Lasik Eye Surgery - FDA Releases Quality Of Life Project Update

The U.S. Food and Drug Administration (FDA) recently released an update on a three-phase study of the LASIK procedure carried out to improve vision, in order to assess the impact that the LASIK procedure has on the quality of life of those who choose to undergo this procedure. This three-phase project, the LASIK Quality of Life Collaboration Project, was jointly initiated by the FDA, the National Eye Institute and the Department of Defense in October 2009.

The first phase of the project involved the gathering of data using web based questionnaires from patients who have undergone the LASIK procedure. The data obtained from these questionnaires, which details conditions experienced by the patient in their own words, are referred to as patient reported outcomes or PROs, and form the basis of this three-phase study.

The second phase of this project, for which candidates will be enrolled over the next few months, involves a clinical study which will be referred to as the Patient Reported Outcomes with LASIK, or PROWL-1. The candidates for this phase of the project will be U.S. military personnel who are due to have the LASIK procedure performed on them, and these individuals will fill out a questionnaire prior to the procedure, and will additionally be required to fill in a further three questionnaires, at 1, 3, and 6 months following the procedure.

The third and final phase of the project will be the PROWL-2 study, which will be a multicenter clinical study, with a protocol based on the experience gained during the second phase of this project.