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EW SHOW DAILY 44 ASCRS Symposia Monday, May 8, 2017 by Rich Daly EyeWorld Contributing Writer that the simplest, safest, and easiest thing to do is to leave you at –2 D." If patients say they don't want that, then Dr. Dell takes that option off the table and offers to make them plano for distance in both eyes, which is the second simplest option. If when he tells them they will need reading glasses for close vision and the patient rejects it then that option is dropped. I t can be a challenge to find the right lens for older myopic cataract patients who read with- out glasses. An approach one surgeon uses is to have them talk him into implanting a multifo- cal IOL. "The way I approach these patients is I make them talk me back into a multifocal," said Steven Dell, MD, Austin, Texas, said. "I will say Then Dr. Dell describes the near sight of nearsightedness, which some refer to as "nearsighted near" or "seeing the wings on a fly," and tells them they cannot have that but they might be able to have some- thing sort of like it. Would they want that? "They begin talking you into the surgery, and when they get to that point then their expectations have been sufficiently modified and they may be multifocal IOL candi- dates, which is probably going to be the best ultimate resolution to their desire of maximum spectacle independence," Dr. Dell said. Vance Thompson, MD, Sioux Falls, South Dakota, said that ap- proach "is so powerful" because it avoids problems he has had with implanting multifocal lenses in low diopter myopic patients. "They're typically fine with their distance but it is the near-sighted near that they lived their life with that they are giving up because so much of the imagery is dedicated to distance vision, so their near is just not the same," Dr. Thompson said. "That is what I've been burned on." The challenge of such patients— who don't usually wear glasses for driving either—can stem from their belief that having forgone refractive surgery in the past, cataract surgery is their time to take care of every vision issue, Dr. Thompson said. Many surgeons think of mono- vision first for such patients because it works great—without complaints of glare and haloes—for many other types of patients, such as those who have undergone corneal refractive surgery. "The problem with monovision is complete spectacle independence is only reported in about a quarter of them," Dr. Thompson said. "Most of them are using glasses for some- thing." If the cataract in such patients is not too far progressed, A. John Kanellopoulos, MD, Athens, Greece, has had good success trialing a multifocal contact lens in such patients. "Seeing how they feel being plano in a high add contact lens, When and how to have a patient talk you into a multifocal In older myopic cataract patients who read without glasses, Dr. Kanellopoulos says he has successfully used multifocal contact lenses with minimally progressed cataracts. or compounding, he said, and there is no approved commercial solution in the U.S. Is this really a problem? It makes the headlines, but in an attempt to look at this, very few people out of the respondents think that they've seen a complication from it. "It's certainly a threat, but probably not very common." Eighty-four percent indicated they would use this if it were available in a commercial product, Dr. Chang said, which he noted is similar to a small survey of ESCRS surgeons in which 90% said they would use it if commercially available. So in their mind, if you take away the safety is- sue by having a commercial product, the efficacy seems to be convincing enough, he said. Wiley Chambers, MD, Wash- ington, D.C., deputy director of the Division of Transplant and Ophthal- mology Products Center for Drug Evaluation and Research at the FDA, discussed a regulatory perspective on off-label communication. Dr. Chambers commented on a num- ber of purposes and policies of the FDA. He also addressed intracameral prophylaxis and endophthalmitis. He recognized that there seems to be a decreasing rate of endophthalmitis over the past 10 years. But what is this attributed to? Dr. Chambers said this could be due to a number of factors including better instrumen- tation in the operating room, use of povidone iodine preoperatively, or intracameral antibiotics, among other things. There are a number of cataract prophylaxis studies, he said, noting that, from his perspective, it's un- fortunate that there are no adequate well-controlled trials because that's the basis to be able to approve the medication. Dr. Chambers also discussed studies looking at the decreasing rate of endophthalmitis, adding that though the rate seems to go down, it's unclear if this is directly related to the intracamerals. The FDA can- not approve the product without an adequate trial, he said. He referenced the ESCRS study, which Dr. Chang discussed as well, noting that it was not an adequate well-controlled trial. There was po- tential bias because treatments were unmasked, he said. There was also no stratification for potential en- dophthalmitis risk factors, and the endophthalmitis rates in the control group were unusually high, he said. Additionally, other potentially troubling factors were the cumula- tive effect of doing multiple interim analysis and the fact that the trial was stopped with a p-value that was higher than would typically stop a trial early. Dr. Chambers added that this trial did not follow U.S. guid- ance for data monitoring committee procedures. The ESCRS study had a number of different teaching points it tried to make, Dr. Chambers said. The risk factor of cefuroxime injections was mentioned, but other risk factors were not identified. The highest risk factor was the surgical site, he said, adding that more cases of clear cor- nea had endophthalmitis than other approaches. Additionally, the use of a silicone IOL had a higher risk of endophthalmitis. Addressing off-label use of prod- ucts directly, Dr. Chambers said that the goal of the FDA is to have all potential uses of a product studied, to convey reliable information for use by patients and physicians, and to convey the benefits and risks of a product and allow for informed use. Dr. Chambers said that the FDA recognizes that off-label use will be important, specifically quoting from an FDA-guidance document that says the FDA "recognizes that off-la- bel uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care." Also during the session Doyle Stulting, MD, PhD, Atlanta, dis- cussed regulations and off-label product use in his presentation, and Charles Leiter, PharmD, San Jose, California, highlighted challenges of compounding pharmacies in this day and age. EW Editors' note: Dr. Chambers works at the FDA but noted that his views are his own; he has no relevant financial interests. Dr. Chang has no relevant financial interests. Looking continued from page 43 continued on page 46

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