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The U.S. Food and Drug Administration (FDA) is preparing a collaborative study with the National Eye Institute and the U.S. Department of Defense to research "the potential impact on quality of life" for patients who have received Laser-Assisted In Situ Keratomileusis (LASIK). LASIK surgery is a procedure that involves an excimer laser for precise and controlled alteration of the cornea to change its focusing power.

According to the American Academy of Ophthalmology, LASIK can treat nearsightedness, farsightedness and astigmatism, with around 90 percent of people who have the procedure achieving between 20/20 and 20/40 vision without the use of glasses or contact lenses. According to LASIK Surgery News, the procedure is the most popular global vision correction procedure, with around 1.3 million LASIK surgeries performed in the U.S. in 2006. In 2007 NASA even approved the use of advanced Lasik surgery for U.S. astronauts.



The FDA states on its "LASIK" medical device page that risks of the procedure include severe dry eye syndrome, glare, halo or double vision, especially at night, and loss of vision.

The FDA says the goal of the "LASIK Quality of Life Collaboration Project" is to find out what percentage of persons who have undergone the surgery later suffer significant quality of life problems and also to identify predictors of such complications.

The project will be commenced in three phases. Phase 1 already began in July, which was to design and implement a web-based questionnaire on patient-reported outcomes. The FDA had previously established a public docket for LASIK so that any interested party can pose comments or concerns regarding LASIK. This docket is available through the FDA LASIK site.

Phase 2 will involve studying quality of life and satisfaction issues after LASIK surgery within a select, active duty population undergoing treatment at the Navy Refractive Surgery Center. Phase 3 will involve a national, multi-center clinical trial with similar study on quality of life following LASIK in the general population and is expected to be completed in 2012. Patient enrollment in Phases 2 and 3 has not yet begun.

The FDA expects that results from the project can be used to identify factors in the side effects of the surgery and hopefully reduce those adverse effects. The FDA will evaluate potential action if any adverse effects are related to the safety or effectiveness of the lasers used in LASIK surgery.

"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 Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, in a press release on the FDA's website.

Continue reading FDA to Launch Study on LASIK Surgery...

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