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FDA NOTE TO CORRESPONDENTS

For Immediate Release: Oct. 19, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Provides Update on LASIK Quality of Life Collaboration Project Status

The U.S. Food and Drug Administration today provided an update on a three-part study of LASIK (Laser-Assisted in situ Keratomileusis), a vision improvement procedure.

In October 2009, the FDA, the National Eye Institute, and the Department of Defense launched the LASIK Quality of Life 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 1, 3, and 6 months postoperatively (after surgery). Enrollment for PROWL-1 is slated to begin within the next three months.

PROWL-1 will be conducted at the Naval Medical Center San Diego (NMCSD). NMCSD provides corneal refractive surgery to 1,200 to 1,500 active duty patients annually and has conducted more than 50 clinical trials and published 28 papers on refractive surgery. NMCSD’s Navy Refractive Surgery Center evaluated the first laser refractive surgeries performed on active duty service members in 1993.

The final phase of the project, the PROWL-2 study, will be a national, multicenter clinical study with a protocol based on the experience from PROWL-1.

LASIK is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser. The procedure is intended to change the focusing ability of the eye, improving a person’s ability to see objects more clearly. A mechanical microkeratome (a blade device) or a laser keratome (a laser device) is used to cut a flap in the cornea. A hinge is left at one end of this flap. The flap is folded back revealing the stroma, the middle section of the cornea. Pulses from a computer-controlled laser vaporize a portion of the stroma and the flap is replaced.

For more information:

FDA LASIK

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