FDA announces LASIK investigation plans

Oct. 15, 2009 at 5:01 PM

WASHINGTON, Oct. 15 (UPI) -- The U.S. Food and Drug Administration says it's starting Phase 2 of a study of the potential dangers from the surgical laser procedure know as LASIK.

The FDA said the study -- to be conducted with and co-funded by the National Eye Institute and the Department of Defense -- will focus on laser-assisted in situ keratomileusis, a surgical procedure that uses a laser to permanently change the shape of a person's cornea to improve their vision.

Officials said the goals of the project are to determine the percentage of patients with significant quality of life problems after undergoing LASIK and to identify predictors of such problems.

The project is composed of three phases. The objective of Phase 1, which began in July, was to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK.

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 and will study LASIK's impact on the quality of life of patients in the general public.

The FDA also announced it issued warning letters to 17 unidentified LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at the facilities.

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