detachmentandsurroundingsubretinalfl sion ofthechoriocapillaris,apeculiarretinalpigment “lumpy-bumpy” surfacecontourandcompres- sclera cency immediatelyoutsidetheglobe,lining measuring 5.3mminthicknesswithsubtlelu- demonstrated anechodensechoroidallesion and autofl ultrasonography, opticalcoherencetomography is associatedsub-Tenon’s fluid outsidethesclera. present withthickening ofthechoroid andsclera. There first visit. A 5.3-mm, elevated, hyperdense massis Figure 2.B-scanultrasonography ofthelefteye atthe Workup, DiagnosisandTreatment 62 REVIEW The presenceofanon-pigmentedfundusmassraised Further investigationwasperformedwith | ReviewofOphthalmology Resident CaseSeries (Figure 2).OCTrevealedamasswith uorescence. B-scanultrasonography | January2018 pigment epithelialdetachment withsurroundingsubretinal fl bumpy contourwithcompression ofthechoriocapillaris. There’s anassociated the datepatientwas first seen. The anteriorfaceofthemasshasalumpy- Figure 3.Ocularcoherence tomography ofthefundusmassinlefteye on uid rare atypical epithelioid cells which were non-diagnostic. rare atypicalepithelioidcellswhichwerenon-diagnostic. A mammogramwaswithinnormallimits.FNABrevealed normal andMRIoftheabdomenrevealedonlyfattyliver. of theheadandchestwithwithoutcontrastwere linear scarringandatelectasiswithnoevidenttumor. CT (FNAB) wasperformed.Chestradiographdemonstrated lignancies wasinitiatedandfi ne needleaspirationbiopsy malignant melanoma.Aninvestigationforsystemicma- posterior margin. chorioretinal foldsonthe pigment disturbanceand with RPEmottling, lipofuscin hypofl uorescence consistent hyper-alternating and fundus massdemonstrates was first seen. The inferior eye onthedatepatient autofluorescence oftheleft Figure 4.Fundus uid. biopsy. needle aspiration tothefi ondary of themasssec- the temporal edge is present along ous hemorrhage of themass. Vitre- decrease insize There isinterval systemic steroids. after atrialof eye two weeks photo oftheleft color fundus Figure 6.Montage ne 12/22/17 10:42 AM On re-examination and review of available data, par- Posterior scleritis was highly considered as a potential ticularly with her history of chronic headache and ocu- diagnosis and a trial of systemic corticosteroids was be- lar “pressure feeling,” and the ultrasound features of gun with close follow-up. After two weeks of treatment echolucency rimming the posterior sclera (T-sign), the consisting of prednisone 60 mg daily, there was reduction differential diagnosis was broadened to include scleritis. of the amelanotic mass from 5.3 mm thickness to 3.7 mm The OCT appearance of a lumpy-bumpy surface was (Figure 5), along with improvement of symptoms and the consistent with metastatic disease; however, extensive appearance of the retinal pigement epithelium detach- systemic workup revealed no evidence of primary tumor. ment (Figure 6).

Discussion

There is a broad differential diagnosis for an elevated studies alone, cytopathologic diagnosis via FNAB can choroidal mass, particular those that are amelanotic. be employed. This proves particularly useful in amela- In the present case, choroidal neoplasia remained an notic tumors that can be diffi cult to distinguish between important and “must-not-miss” consideration in the amelanotic melanoma and other neoplasms, as well as differential diagnosis, including both primary and meta- lesions concerning for metastases with an unremarkable static tumors. Malignant melanoma is the most common systemic workup, as in our patient.4 In a review of 159 primary intraocular malignant neoplasm in adults; how- patients undergoing FNAB for intraocular tumors, 140 ever, clinicians should realize that choroidal metastasis samples provided suffi cient cytopathologic material for is perhaps the most common intraocular malignancy diagnosis with 100-percent sensitivity. The remaining in adults, particularly when considering all tumors.1 19 samples demonstrated a paucity of cells resulting The mass discussed here had features suggestive of in a decrease to 84-percent sensitivity.4 In our patient, both amelanotic melanoma and choroidal metastasis, FNAB revealed rare atypical epithelioid cells with given the lack of pigmentation and fairly asymptomatic insuffi cient quantity for immunological studies and cy- presentation. OCT was more consistent with choroidal topathological diagnosis. This prompted a reassessment metastasis in that the tumor demonstrated a lumpy- of the case with broadening of the differential diagnosis, bumpy surface contour—a feature strongly suggestive including inflammatory conditions such as posterior of choroidal metastasis, effusion and infl ammation, but scleritis. not necessarily melanoma. In a series of 31 eyes with Posterior scleritis is a great mimicker of ophthalmic choroidal metastasis, the characteristic lumpy-bumpy disease. Patients with posterior scleritis may or may not anterior contour of the mass was present in 64 percent, have a red eye, pain, peribulbar edema or other clas- and compression of the choriocapillaris in 93 percent. sic signs. Posterior scleritis can also present as serous This lumpy-bumpy surface was identifi ed in the current retinal detachment, macular edema, optic nerve edema case, strongly biasing the evaluation towards metastatic or annular choroidal detachment leading to acute angle disease.2 closure, which are atypical fi ndings for the classic case.5 B-scan ultrasonography can also aid in identifi cation Further hiding its detection, posterior scleritis can pres- of the underlying tumor. In this case, the mass was ech- ent with substantial pain, blurred vision, redness and/or odense, consistent with choroidal metastasis as well as signifi cant vitritis, or be completely asymptomatic.5 In infl ammation and other tumors, whereas choroidal mel- the current case, the patient noted left eye “pressure,” anoma would typically reveal echolucency. With these but didn’t classify it as pain. This initial piece of evi- concerning features, systemic evaluation for a primary dence can be less suggestive of neoplasia, but it should malignancy was instituted. In a series of 520 uveal me- be noted that choroidal melanoma can occasionally tastases, more than 66 percent of primary tumors iden- cause pain. Choroidal metastasis, especially from lung tifi ed were of breast- or lung-cancer origin.3 However, cancer, can also produce pain, further complicating the there were a substantial number of cases (17 percent) diagnostic investigation.3,5 for which a primary malignancy wasn’t identifi ed.3 In One of the most important imaging modalities in the the present case, mammography and chest radiograph evaluation of a fundus mass is ultrasonography. Along were unremarkable, as were additional systemic studies with measuring tumor thickness, ultrasonography al- including MRI of the abdomen and CT of the brain. lows for characterization of tumor echodensity. Unlike In cases of intraocular tumors without a clear di- melanoma, which is typically echolucent, both scleritis agnosis from clinical examination and non-invasive and choroidal metastases are echodense. In closer

January 2018 | reviewofophthalmology.com | 63

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examination, one can identify anoth- days after stopping all immunosup- Akorn Pharmaceuticals 31, 41 er feature of scleritis, the character- pressive treatments, was 210 days Phone (800) 932-5676 istic T-sign caused by sub-Tenon’s with a 15-percent risk of relapse.7 www.akorn.com edema surrounding the optic nerve This risk of relapse wasn’t signifi- and posterior sclera that takes on cantly different between idiopathic Alcon Laboratories 2, 3, 35, 36 a T-shaped configuration.5 Others cases or cases found to be associ- Phone (800) 451-3937 have found the T-sign on B-scan ated with other systemic infl amma- Fax (817) 551-4352 ultrasonograpy to be useful for diag- tory conditions, such as rheumatoid nosis of posterior scleritis, particular polyarthritis and systemic lupus ery- Bausch + Lomb 7, 8 in those under suspicion for choroi- thematosus.7 Phone (800) 323-0000 dal melanoma.6 In the present case, Posterior scleritis can have a Fax (813) 975-7762 the T-sign was present in a different multitude of presentations, allow- fashion as the sub-Tenon’s fl uid was ing it to mimic other more com- Haag-Streit 33 primarily seen outside the inferiorly mon pathologies. Despite its rarity, Phone (800) 627-6286 located mass, rather than at the pos- posterior scleritis is an important Fax (603) 742-7217 terior pole around the optic nerve. consideration in evaluation of a fun- Despite the classic appearance of dus mass, especially in those cases Imprimis Pharmaceuticals, Inc. 5 the T-sign in posterior scleritis, a without a clear diagnosis. In the Phone (858) 704-4040 recent study of 114 patients with present case, the patient’s amela- Fax (858) 345-1745 posterior scleritis found this sign notic mass was echodense on ultra- www.imprimispharma.com in only 41 percent of patients.7 In sonography, and an unremarkable that series, the most common ul- FNAB and systemic workup made Johnson & Johnson Vision (formerly AMO) 68 trasonographic feature of scleritis neoplasia less likely. With improve- www.vision.abbott was echodensity with thickening of ment in symptoms and remission the sclera and choroid as seen in with immunosuppressive treat- Keeler Instruments 67 our patient.7 B-scan ultrasonogra- ment, posterior scleritis remains a Phone (800) 523-5620 phy can also be useful in identify- treatable condition. Therefore, this Fax (610) 353-7814 ing additional suggestive features case of a 73-year-old woman with of posterior scleritis including an an amelanotic fundus mass serves Oculus, Inc. 19 eyewall thickness greater than 2 mm as a reminder of the importance of Phone (888) 284-8004 and scleral nodules.8 establishing a broad differential di- Fax (425) 867-1881 Once diagnosed, posterior scleri- agnosis. tis is a treatable condition with oral S4OPTIK 21, 23 or periocular corticosteroids or non- 1. Recchia FM. Retinal and Choroidal Tumors. In: Fineman M, Phone (888) 224-6012 Ho A, eds. Color Atlas and Synopsis of Clinical Ophthalmology steroidal anti-infl ammatory medica- (Wills Eye Institute): Retina. Philadelphia: Lippincott Williams Shire Ophthalmics 13, 14 tions, leading to improvement in & Wilkins, 2012. pain and visual acuity. Despite vari- 2. Al-Dahmash SA, Shields CL, Kaliki S, et al. Enhanced depth www.shire.com ation in medications, anti-inflam- imaging optical coherence tomography of choroidal metastasis in 14 eyes. Retina 2014;34:1588-1593. SightLife Surgical 29 matory therapy is the mainstay of 3. Shields CL, Shields JA, Gross NE, et al. Survey of 520 eyes Phone (877) 726-7632 treatment. In the aforementioned with uveal metastases. Ophthalmology 1997;104:1265-1276. series of 114 cases of posterior scle- 4. Shields JA, Shields CL, Hormoz E, et al. Fine-needle aspi- Fax (206) 682-8504 ritis, treatment ranged from topical ration biopsy of suspected intraocular tumors. Ophthalmology [email protected] 1993:100;1677-1684. www.sightlifesurgical.com corticosteroids to systemic immuno- 5. Benson WE. Posterior scleritis. Survey Ophthalmol modulatory therapies such as myco- 1988;32:297-316. phenolate and azathioprine.7 Most 6. Shinisha DP, Elangovan S, Puri SK, et al. Unusual presenta- Sun Ophthalmics 25, 26 tion of posterior scleritis. Health Sciences 2016;5:54-57. SunIsOnTheRise.com commonly, however, patients were 7. Lavric A, Gonzalez-Lopez JJ, Majumdar PD, et al. Posterior treated with systemic non-steroidal scleritis: Analysis of epidemiology, clinical factors, and risk anti-infl ammatory drugs or system- of recurrence in a cohort of 114 patients. Ocul Immunol ic corticosteroids as in the present Infl amm 2016;24:6-15. This advertiser index is published as a 7 8. McClusky, PJ, Watson PG, Lightman S, et al. Posterior scle- convenience and not as part of the advertising case. Across all specifi c treatments, ritis: Clinical features, systemic associations and outcome in contract. Every care will be taken to index the mean time to remission, which a large series of patients. Ophthalmology 1999:106:2380- correctly. No allowance will be made for errors due to spelling, incorrect page number, or failure 2386. is defi ned as no disease activity 90 to insert.

January 2018 | reviewofophthalmology.com | 65

0061_rp0118_wills.indd61_rp0118_wills.indd 6655 112/28/172/28/17 10:0510:05 AMAM Refractive/Cataract

REVIEW Rundown

(Continued from page 15) instances); and their dominant eye to plano and the • barrier laser treatment for hemor- non-dominant to -1 D, because they This leaves these residual, untreated rhagic posterior vitreous detachment have a cataract—their vision is blurry. silicone monomers. In the study, we and a horseshoe retinal tear with sub- With this lens, though, for the first had the option to do two light adjust- retinal fl uid nine months postop (fi nal time we can show them their visual ments, and when the refraction was BSCVA: 20/14.5).1 options after the surgery and they can dead-on, we’d do two mandatory lock- At 12 months, one eye in the choose where they want their optical ins. But, with every treatment we do, RxLAL group and four in the control power to be. You can start discussing the pupil seems to dilate less and less. group had a decrease of two or more ‘optimized monovision’ where you I don’t know why, but that’s what we lines of BSCVA. can change the power of the implant observed. There’s a dilation fatigue A couple of adverse events unique so that one eye is set for the amount that some of these eyes demonstrated. to the RxLAL’s UV-light adjustment of monovision they need for reading We had to use more and more dilating process were also investigated, name- or the distance they want to work at.” drops to get them up to the diameter ly red-tinted vision (erythropsia) and Dr. Miller envisions this, as well. of the lens. color vision abnormalities. The high- “You can play with it,” he says. “You “The worst thing I experienced in est rate of erythropsia occurred prior can ask, ‘Do you prefer distance vision the study was a patient with a macular to the second lock-in treatment, with and vision at computer distance? A burn,” Dr. Miller continues. “It hap- 49 percent of patients reporting mild little farther out? A little closer? You pened because they had changed the erythropsia. This decreased to 17.7 could simulate it with a contact lens supplier of the UV fi lter for the Light percent at one week after that lock-in, and then dial that amount into the Delivery Device and the new filter and to 0.5 percent at six months. One IOL. Though the ‘screaming need’ is was out of spec. The eye got exposed patient (0.3 percent) had mild ery- for some sort of multifocal correction to more light than it was supposed thropsia at the 12-month exam, but it for distance and near vision, this lens to. The vision dropped to 20/150, but resolved two months later.1 won’t provide that just yet. However, the patient recovered to 20/22 vi- As for color vision, seven RxLAL the company had to get the base plat- sion.” Some other adverse events that (1.8 percent) eyes had a new tritan form onto the market fi rst. emerged in the FDA review include anomaly (diffi culty distinguishing be- “The initial interest from surgeons 1.7 percent of patients who needed tween blue, violet and green). Five will be for treating post-refractive sur- a secondary surgical intervention, resolved after the adjustments were gery eyes, which will be off-label,” Dr. which was significantly higher than complete, but two persisted. One of Miller continues. “The study didn’t the historical rate (0.5 percent). These the latter two was due to the faulty UV enroll those types of eyes, but you SSIs consisted of the following: fi lter, and still had the tritan anomaly can do them. These are the types of • explant due to the faulty UV fi lter four years later. The researchers note patients that we surgeons obsess over. mentioned earlier; that both of the persistent and all but They’re particular about their refrac- • explant due to a scratch on the one of the transient tritan anomalies tive outcomes, but we have a hard LAL optic that occurred during im- occurred before a certain safety im- time delivering good outcomes for plantation; lens replacement was re- provement was made to the LDD to them. So, everyone wants a solution. quired three weeks postop, and the reduce the amount of UV exposure.1 Therefore, my guess is that surgeons’ secondary procedure had complica- initial foray into this technology will tions (fi nal BSCVA: 20/20); Putting It into Practice be for treating these eyes. Then, when • explantation because the subject they see that it works, they’ll expand requested lens replacement prior to Though the company hasn’t speci- the LAL’s use to regular eyes, in a way light treatment (fi nal BSCVA: 20/15); fi ed a date for the rollout of the lens, similar to how toric IOLs were fi rst • Descemet’s stripping endothe- surgeons have ideas how it might be used for the high astigmats and then lial keratoplasty due to corneal edema used in practice. their use filtered down to the less- caused by implantation problems (fi - “For patients, I think the benefit challenging eyes.” nal BSCVA: 20/26.4); is they don’t have to make a decision • two incidences of lysing of iris about the type of vision they want pre- Drs. Thompson and Miller consult adhesions (one accompanied by a operatively,” muses Dr. Thompson. for RxSight. sphincterotomy) to treat posterior “Unlike fi tting glasses, with cataract 1. FDA.gov. LAL Summary of Safety and Effectiveness. https:// synechiae that were limiting pupil di- surgery we can’t show them exactly www.accessdata.fda.gov/cdrh_docs/pdf16/P160055B.pdf. lation (fi nal BSCVA: 20/17.4 in both what the result will be if we correct Accessed 11 December 2017.

66 | Review of Ophthalmology | January 2018

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INDICATIONS: The TECNIS Symƒony® Extended Range of Vision IOL, model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symƒony® Toric Extended Range of Vision IOLs, models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model series ZXT IOLs are intended for capsular bag placement only. WARNINGS: May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including: perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions, may be signiﬁcant enough that the patient may request removal of the IOL. Rotation of the TECNIS Symƒony® Toric IOLs away from their intended axis can reduce their astigmatic correction, and misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

RP0118_J&J.indd 1 12/28/17 1:54 PM