Eyeworld

64 November 2016 EW REFRACTIVE by Ellen Stodola EyeWorld Senior Staff Writer Schallhorn said. "But the symptoms on average decreased." It's import- ant for surgeons, the public, and patients to understand what the surgery can do, he added. Physicians can look at preva- lence and how bothersome it is, but what is really patient specific is how much difficulty they're having doing daily activities because of visual symptoms, Dr. Schallhorn said. In every category, the number of patients with difficulty was reduced after surgery. The PROWL-1 study asked about the Ocular Surface Disease Index (OSDI), Dr. Schallhorn said, which many people consider definitive in a questionnaire to ask about symp- toms related to dry eye. Patients can have dry eye symptoms postop, but incidence of severe symptoms is reduced 3 to 6 months after LASIK compared to beforehand. "I think this was one of the most carefully conducted and con- trolled studies on LASIK outcomes, and allows us to understand LASIK variety of other satisfaction-related questions. The PROWL-1 study had a total of 262 patients enrolled, while PROWL-2 had 312 enrolled. Dr. Schallhorn noted that the number of patients in each group who com- pleted the baseline questionnaire, had surgery and then completed questionnaires at 1, 3, and 6 months postop was lower than the initial numbers enrolled in each group. Both the PROWL-1 and PROWL-2 studies showed a low- er prevalence of symptoms at 3 months postop compared to pre- operatively. This included a reduc- tion in ghosting, glare, halos, and starbursts in both groups. Addition- ally, the prevalence of bothersome visual symptoms decreased, in some instances significantly. It's not necessarily the case that LASIK increases visual symptoms, Dr. Schallhorn said. The main out- come was that patients with bother- some or very bothersome symptoms decreased after LASIK. "[That is] not to say that they won't have bother- some symptoms after surgery," Dr. Center of San Diego, and all of the patients in this part of the study were active duty military personnel. PROWL-2, the other arm of the study, had five clinical sites around the U.S. There has been a shift in how people view outcomes now, Dr. Schallhorn said, whether it's a cat- aract or refractive procedure. This shift factors into what the patient thinks about the procedure results and not just the clinical measure- ment of success. The PROWL study drilled down on what patients think about the procedure, Dr. Schallhorn said, and the questionnaire was created with considerable care. He added that the clinical investigators had no access to the questionnaires, which weren't given in the clinic, and patients went on a website to answer the questions independent from their visit. Patients were asked to judge their degree of visual symptoms, if they experienced these symptoms with and without glasses, and a A webinar supported by the ASCRS Refractive Sur- gery Clinical Committee focused on LASIK and LASIK outcomes. "Mod- ern LASIK Outcomes and Patient Satisfaction: A Deep Dive Into What We Learned from the PROWL Study" was moderated by Vance Thompson, MD, Sioux Falls, South Dakota, with presentations by Steven Schallhorn, MD, San Diego, and Steven Dell, MD, Austin, Texas. One key focus of the webinar was the LASIK PROWL study, which looked at patient-reported LASIK outcomes. "The PROWL study was one of the most pivotal studies that has been conducted in LASIK to date," Dr. Schallhorn said. The study was the first of its kind, he added, as it was driven by the director of the FDA's Division of Ophthalmic and Ear, Nose, and Throat Devices, Malvina Eydelman, MD. There were two parts of this clinical study. In PROWL-1, the principle investigator was Elizabeth Hofmeister, MD, Navy Medical ASCRS webinar focuses on LASIK outcomes and satisfaction New refractive option According to Mr. Mazzo, as a next generation procedure, SMILE will invigorate the refractive surgery market in the U.S. "I think we all know the refrac- tive market needs some energy," he said. "I think this is stimulating that marketplace." According to Dr. Dishler, pa- tients are captivated by the idea of SMILE, and refractive surgeons are excited about being able to offer it. Without the need to create a flap, there is no algorithm adjustment needed, and the laser calculates just the right amount of tissue needed to be removed, he said. The benefit of this is that the procedure works just as well for patients with high myo- pia as it does for patients with low myopia, which is not always true of LASIK, he said. The procedure is currently ap- proved to treat between 1 and 8 D of myopia with up to 0.5 D of astigma- tism, so it is not yet a solution for patients with significant astigmatism, but can treat virtually all patients with myopia, Dr. Dishler said. Dr. Dishler is currently part of an ongoing clinical study to exam- ine the effectiveness of SMILE in correcting astigmatism, and if the procedure is approved for that use, this will hopefully make it a more comprehensive option for patients, he said. The inclusion and exclusion criteria for SMILE patients are similar to those of LASIK, but the procedure is not great for extremely nervous patients who are prone to squeeze their eyes during surgery, Dr. Dishler said. "There's a period of about 20 seconds where the lenticule is being cut, and if patients squeeze their eyes, they can interrupt the proce- dure," he said. If that happens, the patient loses the ability to continue with SMILE but can go on to anoth- er procedure such as PRK or LASIK. SMILE is great for patients for whom having a flap is particularly a problem, such as members of the military and first responders, he said. In addition, the learning curve for the procedure is relatively fast for experienced refractive surgeons, he said. While Carl Zeiss Meditec will provide training for physicians new to the procedure, Dr. Dishler rec- ommended acquiring the laser and gaining some experience making corneal flaps before moving on to performing SMILE. Is this the end of LASIK? While some physicians feel the SMILE procedure threatens the current market of LASIK or PRK, Dr. Dishler disagrees. "I think it enlarges the opportunity and is a comple- mentary innovation to what already exists," he said. "I think the people who are going to strongly adopt this are those people who wear soft contact lenses, who didn't feel that LASIK or PRK met their needs. … I think it will increase the number of people who will have refractive sur- gery, rather than steal patients away from other procedures that already exist at this point." Mr. Mazzo does not see SMILE as a procedure that will immediately replace LASIK and PRK. "This is not an anti-LASIK procedure—this is a next generation procedure," he said. "It's a new op- tion for patients who have questions about the existing options." SMILE will likely be a premium procedure, at least in the beginning, according to Dr. Dishler. "The pricing of LASIK has been moderated by the competition; if there is a price differential, that will certainly play into people's decisions about it," he said. However, he sus- pects patients will embrace the new refractive option. "I think the public acceptance of this will be pretty strong because it meets what people expect in today's world from refractive surgery," he said. EW Editors' note: Mr. Mazzo and Dr. Dishler have financial interests with Carl Zeiss Meditec. Contact information Carl Zeiss Meditec: alice.swinton@zeiss.com Dishler: jond@dishler.com SMILE continued from page 63 continued on page 66 Webinar reporter

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