FDA Plans LASIK Quality of Life Project

October 18, 2009

The U.S. Food and Drug Administration has announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense that will examine the potential impact on quality of life from LASIK surgery. The goal of this project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

This project is composed of 3 phases.  During the first phase which started in July 2009, the researchers will design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK; some of these may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial which will evaluate the impact of LASIK on quality of life in the general population. Phase 3 is expected to end in 2012.

The results should help identify factors that may impact quality of life and reduce the risk of adverse effects that can affect the surgical outcome. If any factors related to the lasers themselves are identified, the FDA will determine whether any further action is needed.

The FDA also announced that warning letters were sent out to 17 LASIK ambulatory surgical centers for inadequate adverse event reporting.

Read the release.




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