Getting Femto Cataract up to Speed P. 22 D

INTRAOPERATIVE OCT COMES INTO FOCUS P. 17 • PEDIATRICS: VIGABATRIN & FIELD LOSS P. 57 INSIDE CENTRAL SEROUS CHORIORETINOPATHY P. 40 • THE LATEST ON THE LIGHT-ADJUSTABLE LENS P. 48 A LOOK BACK AT KEY ARVO ABSTRACTS P. 42 • MANAGING THE ‘SUPER SENIOR’ P. 50 eiwo ptamlg o.XI o Jl 04• etscn aaat• ih-dutbeLn Mngn h SprSno’•ARVO Report the ‘Super Senior’ • Managing Light-Adjustable Lens • Femtosecond Cataract • July 2014 • Review of Ophthalmology Vol. XXI, No. 7 •

JulyJuly 22014014 •revo revophth.comphth.com

P. 26

Getting Femto Cataract Up to Speedd P. 22

Also Inside: Toric IOLs: Nailing the Target Axis P. 36

001_rp0714_fc 2.indd 1 6/20/14 2:45 PM Innovative Technologies. Excellent Outcomes.

Experience Laser Cataract Surgery with the CATALYS® Precision Laser System

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IMPORTANT SAFETY INFORMATION INDICATION The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. CONTRAINDICATIONS Patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal rupture, and any contraindications to cataract surgery. ADVERSE EFFECTS Complications associated with the CATALYS® System include mild Petechiae and subconjunctival hemorrhage due to vacuum pressure of the LIQUID OPTICS Interface suction ring. Potential complications and adverse events include those generally associated with the performance of capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or incision of the cornea. CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and who have been trained and certified in its use.

Clinical image courtesy of Jason Jones, MD. CATALYS® is a registered trademark, INTEGRAL GUIDANCE and LIQUID OPTICS are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or afﬁliates. ©2014 Abbott Medical Optics Inc. www.AbbottMedicalOptics.com 2014.01.02-MK8025

RP0314_Abbott.indd 1 2/18/14 2:39 PM REVIEW NEWS Volume XXI • No. 7 • July 2014 Projections Grim for Costs and Prevalence of Visual Problems

As the U.S. population ages, the number any of the included eye diseases. Dia- produces visual fi eld loss that is almost of Americans with eye disease and vi- betic retinopathy patients have an av- identical for each eye, supporting the sion problems will continue to spiral erage age of 66 years, the youngest of idea that the entire degenerative pro- upward. A new report released by Pre- any of the included eye diseases. cess in glaucoma must occur at ran- vent Blindness, “The Future of Vision: “We cannot stand by and passively dom in the individual eye—without Forecasting the Prevalence and Costs accept vision loss as an inevitable brain involvement. of Vision Problems,” predicts more condition of growing old,” said Hugh However, the team’s analysis re- than $384 billion in 2032 and $717 bil- R. Parry, president and CEO of Pre- vealed that as previously disabled optic lion in 2050 in nominal costs related to vent Blindness. “The sheer numbers nerve axons—that can lead to vision eye disease and vision problems. of those who are and will be person- loss—recover, the remaining areas of Statistics from the report, commis- ally and fi nancially impacted by vision permanent visual loss in one eye coin- sioned from researchers at the Univer- impairment and blindness is far too cide with the areas that can still see in sity of Chicago, point to some alarming great to ignore. The time to plan and the other eye. The team found that the projections, including: develop a national strategy for saving visual fi eld of the two eyes fi t together • Costs related to eye disease, in- sight is now.” like a jigsaw puzzle, resulting in much cluding government, insurance and For more information, visit prevent better vision with both eyes open than patient costs, are projected to increase blindness.org. could possibly arise by chance. 376 percent by 2050. “As age and other insults to ocular • Hispanics are projected to exhibit health take their toll on each eye, dis- extremely high growth in diabetic reti- Study Uncovers crete bundles of the small axons within nopathy, glaucoma and cataract cases. the larger optic nerve are sacrifi ced so • As the baby-boomer generation The Brain’s Role in the rest of the axons can continue to ages into the Medicare program, costs carry sight information to the brain,” will further shift from patients and Glaucoma said author William Eric Sponsel, private insurance to government. By Findings from a new study published in MD, of the University of Texas at San 2050, government will pay more than Translational Vision Science & Tech- Antonio, Department of Biomedical 41 percent of costs, while patients will nology show the brain, not the eye, Engineering. “This quite intentional pay 44 percent, and private insurers, controls the cellular process that leads sacrifi ce of some wires to save the rest, 16 percent. to glaucoma. The results may help when there are decreasing resources • Women will continue to outnum- develop treatments for glaucoma and to support them all (called apoptosis), ber men in prevalence of all eye dis- contribute to the development of fu- is analogous to pruning some of the ease and vision loss categories except ture therapies for preserving brain limbs on a stressed fruit tree so the for diabetic retinopathy. function in other age-related disorders other branches can continue to bear • Those aged 90 and older project like Alzheimer’s. healthy fruit.” to be by far the fastest growing popula- The researchers performed a data The researchers say the cellular pro- tion segment. This will have a signifi - and symmetry analysis of 47 patients cess used for pruning small optic nerve cant effect on those living with eye dis- with moderate to severe glaucoma in axons in glaucoma is “remarkably ease, as many of these conditions are both eyes. In glaucoma, the loss of vi- similar to the apoptotic mechanism age-related. sion in each eye appears to be haphaz- that operates in the brains of people The estimated average age of AMD ard. Conversely, neural damage within affl icted with Alzheimer’s disease.” patients is 80 years old, the oldest of the brain caused by strokes or tumors “The extent and statistical strength

July 2014 | Revophth.com | 3

003_rp0714_news.indd 3 6/20/14 2:44 PM REVIEW News

of the jigsaw effect in conserving the stabilized,” said Dr. Calkins. “We have basically created a min- binocular visual fi eld among the clini- Dr. Sponsel has already seen how iature human retina in a dish that not cal population turned out to be re- these fi ndings have positively affected only has the architectural organization markably strong,” said Dr. Sponsel. surgically stabilized patients who were of the retina but also has the ability “The entire phenomenon appears to previously worried about going blind. to sense light,” said study leader M. be under the meticulous control of the “When shown the complementarity Valeria Canto-Soler, PhD, an assis- brain.” of their isolated right and left eye vi- tant professor of ophthalmology at the The TVST paper is the fi rst evidence sual fi elds, they become far less per- Johns Hopkins University School of in humans that the brain plays a part plexed and more reassured,” he said. Medicine. She said the work, reported in pruning optic nerve axon cells. In “It would be relatively straightforward online June 10 in Nature Communica- a previous study, a mouse model sug- to modify existing equipment to allow tions, “advances opportunities for vi- gested the possibility that following infor the performance of simultaneous sion-saving research and may ultimate- jury to the optic nerve cells in the eye, binocular visual fi elds in addition to ly lead to technologies that restore the brain controlled a pruning of those standard right eye and left eye testing.” vision in people with retinal diseases.” cells at its end of the nerve. This ulti- The authors suggest their fi ndings Dr. Canto-Soler cautions that photo- mately caused the injured cells to die. can assist in future research with cel- receptors are only part of the story in “Our basic science work has demon- lular processes similar to the one used the complex eye-brain process of vi- strated that axons undergo functional for pruning small optic nerve axons in sion, and her lab hasn’t yet recreated defi cits in transport at central brain glaucoma, such as occurs in the brains all of the functions of the human eye sites well before any structural loss of of individuals affected by Alzheimer’s. and its links to the visual cortex of the axons,” said David J. Calkins, PhD, of brain. “Is our lab retina capable of pro- the Vanderbilt Eye Institute and au- ducing a visual signal that the brain can thor of the previous study. “Indeed, we From Stem Cells, interpret into an image? Probably not, found no evidence of actual pruning of but this is a good start,” she said. axon synapses until much, much later. Light-Sensitive The achievement emerged from Similarly, projection neurons in the experiments with human induced plu- brain persisted much longer, as well. Photoreceptors ripotent stem cells and could eventu- “This is consistent with the partial Using a type of human stem cell, Johns ally enable genetically engineered recovery of more diffuse overlap- Hopkins researchers say they have cre- retinal cell transplants that halt or even ping visual fi eld defects observed by ated a three-dimensional complement reverse a patient’s march toward blind- Dr. Sponsel that helped unmask the of human retinal tissue in the labora- ness, the researchers say. They turned more permanent interlocking jigsaw tory, which notably includes function- iPS cells into retinal progenitor cells patterns once the eyes of his severely ing photoreceptor cells capable of re- destined to form light-sensitive retinal affected patients had been surgically sponding to light. tissue. Using a simple, straightforward Sensor in Eye Could Track Intraocular Pressure University of Washington engineers have designed a low-power surgeon who does cataract surgeries to be able to use this.” The sensor that could be placed permanently in a person’s eye to track UW engineering team built a prototype that uses radio frequency changes in eye pressure. The sensor would be embedded with an for wireless power and data transfer. A thin, circular antenna spans artifi cial lens during cataract surgery and would detect pressure the perimeter of the device—roughly tracing a person’s iris—and changes instantaneously, then transmit the data wirelessly using harnesses enough energy from the surrounding fi eld to power a radio frequency waves. small pressure sensor chip. The chip communicates with a close- “No one has ever put electronics inside the lens of the eye, so by receiver about any shifts in frequency, which signify a change in this is a little more radical,” said Karl Böhringer, PhD, a UW profes- pressure. Actual pressure is then calculated and those changes are sor of electrical engineering and of bioengineering. “We have tracked and recorded in real-time. shown this is possible in principle. If you can fi t this sensor device The team is working on downscaling the prototype to be tested in into an intraocular lens implant during cataract surgery, it won’t an actual artifi cial lens. Designing a fi nal product that’s affordable require any further surgery for patients.” for patients is the ultimate goal, researchers said. “I think if the The research team wanted to fi nd an easy way to measure eye cost is reasonable and if the new device offers information that’s pressure for management of glaucoma. “The implementation of not measureable by current technology, patients and surgeons the monitoring device has to be well-suited clinically and must be would be really eager to adopt it,” Dr. Shen said. designed to be simple and reliable,” said Tueng Shen, MD, PhD, a The researchers published their results in the Journal of Micro- collaborator and UW professor of ophthalmology. “We want every mechanics and Microengineering.

4 | Review of Ophthalmology | July 2014

003_rp0714_news.indd 4 6/20/14 2:44 PM technique they developed to foster the growth of the retinal progenitors, Dr. Canto-Soler and her team saw retinal Dell* Toric Axis Markers cells and then tissue grow in their petri Precise Alignment For Correct Toric Axis Placement, From Upright Through The Supine Position. dishes. The growth corresponded in timing and duration to retinal development in a human fetus in the womb. Moreover, the photoreceptors were mature enough to develop outer seg- ments, a structure essential for photoreceptors to function. The lab-grown retinas recreate the

three-dimensional architecture of 8-12119: Dell Fixed Toric Lens Marker With Rotating Bezel Used When Patient Is In Supine Position the human retina. “We knew that a 3-D cellular structure was necessary if we wanted to reproduce functional characteristics of the retina,” said Dr. Canto-Soler, “but when we began this work, we didn’t think stem cells would be able to build up a retina almost on their own. In our system, somehow the cells knew what to do.” When the retinal tissue was at a stage Dell Swivel Toric Lens Marker 8-12120: With Rotating Bezel Used When equivalent to 28 weeks of development Patient Is In Upright Position in the womb, with fairly mature photoreceptors, the researchers tested these 8-12119: Rotating Inner Bezel Automatically mini-retinas to see if the photorecep- Orients Marks For The Placement Of A Toric tors could in fact sense and transform IOL In The Correct Meridian. While The Patient light into visual signals. Is Upright, An Orientation Mark Is Placed Vertically They did so by placing an electrode On The Conjunctiva. In Surgery The Rotating Inner Bezel Is Set To The Desired Meridian. While The Instrument Is Positioned into a single photoreceptor cell and So That The Vertical Conjunctival Mark Is Aligned With The 90 Degree Position then giving a pulse of light to the cell, On The Outer Bezel Of The Marker. The Marking Blades On The Undersurface Of which reacted in a biochemical pattern The Instrument Will Automatically Place A Mark In The Correct Meridian When The Cornea Is Indented. similar to the behavior of photoreceptors in people exposed to light. 8-12120: Weighted So That Correct Horizontal Orientation Is Assured. Dr. Canto-Soler said the new system Rotating Inner Bezel Automatically Orients Blades For Corneal Marks For The Placement Of A Toric IOL In The Correct Meridian. Designed gives them the ability to generate hun- For Use With The Patient Upright Immediately Prior To Surgery, The Inner dreds of mini-retinas at a time directly Bezel Is Rotated To The Desired Meridian, And The Cornea Is Indented. from a person affected by a particular The Marking Blades On The Undersurface Of The Instrument Will Automatically Place Marks In The Correct Meridian. retinal disease such as retinitis pigmentosa. This provides a unique biological www.RheinMedical.com system to study the cause of retinal diseases directly in human tissue, instead of relying on animal models. The system opens an array of possibilities for personalized medicine such as testing drugs to treat these diseases in a patient-speciﬁ c way. In the long term, the potential is also there to re-

place diseased or dead retinal tissue 3360 Scherer Drive, Suite B. St.Petersburg, Florida with lab-grown material to restore vi- s4EL s&AX %MAIL)NFO 2HEIN-EDICALCOMs7EBSITEWWW2HEIN-EDICALCOM sion. $EVELOPED)N#OORDINATION7ITH3TEVEN*$ELL -$ Moses, Michelangelo

1269 Rev.D BABC

003_rp0714_news.indd 5 6/20/14 2:45 PM Editorial

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6 | Review of Ophthalmology | July 2014

003_rp0714_news.indd 6 6/20/14 2:45 PM ™

(phenylephrine and ketorolac injection) 1%/0.3% FDA APPROVED

INDICATIONS AND USAGE OMIDRIA™ is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: • Maintaining pupil size by preventing intraoperative miosis • Reducing postoperative pain OMIDRIA™ is added to an irrigation solution used during cataract surgery or intraocular lens replacement.

IMPORTANT RISK INFORMATION Systemic exposure of phenylephrine may cause elevations in blood pressure. The most common reported ocular adverse reactions at 2-24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. OMIDRIA™ must be diluted prior to use. Use of OMIDRIA™ in children has not been established.

Please see full prescribing information for OMIDRIA™ at www.omidria.com/prescribinginformation For more information on OMIDRIA™, please visit www.omidria.com

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RP0414_Keeler PSL.indd 1 3/12/14 3:26 PM July 2014 • Volume XXI No. 7 | revophth.com Feature Articles 22 | Femto Cataract: Getting Up to Speed By Walter Bethke, Managing Editor Expert advice on minimizing the time femtosecond cataract surgery adds to your procedures.

26 | Femto Cataract: Avoiding Complications By Christopher Kent, Senior Editor Like every new surgery, this one is associated with unique potential problems. Here’s how to keep things going smoothly. 36 | Toric IOLs: Nailing the Target Axis By Michelle Stephenson, Contributing Editor Success with torics comes down to measuring and marking the corneal astigmatism axis and accurately placing the lens at that position.

July 2014 | Revophth.com | 9

009_rp0714_toc.indd 9 6/20/14 10:23 AM Departments

42 3 | Review News

13 | Editor’s Page 14 | Technology Update Intraoperative OCT Coming into Focus Manufacturers are finding ways to make this technology available during surgery.

40 | Retinal Insider CSCR: Diagnosis and Treatment Central serous chorioretinopathy afflicts working-age patients. While many can be observed, some will require intervention. 50 42 | Therapeutic Topics ARVO Comes to the City of Magic Highlights from the posters and papers presented at the 2014 ARVO meeting in Orlando.

48 | Refractive Surgery The Latest Results with the LAL An update on the Light-Adjustable Lens and a look at its potential to broaden focal depth.

50 | Glaucoma Management Managing the Increasingly Common ‘Super Senior’ The very elderly will make up a greater part of our patient populations, bringing challenges. 63 57 | Pediatric Patient Vigabatrin and Visual Field Loss in Children The drug has a long history outside the United States in the treatment of epilepsy.

59 | Advertising Index

60 | Classified Ads

63 | Wills Eye Resident Case Series

10 | Review of Ophthalmology | July 2014

009_rp0714_toc.indd 10 6/20/14 10:23 AM The Quintessential

Proven therapeutic utility in blepharitis, conjunctivitis, and other superficial ocular infections

O Profound bactericidal effect against gram-positive pathogens1

O Excellent, continued resistance profile—maintains susceptibility,2,3 even against methicillin-resistant Staphylococcus aureus 4

O Ointment provides long-lasting ocular surface contact time and greater bioavailability5

O Anti-infective efficacy in a lubricating base6

O Unsurpassed safety profile—low incidence of adverse events6

O Convenient dosing—1 to 3 times daily6

O Tier 1 pharmacy benefit status—on most insurance plans7

Bacitracin Ophthalmic Ointment is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms. Important Safety Information The low incidence of allergenicity exhibited by Bacitracin means that adverse events are practically non-existent. If such reactions do occur, therapy should be discontinued. Bacitracin Ophthalmic Ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. www.perrigobacitracin.com This product should not be used in patients with a history of hypersensitivity to Bacitracin.

Please see adjacent page for full prescribing information.

References: 1. Kempe CH. The use of antibacterial agents: summary of round table discussion. Pediatrics. 1955;15(2):221-230. 2. Kowalski RP. Is antibiotic resistance a problem in the treatment of ophthalmic infections? Expert Rev Ophthalmol. 2013;8(2):119-126. 3. Recchia FM, Busbee BG, Pearlman RB, Carvalho-Recchia CA, Ho AC. Changing trends in the microbiologic aspects of postcataract endophthalmitis. Arch Ophthalmol. 2005;123(3):341-346. 4. Freidlin J, Acharya N, Lietman TM, Cevallos V, Whitcher JP, Margolis TP. Spectrum of eye disease caused by methicillin-resistant Staphylococcus aureus. Am J Ophthalmol. 2007;144(2):313-315. 5. Hecht G. Ophthalmic preparations. In: Gennaro AR, ed. Remington: the Science and Practice of Pharmacy. 20th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2000. 6. Bacitracin Ophthalmic Ointment [package insert]. Minneapolis, MN: Perrigo Company; August 2013. 7. Data on file. Perrigo Company. Logo is a trademark of Perrigo.

RP0214_Perrigo.indd 1 1/13/14 3:13 PM 19TH ANNUAL Bacitracin Ophthalmic Ointment USP STERILE Rx Only OPHTHALMIC

DESCRIPTION: Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and PRODUCT Mineral Oil. CLINICAL PHARMACOLOGY: The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the UIDE common Streptococci and Staphylococci. It is G also destructive for certain gram- negative organisms. It is ineffective against fungi. Innovative products to enhance your practice INDICATIONS AND USAGE: For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms. CONTRAINDICATIONS: This product should not be used in patients with a history of hypersensitivity to Bacitracin. PRECAUTIONS: Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to The future become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms is in your particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted. hands. One ADVERSE REACTIONS: Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are tap, many practically non-existent. However, if such reaction should occur, therapy should be discontinued. possibilities. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DOSAGE AND ADMINISTRATION: The Experience the digital edition on your ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In handheld device. Use your smart blepharitis all scales and crusts should be carefully removed and the ointment then device to scan the code below or visit: spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly www.revophth.com/supplements/ to the infected eye. Download a QR scanner app. Launch app and hold your mobile device over the code HOW SUPPLIED: to view http://www.revophth.com/supplements/. NDC 0574-4022-13 3 - 1 g sterile tamper evident tubes with ophthalmic tip. NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured For ® ® Minneapolis, MN 55427 0S400 RC J1 Rev 08-13 A

012_ro0714_housead.indd 12 6/20/14 1:18 PM ® Editor’s Page Christopher Glenn, Editor in Chief REVIEW E DITORIAL S TAFF

Editor in Chief Christopher Glenn (610) 492-1008 [email protected]

Managing Editor New Thinking Needed Walter C. Bethke (610) 492-1024 [email protected] About the Oldest of Us Senior Editor Christopher Kent (814) 861-5559 For most of us, the Sicilian toast, tacular growth in the elderly popula- [email protected] “Cent’anni” came to our attention tion, which will lead to the age group through “The Godfather” where it of persons 90 and older exhibiting by Associate Editor ironically wished 100 years of happi- far the highest rates of growth in the Kelly Hills (610) 492-1025 ness to characters who would often prevalence of vision loss and eye dis- [email protected] be dead within hours. ease of any age group.” For most of our history, only the The leading edge of the trend is, Chief Medical Editor very rare few enjoyed anything near indeed, already here. Even 60 Min- Mark H. Blecher, MD such longevity. Recent, well-docu- utes got in on the story with a recent mented trends show that is chang- extended report. Senior Director, Art/Production ing, and quickly. Obviously, the treatment options Joe Morris (610) 492-1027 Census data cited in a much- and decisions ophthalmologists need [email protected] publicized 2011 report showed that to make in managing a rapidly grow- from 1980 to 2010 the 90-and-older ing population of patients with long- Art Director population has steadily increased term, vision-threatening diseases are Jared Araujo and this trend is expected to con- becoming more complex. (610) 492-1023 tinue into the middle of the century. We’re fortunate this month to fea- [email protected] Two age groups are leading the way. ture the highly practical and timely Graphic Designer “Between 2020 and 2030,” the au- advice of Dr. Carla J. Siegfried, who Matt Egger thors report, “the population aged describes her approach to these “Su- (610) 492-1029 65–89 ... is projected to increase by per Seniors.” In this case, the condi- [email protected] 32 percent and the 90 and over by tion is glaucoma, but the approaches 21 percent. However, in the follow- and tips are useful for almost anyone International coordinator, Japan ing decade (2030s) the 90-and-older interacting with members of this Mitz Kaminuma population is projected to experience population. Our thanks to Dr. Sieg- [email protected] a 71 percent jump.” fried, and Cent’anni! Business Offi ces This week, Prevent Blindness fur- 11 Campus Boulevard, Suite 100 ther refi ned projections on the issue, Newtown Square, PA 19073 focusing on the impact of vision-re- (610) 492-1000 lated diseases and their cost in the Fax: (610) 492-1039 very elderly population (See p. 3). Subscription inquiries: The report projects that “By the United States — (877) 529-1746 year 2032, the baby-boomer popula- Outside U.S. — (847) 763-9630 tion will have almost fully moved into 1. 90+ in the United States: 2006–2008. ACS-17. E-mail: the Medicare ranks and the rapid American Community Survey Reports. Wan He [email protected] growth of the population from ages and Mark N. Muenchrath. Issued November 2011. Website: www.revophth.com 65 to the mid 80s will cause dramatic increases in the prevalence and costs Professional Publications Group of vision problems. In the follow- Jobson Medical Information LLC ing decades, the confl uence of the aging baby-boomers’ numbers and increased longevity will drive spec-

July 2014 | Revophth.com | 13

013_rp0714_edit.indd 13 6/23/14 12:10 PM Technology Update

REVIEW Edited by Michael Colvard, MD, and Steven Charles, MD

Intraoperative OCT Coming into Focus Manufacturers are ﬁ nding ways to make this technology available during surgery, giving surgeons a whole new view. Christopher Kent, Senior Editor

ne way to make manual ocular be controlled from the microscope’s ing Zeiss’s Rescan system under a Osurgery safer is to improve the foot pedal, so the surgeon can take research protocol. “The Rescan 700 surgeon’s ability to see what’s happen- videos, snapshots and 3-D OCT imag- can be used for any ophthalmic surgi- ing. With current microscope optics es without looking up or stopping the cal procedure that requires the mi- at an impressive level, the next step surgery. The Rescan allows the sur- croscope, such as anterior segment forward may be adding another, com- geon to see the surgical fi eld in both a surgeries like lamellar keratoplasty pletely different way to see, such as planar view and a cross-sectional view or vitreoretinal procedures such as optical coherence tomography. simultaneously, in real time. epiretinal membrane peeling,” he A number of companies have been Justis P. Ehlers, MD, an assistant says. “The OCT can be used for either working on that premise, and while professor of ophthalmology at the live action monitoring or stop-action some of the products are not yet ap- Cole Eye Institute of the Cleve- scans, and you can display the scans proved for sale in the United States land Clinic in Ohio, is currently us- alongside the live microscope view (and others are still in development), with a heads-up display. The Lumera the technology appears to be useful 700 has the Callisto video display sys- and promising. Here, surgeons famil- tem on the side; that can also display iar with several current options talk both images, so that anybody in the about their experience using them OR can see the surgical video and the during surgery. OCT signal. Typically, while you’re in the eye operating you’ll be using the OCT in the Microscope live OCT via the heads-up display; when you’re not operating, you can Carl Zeiss Meditec launched its use it for static images. The OCT also Rescan 700 OCT system this spring. Carl Zeiss has different capture modes like those The Rescan 700, which is not ap- Meditec’s Rescan you might fi nd in a clinical OCT sys- proved for sale in the United States, 700 integrates OCT tem, that allow you to capture a still images of the area is a real-time intraoperative SD-OCT being observed into volume cube or a fi ve-line raster.” that can be fully integrated into the the surgeon’s view Dr. Ehlers says the biggest differ- OPMI Lumera 700 microscope; the in the oculars. Key ence between this type of system de- surgeon doesn’t need to look up from OCT functions can sign and previous intraoperative OCT the microscope to see the OCT data. be controlled via systems is that a microscope-integrat- Key functions of the OCT system can the footpedal. ed system allows for real-time OCT

14 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

014_rp0714_tech update.indd 14 6/20/14 1:56 PM AS YOUR PATIENT’S DAY CHANGES, SO WILL THEIR IOP.

For your patients in need of a PGA, LOWER IOP SUSTAIN IOP1,2 Choose BAK-free TRAVATAN Z® Solution

INDICATIONS AND USAGE in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated risk factors for macular edema. intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Angle-closure, Infl ammatory, or Neovascular Glaucoma — TRAVATAN Z® Solution has not been evaluated Dosage and Administration for the treatment of angle-closure, infl ammatory, or neovascular glaucoma. The recommended dosage is 1 drop in the affected eye(s) once daily in the evening. TRAVATAN Bacterial Keratitis —There have been reports of bacterial keratitis associated with the use of multiple-dose ® Z Solution should not be administered more than once daily since it has been shown that more containers of topical ophthalmic products. These containers had been inadvertently contaminated by frequent administration of prostaglandin analogs may decrease the IOP-lowering effect. TRAVATAN patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial. Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. ® If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least Use With Contact Lenses —Contact lenses should be removed prior to instillation of TRAVATAN Z Solution 5 minutes apart. and may be reinserted 15 minutes following its administration. IMPORTANT SAFETY INFORMATION Adverse Reactions ® Warnings and Precautions The most common adverse reaction observed in controlled clinical studies with TRAVATAN Z Solution was ocular hyperemia, which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy Pigmentation —Travoprost ophthalmic solution has been reported to increase the pigmentation due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been eyelid sulcus have been observed. reported to be reversible in some patients. The long-term effects of increased pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop Use in Specifi c Populations noticeably increased iris pigmentation, these patients should be examined regularly. Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. Eyelash Changes —TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the ® treated eye. These changes include increased length, thickness, and number of lashes. Eyelash For additional information about TRAVATAN Z Solution, please see Brief Summary of full changes are usually reversible upon discontinuation of treatment. Prescribing Information on adjacent page. Intraocular Infl ammation —TRAVATAN Z® Solution should be used with caution in patients with active References: 1. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium intraocular infl ammation (e.g. uveitis) because the infl ammation may be exacerbated. chloride: a comparison of safety and effi cacy. J Glaucoma. 2007;16(1):98-103. 2. Gross RL, Peace JH, Smith SE, et al. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008;17(3):217-222. Macular Edema —Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z® Solution should be used with caution

RP0414_Alcon Travatan.indd 1 3/11/14 10:31 AM USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD). BRIEF SUMMARY OF PRESCRIBING INFORMATION In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day INDICATIONS AND USAGE 21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye pressure in patients with open-angle glaucoma or ocular hypertension. opening, pinna detachment and preputial separation, and by decreased motor activity. DOSAGE AND ADMINISTRATION There are no adequate and well-controlled studies of TRAVATAN Z® (travoprost ophthalmic solution) 0.004% The recommended dosage is one drop in the affected eye(s) once daily in the evening. administration in pregnant women. Because animal reproductive studies are not always predictive of ® TRAVATAN Z® (travoprost ophthalmic solution) should not be administered more than once daily since it human response, TRAVATAN Z Solution should be administered during pregnancy only if the potential has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular benefit justifies the potential risk to the fetus. pressure lowering effect. Nursing Mothers Reduction of the intraocular pressure starts approximately 2 hours after the first administration with A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in maximum effect reached after 12 hours. milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs

® TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower are excreted in human milk, caution should be exercised when TRAVATAN Z Solution is administered to a intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be nursing woman. administered at least five (5) minutes apart. Pediatric Use CONTRAINDICATIONS Use in pediatric patients below the age of 16 years is not recommended because of potential safety None concerns related to increased pigmentation following long-term chronic use. WARNINGS AND PRECAUTIONS Geriatric Use Pigmentation No overall clinical differences in safety or effectiveness have been observed between elderly and other Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most adult patients. frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and Hepatic and Renal Impairment eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in change is due to increased melanin content in the melanocytes rather than to an increase in the number patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while laboratory data were observed in these patients. pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. NONCLINICAL TOXICOLOGY The long term effects of increased pigmentation are not known. Carcinogenesis, Mutagenesis, Impairment of Fertility Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the did not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male rats were only iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high treatment with TRAVATAN Z® (travoprost ophthalmic solution) 0.004% can be continued in patients who dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum develop noticeably increased iris pigmentation, these patients should be examined regularly. recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. Eyelash Changes A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes presence of rat S-9 activation enzymes. include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to discontinuation of treatment. 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg Intraocular Inflammation basis (MRHOD)]. At 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation TRAVATAN Z® Solution should be used with caution in patients with active intraocular inflammation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD). (e.g., uveitis) because the inflammation may be exacerbated. PATIENT COUNSELING INFORMATION Macular Edema Potential for Pigmentation Macular edema, including cystoid macular edema, has been reported during treatment with travoprost Patients should be advised about the potential for increased brown pigmentation of the iris, which may be ophthalmic solution. TRAVATAN Z® Solution should be used with caution in aphakic patients, in pseudophakic permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. reversible after discontinuation of TRAVATAN Z® (travoprost ophthalmic solution) 0.004%. Angle-closure, Inflammatory or Neovascular Glaucoma Potential for Eyelash Changes TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory or Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye neovascular glaucoma. during treatment with TRAVATAN Z® Solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Bacterial Keratitis Eyelash changes are usually reversible upon discontinuation of treatment. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, Handling the Container in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by Use with Contact Lenses common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted vision may result from using contaminated solutions. 15 minutes following its administration. When to Seek Physician Advice ADVERSE REACTIONS Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or Clinical Studies Experience infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed reactions, they should immediately seek their physician’s advice concerning the continued use of in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug TRAVATAN Z® Solution. and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with TRAVATAN® (travoprost ophthalmic solution) 0.004% and Use with Contact Lenses ® TRAVATAN Z® (travoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to Contact lenses should be removed prior to instillation of TRAVATAN Z Solution and may be reinserted 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse 15 minutes following its administration. reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye Use with Other Ophthalmic Drugs discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) ® ® 1 to 4% in clinical studies with TRAVATAN or TRAVATAN Z Solutions included abnormal vision, blepharitis, minutes between applications. blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing. Rx Only Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253 angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2006, 2010, 2011, 2012 Novartis 4/135/13 TRV13021JADTRV13049JAD

RP0414_Alcon Travatan PI.indd 1 3/11/14 10:33 AM Technology

REVIEW Update

without pausing the surgery to look is currently available in the United away from the microscope. “There States: Bioptigen’s Envisu C2300 have been a few microscope-inte- Spectral Domain Ophthalmic Imag- grated systems developed, including ing System, designed for handheld or one of the fi rst systems designed at microscope-mounted use. (See pic- Duke University by Drs. Cynthia Toth ture, p. 18.) (In April, Bioptigen un- and Joseph Izatt,” he notes. “Other veiled the Envisu IntraSurgical OCT, systems include our prototype at the designed for real-time imaging dur- Cleveland Clinic. To my knowledge ing ophthalmic surgical procedures, the only two systems that currently compatible with most operating mi- have a heads-up display system are croscopes. The new system, which the Cleveland Clinic prototype and features independent focus and zoom Zeiss’ Rescan 700.” control, is not approved.) Cynthia Toth, MD, professor of A Touchscreen Display ophthalmology at Duke University Medical Center and professor of bio- Haag-Streit’s intraoperative OCT system Haag-Streit’s intraoperative iOCT can be attached to the camera port of the medical engineering at Duke Uni- system, developed by OptoMedical microscope; scans are displayed on a versity’s Pratt School of Engineer- Technologies in Lübeck, Germany screen mounted on the microscope. ing in Durham, N.C., was one of the (also not approved for sale in the early pioneers of using OCT during United States), attaches to the cam- nology helps in diffi cult surgeries and surgery. “Surgeons are used to using era port of the microscope; data is in certain steps of standard surger- OCT before and after their surgical displayed on a screen mounted on the ies. “For example, when performing cases to evaluate their work—par- microscope. The screen is also used DMEK on a very opaque cornea, it ticularly in macular surgery,” Dr. Toth to operate the system (to switch from helps the surgeon determine whether says. “Using OCT in the operating anterior to posterior views, for ex- the orientation of Descemet’s mem- room seems like a natural progres- ample). The device follows the zoom brane is correct,” he says. “It helps sion, both to identify endpoints and to and focus of the microscope so the with Boston keratoprosthesis surgery see whether we’ve reached our surgi- scanned area matches the area being in terms of orientation, correct as- cal goals.” viewed, and scans and images can be sembly and positioning of the device. Dr. Toth initially used the handheld saved for future review. Surgeons re- In DALK it helps with monitoring OCT system from Bioptigen. “The port that the device can reveal struc- the depth of the preparation, the in- Bioptigen device is approved for com- ture to a depth of about 4.2 mm in air terface fl uid, the status of Descemet’s mercial use in supine imaging of adults and 3.1 mm in water, with a resolution membrane and so forth. The only and infants in the OR, but it’s not built of about 10 µm. downside I see is the cost.” into the microscope,” she notes. “The Prof. Claus Cursiefen, FEBO, Professor Cursiefen recently be- handheld portable OCT can go to the managing medical director of the gan using the Zeiss Rescan as well. OR and be held over the patient’s eye, Center of Ophthalmology at the Uni- “The resolution and image quality do and there’s an attachment that hooks versity of Cologne in Germany, has not seem to vary much between the it on to the microscope. Of course, been using this system for several two systems,” he notes. “The main you still have to pause in order to look months. “Online intraoperative OCT differences are that the Zeiss system at it. But I’ve found that the more you is easy and convenient to use since projects the OCT image into the mi- see, the more you want to stop sur- it does not disturb normal operative croscope axis, so you don’t have to gery and check things. I’ve peeled this fl ow,” says Professor Cursiefen. “One move your head to the side to see it, internal limiting membrane, but is can see surgical details via the mi- and the projector on the side shows the hole still open? Should I use a gas croscope and OCT details by looking the standard view and OCT images at bubble? How much of a gas bubble onto the screen next to the oculars. same time, which is good for teaching do I need?” It’s a new and fascinating experience and for assisting personnel.” since it adds a new dimension of vis- Clinical Impact ibility, showing things one cannot see Available in the United States through the operating microscope.” “There are a lot of questions out Professor Cursiefen says this tech- One intraoperative OCT system there regarding where intraopera-

July 2014 | Revophth.com | 17

014_rp0714_tech update.indd 17 6/20/14 1:56 PM Technology

REVIEW Update

tive OCT is useful and how it forming maneuvers, but dif- can make a difference,” notes ferent technologies that will Dr. Ehlers. “Many of the sur- increase the speed are being geons at Cleveland Clinic use developed. Swept-source this technology in almost ev- OCT is coming down the ery macular case. Most of our pike; image-guided surgery corneal surgeons at Cleveland is further down the line. But Clinic do almost all of their even at current speeds having lamellar keratoplasties with SD-OCT in the microscope intraoperative OCT guidance. does make it much easier to They believe it’s a valuable capture images so you can tool in those procedures. stop and view the structure of “To better assess the im- the tissues.” pact this technology is having Dr. Toth is currently help- on surgical decision-making, Bioptigen’s Envisu C2300 (the white device seen here nested in ing to develop a swept-source we’ve been prospectively as- the microscope mount) is designed for handheld or OCT system with a heads- sessing intraoperative OCT intraoperative use. Images are displayed on a separate screen. up display at Duke Univer- over the past three years,” he sity. “With our generation- continues. “We’ve enrolled more than overload. When does this become too one system, you had to look up at a 800 patients in prospective studies. much information? I believe the an- screen; our generation-two system is We’ve found that in a large number of swer will sort itself out as we learn the inside the microscope,” she explains. cases intraoperative OCT appears to best ways to display the information. “We’re trying different display op- inform surgical decision-making. In With that in mind we’ve been experi- tions, including Google Glass. The fact, in 10 percent or more of cases, menting in our lab on different for- current version of Google Glass prob- the OCT data actually causes surgeons mats to show the data to the surgeon ably wouldn’t be my favorite viewing to change their mind. For example, if through a heads-up display feedback option choice, but we’ve just begun the surgeons think they’ve peeled all system. You want to be sure you’re exploring the alternatives.” of the membrane, they may look at providing information that’s helpful Professor Cursiefen says he’s look- the OCT and realize there’s residual and not distracting. (The Zeiss system ing forward to future advances in this membrane that requires peeling. Or also provides some flexibility in its technology, such as precise intraop- the opposite: They think there’s more heads-up display options.) erative measurement of tissue thick- they need to peel, but when they look “The other issue, of course, is cost, ness for surgeries such as DALK, and at the OCT the membranes are en- which currently is a major disadvan- high-resolution imaging of the angle tirely removed and they’re able to tage,” he notes. “In the current cli- during glaucoma surgery. “In fact, fi nish the procedure. mate, the price points of these sys- that’s one of the most exciting things “We’re still investigating how much tems may dictate to some degree how about this technology: where it may difference this technology makes in rapidly the technology is adopted. lead in the future,” says Dr. Ehlers. terms of surgical effi ciency and out- Certainly, the development of a para- “It could potentially open the door to comes,” he says. “If it’s simply used to digm-shifting procedure that requires procedures we haven’t been able to find out whether you accomplished this technology would also dramati- do without this type of information, what you set out to accomplish, it can cally impact the adoption and need such as intratissue-targeted delivery be done very quickly, whether you’re for these systems.” of pharmacotherapy.” using a microscope-integrated system or a portable system mounted to the Down the Line Dr. Ehlers’ research includes equip- microscope.” ment provided by Zeiss, and he owns In terms of potential downsides, “Using OCT to guide you in real intellectual property licensed to Bi- one issue is whether the added in- time as you’re reaching and perform- optigen and Synergetics related to formation might become a distrac- ing maneuvers is the way I think OCT intraoperative OCT technology. One tion. “We don’t yet know for sure will be used in the long run,” says of Dr. Toth’s co-investigators has a what to make of all the information Dr. Toth. “Right now, the speed of fi nancial interest in Bioptigen. Profes- this technology provides,” admits Dr. SD-OCT is probably not ideal for sor Cursiefen has no fi nancial ties to Ehlers. “One concern is information truly guiding the surgeon while per- any product mentioned.

18 | Review of Ophthalmology | July 2014

014_rp0714_tech update.indd 18 6/20/14 1:57 PM Dear Third Year Residency Program Director,

We would like to invite you to review the upcoming 3rd Year Residency Programs for 2014. Each program offers a unique educational opportunity for third-year residents by providing the chance to meet and exchange ideas with some of the most respected thought leaders in ophthalmology. The programs are designed to provide your residents with a state-of-the-art didactic and wet lab experience. The programs also serve as an opportunity for your residents to network with residents from other programs.

After reviewing the material, it is our hope that you will select and encourage your residents to attend these educational programs.

Best regards, Postgraduate Healthcare Education Third-Year Residency Programs 2014:

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There is no registration fee for these activities. Air, ground transportation in Fort Worth, hotel accommodations and modest meals will be provided through an educational scholarship for qualiﬁ ed participants. These meetings are approved for AMA PRA Category 1 CreditsTM.

Endorsed by Jointly Provided by Partially supported by an independent medical educational grant from Review Of Ophthalmology Alcon

2014_CSE_dir.indd 86 6/20/14 1:25 PM Uncover a potential systemic cause of dry eye before it takes hold

What appear to be symptoms of routine dry eye may be rooted in something deeper.

As many as 1 in 10 dry eye patients also have Sjögren’s syndrome, a common but serious autoimmune disease.1,2 Sjö™ is an advanced diagnostic test that allows you to detect Sjögren’s syndrome early and improve patient management.2-4

Introducing

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References: 1. Liew M, Zhang M, Kim E, et al. Prevalence and predictors of Sjögren’s syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012;96:1498-1503. 2. Kassan SS, Moutsopoulos HM. Clinical manifestations and early diagnosis of Sjögren syndrome. Sjö is a trademark of Nicox, Inc. Arch Intern Med. 2004;164(12):1275-1284. 3. Sjögren’s Syndrome Foundation. Sjögren’s Syndrome Foundation. 2013. Available at http://www.sjogrens.org. Accessed September 5, 2013. 4. Shen L, Suresh L, © 2014 Nicox, Inc. All rights reserved. www.nicox.com Lindemann M, et al. Novel autoantibodies in Sjögren’s syndrome. Clin Immunol. 2012;145:251-255.

RP0614_Nicox.indd 2 5/12/14 1:15 PM For more information about Sjö™, please call a myNicox concierge professional at 1.855.MY.NICOX (1.855.696.4269), email [email protected], or visit mynicox.com/Sjo.

RP0614_Nicox.indd 3 5/12/14 1:15 PM Femtosecond Cataract REVIEW Feature Femtosecond Cataract: Getting Up to Speed Walter Bethke, Managing Editor

Expert advice on icture this: You’ve just spent practice was the second to purchase $400,000 on a femtosecond a femto-cataract laser in the United minimizing the Plaser for cataract surgery, and States, says everyone who works with then one morning you walk into the the laser needs to get comfortable. time femtosecond operating room to fi nd it broken and “Initially, your techs aren’t super com- shoved against the wall. Though it fortable with it and so on,” he says. “So cataract surgery sounds like a fi ctional worst-case sce- I’d say it adds eight to 10 minutes to adds to your nario, it actually happened to Denver your case until techs get comfortable ophthalmologist Michael Taravella. with the steps involved.” You’ll even- procedures. “We thought, OK, we have to fi nd a tually shave this time down, though. separate room for this laser,” recalls “When the doctor gets familiar with Dr. Taravella, who had placed the la- docking and the staff gets comfortable ser in an OR he shared with surgeons with the laser programming, they can and staff from other specialties who bring the added time down to maybe had made it a habit of bumping it out three or four minutes,” says Carlos of their way. He says that this dark Bravo, lead OR tech and materials episode illustrates just one potential manager for Specialty Surgical Cen- issue that can crop up when a surgeon ter in Beverly Hills, Calif. Mr. Bravo invests in this new technology and makes sure the center’s fl ow isn’t im- then has to address the logistics of peded by the addition of femtosecond making it work in his surgery center. cataract cases. “When a surgeon be- In this article, surgeons and surgery- gins using the femtosecond for cata- center experts share their tips on how ract surgery, we block out about 10 you can incorporate the femtosecond to 15 extra minutes so there’s enough without slowing down. time for the learning process. Then, as he gets more effi cient we take time Scheduling Cases off that. Now, some are even ahead of schedule because we’ve gotten that Surgeons say your cases will take efficient. Part of this is because the longer when you fi rst begin using the intraoperative time is a little shorter laser, but you’ll speed up with experi- due to the steps that were done with ence. However, they note that even the femtosecond, such as fragmenting then it will usually take more time the cataract.” than a non-laser case. Moran Eye Mr. Bravo says scheduling multiple Center surgeon Alan Crandall, whose surgeons is another aspect that a cen-

22 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

022_rp0714_f1.indd 22 6/20/14 10:27 AM ter needs to address. “Here at the cen- Sandy, Utah, surgeon Robert ter, one of the biggest initial hurdles Rivera, who uses the AMO Catalys when femtosecond was introduced laser, has gone through a couple of was the fact that we have several sur- ways of managing patient flow. “It geons using it on any given day,” Mr. MD Robert Rivera, does require the oversight of an ASC Bravo explains. “In the beginning, we manager or charge nurse who can used to spread them out and try to give help you decide which system would a little time in between each femto work best,” he says. “For example, case so we could turn over the room. when I started, I thought I’d actually But now we schedule them concur- be more effi cient doing two femtos at rently since all the doctors are famil- a time and always staying one femto iar with the technology. A femto laser Your practice will need at least one person ahead. That is to say I wouldn’t go into shouldn’t take longer than four or fi ve to be trained in the programming of the the actual operating room until I’d minutes now. As soon as one patient is laser in order to assist the surgeon. done two patients on the femto laser. wheeled out, the next one comes right Then, when I was done with the OR in. Initially, though, it takes time get- cess to disrupt the system,” he says. part of my fi rst case, I’d go do another ting the staff trained. They also have to “If this happens we make sure that femto—this would be the third—and be effi cient at getting the paperwork the nurse in the room lets the next I’d then bring the second femto into and other postop data that comes out surgeon know that we’re having issues the OR while the third was waiting. of the femto case to the doctor so the so that he knows what’s going on and But, it turns out that, after the direc- next patient can come in. doesn’t get antsy. During our clinical tor of nursing helped us with a little “When multiple surgeons have fem- training with the laser’s clinical ap- time/efficiency study, we found out to cataracts on the same day, we have plication experts, they taught us how that in fact the easiest way for a single a fi rst-come, fi rst-served process,” Mr. to recognize the danger signs, such as surgeon to do surgeries was to just do Bravo adds. “There are times when we when a patient is moving his head a the femto on a patient and then bring have three cases lined up one after the lot or is being uncooperative. At some that patient into the OR.” Dr. Rivera other. In those instances, we’ll come point, you have to know when to stop. schedules all his femto cataract cases out to the preop area and say, ‘The The surgeon will say, “We tried dock- for the beginning of his surgery day. laser room is open and whoever gets ing you and it didn’t work out, so we’ll Some surgeons, however, have had ready fi rst gets to go in.’ In the begin- do your case the traditional way—it’s success with a patient-flow design ning, though, these situations were an not a problem.’ This is rare, though, in which non-femto cases are inter- issue, since a doctor would point out and happens only 1 to 2 percent of the spersed among the femto ones. “We that he was next on the schedule, but time at most.” Mr. Bravo says you can tried a bunch of different ways at fi rst,” it would turn out his team wasn’t ready keep the patient flow going by rec- recalls Dr. Crandall. “We tried to do to move into the laser room. We had to ognizing potentially diffi cult patients them all at once but that wasn’t really get the doctors to communicate with before they’re under the laser. “Some- effi cient; the problem was you’d have each other. Let’s say that two doctors times a doctor may come and tell us to go back to the laser in between. finish at the same time and each of ahead of time that a patient may need It’s true that, once you got going, you their next cases is a femto. We’ll go a little extra sedation or a little extra could do this, but we found it was up to them and say, “Both of you are time because he’s anxious,” he says. easier if you had a break in between fi nished, who would like to go fi rst?” “Sometimes, a surgeon will schedule because it was quicker for the team to In many cases, one of them will say a potentially diffi cult patient, such as have them all ready to go. that he or she doesn’t mind waiting, a patient with a small fi ssure, fi rst or “For instance, in the way we do it and will let the other go ahead, since last in the lineup to keep him out of now, I go into OR-1, and while I start he knows that he can make up for any the way.” a non-femto cataract there, my staff lost time in the OR.” moves a femto patient into the LenSx Sometimes, however, Mr. Bravo Surgeons’ Experiences room,” Dr. Crandall continues. “As says femto cataract throws everyone soon as I’ve finished the non-femto a curveball, and the center has to be Surgeons say it’s one thing to draw cataract, I walk in to the LenSx room ready for it. “It just takes one patient up a patient fl ow schedule on paper and they’ve got the laser ready to go who is uncooperative or maybe scared and another to put it into practice. and the patient situated. I do the Len- and uncomfortable with the laser pro- Here’s what they’ve learned. Sx, which now takes us about two to

July 2014 | Revophth.com | 23

022_rp0714_f1.indd 23 6/20/14 10:27 AM Feature Femtosecond Cataract REVIEW

three minutes and, while that’s OR and put it in a procedure being done, the staff has already room. If there is a problem with moved another non-femto pa- a patient at the laser or a laser tient into OR-2 for me. So I can issue that needs repair, the en-

go into OR-2, and they’ll take MD Taravella, Michael tire operating room goes down the LenSx patient I just com- and no one can use it. Having pleted into OR-1, and so on.” the laser in another room also Surgeons say that such ap- becomes an extra location for proaches work for mild to mod- patients to fl ow to.” erate volumes of femto cataract To ensure an effi cient docking process, make sure the Dr. Taravella says putting patients, such as up to 40 per- patient’s cheek and brow are level, surgeons say. his LenSx laser in the OR just cent or so. If the day ever came caused it to be in the way of when a practice derived most of its Devgan, whose practice has both an other surgeons and staff. “It was in a volume from femto cataract, how- AMO Catalys and an Alcon LenSx, room that was used by non-eye sur- ever, they say a two-surgeon approach says that since the laser needs par- geons,” he says. “The problem with might be best. “I believe the best sys- ticular data before it can perform as- that was it has a cooling fan or some- tem, if you have a suffi cient volume of tigmatic incisions, it’s best to come thing that people didn’t like, so they’d femto cataract cases, will be to have prepared. “Write your exact LRI no- try to move it or bump it. In fact, one a dedicated surgeon doing the fem- mogram on the paperwork ahead of morning we came in and found that tosecond part of the case,” says Dr. time so you can input it in the laser as a small arm connected to a light had Rivera. “This will allow the anterior soon as you get to the center,” he says. been broken and was just dangling segment surgeon to stay in the OR.” “It makes life much easier. Just get to from the machine. Also, we had a lot Surgeons point out, however, that this the surgery center a half-hour early of issues with having to re-calibrate it ties up two surgeons, so the volume in the morning and program all your multiple times when it was in the OR has to be there to support it. eyes for the day.” because of someone bumping it. We Even without a high volume, hav- found a home for it near the primary ing someone such as a subspecialty Logistical Concerns ORs. We’re currently remodeling the fellow around can help alleviate slow- Eye Institute and it will eventually be downs. “In our center, the patients Experts say that, in order to make in a room adjacent to the ORs and can are assigned their surgical times be- the big idea of femtosecond cataract feed the ones I’m working in.” fore they even know whether they’re surgery work, you have to consider • Prep the space. If you’re going getting femto or not, and then we several little ideas fi rst. to place the laser in its own room, work it out,” explains Baylor College • The laser’s location.Though the space it will require will depend of Medicine Chair of Ophthalmol- surgeons have the option of putting on the model you purchase, but ex- ogy and Catalys user Doug Koch. the laser in the OR or in a separate perts say to plan on a minimum of “That may not be optimal, but it’s cer- room, it seems like the consensus around 11 ft. x 12 ft, though some tainly convenient and saves a lot of among experts is the latter is prefer- lasers may be able to squeeze into a headaches such as, ‘We should move able. The main advantage of having smaller space. You may also have to Mary Smith over here because Peter it in the sterile OR is minimizing the do some renovations. “Prepping the Thomas is having that done, etc.’ It transition time between the laser and space was a challenge,” says Mr. Bra- seems to make things simpler. On the the phaco machine. The disadvan- vo. “We had to install a cooling system day of surgery, as those femtosecond tages, however, are many. “If it’s in the and thermostat for the room to keep it patients transition from one room to OR, it’s paramount to make sure that between 65 and 78 degrees or so, and the next, I’ll step out and do the femto whoever’s operating in that room is it had to be close to our wireless in- while my staff is either rolling the pa- out by a certain time for the next sur- frastructure so it could communicate tient into the operating room or while geon,” says Richard Ferdon, a femto- with our printer and phone ports so my fellow is prepping and getting ev- second applications expert for Alcon it would have remote access.” Some erything ready, and maybe making who trains practices on making the lasers also need a 220 VAC power incisions and the capsulorhexis, in the transition to femtosecond cataract. supply. other operating room. The time lost is “So, for multiple physicians with mul- • Mark the patients. Mr. Ferdon quite minimal.” tiple ORs and a high volume of cases, says everything in the femto cataract Beverly Hills, Calif., surgeon Uday it’s best to position a laser outside the process should be managed in a writ-

24 | Review of Ophthalmology | July 2014

022_rp0714_f1.indd 24 6/20/14 10:28 AM ten or symbol format. “The entire of, surgeons say. “In terms of logistics, conventional gurney and the LenSx staff, from admitting to postop, has to the LenSx is somewhat easier because laser gurney is probably the longest be aware of which patients are which with it the patient stays on the same part of the procedure, actually.” He without interrupting or bothering the gurney from preop to the LenSx laser, says in the pending renovation of his patients,” he says. “For instance, may- to the OR and then to recovery,” says surgical center, the laser room will be change the color of the sticker on Dr. Devgan. His Catalys has its own be close enough to the ORs that the the operative eye to make the femto- bed that the patient must be trans- patient can stay on the same gurney second patients’ a different color, and ferred to and from. The LensAR laser throughout. use different colored clips on their doesn’t have an integrated bed while Though adopting femtosecond cat- charts.” He says training the whole the Bausch + Lomb Victus does. aract surgery technology may have its staff to be prepared for femtosecond The gurney used by the LenSx, logistical logjams, surgeons say that patients avoids such situations as the though, may not work for all facilities, you can make the process much easier anesthesia professional instilling a says Dr. Taravella. “LenSx touts its if you can get your staff as motivated nerve block when the patient arrives moveable bed as being able to be used for it as you are. “The biggest advan- that prevents the patient from moving in the OR,” he says. “But the problem tage of the laser that the staff can read- the eye or fi xating on the femtosec- for us is the laser isn’t sitting close ily see is how much easier it makes ond’s fi xation light. (Femto patients enough to the ORs in our current situ- the removal of the cataract,” says Dr. must be aware and able to participate ation so that we can use that bed. Our Rivera. “When they see it takes less for the femto portion of the proce- techs didn’t like it in terms of being phaco energy and infusion fl uid and dure.) able to roll patients any signifi cant dis- so forth, and the surgery team reports • Bed issues. An integrated pa- tance; it’s not really suitable for rolling back to the rest of the staff about the tient bed may or may not be an issue more than 30 or 40 feet. Transferring patient outcomes, that’s where the for you, but it’s something to be aware patients back and forth between the enthusiasm really comes in.”

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022_rp0714_f1.indd 25 6/20/14 10:27 AM Femtosecond Cataract REVIEW Feature Femto Laser Cataract: Avoiding Complications Christopher Kent, Senior Editor

Like every new s more surgeons explore the Preoperative Precautions possibility of femtosecond la- surgery, this one Aser cataract surgery (in which For any surgery to succeed, appro- the incision, capsulotomy and nucleus priate patients must be chosen, and is associated with fragmentation are accomplished by the patients must be made aware of the laser), the focus on the details of possible postop concerns. unique potential the surgery’s advantages and pitfalls • Make sure the patient can lie problems. Here’s has become more intense. And as with flat and remain still. “There are any surgery, one of the most important some challenges that are unique to how to keep details is potential complications. femtosecond cataract surgery—things “Any new surgical technique in- that would not be a challenge in con- things going volves a learning curve, and complica- ventional surgery,” says Sonia H. Yoo, tions will occur,” notes Ronald Yeoh, MD, professor of ophthalmology at smoothly. MD, medical director, founding part- the Bascom Palmer Eye Institute, ner and senior consulting ophthalmic University of Miami School of Medi- surgeon at Eye & Retina Surgeons, cine. “One is that the patient must Camden Medical Centre in Singa- have the ability to lie down ﬂ at in the pore. “The increasing trend towards right position and remain still. Dur- femto-laser-assisted cataract surgery, ing manual surgery we can give the or FLACS, means that we are en- patient IV sedation that can help if he countering complications peculiar to has a tremor or neck pain, but during this surgery. The transitioning surgeon laser surgery the patient has to be alert needs to recognize these and modify and awake. surgical technique to manage them “That’s true for several reasons,” appropriately.” she continues. “For one thing, most Here, Dr. Yeoh and three other sur- surgeons have the laser in a differ- geons with extensive experience using ent room from the operating arena, femtosecond laser technology as part so the patient has to get up and be of cataract surgery share pearls taken transferred to the other room after the from their experience with complica- laser part of the procedure. Also, we tions: what those potential compli- need to have the patient’s cooperation cations are, how to manage them if during the laser, so that he can look at they occur, and how to minimize the the light or adjust his position. With likelihood of them occurring in the IV sedation on board, that might not ﬁ rst place. be possible—the patient might fall

26 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

026_rp0714_f2.indd 26 6/20/14 3:19 PM Robert Weinstock,MD asleep; his head might bob; tosecond laser part of the he’s more likely to move at procedure is completed, be- an inopportune time. As a re- cause after you make your sult, we don’t sedate patients capsulotomy and do the lens before the femtosecond laser softening the pupil will of- part. So when you evaluate ten come down,” she con- patients you need to make tinues. “In that case, at the sure they’ll be able to lie fl at beginning of your manual and remain still.” surgery you might have to • Select cooperative pa- place some mydriatic into tients with wide palpebral the eye to get the pupil to Surgeons need to be aware that when the laser is used to make a apertures. “As any LASIK cube fragmentation pattern, the red refl ex and view of the enlarge. Some surgeons use surgeon knows, suction loss capsulotomy can be obscured, making it diffi cult to fi nd and grasp viscoelastic to expand the pu- will create problems with the capsule. If the capsulotomy is incomplete, the surgeon can pil, or in really severe cases fl ap creation,” says Dr. Yeoh. have diffi culty seeing the adhesion points and might inadvertently use hooks or a ring. “When performing FLACS, tear the anterior capsule. “If you’re surprised on the suction loss can lead to in- day of the surgery by a pupil complete capsulorhexes, incomplete ple of days,” he adds. “Once in a while that you thought would dilate but for nuclear division or incomplete inci- the redness lasts for a longer period, some reason doesn’t,” she adds, “one sions. Prevention is the best cure for but only in patients who are on antico- option is to simply not use the fem- this, so it is best to select patients with agulant therapy. Fortunately, conjunc- tosecond laser. Another option would wide palpebral apertures who are co- tival redness is not as big a problem as be to go ahead and make a wound and operative.” it used to be [in our practice] because inject drugs or use hooks or rings prior Dr. Yoo agrees. “If an individual has the new SoftFit patient interface on to applying the laser, but you’d have to a very deep orbit or high brow, it can our LenSx machine allows us to use weigh the risks and benefi ts of doing be diffi cult to dock the laser to the eye lower pressure.” so, because doing so may increase the just because of the anatomy,” she says. • During the preop examination, patient’s risk of a complication.” • Alert patients of the possibil- make sure the pupil dilates well • An NSAID can help prevent ity of conjunctival redness. “This with drops. “During conventional femtosecond-laser-induced miosis. can result from the suction applied by cataract surgery we’ve gotten pretty “Prostaglandins are released in the an- the patient interface,” explains Zoltan good at dealing with small pupils, us- terior chamber during the femtosec- Z. Nagy, MD, PhD, clinical profes- ing hooks and rings and intraocular ond laser step, causing pupillary con- sor of ophthalmology at Semmelweis mydriatics,” says Dr. Yoo. “A small striction,” explains Dr. Yeoh. “Small University in Budapest, Hungary. (In pupil is also an issue with femtosecond pupils can cause the rest of the surgery 2008, Dr. Nagy performed the fi rst- laser cataract surgery, because if the to be more diffi cult. My publication in ever femtosecond-laser-assisted cata- pupil is too small we might not be able the latest issue of the Journal of Cata- ract surgery.) “This is more of an is- to use the laser. However, the usual ract and Refractive Surgery1 shows sue when the patient is on anticoagu- aids may not be advisable in this situ- that a single application of a non-ste- lant therapy, as many elderly patients ation. The problem isn’t so much hav- roidal anti-infl ammatory agent, used are, so we need to ask patients about ing a drug or hooks or rings inside the with the dilating drops an hour before this before starting the procedure. It eye; it’s that you have to make a wound surgery, is very useful in preventing may be possible for them to stop the to get them into the eye. When you femtosecond-laser-induced miosis.” medication for a few days before the use the laser you pressurize the eye, so surgery, but if they cannot stop it be- if you’ve made any wounds you could Working with the Laser cause of cardiovascular problems, they lose the anterior chamber, putting the should be informed of the possibility patient at risk. Admittedly, there have Surgeons offer these strategies for of postop conjunctival redness before been some reports of surgeons placing minimizing problems during the laser the surgery. Usually, patients accept hooks or rings or drugs in the eye and part of the procedure: this as part of the surgery, so it’s not a then cutting with the laser, but those • When docking the patient, problem. are special cases. make sure the eye is flat to the “In most cases the redness goes “On the other hand, it’s pretty plane of the patient interface and away by the next day, or within a cou- common to use drugs once the fem- properly centered. “Making sure the

July 2014 | Revophth.com | 27

026_rp0714_f2.indd 27 6/20/14 3:19 PM Feature Femtosecond Cataract REVIEW

eye is fl at to the plane of the Sonia H. Yoo, MD same grid pattern the laser was patient interface will minimize making in the lens—but that the relative tilt of the lens,” area was not over the pupil, says Dr. Yoo. “If you have sig- and the cornea was not cut or nifi cant lens tilt, you may end seriously damaged. I’ve been up with an incomplete capsu- following the patient for about lotomy.” 18 months, and you can still “If you put the patient inter- see that pattern on the cornea. face on correctly and in a cen- Other similar cases have been tered manner, lots of complica- reported in the literature. tions can be avoided,” agrees “The best way to prevent Dr. Nagy. “If the patient in- something like this,” she notes, terface of our LenSx machine “is to pay close attention when is well-centered, for example, applying the interface, and the information collected by coach the patient verbally dur- the OCT is accurate, so it can ing the laser application, re- defi ne the lowest and highest In this patient suction loss occured during lens segmentation, minding her to remain still and causing the segmentation pattern to be briefl y applied to points of the anterior capsule focus on the light.” the cornea. The resulting grid pattern left on the cornea was and avoid any piercing of the outside the line of sight, and the patient has done well. • If you lose suction, stop crystalline lens or incomplete and proceed with manual capsulotomies. This has helped us loss include loose conjunctiva and the surgery. Dr. Yoo notes that if the laser achieve a free-fl oating capsulotomy 97 patient moving or blinking while the procedure is interrupted because of to 98 percent of the time. laser is working. “If loose conjunctiva suction loss, most surgeons will just “Good centration is especially gets into the visual area, then the suc- stop using the laser and complete the important for creating the corne- tion may not be secure, which could surgery by hand. “The only exception al wound,” he adds. “If the patient allow the interface to move during might be when the suction loss oc- moves his eye and the interface is de- the treatment,” he says. “The surgeon curs while docking the laser prior to centered, then the corneal wounds should also remind the patient not to administering the laser,” she says. “In may be more central than expected, move or blink while the laser is work- that case, surgeons typically try again. creating surgically induced astigma- ing. If the patient moves his eye, it But once you’re depressing the foot tism. The other possibility is that the could break the suction. It’s rare for pedal and the laser has started, if you wound could become too peripheral. this to happen, but it is possible.” lose suction you’re basically done with It’s good to make the corneal incision Dr. Yoo notes that suction loss isn’t the laser part.” as peripheral as possible, but if it’s too always a big deal because you can of- • Be careful when dealing with peripheral because of a decentered ten reapply or switch to manual sur- a liquefi ed cortex. “Generally, using interface, it may hit the conjunctival gery. However, suction loss can some- the laser reduces complications when vessels, which could lead to bleeding times lead to trouble. “I did have one you’re dealing with a very dense lens,” and an incomplete corneal incision. So case where suction loss occurred dur- says Dr. Yoo. “However, if you have a centering the patient interface is very ing the lens segmentation and the seg- very dense lens and a liquefi ed cortex, important.” mentation pattern was briefl y applied such as a white cataract where the cor- • If bubbles are present, undock to the cornea because the laser is so tex is very liquid, you may get a plume and redock. “Imperforate incisions fast,” she says. (See picture, above.) of lens material once you open the can result from poor docking, with “There’s a safety mechanism on our capsule. That may actually block the air bubbles obstructing the incision laser that cuts it off once suction is lost, lens segmentation. site and poor positioning of the inci- but I guess there’s a brief time dur- “In those cases, you may want to sions,” notes Dr. Yeoh. “Good docking ing which you haven’t completely lost increase the energy a bit on your laser technique will help avoid trapped air suction, and during that instant the when you’re doing the capsulotomy to bubbles.” laser energy was directed in the wrong make sure you cut through the fi brotic • Do everything possible to pre- plane. Fortunately, there were no visu- capsule and make sure the laser ener- vent suction loss during femtosec- al consequences; the patient has done gy penetrates through small amounts ond application. Dr. Nagy notes really well. You can see a waffl e grid of liquefied cortex that may escape that factors which can cause suction pattern in a section of the cornea—the during that capsulotomy,” she says.

28 | Review of Ophthalmology | July 2014

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IMPORTANT RISK INFORMATION ABOUT PROLENSA® Indications and Usage Warnings and Precautions PROLENSA® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti- • Sulfite allergic reactions • Increased bleeding of ocular tissues inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation • Slow or delayed healing • Corneal effects, including keratitis and reduction of ocular pain in patients who have undergone cataract surgery. • Potential for cross-sensitivity • Contact lens wear Dosage and Administration Adverse Reactions Instill one drop into the affected eye once daily beginning 1 day prior to surgery, The most commonly reported adverse reactions in 3%-8% of patients continued on the day of surgery, and through the first 14 days post surgery. were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. Please see brief summary of full Prescribing Information on adjacent page. References: 1. PROLENSA® Prescribing Information, April 2013. 2. Data on file, Bausch & Lomb Incorporated. 3. Baklayan GA, Patterson HM, Song CK, Gow JA, McNamara TR. 24-hour evaluation of the ocular distribution of 14C-labeled bromfenac following topical instillation into the eyes of New Zealand White rabbits. J Ocul Pharmacol Ther. 2008;24(4):392-398. 4. BROMDAY® Prescribing Information, October 2012. ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. ©2013 Bausch & Lomb Incorporated. Printed in USA US/PRA/13/0044(1) 9/13

RP0314_BL Prolensa.indd 1 2/20/14 10:14 AM PROLENSATM (bromfenac ophthalmic solution) 0.07% Brief Summary INDICATIONS AND USAGE PROLENSA following cataract surgery include: anterior chamber PROLENSA (bromfenac ophthalmic solution) 0.07% is indicated for the inflammation, foreign body sensation, eye pain, photophobia and vision treatment of postoperative inflammation and reduction of ocular pain in blurred. These reactions were reported in 3 to 8% of patients. patients who have undergone cataract surgery. USE IN SPECIFIC POPULATIONS DOSAGE AND ADMINISTRATION Pregnancy Recommended Dosing Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic One drop of PROLENSA ophthalmic solution should be applied to exposure 90 times the systemic exposure predicted from the the affected eye once daily beginning 1 day prior to cataract surgery, recommended human ophthalmic dose [RHOD] assuming the human continued on the day of surgery, and through the first 14 days of the systemic concentration is at the limit of quantification) and rabbits postoperative period. at oral doses up to 7.5 mg/kg/day (150 times the predicted human Use with Other Topical Ophthalmic Medications systemic exposure) produced no treatment-related malformations in PROLENSA ophthalmic solution may be administered in conjunction reproduction studies. However, embryo-fetal lethality and maternal with other topical ophthalmic medications such as alpha-agonists, beta- toxicity were produced in rats and rabbits at 0.9 mg/kg/day and blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused Drops should be administered at least 5 minutes apart. delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and CONTRAINDICATIONS reduced postnatal growth at 0.9 mg/kg/day. None There are no adequate and well-controlled studies in pregnant WARNINGS AND PRECAUTIONS women. Because animal reproduction studies are not always Sulfite Allergic Reactions predictive of human response, this drug should be used during Contains sodium sulfite, a sulfite that may cause allergic-type reactions pregnancy only if the potential benefit justifies the potential risk to including anaphylactic symptoms and life-threatening or less severe the fetus. asthmatic episodes in certain susceptible people. The overall prevalence Because of the known effects of prostaglandin biosynthesis- of sulfite sensitivity in the general population is unknown and probably inhibiting drugs on the fetal cardiovascular system (closure of ductus low. Sulfite sensitivity is seen more frequently in asthmatic than in non- arteriosus), the use of PROLENSA ophthalmic solution during late asthmatic people. pregnancy should be avoided. Slow or Delayed Healing Nursing Mothers All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including Caution should be exercised when PROLENSA is administered to a bromfenac, may slow or delay healing. Topical corticosteroids are also nursing woman. known to slow or delay healing. Concomitant use of topical NSAIDs and Pediatric Use topical steroids may increase the potential for healing problems. Safety and efficacy in pediatric patients below the age of 18 have not Potential for Cross-Sensitivity been established. There is the potential for cross-sensitivity to acetylsalicylic acid, Geriatric Use phenylacetic acid derivatives, and other NSAIDs, including bromfenac. There is no evidence that the efficacy or safety profiles for Therefore, caution should be used when treating individuals who have PROLENSA differ in patients 70 years of age and older compared to previously exhibited sensitivities to these drugs. younger adult patients. Increased Bleeding Time With some NSAIDs, including bromfenac, there exists the potential for NONCLINICAL TOXICOLOGY increased bleeding time due to interference with platelet aggregation. Carcinogenesis, Mutagenesis and Impairment of Fertility There have been reports that ocularly applied NSAIDs may cause Long-term carcinogenicity studies in rats and mice given oral increased bleeding of ocular tissues (including hyphemas) in conjunction doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 with ocular surgery. times the systemic exposure predicted from the recommended It is recommended that PROLENSA ophthalmic solution be used with human ophthalmic dose [RHOD] assuming the human systemic caution in patients with known bleeding tendencies or who are receiving concentration is at the limit of quantification) and 5 mg/kg/day (340 other medications which may prolong bleeding time. times the predicted human systemic exposure), respectively, revealed Keratitis and Corneal Reactions no significant increases in tumor incidence. Use of topical NSAIDs may result in keratitis. In some susceptible Bromfenac did not show mutagenic potential in various mutagenicity patients, continued use of topical NSAIDs may result in epithelial studies, including the reverse mutation, chromosomal aberration, and breakdown, corneal thinning, corneal erosion, corneal ulceration or micronucleus tests. corneal perforation. These events may be sight threatening. Patients with Bromfenac did not impair fertility when administered orally to male evidence of corneal epithelial breakdown should immediately discontinue and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, use of topical NSAIDs, including bromfenac, and should be closely respectively (systemic exposure 90 and 30 times the predicted human monitored for corneal health. exposure, respectively). Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial PATIENT COUNSELING INFORMATION defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), Slowed or Delayed Healing rheumatoid arthritis, or repeat ocular surgeries within a short period Advise patients of the possibility that slow or delayed healing may of time may be at increased risk for corneal adverse events which may occur while using NSAIDs. become sight threatening. Topical NSAIDs should be used with caution Sterility of Dropper Tip in these patients. Advise patients to replace bottle cap after using and to not touch Post-marketing experience with topical NSAIDs also suggests that use dropper tip to any surface, as this may contaminate the contents. more than 24 hours prior to surgery or use beyond 14 days post-surgery Advise patients that a single bottle of PROLENSA, be used to treat may increase patient risk for the occurrence and severity of corneal only one eye. adverse events. Concomitant Use of Contact Lenses Contact Lens Wear Advise patients to remove contact lenses prior to instillation of PROLENSA should not be instilled while wearing contact lenses. PROLENSA. The preservative in PROLENSA, benzalkonium Remove contact lenses prior to instillation of PROLENSA. The chloride, may be absorbed by soft contact lenses. Lenses may be preservative in PROLENSA, benzalkonium chloride may be absorbed by reinserted after 10 minutes following administration of PROLENSA. soft contact lenses. Lenses may be reinserted after 10 minutes following Concomitant Topical Ocular Therapy administration of PROLENSA. If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart ADVERSE REACTIONS Rx Only Clinical Trial Experience Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 Because clinical trials are conducted under widely varying conditions, Under license from: adverse reaction rates observed in the clinical trials of a drug cannot be Senju Pharmaceuticals Co., Ltd. directly compared to rates in the clinical trials of another drug and may Osaka, Japan 541-0046 not reflect the rates observed in clinical practice. Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates. The most commonly reported adverse reactions following use of © Bausch & Lomb Incorporated. 9317600

RP0314_BL Prolensa PI.indd 1 2/20/14 10:15 AM Feature Femtosecond Cataract REVIEW Sonia H. Yoo, MD “Once you switch to manual surgery the viscoelastic will clear your view. “Interestingly, because these lasers generate images of the lens once the patient is docked—most platforms use OCT imaging—sometimes you can actually see that the lens is dense but the surrounding cortex is liquefi ed,” she adds. (See example, right.) “In that case you should be prepared to take your foot off the pedal if you see liquid coming out during the capsulotomy.” Femtosecond laser technology often manages advanced cataracts more easily than manual surgery can. Here, the built-in OCT scan (right) reveals there is some liquefi ed cortex Managing the Capsulotomy surrounding the dense inner nucleus of this advanced cataract. The microscopic view (left) is shown for comparison. Once the laser portion of the op- eration is done, several potential prob- ceps or microforceps and complete even if it’s trying to come off and be lems unique to laser-assisted surgery the capsulotomy without any prob- free-fl oating, so you have a better view need to be anticipated and addressed lem. The problem occurs when you of what’s going on. Once I’ve done to ensure complication-free comple- don’t realize that there’s an adhesion. that I can use my microcapsulorhexis tion of the cataract surgery. If you grab the capsule quickly with- forceps to tease all of the fl ap tissue to • Use a specially designed spat- out paying attention and pull it out the center to make sure there are no ula to open the femtosecond-laser- of the eye, it can rip at the point of adhesions. If I fi nd that there’s an ad- created incision. “You can use any adhesion and cause an anterior tear hesion, I just fi nish the capsulorhexis small instrument to open the fem- in the capsule, which then has a risk manually. Also, pushing down gently tosecond laser incisions,” notes Dr. of running around posteriorly. So the in the middle of the capsule can help Yeoh. “However, this is less than ideal, way to prevent this complication is to visualize where an adhesion may be.” as size and shape are not optimized. pay close attention when removing the • Watch for an oval bubble un- Indeed, in the early days of FLACS, capsulotomy tissue. der the anterior capsule. “If the cap- we used Sinskey hooks or cyclodialy- “I find it helpful to put viscoelas- sulotomy is not free-fl oating, there are sis spatulae to open the incisions, but tic inside the eye before I attempt to some telltale signs you can see through they were found wanting. The Slade remove a femtosecond-laser-created the microscope,” says Dr. Nagy. “One Femtosecond Spatula works well; an- capsulotomy,” he continues. “That is an oval bubble under the anterior other option is the Yeoh Femto-inci- does two things. First, in many cas- capsule. If the bubble is oval you can sion Double Ended Spatula, which I es the process of making the capsu- be nearly certain there’s an incomplete designed but have no fi nancial interest lorhexis and breaking up the lens re- cut in that area. The oval bubble will in. The latter is optimized in shape leases gas; those gas bubbles rise into not appear every time you encounter and angulation for use with these inci- the anterior chamber to the underside an incomplete cut, but if it does ap- sions.” (See picture, p. 34.) of the cornea where they interfere pear, it’s a telltale sign that the cap- • Use viscoelastic to avoid miss- with the surgeon’s view. Putting in the sulotomy may be incomplete. If the ing an incomplete capsulotomy. viscoelastic pushes the gas bubbles out capsulotomy is incomplete, use your “When using a femtosecond laser to of the way so you can see what you’re capsulotomy forceps to lift the tissue create the capsulotomy, some areas doing. following the circular contour created can remain incompletely cut,” notes “Second, it can be diffi cult to visu- by the laser. If you follow the contour Robert Weinstock, MD, director of alize what’s happening with the cap- you should avoid tearing the capsule cataract and refractive surgery at the sulotomy tissue,” he says. “If the fl ap 100 percent of the time.” Eye Institute of West Florida in Largo, folds over itself or rolls up like a taco, Fla. “By itself, an incomplete capsu- you can’t see what’s going on where it’s Removing the Nucleus lotomy is not really a complication, near the capsule edge; it might not be because 99 percent of the time you completely separated. Instilling vis- The way the laser creates the cap- can just grab the capsule with a for- coelastic fl attens the anterior capsule, sulotomy and fragments the nucleus

July 2014 | Revophth.com | 31

026_rp0714_f2.indd 31 6/20/14 3:20 PM Feature Femtosecond Cataract REVIEW Robert Weinstock,MD

Above, left: One difference between a laser capsulotomy and manual capsulorhexis is that the laser not only cuts the capsule but also cuts into the cortex. This creates a fl ush edge of cortex fused to the capsule, making it diffi cult to fi nd the plane between the tissues into which you can stick the cannula to hydrodissect between them—sort of a “manhole cover” effect. (After nucleus removal, it often appears that there is no cortex at all, when in fact there is a complete layer present. The clue is that a white ring is present at the anterior capsule.) Center and right: During irrigation and aspiration following use of the femtosecond laser, the aspiration tip has to be placed up under the edge of the anterior capsule in order to grasp the cortex. This is in contrast to non-laser-treated eyes, where there is usually a tongue of cortex protruding centrally that’s easier to grasp.

is very different from a manual ap- synephrine in the eye right after the the underside of the anterior capsule proach, resulting in some unique laser treatment. You should get good and the fi rst layer of cortex. But when problems (and solutions) when it’s penetration with the drops, in part you do femtosecond laser surgery, the time to remove the crystalline lens because you’ve pressed on the eye laser not only cuts the capsule, it goes from the bag. during the laser treatment, causing a down and cuts a rim of cortex too, the • Pupil constriction. As already tiny bit of epithelium breakdown. exact same size and shape as the cap- noted, one issue during femtosecond “Because of the possibility of extra sulorhexis. laser cataract surgery is that the pu- pupil constriction, we now routinely “The result is a kind of manhole pil can come down. “The laser puts put in a strong dilating drop right after cover effect,” he continues. “It makes energy into the eye and—in my opin- using the laser, before the patient goes a flush edge where you’re trying to ion—sets off a little infl ammatory re- under the microscope and is prepped hydrodissect. That makes it very hard sponse,” explains Dr. Weinstock. “If and draped,” he adds. “We do this to fi nd the little space where you need you have a widely dilated pupil that’s for all eyes, not just Flomax cases. Of to stick the cannula to get a true fl uid away from the capsulotomy, usually course, there is a small risk that the wave between the capsule and the you’re fi ne. But if you have a Flomax drops will have a systemic effect, but peripheral cortex. So instead of just case, where the pupil is already pre- patients are under monitored anesthe- doing this through one incision I fi nd disposed to constriction during sur- sia, so if their blood pressure goes up myself going in through my second gery, you’re at risk of the pupil coming they’re in a controlled environment. incision and trying a different orienta- down pretty quickly right after the In any case, we haven’t seen any ad- tion. I fi nd myself trying to puncture laser treatment. For example, if you’re verse complications from that addition through the cortex and elevate it a lit- making a 6-mm capsulotomy and the to our protocol.” tle bit to get into that space. It doesn’t pupil’s only at 7 or 7.5 mm, you will • Be cautious when hydrodis- leave you a lot of room to grab cortex, have enough room to do the capsulot- secting and doing the cortical and you have to go up underneath the omy, but the laser energy will be close cleanup. Dr. Weinstock notes that iris. Because of this, when using fem- to the pupil margin. That can trigger hydrodissection and hydrolineation tosecond laser capsulotomy we’re not pupil constriction. are a little harder to do during femto- typically hydrodissecting as well as we “To minimize the chances of pu- second laser cataract surgery. “We’re have in the past.” pil constriction in this situation, you used to seeing a very good fl uid wave • Problems with gas buildup. An- want to do two things,” he continues. when we do hydrodissection dur- other potential complication with a “First, get the patient under the mi- ing manual cataract surgery, because femtosecond laser using a fragmen- croscope pretty quickly after perform- when we peel off the capsule, usually tation pattern is that one of the by- ing the capsulotomy, probably within the cortex is intact underneath,” he products is gas buildup. “If gas is be- 15 minutes. Second, put a drop of a explains. “It’s very easy just to slip the ing created during the fragmentation, strong dilating agent such as 10% neo- irrigation tip into that space between gas bubbles will accumulate inside

32 | Review of Ophthalmology | July 2014

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Unfamiliar with our products? Visit www.revophth.com and check out our newsletter archives. Go to www.jobson.com/globalEmail/default.aspx to sign up for the e-newsletters that interest you. Feature Femtosecond Cataract REVIEW Ronald Yeoh,MD to escape. If mentation, so the posterior part of any the surgeon nucleus is invariably going to be un- does not do treated and hence unseparated. Sur- this and the geons therefore need to adapt their hydrodis- technique to complete the nucleus section separation. is abrupt “I recommend the use of a paddle with a prechopper to complete this nuclear high-speed division,” he says. “The paddle pre- water jet, chopper from ASICO (designed by then there’s me with no fi nancial interest) is help- Opening the wounds created by the laser is more easily done with a tool specially designed for that purpose, such as the Slade Femtosecond no chance ful in most cases. It’s simple to insert Spatula or Yeoh Femto-Incision Double-Ended Spatula (pictured above). for the gas into the lasered grooves; then opening The latter has ends that are optimized for the main port (160-degree bubble to the prechopper completes the separa- angle) and side port (130-degree angle). escape. tion. After that, emulsifi cation of the This can nucleus is straightforward.” the lens or behind the lens—and the result in a rupture of the posterior • Beware of unnoticed capsu- greater the density of the lens, and capsule, the so-called capsular block lar tags when during irrigation/ the more fragmentation patterns you syndrome.” aspiration of cortex. “Current fem- lay down in the lens, the greater the Dr. Weinstock also favors the rock- tolasers have reduced the risk of in- gas buildup,” notes Dr. Weinstock. “In and-roll technique. “It helps to de- complete capsulotomies to well under theory, this will create increased ten- compress the eye a little by rocking the 5 percent,” says Dr. Yeoh. “Among the sion inside the capsular bag. lens a bit as you’re hydrodissecting,” current instruments, AMO’s Catalys “Early on, when people fi rst started he says. “Sometimes the gas will re- makes the capsulotomy the quickest, using femtosecond lasers for this pur- lease and pop forward, relieving some taking only about 1.5 seconds, which pose, there were several reports of of the pressure inside the capsular may further reduce the risk of incom- nuclei dropping into the posterior seg- bag. For the same reason, I depress plete capsulotomies. Nevertheless, the ment,” he continues. “Many people the wound and burp a little viscoelas- surgeon needs to make sure the fem- believe these were caused by overly tic out of the eye before I hydrodissect to-created capsulotomy is complete aggressive hydrodissection. Essential- to make sure the eye is a little soft as without tags, and he needs to take spe- ly, you’ve created pent-up pressure in I’m doing it. Fortunately, I have not cial care when doing irrigation/aspira- the bag from the gas and then you’re had any posterior rips from hydrodis- tion of cortex around the edge of the adding fl uid. In theory, you can blow section or hydrodelineation.” capsulotomy to make sure that a hid- the capsule open just from the pres- Dr. Yoo notes that in her experi- den capsular tag is not inadvertently sure. For this reason it makes sense to ence, capsular block syndrome is rare. aspirated, leading to a radial tear.” titrate your hydrodissection when you Dr. Yeoh agrees. “With gentler hy- Dr. Weinstock agrees. “It’s possible perform femtosecond laser cataract drodissection after burping the gas out to engage the capsule by accident dur- surgery, and do it a little more slowly.” from the capsular bag,” he says, “there ing cortical cleanup and damage it,” he “How much gas is formed depends have been no more reports of dropped notes. “Sometimes it’s easier to leave on the energy we use and the spot size nuclei after FLACS.” cortex behind, and that means poten- and spot separation parameters dur- • Use a paddle prechopper to tial complications down the road.” ing the femtosecond pretreatment,” complete the nuclear division • Do a careful sweep of the angle Dr. Nagy points out. “If a gas bubble before emulsifying the nucleus. underneath the wound with your forms within the crystalline lens, the “FLACS can divide a nucleus up in irrigation/aspiration tool. When a surgeon should allow the gas to leave many ways: cross; cylinder; grid; and surgeon uses the laser to chop a lens the eye through the anterior chamber so forth,” says Dr. Yeoh. “However, into very small pieces, some pieces and the corneal wound. I recommend surgeons don’t always realize that fem- may be out of sight and difficult to the so-called “rock-and-roll” tech- tosecond nuclear fragmentation leads fi nd at the end of the removal process, nique. This means that we perform a to incompletely divided nuclei, which causing them to be left behind. “Of gentle hydrodissection and then move can be diffi cult to remove. There’s a course, this can also happen in man- around the lens, pushing it down and 500- to 700-µm offset from the pos- ual surgery after emulsifi cation of the back a little to allow the gas bubble terior capsule during nucleus frag- lens,” Dr. Yoo notes. “You simply need

34 | Review of Ophthalmology | July 2014

026_rp0714_f2.indd 34 6/20/14 3:20 PM to be aware that this could happen. and avoid most mistakes. Until reach- anterior capsule because of an injury, To make sure it doesn’t, use irrigating ing this point, the surgeon should be and also in pediatric cases because fl uid through your paracentesis to gen- very cautious.” the pediatric anterior capsule is very erate some high-velocity fl ow inside Dr. Nagy believe that despite being elastic; a manual capsulotomy tends to the bag. If there’s a little chip hiding associated with a few possible com- end up much larger than you intended somewhere, it’s more likely to emerge plications, femtosecond laser cataract it to be. The laser also has great prom- so you can see it prior to fi nishing the surgery has many real advantages. “I ise for other related surgeries, such as case.” think this technology helps to create posterior capsulotomy.” consistent results, with a customized One thing is clear: While many sur- Experience Counts capsulotomy, customized corneal geons remain skeptical of the value of wounds and prefragmentation of the femtosecond laser cataract surgery— Perhaps the most important pearl crystalline lens,” he says. “Now we’re especially given its price tag—it does for surgeons considering performing using this technology up to Grade +4 appear to be here to stay. femtosecond laser cataract surgery is cataracts. If a lens is white with a lot of to expect a signifi cant learning curve. water content, femtosecond laser cap- Dr. Nagy is a consultant to LenSx/ “Capsular block syndrome was first sulotomy is especially useful, reducing Alcon. Dr. Yeoh is on Alcon and AMO’s described by an Australian group,” the risk of a peripheral tear and help- speaker panels. Dr. Yoo is a consultant says Dr. Nagy. “They were early using to avoid the so-called “Argentinean for Alcon and AMO. Dr. Weinstock ers of the femtosecond laser for this fl ag” sign—the spontaneous rupture has no fi nancial interest in any prod- purpose, and they didn’t realize how of the anterior capsule due to high uct mentioned. much of a learning curve was involved. pressure within the crystalline lens. 1. Yeoh R. Intraoperative miosis in femtosecond laser-assisted I think it takes 30 to 50 cases to be- This technology is very good for trau- cataract surgery. J Cataract Refract Surg 2014;40:5:852-3. doi: come comfortable with this procedure ma cases where there’s damage to the 10.1016/j.jcrs.2014.02.026.

026_rp0714_f2.indd 35 6/20/14 3:19 PM IOLs REVIEW Feature Toric IOLs: Nailing The Target Axis Michelle Stephenson, Contributing Editor All images: Uday Devgan, MD Success with torics s toric intraocular lenses continue to gain popularity, ac- comes down to Acurate alignment of the lenses inside the eye remains a challenge. measuring and According to Uday Devgan, MD, a surgeon from Los Angeles, the key marking the corneal to success with toric lenses is lining astigmatism axis them up accurately with the pre-existing corneal astigmatism axis. “This and accurately consists of three steps: measuring the corneal astigmatism axis; marking that placing the lens at axis; and placing a lens at that posi- Figure 1. This is a toric IOL in the eye with tion. Errors can occur during any of the capsulorhexis overlapping the edge of that position. these three steps,” he says. And even the IOL to hold it in position. The three dots small errors can signifi cantly impact on the IOL indicate the axis of astigmatism correction on the optic. patients’ vision. It is important to be extremely accurate because, for every degree that the patient’s head has a slight tilt to it, the lens is off, the patient loses 3.3 everything is going to be off because percent of astigmatism correction. In the measurement will be off. When other words, if the toric lens is off by measuring, the patient’s head must be 30 degrees, it has no effect. “One min- absolutely perpendicular to the fl oor,” ute on a clock is 6 degrees. If you are Dr. Devgan says. off that much, 20 percent of the astig- To measure the axis of astigmatism, matic correction of the lens is lost,” Daniel H. Chang, MD, in private Dr. Devgan notes. practice in Bakersfield, Calif., first performs IOLMaster biometry on all Measure of his IOL patients followed by Atlas corneal topography. “I do at least two There are several ways to measure different IOLMaster measurements the axis of astigmatism. “Most oph- on separate days,” he says. “That way, I thalmologists use a corneal topog- can see if there is signifi cant variability rapher to measure the corneal axis, in the keratometry readings. Typically, but what if the patient’s head is not I determine the amount or power of straight during the measurement? If cylinder from the IOLMaster, and I

36 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

036_rp0714_f3.indd 36 6/20/14 3:22 PM determine the axis from topography. I then print out the pupil image from my topographer, and I use the iris and limbal structures as a reference point for ﬁ nding the axis on the eye.”

Mark

There are several methods for marking the axis of astigmatism, and they vary in accuracy. Since the approval of the first toric IOL, the standard of care for marking the axis has been ink. However, because of the precision required for both measuring and marking the target axis, ink pens are not ideal. “This is the least accurate method because it is a guesstimation,” Figure 2. Here is the corneal astigmatism map of with-the-rule cylinder overlaid onto a says Robert H. Osher, MD, in practice photo of the front of the eye. The red line shows the steep axis of astigmatism, and this is at the Cincinnati Eye Institute. “The the meridian at which the toric IOL should be aligned. ink diffuses and may even completely disappear. Surgeons who rely on ink is dependent on an estimate.” The next method is limbal registra- cannot have a very high degree of con- Another method is using imaging or tion. “Basically, you take a picture of fi dence that they have nailed the tar- fi ngerprinting. “A picture is taken of the limbus, and the technology memo- get meridian with the lens.” the iris when the pupil is dilated dur- rizes it,” says Dr. Osher. “In surgery, He notes that surgeons are always ing the original examination, and then you can use a thumb drive to re-create aiming for precise toric lens align- software superimposes a protractor the image on a monitor or through ment. “We have all of this sophisti- so every landmark on the iris or the the microscope and then overlay the cated technology for removing the limbus has the exact degree associated digital degree marker. You can see the cataract and wonderfully sophisticat- with it,” says Dr. Osher. “The surgeon target meridian based on the captured ed intraocular lenses to replace the can easily identify crypts, pigment, the registered image, and then it’s very cataractous crystalline lens. So, how vessels and the unique stromal pat- easy to know exactly where to orient can the international standard of care terns of the iris. A detailed photograph the toric lens. SMI (Germany) pio- for aligning the toric lens be a $1 ink of the iris when the pupil is dilated, neered this technology, and Zeiss has pen?” Dr. Osher asks. just like it is going to be in surgery, al- developed its own registration soft- Dr. Chang agrees that marking lows the surgeon to be confi dent about ware. Alcon bought SMI and is pio- pens are not ideal. “They are okay, but fi nding the target meridian. This is an neering this approach in the United the ink mark itself is wide,” he says. accurate method that I introduced States with the Verion Guidance Sys- “These ink marking pens don’t have during the Kelman Innovator’s Lec- tem.” a microscopically fine tip. It’s more ture in 2009.” The last method is wavefront in- like a Sharpie. It makes a thick mark To avoid the smearing or disap- traoperative aberrometry, and there instead of a tiny pinpoint mark. Ad- pearance of an ink dot, Dr. Osher has are currently two of these systems: ditionally, the marks bleed and can developed Thermodot with BVI. “A WaveTec’s ORA System with VerifEye smear out after a while.” probe leaves a tiny cautery dot that and Clarity’s Holos. “An intraoperative Dr. Osher notes that there are basi- is placed at the limbus, signifying ei- refraction using wavefront aberrom- cally four methods of alignment. The ther the major meridia or where the etry will identify where the cornea is fi rst method is to place a mark at the target meridian is located,” he says. steepest,” Dr. Osher says. “It takes into limbus or on the cornea prior to sur- “The intraoperative version is avail- account both the anterior and poste- gery. “The mark can be used during able today, and BVI is planning to rior cornea and does not depend upon surgery for a protracting device to fi nd introduce a portable unit for marking preoperative diagnostics. This tech- the target meridian,” he says. “Yet, this in the preoperative area at ASCRS nology provides a surgeon with infor- can be inaccurate because the surgeon next year.” mation that allows rotation of the toric

July 2014 | Revophth.com | 37

036_rp0714_f3.indd 37 6/20/14 3:22 PM Feature IOLs REVIEW

lens until it is precisely are better than others at aligned. In addition, this maintaining stability in- sophisticated technology side the eye. Lenses like not only confi rms the to- the Alcon AcrySof are ric axis, but also confi rms made of acrylic, which emmetropia. Intraopera- tends to be tacky. “Lenses tive wavefront has the that are slightly tacky end potential to confi rm that up staying exactly where both the sphere and the you put them because cylinder are corrected. they hold on to the cap- Confi rming emmetropia sular bag,” Dr. Devgan on the table is every oph- says. “Another advantage thalmologist’s holy grail.” of the AcrySof is that the Dr. Devgan notes that haptics have bulbous tips the ORA and Holos de- at the end. When the cap- vices work well, but he sule shrink-wraps down says they will be even Figure 3. This shows the three dots of the toric IOL aligned with three hash to hold the new lens in better after a few gen- marks made in the cornea at the steep astigmatism axis. The yellow line/ place, that bulbous tip erations. “With aberrom- box shows that this toric IOL is very well aligned. prevents the lens from etry, after the toric IOL rotating. In fact, after the is placed in the eye, the machine indi- you are also inducing astigmatism in capsule shrink-wraps down, you can’t cates whether the lens needs to be ro- another meridian,” he says. even surgically rotate this lens.” tated and how much,” he says. “If the Bausch + Lomb’s Trulign toric lens needs to be rotated, that is done, Lens Placement IOL has the advantage of four hap- and then placement is checked again. tics. “That lens ends up being exqui- These systems work better in patients The last step is to keep the toric IOL sitely stable in the eye. The haptics with larger amounts of astigmatism. in place after it has been implanted. are made of polyamide, which is a The more astigmatism, the easier it According to Dr. Devgan, there are material that glues itself to the capsu- is to measure. For mild degrees of several pearls for achieving lens stabil- lar bag. That lens will not shift,” Dr. astigmatism, these machines are less ity. First is to make the capsulorhexis Devgan says. accurate. For more than 3 D of astig- so that it overlaps the edge of the op- According to Dr. Devgan, there are matism, they are super accurate.” tic. “If the optic is 6 mm wide, even currently four FDA-approved toric Dr. Chang notes that it is not un- if the capsulorhexis is 5 mm, it will IOLs: Staar toric, AcrySof, Trulign, usual for one side of the implant to shrink wrap down and really hold that and Tecnis. “Staar was the fi rst one to match the axis mark while the other lens very well. The second pearl is to enter the marketplace,” he says. “It side does not. “If one set of marks on remove all of the viscoelastic. After is a single-piece plate haptic design the implant matches the axis mark on you put the lens in the eye, you’ve got made of silicone. It has two steps of the cornea and the other one does not, to go behind the IOL with your I/A correction. Next was the AcrySof lens, it is not immediately obvious which probe and suck out all of the visco- which is available in the most sizes and one is misaligned. The answer lies elastic because you want that lens to has seven steps of correction. B&L’s in the centration of the toric lens. I directly touch the capsular bag. If you Trulign and AMO’s Tecnis toric are would prefer my toric lens to be cen- leave viscoelastic in there, it acts as a the newest lenses, and they each have tered, with the lens marks parallel to lubricant and allows the lens to slip,” three steps of correction available. my limbal marks rather than to have he explains. More toric lenses will be coming out in my toric lens decentered and both sets It is also imperative to ensure that the future, and these lenses are among of marks aligned. Therefore, I am ac- the incision is completely watertight. my very favorites, because they abso- tually trying to line up the two limbal “If there is even a microscopic leak lutely deliver on their promise. There corneal marks, the two marks on the there, it may leak slowly over the next is very high patient satisfaction. The implant and the center of the implant. few hours. When the eye defl ates be- only caveat with toric lenses is that the Rotational accuracy is important because of a leak, the lens can rotate a lenses must be stable in the eye and cause if there is malrotation, not only little,” Dr. Devgan says. the corneal astigmatism should be reg- are you losing astigmatic effect, but Additionally, certain lens designs ular and symmetric.”

38 | Review of Ophthalmology | July 2014

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2013_cme_housead_ad.indd 1 5/22/13 12:08 PM Retinal Insider

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

CSCR: Diagnosis And Treatment Central serous chorioretinoapthy afﬂ icts working-age patients. While many can be observed, some will require intervention. John D. Pitcher, III, MD and Jason Hsu, MD, Philadelphia

entral serous chorioretinopathy CSCR.7,8 Optical coherence tomog- varying success. Focal laser photoco- C(CSCR) is a relatively common raphy demonstrates subretinal fluid, agulation to pinpoint areas of leakage cause of visual impairment in the often associated with a focal pigment on FA was the fi rst treatment shown to Western world, and is characterized epithelial detachment (See Figure 2).9 be of some benefi t for CSCR.14 How- by the accumulation of subretinal fl uid More recently, enhanced-depth imag- ever, photocoagulation is destructive, in the macula.1,2 The disease classi- ing spectral domain OCT has shown can lead to symptomatic scotomas, and cally affects men between the ages increased subfoveal choroidal thick- occasionally formation of secondary of 20 and 50 and has been associated ness in some patients with CSCR as choroidal neovascularization. There- with corticosteroid exposure, phospho- compared to normal eyes (See Figure fore, this treatment is reserved for fo- diesterase inhibitor use, obstructive 3).10 cal extrafoveal areas of dye leakage. sleep apnea and “type A” personality The typical natural history of CSCR Photodynamic therapy more di- traits. Patients can present with a vari- is complete spontaneous resolution rectly targets the choroidal circulation ety of visual symptoms including rela- of subretinal fl uid with restoration of and may be used in patients with sub- tive central scotoma, metamorphopsia, visual acuity by three months after on- foveal and/or multifocal points of leak- dyschromatopsia and micropsia.3,4 On set of symptoms. However, up to 20 age. PDT has been used for persistent examination, the characteristic find- percent of patients may have persis- CSCR with some success. However, ing is a posterior neurosensory retinal tent serous macular detachment and it is not approved by the Food and detachment caused by leakage of fl uid vision loss past six months, and may Drug Administration for the treatment from the level of the retinal pigment be left with some degree of subjective of CSCR and has a number of side epithelium. visual impairment such as micropsia or effects, including photosensitivity to Multimodal imaging is useful in reduced color perception.11-13 If sub- intravenous dye and choroidal hypo- making the diagnosis of CSCR. Clas- retinal fl uid has not resolved by three perfusion following treatment.15,16 Sev- sically, fl uorescein angiography dem- months, the patient is defi ned as hav- eral recent studies have demonstrated onstrates an expanding point of fl uo- ing chronic CSCR, and treatment is the use of half-fl uence and half-dose rescein leakage with late pooling into often considered. PDT in acute and chronic CSCR, with a serous detachment (See Figure 1). the goal of maintaining effi cacy while Multiple points of leakage can be seen Treatment Options minimizing risk.17-20 in some patients.5,6 Indocyanine green Anti-VEGF medications have a angiography may show focal delays There is no gold standard for treat- number of effects that are theoretically and hyperpermeability in the choroi- ment of persistent CSCR, and a num- beneficial in CSCR, such as the up- dal circulation in many patients with ber of therapies have been tried with regulation of tight junctions between

40 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

040_rp0714_rtinsider.indd 40 6/20/14 3:24 PM cation is generally well-tolerated but drug interactions must be ruled out prior to initiation and serum potassium and blood pressure must be monitored during treatment. Larger, prospective, placebo-controlled studies are under Figure 1. Color fundus photo in a patient with acute central serous chorioretinopathy way to further investigate the effi cacy demonstrating a serous detachment of the neurosensory retina in the macula. Fluorescein of this treatment option.40 Currently, angiography revealed early pinpoint hyperfl uorescence expanding over the course of the pharmacologic treatments for CSCR angiogram to pool into the subretinal space. remain investigational and are not considered standard of care. If medically endothelial cells and reduction of vas- and effi cacy of anti-VEGF therapies appropriate, systemic corticosteroids cular fenestrations.21-23 A study by Ji in CSCR. should be discontinued in patients Won Lim, MD, and colleagues sug- Several small studies have shown with active CSCR. A sleep study may gested that VEGF levels in the aque- mixed results from a variety of system- be considered in patients with suspected obstructive sleep apnea.41 Central serous chorioretinopathy is a disease of working-aged patients, many of whom have Figure 2. SD-OCT showing subretinal fl uid associated with a focal pigment epithelial defect (yellow arrow). occupations that demand high levels of visual acuity. Characteristic angiographic and OCT findings are helpful in confi rming the di- Figure 3. Enhanced depth imaging SD-OCT in a patient with CSCR demonstrating a thickened choroid (yellow bracket). agnosis. While the majority of ous humor of patients with chronic ic medications for CSCR, including patients will return to baseline with CSCR may be elevated compared to carbonic anhydrase inhibitors (acet- observation, a subset of patients may normal eyes.24 Case studies and anec- azolamide),32 adrenergic receptor an- be considered for intervention. No dotal reports of intravitreal anti-VEGF tagonists (metoprolol, propranolol),33,34 therapeutic options are approved by medications in patients with persis- and steroid hormone antagonists (ke- the FDA, but local modalities, both tent or chronic CSCR have shown toconazole, mifeprestone, fi nasteride, pharmacologic and photic, and sys- improvements in visual acuity, reso- eplerenone).35-38 temic medical treatments are under lution of neurosensory detachments Eplerenone, a selective aldosterone- ongoing investigation and may hold and decreased RPE leakage on FA.25-28 receptor antagonist and potassium- promise for future patients diagnosed Prospective studies using anti-VEGF sparing diuretic that was originally with CSCR. medications have shown inconsistent approved in 2002 by the FDA for results.29,30 So far, however, the cumu- treatment of hypertension, was recent- Dr. Pitcher is a second year fellow lative weight of evidence has failed to ly shown in a small series of patients in vitreoretinal surgery at Wills Eye show sustained, clinically significant with chronic CSCR to improve visual Hospital and a clinical instructor of benefi ts.31 Controlled clinical trials are acuity and signifi cantly decrease cen- necessary to determine the tolerability tral macular thickness.39 The medi- (continued on page 65)

July 2014 | Revophth.com | 41

040_rp0714_rtinsider.indd 41 6/20/14 3:24 PM Therapeutic Topics REVIEW

ARVO Comes to The City of Magic Highlights from the posters and papers presented at the 2014 ARVO meeting in Orlando. Mark B. Abelson, MD, CM, FRCSC, FARVO, and Ora Staff, Andover, Mass.

he annual meeting of the As- eral decades; affected individuals have who had more advanced impairment, T sociation for Research in Vision signifi cant loss of night vision by the including retinal detachment. (Groppe and Ophthalmology returned to Flor- second decade and are legally blind by M, et al. ARVO E-Abstract 3295) De- ida this year after spending 2013 on 40 to 50 years of age.1,2 The disease is spite these potential limitations, both the West Coast. As in previous years, due to the absence of the REP1 gene subjects tolerated the viral injections ARVO 2014 featured a range of top- product, a choroid protein involved without adverse effects and showed ics, with special attention given to in post-translational prenylation. The signifi cant increases in visual acuity. new imaging methods, ocular genom- slow rate of visual decay and small size Another test case for gene therapy in ics and some exciting reports on the of the affected gene make this condi- the eye is Leber’s congenital amaurosis latest gene-therapy efforts. Even as it tion an ideal test case for gene ther- (type II), a condition resulting from adopts a changing venue every year, apy. A research group headed by Dr. mutations in retinal proteins leading ARVO remains the singular location Robert MacLaren (Oxford Eye Hos- to premature retinal atrophy. LCA is a where basic and clinical ophthalmic pital; Oxford, U.K.) recently published much more complex disease than cho- research converge. Here’s a sampling results from six patients treated with roideremia, so signifi cant effort is also of the presentations that caught our a functional copy of the REP1 gene focused on details of the gene-function eye this year. (Unless otherwise speci- packaged in an adeno-associated viral defects and how these might impact fi ed, all of the abstract citations are vector designed for choroidal expres- therapeutic strategies. One presenta- from this year: IOVS 2014;55) sion. All six patients showed signifi cant tion (Stasheff S, et al. ARVO E-Ab- increases in VA.3 stract 357) showed that in two differ- Gene Therapy Pushes Forward At ARVO, experimental details and ent mutations linked to the disease, obstacles to effective therapy were ganglion cell degeneration progressed One of the most exciting areas of discussed in a series of presentations. at different time courses, suggesting current ophthalmic research is gene (Fischer M, et al. ARVO E-Abstract some difference in mechanism. An- therapy. Scientists and clinicians are 6001; MacLaren R, et al. ARVO E- other LCA presentation demonstrated taking advantage of the unique fea- Abstract 832) A study aimed at screen- effective use of dual AAV vectors to tures of the visual system to make the ing for immune responses to the vector overcome the need to introduce larger fi rst efforts at correcting genetic oph- or the rescue gene product was also gene constructs into affected retinas thalmic disorders. A prime target for presented, (Barnard A, et al. ARVO (Carvalho L, et al. ARVO E-Abstract these efforts is choroideremia, a single- E-Abstract 3296) while another pre- 6002), one of the major obstacles to locus, x-linked condition that results in sentation focused on the two subjects treating other forms of LCA. a progressive loss of vision over sev- out of six from Dr. MacLaren’s study Stepping back from the clinic for

42 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

042_rp0714_ttops.indd 42 6/20/14 10:20 AM a more long-term view, we were ex- cited by a number of presentations on progress that’s being made with induced pluripotent stem cells. The

logic behind this approach, at least in MD Charles Mango, part, is that a patient’s own cells are the best targets for reprogramming with a corrected gene. These cells are then induced to develop into the tissue of choice. Introduction of the genetic correction involves one of several DNA A spectral-domain optical coherence tomograph of a patient with diabetic macular edema editing schemes followed by transplan- (left) and the same patient imaged with a new swept-source OCT (right). Researchers say standardization will be necessary before they will be able to make tation of repaired cells.5 Examples of meaningful comparisons of the two technologies’ measurements. this approach were described for a therapy to treat Knoblach’s syndrome SS in control eyes and in eyes with Abstract 930; Lee K, et al. ARVO E- (Nguyen H, et al. ARVO E-Abstract various opacities, including those with Abstract 904) The resolution of the 2982), as well as a test treatment to cataracts, vitreous opacity or corneal swept-source devices allows for precise correct the male germ cell-associated opacity. (Shin Y, et al. ARVO E-Ab- morphometric analysis and provides kinase mutation that causes retinitis stract 3359) The captured images were support for the growing emphasis of pigmentosa in patients of Ashkenazi subjectively graded by two retina spe- these imaging metrics in the diagnosis Jewish ancestry. (Stone E, et al. ARVO cialists using a standardized OCT grad- of glaucoma. In a related study, defects E-Abstract 2676) Edwin Stone, MD, ing system. While images from nor- in the lamina cribrosa were compared of the University of Iowa, showed that mal eyes obtained by either method in myopes with or without glaucoma a corrected MAK was functionally ex- weren’t signifi cantly different, SS pro- along with normal controls. (Miki A, pressed in iPSCs, a key step in bringing vided a signifi cant improvement over et al. ARVO E-Abstract 908) This pi- this technology to the clinic. SD in all eyes with reduced opacity. lot study confi rmed reports that such Another area of considerable inter- defects may be associated with devel- Swept-Source OCT est was highlighted by studies that add- opment of the disease. The number ed a time component to SS-OCT to of eyes with at least one focal defect ARVO is a particularly opportune generate 4-dimensional images. One in the LC were signifi cantly different time to explore the latest in imag- such study (Migacz J, et al. ARVO E- between groups: 1/20 in normal eyes; ing technology. This year the biggest Abstract 5019) employed a technique 6/32 in myopes; and 27/66 in the eyes buzz seemed to focus on comparisons termed phase variance OCT to im- with both myopia and glaucoma. between spectral-domain and swept- age chorioretinal vascular flow. This SS-OCT is also being employed source optical coherence tomography.6 study showed that the technique may for anterior-segment imaging, as de- As these technologies evolve, there provide greater depth resolution than scribed in a study comparing corneal seems to be a progression of applica- traditional fluorescein angiography. thickness measurements determined tions as well, as OCT use for imaging Other presentations that added a time by ultrasonic pachymetry and ante- anterior structures expands as it has for component to SS-OCT were aimed at rior segment tomography with those the retina. integrating this imaging modality into obtained by SS-OCT. (Haines L, et Several reports provided compari- the operating theater to track surgical al. ARVO E-Abstract 2464) Although sons of retinal nerve fi ber layer thick- maneuvers in real time. (Carrasco- the sample size was small (n=16 eyes), ness measurement using SD and SS Zevallos O, et al. ARVO E-Abstract the study showed all devices provided OCT. (Ha A, et al. ARVO E-Abstract 1633; Keller B, et al. ARVO E-Abstract comparable measures. The authors 4741; Lee B, et al. ARVO E-Abstract 1631) These studies suggest that such point out that “in addition to high reso- 3347) In most of these studies, com- high-resolution, high-speed imaging lution morphological imaging of the parison of measures from SS and SD devices may be part of the operating cornea, SS-OCT can provide precise showed significant differences, sug- rooms of the future. morphometric analysis of the human gesting values from the two methods Two reports used SS-OCT in as- cornea.” are not readily comparable without sessments of angle dimensions and Several head-to-head comparisons further standardization. Another study lamina cribrosa insertion in open-angle of devices from different manufac- compared retinal imaging by SD and glaucoma. (Rigi M, et al. ARVO E- turers also provided a key perspec-

July 2014 | Revophth.com | 43

042_rp0714_ttops.indd 43 6/20/14 10:20 AM Therapeutic

REVIEW Topics

tive. Heidelberg Spectralis SD-OCT thodical series of experiments, Ilene some therapeutic synergy. and Topcon Deep Range Imaging Gipson and colleagues showed that Several presentations described SS-OCT for macular imaging were goblet cells also produce a variant of clinical studies of topical antihista- used on the same subjects, providing a Muc16 and contribute this to the tear mines for allergic conjunctivitis. Aciex concise depiction of relative strengths fi lm in both mouse and human eyes. Therapeutics presented a study of its and limitations of each device. (Bar- (Gipson IOVS 2014 55: ARVO E-Ab- topical formulation of cetirizine, AC- teselli G, et al. ARVO E-Abstract 360) stract 2760) This fi nding is noteworthy 170, an antihistamine commonly used Authors summarized their results by for a number of reasons, but particu- in oral formulations but not yet avail- concluding that while “details of the larly because it suggests a greater than able for topical use. The formulation pre-retinal vitreous are better imaged previously appreciated role for goblet was shown to significantly and rap- using the shorter wavelength of the cells in tear-fi lm homeostasis. idly reduce ocular itch, lid swelling and spectral domain OCT, the sharpness of other signs of ocular allergy. (Gomes P, the choroidal structures is better using Therapeutic Highlights et al. ARVO E-Abstract 2490) Alcon the higher scanning speed of the SS- presented Phase III results for olopa- OCT.” They also point out that the two For us, the bread and butter of tadine 0.77%, a new higher-strength devices are comparable for visualizing ARVO are the presentations on new formulation of the topical antihista- the choroidal border, and that these therapeutics, both pre-clinical and mine currently available as Pataday or are the images that are used to gener- clinical. Among the preclinical stud- Patanol, that confi rmed that this new ate choroidal thickness measurements. ies was a description of a new type formulation is superior to placebo at OCT has been used in published of antihistamine with mixed receptor both 16 and 24 hours, providing un- studies for measurement of tear me- specifi city. (Chapin M, et al. ARVO E- qualifi ed q.d. dosing for ocular itching. niscus height, but the higher speed Abstract 2482) These new compounds, (McLaurin E, et al. ARVO E-Abstract and resolution of SS-OCT allow for GD135 and GD136 (Griffi n Discover- 2488) unique studies of meniscus dynamics. ies; Amsterdam, Netherlands), antago- The anti-proliferative agent PRI-321 (Fukuda IOVS 2014 55: ARVO E-ab- nize both H1 histamine receptors (the (Prism Pharma; King of Prussia, Pa.) stract 1981) In a trial of 23 subjects, all target of traditional antihistamines) holds promise as an anti-fi brotic treat- with normal values for tear-fi lm break- and the H4 receptor, which is thought ment for conditions such as choroi- up, Schirmer’s test and corneal fl uo- to be important in various signal-pro- dal neovascularization or proliferative rescein staining, a time course of tear cessing pathways, including those in- vitreoretinopathy. (Whitlock A, et al. meniscus height and volume was gen- volving pruritis.7 In a mouse model ARVO E-Abstract 1203) In a laser- erated following instillation of saline, of allergic conjunctivitis, research- induced model of CNV, Prism Pharma sodium hyaluronate or rebamipide. ers from Ora and Griffi n Discover- researchers and others found PRI-321 Time points ranged from 30 seconds ies BV found that these compounds to be as good as an anti-VEGF com- to 20 minutes after instillation. Signifi - outperformed both olopatadine and parator. A retinal detachment model of cant increases in meniscus measures prednisolone for reduction of hyper- PVR showed similar results, with PRI- were observed until one minute post- emia and squinting, while a pure H4 321 signifi cantly reducing Müller cell instillation for saline, three minutes receptor was ineffective, suggesting proliferation and scar formation. Data post-instillation for 0.1% sodium hy- the H1/H4 combination may provide on another new compound of interest aluronate, 10 minutes post-instillation came from Amakem’s (Diepenbeek, for 0.3% sodium hyaluronate, and fi ve Belgium) successful first-in-human minutes post-instillation for rebamip- Phase I/Phase II trial of AMA0076, a ide. The authors suggest that SS-OCT Rho kinase inhibitor with properties could provide a new metric in studies that minimize adverse effects without of eye-drop effi cacy. impacting effi cacy. (Hall J, et al. ARVO Tear dynamics are always a topic of E-Abstract 565) Another report of a interest. One study examined expres- successful Phase I/Phase II trial came sion of Muc16, an important mucin from Aerpio, whose drug AKB-9778 component of the tear fi lm. Muc16 is is showing promise as an alternative to expressed by conjunctival and corneal VEGF inhibitors for DME. (Brigell M, apical epithelium cells, which shed the Researchers theorize that antagonizing H1 et al. ARVO E-Abstract 1757) extracellular domain of the protein into and H4 receptors in combination may be In terms of new therapies, biomark- the surrounding tear layer. In a me- effective in treating allergic conjunctivitis. ers and diagnostic approaches, there is

44 | Review of Ophthalmology | July 2014

042_rp0714_ttops.indd 44 6/20/14 10:20 AM Smarter. Better. Faster. LenSx® Laser. There’s only one.

Delivering uncompromised precision and consistency, the LenSx® Laser has maintained its global leadership through continuous innovation in laser refractive cataract surgery. The LenSx® Laser leverages the power of The Cataract Refractive Suite by Alcon with tools designed to further streamline and improve the entire procedure. LenSxLasers.com

SMARTER BETTER FASTER2 - Pre-population of patient and - Customizable lens fragmentation for - Laser procedure efficiency with incision data easy lens removal2 reduced programming and - Advanced pre-positioning of - SoftFit™ Patient Interface for easy suction time incisions and capsulotomy docking, secure fixation and lower IOP3 - Designed for maximum procedural - Platform design enables continued - Compatible with the VERION™ Digital flexibility and ease of patient flow innovation and rapid enhancements Marker for surgical planning and and transfer execution1 - Simpler, easier patient docking

1. Multicenter prospective clinical study. Alcon data on fi le. 2. Using current LenSx® Laser systems 3. Alcon data on file.

RP0314_Alcon Lensx.indd 1 2/4/14 3:49 PM IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION FOR THE VERION™ REFERENCE UNIT AND VERION™ DIGITAL CAUTION: United States Federal Law restricts this device to sale and use by or on the order of a physician or MARKER licensed eye care practitioner. CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. INDICATION: The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of INTENDED USES: The VERION™ Reference Unit is a preoperative measurement device that captures and utilizes a the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, high-resolution reference image of a patient’s eye in order to determine the radii and corneal curvature of steep and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be and flat axes, limbal position and diameter, pupil position and diameter, and corneal reflex position. In addition, performed either individually or consecutively during the same procedure. the VERION™ Reference Unit provides preoperative surgical planning functions that utilize the reference image RESTRICTIONS: and preoperative measurements to assist with planning cataract surgical procedures, including the number and • Patients must be able to lie flat and motionless in a supine position. location of incisions and the appropriate intraocular lens using existing formulas. The VERION™ Reference Unit • Patient must be able to understand and give an informed consent. also supports the export of the high-resolution reference image, preoperative measurement data, and surgical • Patients must be able to tolerate local or topical anesthesia. plans for use with the VERION™ Digital Marker and other compatible devices through the use of a USB memory • Patients with elevated IOP should use topical steroids only under close medical supervision. stick. Contraindications: The VERION™ Digital Marker links to compatible surgical microscopes to display concurrently the reference and • Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, the wavelength planned capsulorhexis position and radius, IOL positioning, and implantation axis from the VERION™ Reference • Descemetocele with impending corneal rupture Unit surgical plan can be overlaid on a computer screen or the physician’s microscope view. • Presence of blood or other material in the anterior chamber CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy VERION™ Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. • Conditions which would cause inadequate clearance between the intended capsulotomy depth and the In addition, patients should refrain from wearing contact lenses during the reference measurement as this may endothelium (applicable to capsulotomy only) interfere with the accuracy of the measurements. • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape Only trained personnel familiar with the process of IOL power calculation and astigmatism correction planning • Corneal thickness requirements that are beyond the range of the system should use the VERION™ Reference Unit. Poor quality or inadequate biometer measurements will affect the • Corneal opacity that would interfere with the laser beam accuracy of surgical plans prepared with the VERION™ Reference Unit. • Hypotony or the presence of a corneal implant The following contraindications may affect the proper functioning of the VERION™ Digital Marker: changes in • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye recurrent corneal erosion, severe basement membrane disease) fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops • History of lens or zonular instability that constrict sclera vessels before or during surgery should be avoided. • Any contraindication to cataract or keratoplasty • This device is not intended for use in pediatric surgery. WARNINGS: Only properly trained personnel should operate the VERION™ Reference Unit and VERION™ Digital Marker. WARNINGS: The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of Only use the provided medical power supplies and data communication cable. The power supplies for the an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables VERION™ Reference Unit and the VERION™ Digital Marker must be uninterruptible. Do not use these devices in used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of combination with an extension cord. Do not cover any of the component devices while turned on. disposables other than those manufactured by Alcon may affect system performance and create potential ™ ™ ™ hazards. Only use a VERION USB stick to transfer data. The VERION USB stick should only be connected to the VERION ™ ™ The physician should base patient selection criteria on professional experience, published literature, and Reference Unit, the VERION Digital Marker, and other compatible devices. Do not disconnect the VERION ™ educational courses. Adult patients should be scheduled to undergo cataract extraction. USB stick from the VERION Reference Unit during shutdown of the system. PRECAUTIONS: The VERION™ Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid • Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. direct eye exposure to the emitted or reflected beam. • Discard used Patient Interfaces as medical waste. PRECAUTIONS: To ensure the accuracy of VERION™ Reference Unit measurements, device calibration and AES/COMPLICATIONS: the reference measurement should be conducted in dimmed ambient light conditions. Only use the VERION™ • Capsulotomy, phacofragmentation, or cut or incision decentration Digital Marker in conjunction with compatible surgical microscopes. • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure ATTENTION: Refer to the user manuals for the VERION™ Reference Unit and the VERION™ Digital Marker • Capsular tear for a complete description of proper use and maintenance of these devices, as well as a complete list of • Corneal abrasion or defect contraindications, warnings and precautions. • Pain • Infection • Bleeding • Damage to intraocular structures • Anterior chamber fluid leakage, anterior chamber collapse • Elevated pressure to the eye ATTENTION: Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.

RP0314_Alcon Lensx PI.indd 1 2/4/14 3:52 PM Therapeutic

REVIEW Topics

never a shortage of presentations on development applications. jor contributor to visual stress and dry eye. A series of posters describe An animal model using an injection ocular discomfort, while at the same our work at Ora in refi ning our abil- of concanavalin A into the lacrimal time being a key aspect of a patient’s ity to quantify and characterize blink gland may improve upon the con- quality of life. It’s not surprising that behavior and pathophysiology. One ventional scopolamine-based model impairment of reading is one of most study characterized our continuous, of dry eye. (Belen L, et al. ARVO E- important reasons patients seek help automated blink monitoring device, Abstract 3663) Transiently elicited for their dry eye. Several studies ex- confi rming that it provides valid met- decreases in tearing and increases amined this issue to understand how rics of blink dynamics. (Rodriguez J, in corneal staining were reduced by dry eye impacts reading function, as- et al. ARVO E-Abstract 3681) A sec- oral dexamethasone, suggesting that sess these effects and determine the ond study then used the device to re- dry-eye symptomology generated by extent to which reading function can veal dramatic differences in blinking ConA injection is modifi able and thus be used as a metric in dry-eye stud- behavior in subjects who wore either useful in testing novel dry-eye thera- ies. A pilot study compared results of spectacle or contact lens correction. pies. reading tests such as the Wilkins test (Heckley C, et al. ARVO E-Abstract One study found an increased inci- and the IreST test in normals and in 6062) This study also showed large dence in signs of dry eye in patients dry-eye patients and found a clear differences in blink between lens with diabetic peripheral neuropathy pattern of reduced scores in those products, suggesting that blink moni- when compared to age-matched con- with dry eye. (Ousler G, et al. ARVO toring may be a useful metric in lens trols. (DeMill D, et al. ARVO E-Ab- E-Abstract 160) Another study sur- development. stract 1483) While the investigators veyed patients to assess how dry eye A number of studies presented ap- saw no clear association between the impacted their reading tasks. (Watson proaches to ocular surface pathology, severity of the two diseases, dry-eye M, et al. ARVO E-Abstract 1997) As a exploring novel methods to assess the signs (osmolarity, Schirmer’s test) critical issue of quality of life, it seems corneal and conjunctival insults that were signifi cantly higher in diabetic that reading might be an appropriate occur in chronic allergy, dry eye and neuropathy patients. As with other clinical metric for dry-eye therapies in other conditions. One study corre- types of dry eye, there was a lack of the future. lated tear fl uid biomarkers with vari- association between signs and OSDI- We enjoyed our visit to Orlando, ous subgroups of dry-eye patients, based symptoms.8 and hope that next year’s meeting can and uncovered a strong correlation A number of studies examined fac- match the variety of science, technol- between the tear protein PRR4 and tors thought to contribute to dry-eye ogy and therapeutics at ARVO 2014. aqueous-defi cient dry eye. (Perumal disease. One group examined tear If past experience is any predictor of N, et al. ARVO E-Abstract 2002) An- cytokines before and after computer what’s ahead, ARVO 2015 in Denver other group examined the utility of use. (Kumar N, et al. ARVO E-Ab- will not disappoint. matrix-metalloproteinase-9 assays in stract 1859) Even after only an hour tear samples from dry-eye patients. of exposure, increases in galectin-3 Dr. Abelson is a clinical professor (Messmer E, et al. ARVO E-Abstract and epithelial expression of MMP9 of ophthalmology at Harvard Medical 2001) Objective assessments of dry indicated the presence of surface in- School. eye are notorious for their lack of flammation. Though the study was 1. Kalatzis V, Hamel CP, MacDonald IM. First International correlation, but this group found small (n=5), results suggest that the Choroideremia Research Symposium. Choroideremia: Towards a that MMP-9 levels in 101 subjects infl ammatory effects of ocular stress therapy. Am J Ophthalmol 2013;156:433-7. 2. Huckfeldt RM, Bennett J. Promising fi rst steps in gene therapy showed a strong positive correlation occur within a very short time period. for choroideremia. Hum Gene Ther 2014;25:2:96-7. with OSDI scores, tear-fi lm breakup Another study compared 20 patients 3. MacLaren RE, Groppe M, Barnard AR, et al. Retinal gene therapy in patients with choroideremia: Initial fi ndings from a times, Schirmer’s scores and ocular with dry eye to 20 age-matched con- phase I/II clinical trial. Lancet 2014;383:9923:1129-37. surface staining. In addition, levels trols using a driving simulator in com- 4. Dalkara D, Sahel JA. Gene therapy for inherited retinal degenerations. C R Biol 2014;337:185-92. were significantly increased in fe- bination with traditional DE metrics. 5. Tucker BA, Mullins RF, Stone EM. Stem cells for investigation males, subjects with autoimmune or (Deschamps N, et al. ARVO E-Ab- and treatment of inherited retinal disease. Human Mol Gen 2014;R1–R8. thyroid disease and those who identi- stract 1987) Subjects with DE show 6. Adhi M, Duker JS. Optical coherence tomography—current and future applications. Curr Opin Ophthalmol 2013;24:3:213-21. fied themselves as having Sjögren’s signifi cantly longer reaction times and 7. Thurmond RL, Gelfand EW, Dunford PJ. The role of histamine syndrome. Combined with the sim- a decreased ability to avoid randomly H1 and H4 receptors in allergic infl ammation: The search for new antihistamines. Nat Rev Drug Discov 2008;7:41-53. plicity of the assay, these fi ndings sug- displayed targets. 8. Walker PM, Lane KJ, Ousler GW 3rd, Abelson MB. Diurnal gest that MMP-9 may be a valid met- One of the biggest issues with dry- variation of visual function and the signs and symptoms of dry ric for both clinical diagnosis and drug eye patients is reading, which is a ma- eye. Cornea 2010;29:6:607-12.

July 2014 | Revophth.com | 47

042_rp0714_ttops.indd 47 6/20/14 10:20 AM Refractive Surgery

REVIEW Edited by Arturo Chayet, MD

The Latest Results With the LAL An update on the Light-Adjustable Lens and a look at a potential application for it in broadening focal depth. Walter Bethke, Managing Editor

he Calhoun Vision Light-Adjust- takes place during the period follow- of the unused macromer into a part T able Lens is a technology that is in- ing the cataract surgery and implanta- of the lens where it can be consumed, triguing for a lot of ophthalmologists, tion of the lens. however, and lock-in two consumes all since it may enable them to avoid “The FDA protocol requires im- of the unused macromer that lock-in postop refractive “surprises” by let- plantation of the IOL and a wait of one does not. After lock-in two, the ting them adjust the lens’s power after 17 days to start the adjustment pro- IOL power is fi xed and stable.” At this it’s been implanted, and may even cess,” says Indianapolis surgeon and point in its development, the lens can be able to afford presbyopic patients LAL investigator Kevin Waltz. “The be adjusted to eliminate up to 2 D of a form of multifocal vision, as well. preop astigmatism is not treated dur- spherical error and up to 2 D of astig- Here, surgeons who’ve worked with ing cataract surgery, and the refractive matism (which is 3 D of cylinder at the the unapproved lens, both outside of target at the time of cataract surgery corneal plane). the United States and within the lens’s is approximately +0.50. All post-im- During this adjustment process, U.S. Food and Drug Administration plantation treatments are preceded by it’s important for the patient to wear trial, discuss the current results. testing, including two independent re- UV eye protection, since UV light fractions. The fi rst treatment is called can actually alter the lens before it’s Adjusting the Lens adjustment number one; it targets the shape is finally locked in. “We have cylinder and decreases the plus sphere some patients we suspect of being less The LAL is a silicone lens composed toward zero. The next treatment is than perfect with their UV protec- of both stable material and photosensi- adjustment number two, and is used tion,” says Dr. Waltz. “But it doesn’t tive silicone macromers. When the if some refractive error remains after appear to have harmed them, or to lens is exposed to ultraviolet energy adjustment one. If there is very little have had a serious adverse effect on emitted by a special radiation device, refractive error after adjustment one, the adjustment process. We don’t have the macromers polymerize in what- we go directly to lock-in number one. any patients that we’ve confi rmed as ever shape or pattern is imposed by The purpose of this lock-in step is to non-compliant with the UV protection the radiation application. Non-polym- consume the remainder of the reac- requirement.” erized macromers will then migrate tive macromer in order to stabilize and to the area of the polymerized ones, ‘lock’ the refraction. There is some Current Results causing the lens to enlarge in that area. inefficiency in lock-in number one, This shape change is what alters the though, because, for technical rea- Calhoun Vision’s medical monitor R. refractive power of the lens. This pro- sons, it can’t consume all of the unused Doyle Stulting presented results from cess, known as adjustment and lock-in, macromer. Lock-in one does draw all one of the LAL investigational sites

48 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

048_rp0714_rs.indd 48 6/20/14 10:22 AM at the 2014 meeting of the dominant eye will lose a little American Society of Cataract bit of distance vision because and Refractive Surgery. The any time you create a multifo- results he presented were af- cal effect or a different focus ter one adjustment. In the MD Arturo Chayet, in one eye, the eye loses a little eyes presented, one week after at some focal distance. Basi- lock-in, 83 percent achieved cally, the eye will go from 20/20 20/20 or better uncorrected vi- to 20/25 in order to gain near sion vs. zero who saw at that vision. Typically, that eye will level before the adjustment, be able to see between J2 and with a quarter of the eyes see- J3. If the patient wants J1 being 20/12 or better. cause his lifestyle requires very Dr. Stulting also provided good vision at, say, 40 cm, then data on how well patients see you can leave that eye around uncorrected postop versus how -0.5 D. The patient will still well they’d see with correction. have very good intermediate Before the lens adjustment, vision, and the eye will typically only 8 percent of the cases had have an uncorrected vision be- less than one line of difference tween 20/30 and 20/40. The between uncorrected and best- difference between the eyes is corrected vision. After adjust- well-accepted by the brain, as ment, 83 percent were in this opposed to the typical monovi- category. sion treatment in which there In terms of astigmatism con- is more than a 1.5-D difference trol, after lock-in, 67 percent of between the eyes.” the eyes had zero astigmatism. In a study of binocular vision All of the eyes had 0.5 D or less Though increasing the amount of negative spherical results in 20 ABV patients at of astigmatism (preop range: aberration in a lens decreases its distance acuity, it also Dr. Chayet’s practice, 75 per- 0.5 to 1.75 D) post lock-in. increases its depth of focus. This is the mechanism behind cent could see 20/16 or bet- At Dr. Waltz’s practice, he the Light-Adjustable Lens’s adjustable blended vision. In ABV, ter at distance after lock-in. notes that all of his patients, if the dominant eye’s LAL gets a small amount of SA while the Eighty-five percent now see non-dominant eye’s lens gets a greater amount. done without the LAL, would 20/20 or better and 100 percent have required a toric lens. “All see 20/32 or better. In terms patients in the FDA Phase III Cal- a process called adjustable blended of binocular intermediate vision at houn trial must have between 0.75 vision. The goal of these adjustments 60 cm, 60 percent see J1+ versus zero and 2.25 D of anterior corneal astig- is to broaden patients’ range of vision. patients preop, 75 percent see J1 ver- matism to enter the trial,” he says. Tijuana surgeon Arturo Chayet, who sus 20 percent at this level preop and “This makes them very challenging consults for Calhoun Vision, says the 100 percent see J2 or better compared patients to achieve a plano endpoint. ABV treatment relies on inducing dif- to 45 percent preop. Ninety percent Given this, in my site’s experience, ap- ferent levels of asphericity in the lens- see J2 or better binocularly at near (40 proximately one-third of our patients es. “First of all, we make sure the pa- cm) versus 15 percent preop. Fifty- have uncorrected vision of 20/20 post- tient can see well for distance, because ﬁ ve percent now see at least J1, com- op, one-third see 20/16 and a third see individuals like to have good distance pared to 5 percent who could see that 20/12. There is an occasional patient vision,” Dr. Chayet explains. “We do well preop. with less than 20/20 after treatment, that by making sure the dominant eye “Right now, I think we’re learning a but it’s rare.” will have great distance vision, though lot about how to present the technol- we still give that eye a little negative ogy to patients and create the right ex- Presbyopic Correction asphericity so it can have the so-called pectations in them,” says Dr. Chayet. ‘summation’ with the other eye, and “This is a new technology and, as with Researchers and investigators are have some improved intermediate any new technology, we’re learning also using the UV light to make special acuity. Then, in the non-dominant eye, more about it, but we’re making very aspheric adjustments to the LAL in we’ll give high asphericity. The non- good progress.”

July 2014 | Revophth.com | 49

048_rp0714_rs.indd 49 6/20/14 10:22 AM Glaucoma Management

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

Meeting the Needs of the Emerging ‘Super Senior’ Elderly patients are an ever-increasing part of our patient populations, bringing special challenges and considerations. Carla J. Siegfried, MD, St. Louis

here’s an old saying that the fi rst a “super senior” as someone over the the past, we really have to think about T 20 years of managing a patient with age of 90. The individuals in this age how aging affects all of the aspects of glaucoma are pretty easy. (There’s group are different from those of this managing glaucoma—from diagnosis also a saying that the best thing to do age a few decades ago. Today these to therapy to monitoring progression. when managing glaucoma patients is individuals may have some chronic We also have to be prepared to offer to move every 10 years!) In fact, in the medical conditions, but they often more help to the patient. Patients past it was very unusual to manage a don’t have anything imminently life- with arthritis may have more diffi culty patient for 40 or 50 years, unless the threatening; they desire a continued instilling drops; being on a fi xed in- patient was very young at the time of high quality of life. These are people come can make costs a major issue; the original diagnosis. who are active, not sitting around memory diffi culties may lead to ad- Today, however, Americans are in skilled nursing facilities. Many of herence problems; being on many living healthier lives with better med- them are still living independently. systemic medications can lead to ical care and preventive care, and this These are not patients that you’d unexpected drug interactions and is increasing our life expectancy. The want to give up on or manage half- adverse effects; and so on. U.S. population over the age of 65 has heartedly. You know that as their The reality is, when you see doubled since 1980, and if current ability to ambulate decreases they’re somebody for the fi rst time at the age trends continue, the U.S. population going to depend more and more on of 70 and know that he or she could over the age of 80 will triple by 2050. their vision to lead a high-quality easily live another 20 to 30 years, In fact, children born today are life. Good vision helps keep these you’re looking at a disease process very likely to live to 100. Of course, individuals safe; among other things, that’s somewhat different from what this means an increasing number they’ll have less risk of falling. And if you’d encounter in a younger patient. of glaucoma patients; age is a very someone has severe arthritis and can’t And today, you have to think about it important risk factor for the disease. get around, his world gets smaller— in terms of the long run. As a result, many of us fi nd ourselves but he really needs to see that world. managing patients for an extended So it’s important to not have someone Monitoring the Patient period of time—and more patients in this group succumb to vision loss who are over 80 or 90 years old. because of a progressive disease like Visual fi eld testing is an important glaucoma. part of monitoring progression in most The Super Senior Given that we’re going to follow glaucoma patients, but automated these patients for a much longer time visual fi eld testing may be much more For our purposes here, let’s defi ne than ophthalmologists would have in difficult in elderly patients. Their

50 | Review of Ophthalmology | July 2014 This article has no commercial sponsorship.

050_rp0714_gm.indd 50 6/20/14 1:58 PM reaction time is different and their Population Aged 90 and Over: 1980 to 2050 attention span is shorter. One helpful alternative is to try a kinetic (e.g., Goldmann) visual 10 fi eld test, which is much more user- friendly than automated static visual 8 fi elds. In this type of testing, there’s a technician sitting with the patient 6 who can alter the speed of the test and respond to the patient’s limitations. Millions 4 The Goldmann visual fi eld test is not always reliable, but it’s often better than no formal testing at all. 2 Unfortunately, not all offi ces have the Goldmann technology today, 0 and the instrumentation is no longer 1980 1990 2000 2010 2020 2030 2040 2050 manufactured. Furthermore, fewer Data from United States Census Bureau, 1980 to 2010. Projections calculated by the and fewer people are being trained Census Bureau in 2008. to perform this test. That means this method of testing may soon be and the retinal nerve fi ber layer). A pressure is 14 or 16. Still, you have unavailable, but there are newer more recent paper from the Journal to make those diffi cult decisions and versions of automated kinetic visual of Glaucoma looked specifi cally at the recommendations for therapy. fi eld testing that are increasing in use. changes in the different quadrants Hopefully, in the future there will be of the retinal nerve fi ber layer over Treating the Super Senior improved objective methods to obtain time.2 It found more age-related this functional data from patients. change in the superior and inferior Given the limitations and special Structural information about the quadrants; in contrast, glaucomatous concerns that accompany treating optic nerve is very important and loss paralleled the decline in average an elderly patient, it’s important to requires interpretation of optic nerve thickness. The study also found that approach this as a special case. A few and retinal nerve fi ber layer imaging true glaucomatous progression was points to keep in mind: scans; you’ll depend on them much much more rapid than age-related • Older treatment options may more as an objective measure of decline; even the fastest age-related be worth considering. We do progression with this group of patients. decline was still slower than most tend to treat elderly patients more Of course, a key issue will be deciding glaucomatous loss. So if you look care- with medications than with sur- whether a change is attributable to fully, you can probably distinguish one gery, because we’re trying to avoid aging or progression. Unfortunately, from the other in most patients. taking them to the operating room most studies of optic nerve imaging Ultimately, you may not be able to —especially if they have other co- have been cross-sectional; they look at get visual fi eld information or measure morbidities. In addition, many of different patients at a specifi c point in retinal nerve fi ber layer loss in some them are resistant to having surgery. time. As a result, we don’t know a lot of these patients because of advanced For that reason it often makes sense about longitudinal changes in OCT or optic nerve damage. In that situation to try alternatives you might not try HRT scans, or about what is normal you’re left with just the patient’s IOP with a younger patient. Some of the for an aging individual. and your gut instinct as to whether the older medications, like pilocarpine One study from 2007 by Don patient is getting worse. If the mean and phospholine iodide, may be Budenz, MD, and colleagues looked pressure is 18 or 20 mmHg and the worth trying. Laser trabeculoplasty at the changes in the retinal nerve patient has advanced nerve damage can also be a very good adjunct to fiber layer for every decade of in- and visual field loss and you feel medical therapy, and even transcleral creased age.1 They found an average the patient is getting worse, you’re diode cyclophotocoagulation may be 2-µm decrease in thickness for every probably right. But if the pressure benefi cial in this population. I’ve had decade, after making adjustments for is 12 or 10, it’s a lot harder to say some very good results with diode age, ethnicity and axial length (all of whether the patient is getting worse; CPC in elderly patients who didn’t which can affect the optic disc size and its really hard to judge when the want to have intraocular surgery in

July 2014 | Revophth.com | 51

050_rp0714_gm.indd 51 6/20/14 1:58 PM ENRICH YOUR PRACTICE

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2014_rp_tsrad.indd 90 6/18/14 10:47 AM Glaucoma

REVIEW Management Carla J. Siegfried, MD the OR. care with the primary-care • Make sure the patient doctor. and family understand that glaucoma eye drops Seniors and Surgery are medications. The reality is that these drugs There are some special may have systemic effects, considerations when taking not just local effects on the these patients to the OR, eye. The patient and the including issues surrounding family must be made aware informed consent (especially of this. depending on the patient’s Use of topical medications cognitive status); risks as- is sometimes overlooked by sociated with anesthesia, primary-care physicians, for which can have more pro- example. I’ve had patients A kinetic visual fi eld test such as the Goldmann (pictured above) found effects in this age on beta blockers come back is more user-friendly for senior patients than an automated group; questions involving and say, “I had a pacemaker perimetry test. A technician sits with the patient, able to alter hygiene and infection risk; the speed of the test in response to patient limitations. For some implanted a couple of and avoiding suprachoroid- patients, this may be the only visual fi eld test that’s manageable. months ago.” I look through al hemorrhages, which is a their medication list and see greater risk because of these that they’re on a topical beta blocker; their blood pressure is too low—so patients’ vessel fragility, tissue quality beta blockers may cause bradycardia they take it right before they go to bed and potential issues with their healing in some patients. I ask whether when they’ll be lying down, fi guring response. their cardiologist was aware of that. that’s safer. Of course, that’s actually Here are some strategies that will They say, “Oh yes, she made a list not a good thing to do; their blood help make surgery go more smoothly: of all of my medicines.” But did the pressure can drop too low, along with • Make sure the informed con- cardiologist consider that the topical the perfusion pressure to the optic sent involves the patient’s family. beta blocker might be contributing to nerve, placing their eye at risk. So, This is especially true if the patient’s the patient’s need for a pacemaker? I take a history about some of these cognition is impaired, and/or if the • Be prepared to manage pres- issues, including what time of day family is involved with managing the sure-independent factors. In ad- they’re taking their blood pressure patient’s day-to-day living situation dition to IOP, blood flow-related medicine. (I’ll also have patients and there are legal guardianship factors such as ocular perfusion check their blood pressure at night.) issues. pressure and blood pressure are • If blood pressure is an issue, • At the same time, make sure the important; these may help us de- coordinate with the primary-care ultimate decision is the patient’s. termine how much blood flow is doctor. There’s sometimes a disparity I’ve seen family members say, “Oh reaching the optic nerve. Of course, in what we feel the blood pressure Grandma, you need to do this, the when we’re managing these patients should be and what the primary-care doctor says so.” As long as I feel that we lower intraocular pressure as doctor believes the blood pressure the patient can make the decision, I much as we can, but if they’re still should be. Many primary-care doctors encourage the patient to make the progressing and we don’t think we can want the pressure as low as possible, as decision. I give her the information easily lower the pressure further— long as the patient is not falling. From she needs; I spell out the risks and i.e., surgery may be required—then our perspective, that’s not necessarily benefits and how it relates to her it’s helpful to examine these other a good thing; we want to make sure quality of life currently and in the factors. (Sleep apnea is another im- the diastolic blood pressure stays over future. Then I let the patient know portant condition to consider for diag- 60 mmHg so there will be less chance that it has to be her decision. I won’t nosis and management.) of hypotension, especially at night. schedule a procedure just because the Obviously, it’s important for blood • Salt tablets at night may help patient’s family says the patient needs pressure to be properly controlled. keep blood pressure up. This to do it. However, sometimes patients get is another strategy for helping to If patients are not prepared to dizzy when they take their blood prevent hypotension. However, the make that decision, I urge them go pressure medicine—indicating that best strategy is to coordinate your home and think about it, unless the

July 2014 | Revophth.com | 53

050_rp0714_gm.indd 53 6/20/14 1:58 PM Glaucoma

REVIEW Management

sible. IV sedation at the limbus. Also, after decades of with a short-acting medication, their ﬁ broblasts may be drug such as pro- different. (We don’t know that for pofol, which causes certain because there aren’t studies

Carla J. Siegfried, MD Siegfried, Carla J. amnesia about what relating to that in this population, but happens during the we do know that long-term use of surgery, can be a medication can alter the tissue.) good option. Even Fortunately, many of these patients if the patient claims do not have as much risk of scarring as to feel something a younger patient might, which means during the surgery, you can potentially cut back on the he probably won’t mitomycin or 5-fl uorouracil and still remember it. Gen- achieve a good result. Given that fact, It’s important to make sure the patient and any caregivers—as eral anesthesia, I titrate my antimetabolite use based well as the patient’s primary care physician—understand that where the patient on how the tissue looks at the time of topical eye drops can have systemic interactions with other is intubated on a surgery, with the goal of a low, diffuse medications the patient may be taking. breathing machine, posterior bleb. is a much riskier pro- • Be aware that the patient may procedure should be performed cedure in this population. have had large-incision extracap urgently. There’s often no reason to Note that this is also a very impor- cataract surgery many years ago. rush, so allowing them to think about tant part of the informed consent with This should be factored into con- the issues and giving them time to the patient and the family. Even if a sideration when deciding where to consider more questions is appro- patient says, “I don’t want to know make your incision. If a patient had priate. anything about the surgery, I want to extracapsular cataract extraction, • Only broach the idea of avoid- be put completely to sleep,” I really the sutures may be gone, but that ing “vision-saving” surgery if the push against that. A trabeculectomy incision site will always be there; eye is no longer helping the pa- or tube shunt procedure is very safe your glaucoma surgery can get into tient. Very few patients ever say they for most of these patients when done trouble if you don’t realize that and don’t care about their vision. The only using very short-acting sedative; make your incision at that location. time I hear that is when one eye is there’s no reason to increase the risk You may not fi nd this information in severely compromised in terms of by using general anesthesia. the patient’s record, either, if a 90- visual acuity and visual field, and • If possible, work with an anes- year-old patient had cataract sur- the other eye is perfectly normal. If thesiologist who has experience gery 30 years ago. So, make sure a patient says, “You know doc, this working with elderly patients in your physical exam considers this eye is really not of any use to me,” these types of procedures. Such possibility. I have the patient cover the better an individual will know better when If you determine that this is the eye and try to cross the room. If the to give a little sedation and will know case, you may want to alter which patient can’t make it to the door using how to make the patient more aware procedure you do. You might decide only the worse eye—and I know the when you want the patient to be more to put a tube in, rather than do a other eye is perfectly normal—then aware. That makes the surgery safer trabeculectomy or ExPress shunt, I’ll give them the option of skipping for everybody. just because the tissue is not really the surgery. However, if I think there’s • Be cautious with the use of amenable to a fi ltering procedure. any chance that the bad eye might antimetabolites. My experience • Err on the side of higher postop become their better eye at some point suggests that these patients have a pressures. Delayed suprachoroidal in the course of their lifetime, then I’ll thinner Tenon’s capsule, as it seems to hemorrhage is probably our worst encourage them to proceed. Again, become attenuated over time. They nightmare in glaucoma surgery; it’s the fi nal decision has to be theirs. may have had prior surgery, leaving associated with aging, hypertension, On the day of surgery: the conjunctiva scarred, more friable hardening of the arteries, arterial • Avoid general anesthesia.I and easily torn, or the sclera more sclerosis and anticoagulant therapy. nearly always recommend monitored vulnerable, if the patient had a surgery Recovery following a limited supra- local anesthesia and sedation rather such as an extracapsular cataract ex- choroidal hemorrhage is certainly than general anesthesia, if at all pos- traction, involving a large incision site possible, but this event is often

54 | Review of Ophthalmology | July 2014

050_rp0714_gm.indd 54 6/23/14 9:48 AM devastating. Many super senior pa- good hygiene and is compliant with of medications the patient has to use. tients are on low-dose aspirin, and therapy, this isn’t likely to become an Performing a MIGS procedure at many others are on Plavix or Couma- issue. However, I’ve observed that the time of cataract extraction could din therapy because they’ve had sometimes when an infection does be ideal for select patients in this some sort of cardiac procedure or occur, the patient doesn’t come in population. have had a stroke in the past, putting right away because she “doesn’t want them at greater risk. Patients with a to bother anybody.” Thus, it’s very Keeping Things Super suprachoroidal hemorrhage usually important to get the family involved, present to the offi ce with acute, se- and say, “If you see any of these signs Thanks to increasing life expectancy, vere pain and loss of vision. or symptoms, the patient needs to all of us will be seeing patients for Delayed suprachoroidal hemor- come in immediately.” longer and longer stretches of rhage can occur days or weeks after time—and seeing more patients in the surgery if the pressure in the eye What About MIGS? their 80s and 90s (and maybe over drops low, so you need to be careful to 100). With any glaucoma patient, the avoid postop hypotony. I recommend Microinvasive glaucoma sur- ultimate goal of therapy is to improve putting in additional sutures at the geries, or MIGS, have garnered a the patient’s quality of life in terms end of surgery to keep the pressure lot of attention recently; they’ve of function and comfort. When the a little bit higher for the fi rst week or raised the possibility of lowering patient is a super senior, maintaining two after surgery. Avoiding lowering pressure surgically without the good vision is especially important: the head below the heart is also im- risks and drawbacks associated with Being able to see well offsets some portant. trabeculectomy and tube shunts. of the physical limitations that may • Make sure the family parti- For a super senior, however, such an come with aging and gives the indi- cipates in post-surgery care. The approach may not be all that useful, vidual a fi ghting chance to continue family must be involved when it for two reasons. First of all, many activities such as driving that are so comes to follow-up appointments, MIGS procedures are approved by important to quality of life. (If we can and especially in terms of monitoring the Food and Drug Administration also fi nd ways to reduce the treatment how the patient takes the medications to be performed only at the time of burden, so much the better. Taking after surgery. This can be a challenge cataract surgery. The majority of these eye drops that make you miserable is for patients because the postop regi- patients had cataract surgery years not an ideal way to live.) men may be very different from earlier, so they wouldn’t be considered Today, my own parents are 86 and what they’ve been taking for their candidates for MIGS. 96 and blessed with good health, an glaucoma. They may be accustomed Second, while MIGS procedures experience that I believe is increas- to using drops once or twice a day, are known for being safe, they don’t ingly common. Our attitudes about while the postoperative regimen lower pressure nearly as dramatically the elderly need to refl ect that reality. could be every two to four hours. It’s as the more invasive surgeries. That’s You wouldn’t want to say to them, defi nitely a step up in frequency of a problem because if you don’t get the “Well, we’ll just kind of manage your medication. pressure reduction the patient needs glaucoma, and if you slowly lose vi- They may also need to change their to halt or decrease progression you’ll sion, that’ll be OK.” With a little extra activities for a while, although this have to take the patient back into thought and persistence, we can help is not usually a big change. These the OR for more surgery later. With them maintain their best possible patients are not necessarily doing a younger patient this may be very vision—and their quality of life. heavy lifting, but they may want to reasonable, but it doesn’t necessarily work in the garden; however, they’ll make sense when the patient is in her Dr. Siegfried is a professor in need to avoid doing this type of 90s. Surgery is inherently riskier at the department of ophthalmology activity with a head-down position. this age, and these patients may not and visual sciences at Washington • Make sure the patient and be enthralled with the prospect of University in St. Louis.

family understand the signs and more surgery. 1. Budenz DL1, Anderson DR, Varma R, et al. Determinants of symptoms of infection. Infection Yes, in some circumstances it normal retinal nerve fi ber layer thickness measured by Stratus OCT. Ophthalmology 2007;114:6:1046-52. does not appear to be a greater risk might be a good option, as long as 2. Feuer WJ, Budenz DL, Anderson DR, Cantor L, Greenfi eld DS, with elderly patients; at least there’s the patient understands and agrees. It Savell J, Schuman JS, Varma R. Topographic differences in the age-related changes in the retinal nerve fi ber layer of normal not much data supporting a greater might help to control the pressure for eyes measured by Stratus optical coherence tomography. J risk. As long as the patient displays a few years and reduce the number Glaucoma 2011;20:3:133-8.

July 2014 | Revophth.com | 55

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rickbay_housead.indd 1 2/28/14 1:14 PM Pediatric Patient Edited by Christopher M. Fecarotta, MD

Vigabatrin and Visual Field Loss in Children The drug has a long history outside the United States in the treatment of epilepsy. Its use in children requires close follow-up. Christopher M. Fecarotta, MD, Brooklyn, N.Y.

igabatrin, used around the world to cently approved for use in the United tropic hormone (ACTH) can also be Vtreat epilepsy, was approved a few States. Vigabatrin is often effective for used as fi rst-line treatment for infan- years ago for use in the United States the management of refractory com- tile spasms, since excess production for the management of refractory, plex partial seizures in adults who have of corticotropin-releasing hormone complex partial seizures in adults who failed multiple medications. Such pa- is another possible etiology, but this have failed other anti-epileptic drugs. tients are often debilitated by their sei- treatment carries a higher risk profi le. Ophthalmologists may be involved in zures and are desperate for treatment. In 1997, Dr. Tom Eke and col- the care of children who are receiving Compared with other anti-epileptics, leagues described cases of peripheral vigabatrin; this article will review the vigabatrin has a relatively low inter- visual fi eld constriction associated with drug’s uses and effects and the consid- action rate with other medications, a vigabatrin.5 Since then, vigabatrin has erations to keep in mind in treating or lower overall rate of side effects, and is clearly been shown to cause a dose-de- monitoring this population of patients. particularly effective when spasms are pendent, permanent peripheral fi eld associated with tuberous sclerosis.3,4 constriction.2,6 Other, less common Background In children, it is an option for first- side effects include somnolence, head- line therapy for infantile spasms (West ache, dizziness, fatigue and weight Gamma-aminobutyric acid is the syndrome), which are seizures hypoth- gain. Psychosis has also been reported, brain’s major inhibitory neurotrans- esized to be malfunctions of the GABA although this side effect is more com- mitter. Vigabatrin (Sabril) is a selec- regulation process and are notoriously mon in adults than in children. The tive, irreversible, inhibitor of GABA difficult to control. Adrenocortico- prevalence of visual fi eld constriction transaminase that increases is uncertain and ranges levels of GABA in the brain; it from 14 to 92 percent was synthesized in the 1980s in various studies. Be- and 1990s as an anti-epileptic cause of this side effect, medication.1,2 The molecule nearly two decades of resembles GABA, but the ad- debate delayed the ap- dition of an extra vinyl group proval of vigabatrin in allows it to sit in the active the United States until site of GABA transaminase August 21, 2009. Prior and render it inactive. It has to approval, patients been used around the world and their family had to since the 1990s and was re- obtain vigabatrin from

July 2014 | Revophth.com | 57

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REVIEW Patient

Canada, Mexico and the United King- if vigabatrin provides freedom from • Optical coherence tomogra- dom. After approval, the Food and seizures, while others would prefer not phy. OCT has revolutionized our un- Drug Administration implemented a to risk visual impairment. derstanding of many different diseases Risk Evaluation and Mitigation Strat- that affect the nerve fiber layer and egy (REMS) to promote compliance Toxicity Evaluation Options is a useful tool for detection of nerve with its screening recommendations. fi ber layer thinning in adults and old- The earliest reports of toxicity were The FDA has recommended that er, cooperative children. Lisa Clayton after 11 months of exposure. The vi- all patients have complete eye exami- and colleagues recently illustrated the sion loss is usually asymptomatic and nations and visual fi eld testing before effectiveness of OCT for evaluation spares the macula, but sub-clinical de- starting vigabatrin. Patients should re- of patients taking vigabatrin.17 In this pression of macular function and color turn for follow-up exams every three study, the average retinal nerve fi ber vision deficits have been reported. months to monitor for side effects. Un- layer thickness in patients taking vi- The mechanism has not yet been fully fortunately, detection of visual field gabatrin was signifi cantly thinner than demonstrated, but most likely involves defects in this population of children is in healthy controls. The extent of the toxicity to both retinal photoreceptors very diffi cult. The majority of children nerve fi ber layer thinning correlated and ganglion cells. There is some evi- who require vigabatrin for seizure con- well with the extent of visual fi eld loss. dence that vigabatrin induces a taurine trol are very young, non-verbal, or are The authors conclude that OCT is a re- deficiency that leads to toxicity, and unable to cooperate with the most sen- liable and objective tool for evaluating some authors have suggested taurine sitive tests. The American Academy patients on vigabatrin. Unfortunately, supplementation as a way to prevent of Pediatric Ophthalmology & Stra- it will not provide reliable information toxicity.7 Dr. Pedro Gonzalez and col- bismus has recommended alternative on younger children and patients who leagues have recently suggested that, ways to evaluate for toxicity: are unable to cooperate. Recent de- as an anti-epileptic medication with • Serial fundus examinations. velopment of a handheld supine OCT inhibitory effects, vigabatrin may also The appearance of the fundus may may improve screening for vigabatrin dampen the visual system as a whole.8 be completely normal despite toxicity toxicity in infants and young children. The authors suggest that other anti- and visual fi eld constriction; however, Such devices have been used success- epileptic medications may have similar indirect ophthalmoscopy may be the fully in a subset of these patients. effects, but retinal toxicity caused by best method for a large proportion of • Visual evoked potentials. Gra- vigabatrin exacerbates this effect. pediatric patients. Optic nerve fi ndings ham Harding, DSc, and colleagues Current recommendations limit the include thinning of the nasal retinal illustrated that VEP can be used to dose of vigabatrin to 3 g per day in nerve fi ber layer often referred to as detect visual fi eld defects secondary to adults, or 50 to 100 mg/kg/day in chil- “reverse optic atrophy.”11-13 Macular vigabatrin.18 Their fi eld-specifi c stimu- dren, and the drug should be with- pigment epithelial changes have also lus identifi ed three of four abnormal drawn if it does not provide adequate been described.14-16 perimetry results and seven of eight seizure control.9 Adult ophthalmolo- • Serial automated static perim- normal perimetry results, giving a sen- gists will be seeing patients on vi- etry. Reliable results are usually only sitivity of 75 percent and a specifi city gabatrin more frequently as its uses achievable in older children, at least of 87.5 percent. The authors conclude expand. Robert Fechtner, MD, and 9 years old, who are able to cooper- that fi eld-specifi c VEPs are well-toler- colleagues recently showed that vi- ate for the examination. Formal visual ated by children older than 2 years and gabatrin is effective in treating cocaine field testing performed on younger are sensitive and specific enough to and methamphetamine dependence.10 children, even those who can sit for identify vigabatrin-associated defects. Their study enrolled 28 patients and the test, is not reliable or sensitive Unfortunately, despite the results of found that 16 remained negative for enough to detect early subtle changes. such studies, the authors conclude that substance use during the last six weeks Recent studies also suggest that pe- “ …in individual subjects, the tests are of the study. Furthermore, no ocular rimetry alone may not be enough to simply too unreliable to guide deci- adverse effects were reported. prove vigabatrin toxicity. Dr. Gonzalez sion-making with regards to vigabatrin Use of vigabatrin involves a continu- and coworkers illustrated bilateral vi- maintenance.”9 ous analysis of its risks and benefi ts. sual fi eld constriction in 24 percent of • Electroretinograms. ERGs have This approach requires cooperation vigabatrin-naive epileptic patients and been shown to detect early changes as- among the patient’s neurologist, oph- concluded that visual fi elds constric- sociated with vigabatrin toxicity; how- thalmologist and family. Some families tion alone is not necessarily indicative ever, several problems prevent ERG will accept risk of a visual fi eld defect of medication toxicity.8 from being an ideal screening tool. A

58 | Review of Ophthalmology | July 2014

057_rp0714_peds.indd 58 6/20/14 11:42 AM Advertising

REVIEW Index

recent report warned against over-reliance on the ERG to detect vigabatrin For advertising opportunities contact: toxicity. Their study found no signifi cant association of any ERG parameter Michelle Barrett with visual fi eld defects and could not determine if the ERG abnormalities they (610) 492-1014 found were due solely to the effects of vigabatrin. Furthermore, there is no ac- or [email protected] cepted “normal” waveform for very young children, and ERG in the pediatric James Henne population often requires general anesthesia, which may also alter the wave- (610) 492-1017 form. Finally, general anesthesia every three months is not convenient and is or [email protected] potentially dangerous. Most parents are hesitant to accept subjecting their child Scott Tobin to the risks inherent in general anesthesia. (610) 492-1011 In conclusion, vigabatrin is a very effective drug for treatment of infantile or [email protected] spasms and seizure disorders refractory to other medications. Its use, however, is complicated by an irreversible, dose-dependent visual fi eld constriction from Abbott Medical Optics, Inc. (AMO) photoreceptor toxicity. The majority of patients are asymptomatic since the 2 macula is usually spared. Screening for this side effect in young children can be Phone (800) 366-6554 very diffi cult, especially given the fact that many children who need vigabatrin are non-verbal and poorly cooperative. Methods of screening for visual fi eld Alcon Laboratories constriction include serial fundus examination, serial automated static perim- 15, 16, 45, 46 etry, OCT, VEP and ERG. Each method has its advantages and disadvantages. Phone (800) 451-3937 Fax (817) 551-4352 Most commonly, parents opt for serial fundus examination and prefer to avoid repetitive general anesthesia for their child. “Reverse” optic atrophy and Allergan, Inc. macular pigment epithelial changes are the most common ophthalmoscopic 66, 68 fi ndings. Any ophthalmologist screening children on vigabatrin should be ready Phone (800) 347-4500 to discuss the options with parents so they can make informed decisions. In addition, a periodic re-evaluation of the need for vigabatrin should be initiated by Bausch + Lomb 29, 30 the patient’s neurologist to ensure patients do not needlessly remain exposed to Phone (800) 323-0000 the risk of vision loss. The AAPOS policy statement on vigabatrin can be found Fax (813) 975-7762 at: http://www.aapos.org//client_data/fi les/2012/504_vigabatrin_05.09.12.pdf. Hopefully, future research will discover more effective tests of peripheral vision Keeler Instruments for patients who cannot comply with traditional methods. 8, 67 Phone (800) 523-5620 Dr. Fecarotta is an assistant clinical professor of ophthalmology at SUNY Fax (610) 353-7814 Downstate Medical Center in Brooklyn, N.Y. NicOx, Inc. 20-21 1. Dichter MA, Brodie MJ. New antiepileptic drugs. N Engl J Med 1996;334:1583-90. 2. Ben-Menachem, E. 1995 Vigabatrin. Epilepsia 36 (Suppl. 2), S95-S104. Phone (214) 346-2913 3. Camposano S, Major P, Halpern E, Thiele E. Vigabatrin in the treatment of childhood epilepsy: A retrospective chart review of effi cacy www.nicox.com and safety profi le. Epilepsia 2008;49:1186-91. 4. Hancock E, Osborne J. Vigabatrin in the treatment of infantile spasms in tuberous sclerosis: Literature review. J Child Neurol Omeros 1999;14:71-74. 5. Eke T, Talbot JF, Lawden MC. Severe persistent visual fi eld constriction associated with vigabatrin. BMJ 1997;314:180-1. 7 6. Bruni J, Guberman A, Vachon L, Desforges C. Vigabatrin as add on therapy for adult complex partial seizures: A double blind, placebo- Phone (206) 676-5000 controlled multicentre study. The Canadian Vigabatrin Study Group. Seizure 2000;9:224-232. Fax (206) 676-5005 7. Jammoul F, Wang Q, Nabbout R, et al. Taurine defi ciency is a cause of vigabatrin-induced retinal phototoxicity. Ann Neurol 2009 Jan: 65(1):98-107. 8. Gonzalez P, Sills GJ, Parks S. Binasal visual fi eld defects are not specifi c to vigabatrin. Epilepsy Behav 2009 Nov;16(3):521-6. doi: Perrigo Specialty Pharmaceuticals 10.1016/j.yebeh.2009.09.003. Epub 2009 Oct 7. 11, 12 9. http://www.aapos.org//client_data/fi les/2012/504_vigabatrin_05.09.12.pdf. Phone (866) 634-9120 10. Fechtner RD, Khouri AS, Figureoa E, Ramirez M, et al. Short term treatment of cocaine and/or methamphetamine abuse with vigabatrin: Ocular safety pilot results. Arch Ophthalmol 2006;124:1257-62. www.perrigo.com 11. Frisen L, Malmgren K. Characterization of vigabatrin-associated optic atrophy. Acta Ophthalmol Scand 2003;81:466-73. 12. Wild JM, Robson CR, Jones AL, Cunliffe IA, Smith PE. Detecting vigabatrin toxicity by imaging of the retinal nerve fi ber layer. Invest Rhein Medical Ophthalmol Vis Sci 2006;47:917-24. 13. Buncic JR, Westall CA, Panton CM, Munn JR, McKeen LD, Logan WJ. Ophthalmology 2004;101:576-580. 5 14. French JA, Mosier M, Walker S, Sommerville K, Sussman N. A double-blind, placebo-controlled study of vigabatrin three g/day in Phone (800) 637-4346 patients with uncontrolled complex partial seizures. Vigabatrin Protocol 024 Investigative Cohort. Neurology 1996;46:54-61. Fax (727) 341-8123 15. Guberman A, Bruni J. Long-term open multicentre, add-on trial of vigabatrin in adults resistant partial epilepsy. The Canadian Vigabatrin Study Group. Seizure 2000;9:112-118. 16. Sander JW, Trevisol-Bittencourt PC, Hart YM, Shorvon SD. Evaluation of vigabatrin as an add-on drug in the management of severe epilepsy. J Neurol Neurosurg Psychiatry 1990;53: 1008-1010. This advertiser index is published as a convenience 17. Clayton LM, Devile M, Punte T, et al. Retinal nerve fi ber layer thickness in vigabatrin- exposed patients. Ann Neurol 2011;69:845-854. and not as part of the advertising contract. Every care will be taken to index correctly. No allowance 18. Harding GFA, Spencer EL, Wild JM, Conway M, Bohn RL. Field-specifi c visual evoked potentials: Identifying fi eld defects in vigabatrin- will be made for errors due to spelling, incorrect page treated children. Neurology 2002; 58(8):1261-1265. number, or failure to insert.

July 2014 | Revophth.com | 59

057_rp0714_peds.indd 59 6/20/14 11:42 AM REVIEW Classiﬁ eds

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2013 Digimag hous ad_RP.indd 1 5/7/14 11:30 AM 063_rp0714_wills.indd 63 Examination paternal grandmother. Hereportedoccasionalmarijuanause,butdidnotsmokecigarettesordrinkalcohol. cal herniaasaninfant.Hewasnotonanychronicmedications.Familyhistorysignifi cant forglaucomainhis Medical History over threedays.Healsoreportedright-sidedperiorbitalpain,andnewdiplopiaonupgaze. sentation, thepatientpresentedwithrecurrenceofrightuppereyelidswelling,whichhadrapidlyprogressed headaches, andhewasreferredtohisprimary-careproviderforfurtherevaluation.Fiveweeksafterinitialpre- swelling wasnearlycompletelyresolved.Thepatientmentionedatthistimethatheexperiencingright-sided mycin ointmentatbedtimeinbotheyes,aswellwarmcompresses.Athistwoweekfollow-upappointment, the or detergents.Hisocularexamwasonlynotableforfl oppyeyelidsandblepharitis,hewasprescribederythro- blurry visionintherighteye.Hedeniedhistoryofpriortrauma,recentinsectbitesorusenewfacialproducts with hotandcoldcompresses,butpersistentrecurrence.Theswellingwasaccompaniedby occasional tearingand upper eyelidswellingthathadbeenoccurringforapproximatelyonemonth.Henotedtemporaryimprovement Presentation Christine Talamini,MD soon returnsaccompaniedbyheadachesandeyepain. Recent eyelidswellingappearstoberesolvedafteranERvisit,but upper eyelid,aswellsuggestionofhypoglobusintherighteye. confrontation inbotheyes.Intraocularpressurewaswithinnormallimits.Theresignificant swellingoftheright afferent pupillarydefect.Colorvisionwasfullinbotheyes.Ocularmotilityfull,andvisualfi elds werefullto What isyourdifferentialdiagnosis? Whatfurtherworkupwouldyoupursue?Please turntop. 64 The patienthadnopriorophthalmichistory. Hehadchronicanxietyandunderwentsurgicalrepairofanumbili- A 19-year-old manpresentedtotheWills EyeHospitalEmergencyRoomforevaluationofintermittentright Visual acuitywas20/25intherighteye,20/20lefteye.Pupilswerebrisklyreactivebotheyeswithno REVIEW Wills Eye Wills Eye Resident CaseSeries Edited by David Perlmutter,Edited byDavid MD July 2014 | Revophth.com |

63 6/20/14 3:25 PM 063_rp0714_wills.indd 64 Discussion Neurosurgery was consultedanda epidural extension(SeeFigure1). cranial involvementwithduraland right frontalcalvariumandintra- right orbitwithextensiontothe gressive enhancinglesioninthe MRI demonstrateda2.4-cmag- bony erosion.Furtherworkupwith mass intherightorbitalroofwith ing oftheorbitswhichrevealeda 64 neoplastic andreactiveinfl it hasbeencharacterizedas botha ing pathogenesisremainsunclear, as five-year survivalrate.Itsunderly- the mostsevere,witha50-percent multi-system disease),thelastbeing Letterer-Siwedisease (multifocal, (multifocal, uni-systemdisease);and Hand-Schuller-Christian disease disease); loma (unifocal,uni-system systems involved:eosinophilicgranu- the extent andthenumberoforgan cell histiocytosis, differentiated by der theclassifi cation ofLangerhans’ Three diagnoseshistoricallyfellun- ous locationsthroughoutthebody. tion ofhistiocytes,occuringinvari- conditions withabnormalprolifera- tosis X,describesararespectrumof (LCH), previouslyknownashistiocy- demonstrating alarge enhancingmassintherightsuperiororbit. MRI, T1 postcontrast withfatsuppression (left)andMRI, T2-weighted (right), Diagnosis, Workup andTreatment REVIEW The patientunderwentCTimag- Langerhans’ cellhistiocytosis | ReviewofOphthalmology Resident CaseSeries ammatory | July2014 (See Figure2). erhans’ cellhistiocytosis fi staining withCD1acon- dendritic cells,andpositive eration ofmacrophagesor opsy demonstratedprolif- Pathology ofthetissuebi- pletely resectedthemass. ophthalmology teamcom- collaborative neurosurgery- with aworseprognosis. present withmulti-systemdisease, nance. Younger childrentendto 4 yearsofageandamalepredomi- dren, withapeakincidenceat1to remain controversial. viruses andminortrauma,butthese posited intheliterature,including process. Severaltriggershavebeen conjunctiva, caruncle,choroid, optic LCH mayalsoariseinthe eyelids, through adulthood.Lesscommonly, ing hematopoiesisinthefrontalbone thought tobederivedfromtheongo- bone, asseeninourpatient,whichis bit commonlyinvolvesthefrontal periorbital cellulitis.LCHoftheor- swelling, whichcanbemistakenfor bit isanteriorsuperolateralorbital acteristic presentationintheor- rmed adiagnosisofLang- LCH classicallypresentsinchil- 1,2 2 Thechar- CD1a staining, amarker forLangerhans’ cells(bottom). revealed proliferation ofhistiocytes (top)withpositive Figure 2.Microscopic review ofthetissuespecimen peanut lectin,alpha-mannosidase, ine triphosphatase,acidphosphatase, also bepositive,including adenos- diagnosis. Othertissuemarkersmay hans’ cellsandhelptoconfi forLanger-and CD1aarespecific staining withneuronalmarkersS100 aging. Positiveimmunohistological clinical examandradiographicim- tumors mayalsopresentsimilarlyon and Wilms tumor, andotherbony as neuroblastoma,Ewingsarcoma other orbitallesionsinchildren,such necessary toconfirm thediagnosisas cranial fossae.Biopsyofthelesionis tissue extensionintotheorbitand of boththebonychangesandsoft allows forenhancedcharacterization sinus. chiasm, orbitalapexorcavernous Imaging withbothCTandMRI rm the rm 6/23/14 10:31 AM Retinal

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CD207, fascin, CD4, CD45, CD101, (continued from page 41) HLA-DR, MHC Class II antigens and receptors for the Fc fragment of ophthalmology at Thomas Jefferson University in Philadelphia. He can be immunoglobulins.2 Birbeck granules, reached at [email protected]. rod or racquet-shaped inclusion bod- Dr. Hsu is an assistant professor of ophthalmology on the Retina Service of ies seen on electron microscopy, are Wills Eye Hospital and practices at Mid Atlantic Retina. He can be reached considered pathognomonic. Howev- at [email protected]. er, the absence of Birbeck granules, 1. Wang M, Munch IC, Hasler PW, et al. Central serous chorioretinopathy. Acta Ophthalmologica 2008;86:126-45. which are present in 50 to 70 percent 2. Kitzmann AS, Pulido JS, Diehl NN, et al. The incidence of central serous chorioretinopathy in Olmsted County, Minnesota, 1980–2002. of cases, does not exclude a diagnosis Ophthalmology 2008;115:169-73. 3. Gass JD. Pathogenesis of disciform detachment of the neuroepithelium. Am J Ophthalmol 1967;63:1-139. of LCH. 4. Ross A, Ross AH, Mohamed Q. Review and Update of Central Serous Chorioretinopathy. Curr Opin Ophthalmol 2011;22:166-73. 5. Yamada K, Hayasaka S, Setogawa T. Fluorescein-angiographic patterns in patients with central serous chorioretinopathy at the initial Once the diagnosis is established visit. Ophthalmologica 1992;205:69-76. by tissue biopsy, systemic evaluation 6. Spitznas M, Huke J. Number, shape, and topography of leakage points in acute type I central serous retinopathy. Graefe’s Arch Clin Exp Ophthalmol 1987;225:437-40. is necessary for proper staging of 7. Kitaya N, Nagaoka T, Hikichi T, et al. Features of abnormal choroidal circulation in central serous chorioretinopathy. Br J Ophthalmol the disease. This includes laboratory 2003;87:709-12. 8. Maruko I, Iida T, Sugano Y, Ojima A, Ogasawara M, Spaide RF. Subfoveal thickness after treatment of central serous chorioretinopathy. testing with complete blood count, Ophthalmology 2010;117:1792-9. 9.Shinojima A, Hirose T, Mori R, et al. Morphologic fi ndings in acute CSC using spectral domain OCT with simultaneous angiography. comprehensive metabolic panel, co- Retina 2010;30:193-202. agulation studies, urine osmolality, 10. Imamura Y, Fujiwara T, Margolis RON, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina 2009; 29:1469-73. and imaging with skeletal survey and 11. Gilbert CM, Owens SL, Smith PD, Fine SL. Long-term follow-up of central serous chorioretinopathy. Br J Ophthalmol 1984;68:815-20. CT or MRI to search for metastases. 12. Bujarborua D. Long-term follow-up of idiopathic central serous chorioretinopathy without laser. Acta Ophthalmologica Scandinavica 2001; 79:417–21. Our patient had an extensive workup 13. Singer M, et al. Non-steroidal anti-infl ammatory topical therapy speeds recovery in central serous chorioretinopathy. AAO 2013 meeting, New Orleans. Unpublished data. that did not demonstrate any other 14. Leaver P, Williams C. Argon laser photocoagulation in the treatment of central serous retinopathy. Br J Ophthalmol 1979;63:674-77. concerning lesions or multi-system 15. Yannuzzi LA, Slakter JS, Gross NE, et al. Indocyanine green angiography-guided photodynamic therapy for treatment of chronic central serous chorioretinopathy: A pilot study. Retina 2003;23:288-298. involvement. The usual treatment 16. Piccolino FC, Eandi CM, Ventre L, et al. Photodynamic therapy for chronic central serous chorioretinopathy. Retina 2003;23:752-763. strategies for LCH include observa- 17. Smretschnig E, Ansari-Shahrezaei S, Hagen S, Glittenberg C, Krebs I, Binder S. Half-fl uence photodynamic therapy in chronic central serous chorioretinopathy. Retina 2013:33:316-23. tion, biopsy with either subtotal or 18. Chan W, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfi n photodynamic therapy for acute central serous chorioretinopathy. Ophthalmology 2008;115:1756-1765. total curettage, intra-lesional steroid 19. Shin JY, Woo SJ, Yu HG, Park KH. Comparison of effi cacy and safety between half-fl uence and full-fl uence photodynamic therapy for injections, systemic steroid therapy chronic central serous chorioretinopathy. Retina 2011;31:119-126. 20. Bae SH, Heo J, Kim C. Low-Fluence Photodynamic Therapy versus Ranibizumab for Chronic Central Serous Chorioretinopathy: or chemotherapy. Excision and intra- One-Year Results of a Randomized Trial. Ophthalmol 2013 Nov 20. S0161-6420(13)00844-0. doi: 10.1016/j.ophtha.2013.09.024. [Epub lesional steroid injections can spare ahead of print] 21. Witkin AJ, Brown GC. Update on nonsurgical therapy for diabetic macular edema. Curr Opin Ophthalmol 2011;22:185-9. children from the adverse effects of 22. Chiang A, Regillo CD. Preferred therapies for neovascular age-related macular degeneration. Curr Opin Ophthalmol 2011;22:199-204. 23. London NJ, Brown G. Update and review of retinal vein occlusion. Curr Opin Ophthalmol 2011;22:159-65. chemotherapy, with systemic chemo- 24. Lim JW, Kim MU, Shin M-C. Aqueous humor and plasma levels of vascular endothelial growth factor and interleukin-8 in patients with therapy and systemic steroid therapy central serous chorioretinopathy. Retina 2010;30:1465-1471. 25. Kim H-S, Lee JH. The short-term effect of intravitreal bevacizumab for treatment of central serous chorioretinopathy. J Korean reserved for recurrent lesions or le- Ophthalmol Soc 2010;51:860-864. sions that fail to respond to initial 26. Torres-Soriano M, Garcıá-Aguirre G, Kon-Jara V, et al. A pilot study of intravitrealbevacizumab for the treatment of central serous chorioretinopathy (case reports). Graefe’s Arch Clin Exp Ophthalmol 2008;46:1235-1239. excision. 27. Seong HK, Bae JH, Kim ES, et al. Intravitreal bevacizumab to treat acute central serous chorioretinopathy: Short-term effect. Ophthal- mologica 2009;223:343-347. 28. Lim JW, Ryu SJ, Shin M-C. The effect of intravitreal bevacizumab in patients with acute central serous chorioretinopathy. Korean J The author would like to thank Ophthalmol 2010;24:155-158. 29. Bae SH, Heo JW, Kim C, et al. A randomized pilot study of low-fl uence photodynamic therapy versus intravitreal ranibizumab for Edward Bedrossian, MD, Wills Eye chronic central serous chorioretinopathy. Am J Ophthalmol 2011;152:784-92. Hospital Oculoplastics and Orbital 30. Artunay O, Yuzbasioglu E, Rasier R, et al. Intravitreal bevacizumab in treatment of idiopathic persistent central serous chorioretinopathy: A prospective, controlled clinical study. Curr Eye Res 2010;35:91-98. Surgery Service, Ralph Eagle, MD, 31. Chung Y-R, Seo EJ, Lew HM, Lee KH. Lack of positive effect of intravitreal bevacizumab in central serous chorioretinopathy: Meta- analysis and review. Eye 2013;27:1339-46. Wills Eye Pathology Service, and 32. Pikkel J, Beiran I, Ophir A, Miller B. Acetazolamide for central serous retinopathy. Ophthalmology 2002;109:1723-5. Brian Doyle, MD, for their time and 33. Avci R, Deutman AF. Treatment of central serous choroidopathy with the beta receptor blocker metoprolol (preliminary results). Klin Monbl Augenheilkd 1993;202:199-205. assistance in preparing this report. 34. Tatham A, Macfarlane A. The use of propranolol to treat central serous chorioretinopathy: An evaluation by serial OCT. J Ocular Pharmacol Therapeut 2006;22:145-9. 1. Maccheron LJ, McNab AA, Elder J, Selva D, Martin FJ, 35. Golshahi A, Klingmuller D, Holz FG, Eter N. Ketoconazole in the treatment of central serous chorioretinopathy: A pilot study. Acta Clement CI, Sainani A, Sullivan TJ. Ocular adnexal Langerhans Ophthalmologica 2010;88:576-81. cell histiocytosis clinical features and management. Orbit 2006 36. Nielsen JS, Jampol LM. Oral mifepristone for chronic central serous chorioretinopathy. Retina 2011;31:1928-36. 37. Forooghian F, Meleth AD, Cukras C, Chew EY, Wong WT, Meyerle CB. Finasteride for chronic central serous chorioretinopathy. Retina Sep;25(3):169-77. 2011;31:766-71. 2. Harris GJ. Langerhans Cell Histiocytosis of the Orbit: A Need 38. Zhao M, Célérier I, Bousquet E, et al. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest for Interdisciplinary Dialogue. Am J Ophth 2006; 141: 374-78. 2012;122(7):2672-9. 3. Herwig MC, Wojno T, Zhang Q, Grossniklaus HE. Langerhans 39. Bousquet E, Beydoun T, Zhao M, Hassan L, Offret O, Behar-Cohen F. Mineralocorticoid receptor antagonism in the treatment of chronic Cell Histiocytosis of the Orbit: Five Clinicopathologic Cases central serous chorioretinopathy: A pilot study. Retina 2013;33:2096-102. and Review of the Literature. Surv Ophthalmol 2013 Jul- 40. http://clinicaltrials.gov/ct2/show/NCT01990677 Aug;58(4):330-40. 41. Yavas GF1, Küsbeci T, Kasikci M, Günay E, Dogan M, Unlü M, Inan UÜ. Obstructive sleep apnea in patients with central serous chorioretinopathy. Curr Eye Res 2014 39(1):88-92..

July 2014 | Revophth.com | 65

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