EyeWorld India June 2015 Issue

48 EWAP REFRACTIVE June 2015 by Ellen Stodola EyeWorld Staff Writer FDA shines light on LASIK PROWL 1 and 2 studies look at patient experiences after LASIK surgery T he recent PROWL 1 and PROWL 2 LASIK studies evaluated the measurement characteristics of a questionnaire assessing patients’ experience after LASIK. Edward Manche, MD , Stanford, Calif., Elizabeth Hofmeister, MD , San Diego, R. Doyle Stulting, MD, PhD , Atlanta, and Malvina B. Eydelman, MD , director of the Division of Ophthalmic and Ear, Nose and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), spoke about the topic. Key results Unlike a clinical trial for the evaluation of LASIK devices, the PROWL studies evaluated the measurement characteristics of a newly developed questionnaire assessing the patient’s experience following LASIK surgery, Dr. Eydelman said. “This questionnaire was developed by incorporating feedback from patients and providers about their postoperative experience,” she said. PROWL 2 assessed the presence of visual symptoms and their severity in the civilian U.S. population, and also measured the impact those symptoms had on a patient’s ability to function. “Overall, the prevalence of visual symptoms did not increase postoperatively as compared to preoperatively. A noteworthy percentage of the patients with visual symptoms preoperatively in both PROWL 1 and PROWL 2 had resolution of those symptoms postoperatively,” Dr. Eydelman said. Dr. Hofmeister was an investigator with the PROWL 1 study, which focused on the U.S. military population. The most important study result was the validation of the questionnaire, she said. “At 6 months, 99.5% of patients had 20/20 or better uncorrected binocular visual acuity, and 76% were 20/12.5 or better (n=217 patients, 434 eyes),” she said. Patients reported a relatively high level of preoperative visual complaints, but 6 months after surgery, complaints had decreased in every category, she said. The biggest drop was for glare symptoms, with 41% complaining of glare symptoms preop and only 17% of the cohort with the symptom at 6 months postop. “The only increase in symptoms was an increase in reported halos at 1 month postop, but these decreased to levels lower than preop by 3 months postop,” she said. Dry eye symptoms in the postoperative period were also examined. While some patients did experience worse dry eye symptoms, overall more patients saw an improvement. “Our satisfaction results were outstanding,” Dr. Hofmeister said. “Six months after treatment, 98% of subjects were satisfied with the result of their LASIK surgery, and 97% of patients were satisfied with their present vision.” Dr. Manche was an investigator at one of the PROWL 2 study sites, which included a civilian population, and he thinks that the study showed great results. “If you look at visual outcomes, greater than 91% of eyes had an uncorrected visual acuity of 20/20 or better at 3 months,” he said. “If you look at binocular, uncorrected visual acuity was greater than 95% of eyes 20/20 or better.” “The other noteworthy thing is the safety of the surgery,” Dr. Manche said. If you look at symptoms, comparing preop to postop and Patients were asked, “How satis ed are you with the result of your LASIK surgery?” Source: Elizabeth Hofmeister, MD continued on page 50