Eyeworld

86 A SCRS and the American Academy of Ophthalmol- ogy (AAO) recently re- viewed some aspects of the LASIK Quality of Life Collaboration Project and issued a joint statement on the project. "We believe that a scientifically sound study will affirm that the vast majority of patients are happy with their outcomes and further refine optimal patient selection and pre- operative counseling," said R. Doyle Stulting, M.D., Ph.D., president, ASCRS, and professor of ophthal- mology, Emory University, Atlanta. During a recent LASIK panel symposium and subsequent discus- sions with the FDA, ASCRS and AAO reviewed some aspects of the highly anticipated project. The project, which was launched in 2009, examines patient-reported outcomes following LASIK and is being conducted by the FDA, the National Eye Institute, and the U.S. Department of Defense. It has three phases. Phase one is a web-based questionnaire devel- oped to evaluate patient-reported outcomes that could impact quality of life after LASIK surgery, some of which may be related to the safety of the lasers used in this procedure. The second phase involves a clinical study called Patient-Reported Out- comes with LASIK (PROWL-1), where U.S. military personnel elect- ing LASIK will complete the ques- tionnaire pre-op and at 1, 3, and 6 months post-op. The final phase of the project, the PROWL-2 study, will be a national, multicenter clinical study with a protocol based on the experience from PROWL-1. Phase two, which was reported on by Cdr. Elizabeth Hofmeister, M.D., San Diego, is evaluating the quality of life and satisfaction of post-LASIK patients at the Navy Refractive Surgery Center in San Diego. "In (PROWL-1), military pa- tients are going to serve as a test group to evaluate a questionnaire that we hope can be generalized to any patient, civilian or military," Dr. Hofmeister explained at a recent AAO meeting. The single-arm prospective study will review 500 pa- tients who will fill out a web-based, pre-op, anonymous questionnaire that will serve as a baseline and then three more questionnaires at 1, 3, and 6 months post-op. "One aspect that I'm excited about is the incorporation of sample pictures to try to explain to patients what glare is, what starbursts are, what ghosting is," Dr. Hofmeister said. She added that the data analy- sis of the study will include all of the clinical data and the answers from the questionnaires so that the two can be compared. "We hope to look for contribut- ing factors to these patients' re- ported outcomes," she said. "I have attended several meet- ings with the FDA at the AAO and ASCRS meetings," said Eric D. Donnenfeld, M.D., co-chairman, cornea, Nassau University Medical Center, East Meadow, N.Y. "In these meetings there have been few spe- cific details regarding PROWL-1 and 2. However, I have confidence in the study design based on my conversa- tions with the individuals involved in the study and their commitment to creating a trial that is comprehen- sive and well-balanced." Dr. Donnenfeld said the study will be designed by skilled scientists with the input of quality LASIK sur- geons. Numerous published studies have shown that 95% of patients are satisfied with their LASIK outcomes. Many of those who are not initially satisfied may have experienced is- sues such as glare, halos, and dry eye, which usually diminish with time. Sometimes a patient's vision is unintentionally undercorrected or overcorrected, and a surgical en- hancement may be recommended to achieve optimal results, ASCRS said in a prepared statement. "The data that currently exists conclusively demonstrates the safety and efficacy of LASIK," Dr. Donnenfeld said. "I think these ad- ditional studies will further support what we already know and will help patients understand the minimal risks and overwhelming benefit of LASIK." Dr. Stulting agreed. "We believe that a scientifically sound study will affirm that the vast majority of pa- tients are happy with their outcomes and further refine optimal patient selection and pre-operative counsel- ing," he said. "Our duty as physi- cians is to help our patients understand all of the factors that go into making this decision." During a special session at the 2010 AAO meeting in Chicago titled Dialogue with the FDA: An Eye on LASIK, doctors explained the goal of the project. "The project's ultimate goal is to determine the percentage of patients with significant functional limita- tions after LASIK surgery," said Malvina Eydelman, M.D., director, Division of Ophthalmic, Neurologi- cal, and Ear, Nose, and Throat De- vices, Center for Devices and Radiological Health, FDA, Silver Spring, Md. Dr. Eydelman added that researchers hope to identify fac- tors that led to those patient-re- ported limitations. EW Editors' note: Dr. Donnenfeld has financial interests with Abbott Medical Optics (AMO, Santa Ana, Calif.), Alcon (Fort Worth, Texas), Bausch & Lomb (Rochester, N.Y.), and TLC Vision Corporation (Chesterfield, Mo.). Drs. Eydelman and Hofmeister have no financial interests related to this topic. Dr. Stulting has financial interests with AMO, Alcon, and Bausch & Lomb. Contact information Donnenfeld: 516-446-3525, eddoph@aol.com Eydelman: 301-796-5620, malvina.eydelman@fda.hhs.gov Hofmeister: 619-524-5515, elizabeth.hofmeister@med.navy.mil Stulting: 770-255-3330, dstulting@woolfsoneye.com EW REFRACTIVE SURGERY 86 March 2011 by Jena Passut EyeWorld Staff Writer Study examines patient-reported outcomes after LASIK

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