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FDA provides update on LASIK QOL project status

February 13, 2012

The U.S. Food and Drug Administration provided an update on a three-part study of LASIK (laser-assisted in situ keratomileusis).

In October 2009, the FDA, the National Eye Institute, and the Department of Defense launched the LASIK Quality of Life (QOL) Collaboration Project. This project examines patient-reported outcomes (PROs) following LASIK, a surgical procedure intended to reduce a person’s dependence on glasses or contact lenses. A PRO is a report of a condition experienced by the patient and reported by the patient, not the health care provider.

Results from all three phases of the project will help identify factors that can affect quality of life following a LASIK procedure and potentially reduce the risk of adverse effects that can impact the surgical outcome.

In the first portion of the project, researchers designed and developed a Web-based questionnaire to evaluate patient-reported outcomes that could impact quality of life after LASIK surgery, some of which may be related to the safety of the lasers used in this procedure.

The second phase involves a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), where U.S. military personnel electing LASIK will complete the questionnaire preoperatively (before surgery) and at one, three, and six months postoperatively. Enrollment for PROWL-1 is slated to begin within the next three months.

For more information, visit the FDA Web site Lasik page (http://tinyurl.com/ye7eaad).

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