New FDA Study Seeks Feedback on Lasik Surgery

FRIDAY Oct. 16, 2009 -- The percentage of patients who experience serious quality-of-life problems after Lasik eye surgery is being studied by the U.S. Food and Drug Administration, which has also issued warning letters to a number of Lasik facilities that weren't properly reporting problems with the procedure.

The FDA study, which will also identify factors that predict quality-of-life problems in Lasik patients, has three phases. Phase 1, launched in July 2009, involves the design and launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues after the laser-assisted eye surgery.

Phase 2 will examine quality of life and satisfaction among patients treated at the Navy Refractive Surgery Center, and phase 3 will be a national, multi-center clinical trial to study quality of life after Lasik among the general population.

"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," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

If the study identifies any problems with the safety or effectiveness of the lasers used in Lasik surgery, the agency will evaluate whether any action is necessary.

In related news, the FDA also noted in the release that it issued warning letters to 17 Lasik ambulatory surgical centers after inspections revealed that the centers had inadequate systems for reporting problems suffered by patients. The types of problems were specified.

"Many people in the U.S. undergo Lasik procedures. Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," Shuren said in the news release. "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."

Posted: October 2009


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