News on LASIK and Other Refractive Eye Surgery: Government Agencies To Study Quality of Life After LASIK

November 30, 2009

The LASIK Quality of Life Project is a new joint study by the U.S. Food and Drug Administration (FDA), National Eye Institute and U.S. Department of Defense to determine the percentage of LASIK patients who have significant problems that affect their quality of life after the procedure. The study also aims to discover predictors of such problems.

In Phase 1, which began in July, a Web-based questionnaire was created to assess patient-reported LASIK outcomes and evaluate associated quality-of-life issues.

Phase 2 will study quality of life and post-LASIK satisfaction as reported by active-duty personnel at the Navy Refractive Surgery Center.

And Phase 3, to end in 2012, will study these issues in the general population.

If any negative results are related to the safety or effectiveness of LASIK lasers, the FDA will decide whether action is needed.

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