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FDA leads LASIK quality-of-life study, warns ASCs about adverse event reporting
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The U.S. Food and Drug Administration, National Eye Institute and U.S. Department of Defense are joining forces to scrutinize LASIK outcomes and their impact on quality of life, according to an FDA press release.
"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health, said in the release.
The government-funded LASIK Quality of Life Collaboration Project will be conducted in three phases. The first phase, launched in July, will involve the creation of a Web-based questionnaire to gauge patient-reported LASIK outcomes and related quality-of-life issues.
The second phase will assess patient satisfaction after LASIK and quality of life based on reports from active-duty military personnel who undergo LASIK at the Navy Refractive Surgery Center.
The third phase, a national, multicenter clinical trial, is designed to gauge quality of life after LASIK in the general population.
Patients are not yet enrolled in the second and third phases. The third phase is anticipated to be completed in 2012, the release said.
In addition, the FDA issued warning letters to 17 LASIK ASCs after inspections showed that the centers did not have sufficient adverse event reporting procedures. The inspections did not identify problems related specifically to the use of LASIK devices at those centers.
Under federal law, nursing homes, outpatient clinics, ASCs and other user facilities are required to report device-related deaths to the FDA and the device manufacturer. They must also report device-related serious injuries to the manufacturer or to the FDA if the manufacturer's identity is not known.
The FDA plans to inspect more ASCs, the release said.
"Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law," Dr. Shuren said. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."