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.
As of March 24, 2011, the FDA and the National Eye Institute of the National Institutes of Health are requesting proposals for participation in the project from LASIK surgery sites with the capabilities to perform clinical research. Phase III of the project consists of a national, multi-center clinical study examining the reliability of the questionnaire (developed in Phase I and II) in a civilian population.
Read more about the project and the request for proposals. Proposals are due by May 25, 2011, by 5:00 PM E.S.T. Notification of selected sites is anticipated to occur during the summer of 2011.