The goal of the study, called the LASIK Quality of Life Collaboration Project, is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.
The FDA also announced that it issued warning letters to 17 LASIK surgery centers after inspections revealed inadequate adverse event-reporting systems at the centers. The inspections, however, did not identify problems with the use of the LASIK devices at these facilities, according to the release.
The study will take place in three phases. Phase one, which began in July, was the launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure. Phase two will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active-duty population treated at the Navy Refractive Surgery Center. Phase three will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases two and three have yet to begin, according to the report.
The results of the study will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. The FDA stated that if any of the factors identified by the study related to the safety or effectiveness of the lasers used in LASIK surgery, it will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery, according to the release.
Read the FDA’s release on the LASIK Quality of Life Collaboration Project.
