Patients that have undergone LASIK surgery in the States are to be part of a study by The U.S. Food and Drug Administration.
Laser-Assisted In Situ Keratomileusis (LASIK) is the procedure that uses an eximer laser. This laser permanently changes the cornea shape but many patients that have chosen LASIK have reported discomfort and pain post surgery. The study is called the LASIK Quality of Life Collaboration Project and the FDA has been working with the National Eye Institute and the U.S. Department of Defense.
This year sees the final of three phrases of the study, the first started back in Summer 2009.
With government agency funds, the first phase was to construct and implement a questionnaire on-line. The questions were to evaluate how the surgery had affected the lives of patients. Following on from that they investigated an evaluation of quality of life and patients satisfaction in a select, active duty population that had received treatment as the Navy Refractive Surgery Centre.
This years final phase is a clinical trial involving multi-centres across the nation to study the impact of the surgery within the general population
Phase 3 is a national, multi-center clinical trial and has been studying the impact of the procedure on quality of life following LASIK in the general population.
The results of the project will aim to reduce potential adverse affects that can impact the outcome of the surgery. It will also help to identify factors that can and will affect a patients quality of life following LASIK, If it is found that any of the factors are related to the safety of the lasers or their effectiveness when used in during surgery, then the FDA will have to evaluate whether it is necessary to take any action as part of their ongoing effort to improve the safety and effectiveness of the lasers used.