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EW SHOW DAILY 56 ASCRS Symposia Saturday, April 14, 2018 D o you know what to do if you have an unexpected challenge during cataract surgery? Unless you have a no-fail game plan, you'll want to attend tomorrow's sympo- sium "Surgical Essentials: Getting You Out of Trouble in Cataract Surgery." The symposium is sponsored by the Alliance of Cataract and Refrac- tive Specialty Societies, a group that includes ASCRS, the Asia-Pacific As- sociation of Cataract and Refractive Surgeons (APACRS), the European Society of Cataract and Refractive Surgeons (ESCRS), and the Latin American Society of Cataract and Refractive Surgeons (ALACCSA-R/ LASCRS). The moderators will be Gra- ham Barrett, FRANZCO, Nedlands, Australia, William De La Peña, MD, Huntington Park, California, and Beatrice Cochener, MD, Brest, France. Edward Holland, MD, Cin- cinnati, will chair the symposium. The session schedule is as follows: 8:00 a.m.: Welcome and Introductions Edward Holland, MD 8:02 a.m.: Fuchs' Dystrophy Jesper Hjortdal, MD Learn how to "get out of trouble" during cataract surgery Find out steps FDA is taking to accelerate the process during Sunday symposium T his year's FDA symposium, "Accelerating Drug and Device Innovation: FDA's Reorganization and Over- haul of the Regulatory Review Process to Bring Innovative How will FDA reorganization impact the drug and device review process? 8:13 a.m.: Small Pupil Virgilio Centurión, MD 8:24 a.m.: Capsular Tears Mun Wai Lee, MD 8:35 a.m.: High Intraocular Pressure/Shallow AC Richard Hoffman, MD 8:46 a.m.: Hard Nucleus Ernesto Otero, MD 8:57 a.m.: Vitreous Loss Samaresh Srivastava, MD 9:08 a.m.: Unhappy Multifocal IOL Patient Gerd Auffarth, MD 9:19 a.m.: Zonular Loss Terry Kim, MD 9:27 a.m.: Discussion The symposium will be held tomor- row from 8:00–9:30 a.m. in the Con- vention Center, Level 1, 146BC. The symposium is part of the Essentials track. EW and Effective Products to Market," will look at the agency's efforts to improve the regulatory process, including through recent reorganiza- tion and how it will impact ophthal- mic drugs and devices. Tasked with improving access to the safest and most effective treat- ments by the recent 21st Century Cures Act, the FDA is undertaking major reorganization to meet these goals. FDA speakers Malvina Eydel- man, MD, director of the Division of Ophthalmic and Ear, Nose and Throat Devices, and Peter Stein, MD, deputy director of the Center for Drug Evaluation and Research, will discuss the reorganization and efforts to bring new ophthalmic drugs and devices to the market through a new, streamlined pro- cess to accelerate decision-making. Following Dr. Eydelman's and Dr. Stein's presentations, ASCRS FDA Committee Chair Natalie Afshari, MD, San Diego, will moderate a discussion, including questions from the audience. The FDA symposium will be held tomorrow from 1:00–2:30 p.m. on Level 1, 152AB of the Conven- tion Center. EW View the EyeWorld CME and non-CME supplements at: cmesupplements. eyeworld.org supplements. eyeworld.org The third refractive surface: Improving surgical outcomes with advanced diagnostics and therapeutics continued on page 2 Accreditation Statement This activity has been planned and imple- mented in accordance with the accreditation requirements and policies of the Accredi- tation Council for Continuing Medical Edu- cation through the joint providership of the American Society of Cataract and Refractive Surgery (ASCRS) and EyeWorld. ASCRS is accredited by the ACCME to provide continu- ing medical education for physicians. Educational Objectives Ophthalmologists who participate in this activity will: • Improve practice protocols for the screening, diagnosis, and classification of ocular surface disease Designation Statement The American Society of Cataract and Refractive Surgery designates this enduring materials educational activity for a maximum of 1.0 AMA PRA Category 1 Credits. ™ Phy- sicians should claim only credit commensu- rate with the extent of their participation in the activity. Claiming Credit To claim credit, participants must visit bit.ly/2vfjjgk to review content and down- load the post-activity test and credit claim. All participants must pass the post-activity test with a score of 75% or higher to earn credit. Alternatively, the post-test form included in this supplement may be faxed to the number indicated for credit to be awarded, and a certificate will be mailed within 2 weeks. When viewing online or downloading the material, standard internet access is required. Adobe Acrobat Reader is needed to view the materials. CME credit is valid through February 28, 2018. CME credit will not be awarded after that date. Notice of Off-Label Use Presentations This activity may include presentations on drugs or devices or uses of drugs or devices that may not have been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for specific uses only. ADA/Special Accommodations ASCRS and EyeWorld fully comply with the legal requirements of the Americans with Disabilities Act (ADA) and the rules and regulations thereof. Any participant in this educational program who requires special accommodations or services should contact Laura Johnson at ljohnson@ascrs.org or 703-591-2220. Financial Interest Disclosures Kenneth Beckman, MD, has an investment interest in and has received a retainer, ad hoc fees or other consulting income from EyeXpress and RPS. He has received a retainer, ad hoc fees or other consulting income from and is a member of the speakers bureau of: Alcon, Allergan, Shire, Sun Pharma, and TearLab. Dr. Beckman has received a retainer, ad hoc fees or other consulting income from Bausch + Lomb and TearLab. Eric Donnenfeld, MD, has an investment interest in and has received a retainer, ad hoc fees or other consulting income from: AcuFocus, AqueSys, Elenza, Glaukos, Icon Biosciences, Kala Pharmaceuticals, Katena, Mimetogen, Novabay, Omeros, PRN, and TearLab. He has an investment interest in: LacriScience, Mati, Omega Ophthal- mics, Ocuhub, Pogotec, RPS, Strathspey Crown, TrueVision, and Versant Ventures. Dr. Donnenfeld has received a retainer, ad hoc fees or other consulting income from: Abbott, Alcon, Allergan, Bausch + Lomb, Beaver-Visitec, Foresight, Novaliq, Shire, and TLC Laser Centers. He is a member of the speakers bureaus of: Pfizer, RPS, and TLC Laser Centers, and he has received research funding from: Alcon, Allergan, Bausch + Lomb, Beaver-Visitec, Icon Biosciences, Kala, Omeros, PRN, and Shire. Francis Mah, MD, has an investment inter- est in Sydnexis. He has received a retainer, ad hoc fees or other consulting income from Abbott, Aerie, Alcon, Allergan, Bausch + Lomb, CoDa, NovaBay, Ocular Science, Okogen, Omeros, PollyActiva, Shire, Sun Pharma, TearLab. Dr. Mah is a member of the speakers bureau of: Abbott, Alcon, Allergan, Bausch + Lomb, Shire, and Sun Pharma. He has received research funding from Abbott, Allergan, and Ocular Science. Christopher Starr, MD, has an investment interest in GlassesOff/Innovision and Tear- Lab. He has received a retainer, ad hoc fees or other consulting income from: Allergan, Bausch + Lomb, GlassesOff/Innovision, Re- Focus, RPS, Shire, Sun Pharma, and TearLab. Dr. Starr is a member of the speakers bureau of Alcon, Allergan, and Bausch + Lomb He has received research funding from RPS and travel expense reimbursement from TearLab. Elizabeth Yeu, MD, has an investment interest in Modernizing Medicine and RPS. She has received a retainer, ad hoc fees or other consulting income from and is a member of the speakers bureau of: Abbott, Alcon, Allergan, BioTissue, iOptics, Shire, and TearLab. Dr. Yeu has received a retainer, ad hoc fees or other consulting income from: ArcScan, Bausch + Lomb, Kala, Ocular Therapeutix, OcuSoft, Omeros, and TopCon. She has received research funding from BioTissue, iOptics, and Kala. Staff members: Kristen Covington and Laura Johnson have no ophthalmic-related financial interests. Supplement to EyeWorld September 2017 allows us to examine patients' lids and meibomian glands. Further- more, we can show our findings to patients so they understand their disease, especially if they have no symptoms. we are more likely to diagnose the condition accurately. In addition to point-of- care tests, I use lissamine green staining. We perform dynamic meibomian gland imaging on al- most every surgical candidate and patient with dry eye symptoms. It surgery, refractive cataract sur- geons are less likely to achieve the surgical outcomes patients seek. Diagnostic advances Dry eye is often misdiagnosed, and if patients are treated for the incorrect disease, they will not respond to therapy. To improve treatment, oph- thalmologists need to make the correct diagnosis the first time, but we need to do it simply and efficiently. Point-of-care tests have changed the way we diagnose dry eye. Ophthalmologists should empower technicians to order and perform this testing based on patients' symptoms. Combin- ing these results with our other findings from the examination, Advanced OSD diagnostics and treatments play key role in surgical results P atients older than 70 years have an almost 100% chance of having meibomian gland disease, and many also have aqueous deficiency dry eye. If dry eye remains undiagnosed or is not treated properly before by Eric Donnenfeld, MD Preoperative strategies help clinicians achieve optimal postoperative outcomes Eric Donnenfeld, MD " Refractive cataract surgeons cannot perform premium surgery without a premium ocular surface. " —Eric Donnenfeld, MD Supported by unrestricted educational grants from Allergan, Shire Pharmaceuticals, TearLab, and TearScience Click to read and claim CME credit Supplement to EyeWorld March 2018 surface," Preeya Gupta, MD, said. There is some- times confusion on how to use these tests. They can help to push the needle in terms of your Supported by unrestricted educational grants from Shire, TearLab, and TearScience Customizing modern OSD therapies to individual patient needs Accreditation Statement This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continu- ing Medical Education through the joint providership of the American Society of Cataract and Refractive Surgery (ASCRS) and EyeWorld. ASCRS is accredited by the ACCME to provide continuing medical education for physicians. Educational Objectives Ophthalmologists who participate in this activity will: • Evaluate current protocols for screen- ing, diagnosis, and classification of OSD • Modify protocols as necessary • Match therapeutic classes to associated diagnosis Designation Statement The American Society of Cataract and Refractive Surgery designates this enduring materials educational activity for a maximum of 1.0 AMA PRA Category 1 Credits. ™ Physicians should claim only credit commensurate with the extent of their participation in the activity. Claiming Credit To claim credit, participants must visit bit.ly/2E60E7R to review content and download the post-activity test and credit claim. All participants must pass the post-activity test with a score of 75% or higher to earn credit. Alternatively, the post-test form included in this supplement may be faxed to the number indicated for credit to be awarded, and a certificate will be mailed within 2 weeks. When viewing online or downloading the material, standard internet access is required. Adobe Acrobat Reader is needed to view the materials. CME credit is valid through July 31, 2018. CME credit will not be awarded after that date. Notice of Off-Label Use Presentations This activity may include presentations on drugs or devices or uses of drugs or devices that may not have been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for specific uses only. ADA/Special Accommodations ASCRS and EyeWorld fully comply with the legal requirements of the Americans with Disabilities Act (ADA) and the rules and regulations thereof. Any participant in this educational program who requires special accommodations or services should contact Laura Johnson at ljohnson@ascrs. org or 703-591-2220. Financial Interest Disclosures Zaina Al-Mohtaseb, MD, has received a retainer, ad hoc fees or other consulting income from Allergan and is a member of the speakers bureau of Alcon. Preeya Gupta, MD, has received a retainer, ad hoc fees or other consulting income from Alcon, Allergan, Aurea, Bio-Tissue, Johnson & Johnson Vision, NovaBay Pharmaceuticals, Ocular Science, Shire, TearLab, and TearScience. Terry Kim, MD, has an investment interest in Ocular Therapeutix, Omeros, and TearScience. He has received a retainer, ad hoc fees or other consulting income from Acucela, Aerie, Alcon, Allergan, Avellino Labs, Bausch + Lomb, BlephEx, CoDa Therapeutics, Foresight Biotherapeutics, Kala Pharmaceuticals, NovaBay, Novartis, Ocular Systems Inc., Ocular Therapeutix, Oculeve, Omeros, PowerVision, Presbyopia Therapies, Shire, TearLab, and TearScience. Francis Mah, MD, has an investment interest in Sydnexis. He has received a retainer, ad hoc fees or other consulting income from Abbott, Aerie, Alcon, Allergan, Bausch + Lomb, CoDa, NovaBay, Ocular Science, Okogen, Omeros, PollyActiva, Shire, Sun Pharma, and TearLab. Dr. Mah is a member of the speakers bureau of Abbott, Alcon, Allergan, Bausch + Lomb, Shire, and Sun Pharma. He has received research funding from Abbott, Allergan, and Ocular Science. Staff members: Kristen Covington, Laura Johnson, and Ellen Stodola have no oph- thalmic-related financial interests. continued on page 2 together information in addition to a slit lamp exam. "I look at diagnostic and point-of-care testing as getting a snapshot of the health of the ocular pacts patient satisfaction in postop cataract and refractive patients. Other survey questions asked about primary therapy for moderate and severe dry eye, as well as treat- ment options for meibo- mian gland dysfunction (MGD). Additionally, 83% of respondents indicated that they would find an algorithm for ocular sur- face diagnostics valuable. A lot of patients who have dry eye are often asymptomatic, Zaina Al-Mohtaseb, MD, said. This is why in addition to subjective questionnaires, objective tests like MMP-9 and osmolarity are im- portant. Physicians have access to various diag- nostic tests that can be used collectively to piece Clinical Survey and introduction Terry Kim, MD The ASCRS Clinical Survey was completed in May 2017 to assess clini- cal opinions and practice patterns. Data from the survey indicates that 91% of ASCRS respondents think mild to moderate dry eye significantly im- " Data from the survey indicates that 91% of ASCRS respondents think mild to moderate dry eye significantly impacts patient satisfaction in postop cataract and refractive patients. " —Terry Kim, MD Click to read and claim CME credit The news magazine of the Asia-Pacific Association of Cataract & Refractive Surgeons Sponsored by Carl Zeiss Meditec SMILE: Redefining refractive surgery APACRS Supplement to EyeWorld Asia-Pacific Fall 2017 Rupal Shah, MD, Vadodara, India Figure 1. Change in BCVA over time My 9-year SMILE journey I t's been a long time since Rupal Shah, MD, Va- dodara, India, started her journey with SMILE using the VisuMax femtosecond laser. Some things, she said, have remained unfulfilled, but certain dreams did come true. Dr. Shah started her SMILE journey 9 years ago, and she considers it the most fortunate thing that has hap- pened to her. Performing and being able to contribute mean- ingfully to the development of the procedure as well as mak- ing great friends, traveling, and developing as a person have all made SMILE the most fulfilling part of her professional life. Changes over the years Nine years ago, she said, SMILE was just a possibility, beginning as FLEx, femtosec- ond lenticule extraction. The laser was much slower—just 200 kHz against today's 500 kHz. The laser also used a re- verse scanning pattern, higher energy, and lower spot and track spacing. The scanning pattern would begin at the center, moving to the periphery. The second pass would then move from the periphery to the center, taking much longer to complete than the laser does today. The incision length was also much larger, allowing the surgeon to lift a flap and re- move the lenticule. After a few procedures, Dr. Shah realized that FLEx lenticule extraction had few advantages over conventional LASIK surgery, and so proceeded to perform pseudoSMILE within a month from starting FLEx, and SMILE just a few months later. What made the difference from those early days, Dr. Shah said, was the change in scanning pattern. The original scanning pattern allowed bub- bles to accumulate in the cen- ter, distorting the tissue before the second incision laser pass. This resulted in distorted corne- al topography and delayed visual recovery. Changing the scanning pattern produced starkly dif- ferent results—from just 65% achieving a 1-day postop un- corrected visual acuity (UCVA) equivalent to the preop best corrected visual acuity (BCVA) to 83% visual recovery. This was the procedure's eureka moment, changing the whole scenario. The test of time Long-term follow-up is particu- larly important for establishing the value of SMILE in refractive practice; with the procedure being done primarily for young individuals, refractive changes can occur over the years. Fur- thermore, SMILE is competing with earlier procedures such as PRK and LASIK, which are more than 20 years in clinical practice. Dr. Shah has thus been conducting an ongoing study to see how the procedure stands the test of time. To date, out of 132 patients who underwent SMILE or FLEx for myopia or myopic astigmatism with spherical equivalent less than –10 D between August 2008 and 2009, 30 returned for a fol- low-up in April and May 2016. All patients had been treated with the 200-kHz laser, most with the old scanning pattern. The results, Dr. Shah said, even with the older techniques, were astonishing. In 7.5 years, the refraction remained stable, with very little deviation from that achieved at 6 months and 1 year postop. In terms of efficacy and safety, the UCVA and BCVA, respec- tively, changed very little over time, with a non-statistically significant improvement in BCVA over time (Figure 1). Topography studies further showed true 6-mm zones, while induced higher order ab- errations were equal to or less than LASIK treatment. In terms of subjective satisfaction, 100% of patients reported satisfaction with the procedure, saying they would recommend the procedure to friends or relatives, four patients reported dryness or grittiness in their eyes, and two patients reported difficul- ties driving at night. No other subjective symptoms were reported. SMILE: 9 years on SMILE has come a long way over the years, with better surgical techniques and a faster laser with better energy parameters and an improved scan pattern. However, early results are, in Dr. Shah's ex- perience, as good as or better than other competing refractive procedures—even after several years. In April 2017, Carl Zeiss Meditec (Jena, Germany) conducted a user meeting in Singapore. More than just a showcase for their latest technologies, the company's user meeting has grown into a venue for peer-to-peer sharing of information among the world's top ophthalmic surgeons. The first symposium of the meeting focused on SMILE, small incision lenticule extraction, performed with the ZEISS VisuMax femtosecond laser, and how this cutting-edge procedure is redefining the field of refractive surgery. 100 75 50 25 0 <=20/15 <=20/20 <=20/25 <=20/30 Six months 7.5 years The news magazine of the Asia-Pacific Association of Cataract & Refractive Surgeons Optimizing SMILE APACRS Supplement to EyeWorld Asia-Pacific Winter 2018 Effect of angle kappa on visual outcomes in SMILE T he centration of any refractive surgery is vital, said Jodhbir Mehta, MD, Singapore. Accurate centration reduces photic phenomena such as glare, halos, and induced higher order aberrations that can occur postoperatively. Experience with LASIK, Dr. Mehta said, has shown that accurate centration is achieved by several means—via faster lasers, greater accuracy with smaller spot sizes, and the use of eye trackers. There are also several options for centration: It can be done centering on the pupil, the visual axis, the corneal vertex or the coaxial sight- ed corneal light reflex. Some of these, he said, are easier and more well defined than others. Reference points, axes, angles When centering a refractive proce- dure, it is important to understand the relationship between various reference points, axes, and angles: angle kappa, the angular distance between the visual and pupillary axes; the pupillary axis, a line passing through the center of the pupil perpendicular to the cornea; the visual axis, connecting the fovea with a fixation point, passing the nodal point of angle lambda; angle lambda, the angular distance between the pupillary axis and line of sight; line of sight, the line run- ning through the center of the pupil to a fixation point; the corneal ver- tex, the point of maximum elevation when viewing a target, near the line of sight, reproducible independent of pupil size; and Purkinje images. Dr. Mehta focused on the effect of angle kappa on SMILE outcomes. Considering angle kappa Several corneal topographers currently available provide mea- surements of angle kappa, though surgeons should be aware that some provide them in polar coordi- nates, others in Cartesian coordi- nates; these can be interchanged using appropriate mathematical formulations. In terms of distribution, angle kappa trends smaller in myopic eyes, tending to be larger in the left eye and reducing with age, but varies such that some myopic eyes have no angle kappa and others have negative angle kappa—an important consideration for myopic treatments. One other consideration for surgeons: While docking with the femtosecond laser obviates the need for an eye tracker, this means that centration must be accurate at the time of docking—being based on patient fixation, the docking does not aim for the center of the pupil. Angle kappa and SMILE Studies have looked into basic centration with SMILE, showing it to be comparable to centration with LASIK. However, all studies rely on comparison with topography scans following patient treatment; what surgeons really need to know with regard to centration, Dr. Mehta said, is whether there is something they can do either intraoperative- ly or before treatment to predict whether a procedure will go badly. Dr. Mehta and his colleagues conducted a retrospective study on 164 consecutive eyes to evaluate centration during SMILE, investi- gating the impact on predictability, efficacy, and safety. Correlating outcomes with decentration from the pupillary cen- ter, there was a tendency toward better vision with around 0.2 mm of decentration; visual acuities of 20/20 or better were achieved by 78.6% of eyes with more than 0.2 mm of decentration, compared with only 68.8% in eyes with less than 0.1 mm of decentration and 66.7% in eyes with between 0.1 mm and 0.2 mm of decentration. Correlating outcomes with decentration from the angle kappa, on the other hand, showed that better uncorrected visual acuity was achieved with from 0.4 mm to less than 0.6 mm of decentration. Moreover, all of the patients who had the greatest decentrations of 0.6 mm or above were the pa- tients who had the highest degree of angle kappa preoperatively; pa- tients with large angle kappa preop show a large offset from the pupil center after docking (Figure 1). The surgeon can therefore predict this outcome preoperatively by measuring the angle kappa. Aiming for centration close to the visual axis is supposed to provide the best visual outcomes. The study confirms that SMILE lenticules not centered on the pupil center provide better visual outcomes for patients with large angle kappa. In April 2017, Carl Zeiss Meditec (Jena, Germany) conducted a user meeting in Singapore. More than just a showcase for their latest technologies, the company's user meeting has grown into a venue for peer-to-peer information sharing, where the world's top ophthalmic surgeons come not only to teach, said symposium chair Gerard Sutton, MD, but also to learn. The second symposium of the meeting focused on optimizing SMILE (small incision lenticule extraction) performed with the ZEISS VisuMax femtosecond laser. Sponsored by Carl Zeiss Meditec Jodhbir Mehta, MD, Singapore Figure 1. Patients who had the greatest decentrations were also those who had the highest degree of angle kappa preop. Kappa intercept Decentration from kappa intercept <0.2 0.2 to <0.4 0.4 to <0.6 At least 0.6 Total 0 to < 0.1 5 0 0 0 5 Proportion 23.8% 0.0% 0.0% 0.0% 3.1% 0.1 to < 0.2 7 13 0 0 20 Proportion 33.3% 24.5% 0.0% 0.0% 12.3% 0.2 to < 0.3 6 19 3 0 28 Proportion 28.6% 35.8% 7.1% 00% 17.3% 0.3 to < 0.4 3 13 12 0 28 Proportion 14.3% 24.5% 28.6% 0.0% 17.3% 0.4 to < 0.5 0 8 17 5 30 Proportion 0.0% 15.1% 40.5% 10.9% 18.5% 0.5 to < 0.6 0 0 6 8 14 Proportion 0.0% 0.0% 14.3% 17.4% 8.6% 0.6 to < 0.7 0 0 4 8 12 Proportion 0.0% 0.0% 9.5% 17.4% 7.4% 0.7 to < 0.8 0 0 0 10 10 Proportion 0.0% 0.0% 0.0% 21.7% 6.2% 0.8 and above 0 0 0 15 15 Proportion 0.0% 0.0% 0.0% 32.6% 9.3%

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