FDA launch project assessing post-LASIK problems
There is an ongoing study about LASIK surgery in the United States now. Launched by the US Food and Drug Administration, the LASIK Quality of Life Collaboration Project has three phases. With the collaboration with the National Eye Institute and the US Department of Defense, FDA launched this research with the purpose to evaluate the quality of life problems in those people who have received LASIK procedure.
LASIK is widely performed to permanently correct patient’s refractive errors through reshaping the cornea of the eye. These patients mostly need not to wear eyeglasses or contact lenses any more after the surgery. However, LASIK is not perfect that complications such as blurry vision and dry eye are potential postoperatively. And the project launched by FDA just aims at establishing the proportion of LASIK patients suffering from these complications or side effects.
The project was announced to have three phases. Beginning from July 2009, the first phase designs a web-based quality of life questionnaire. Phase 2 will involve some patients who have received LASIK at the Navy Refractive Surgery Center and evaluate their life quality and satisfaction with the surgery. Moreover, the third phase will conduct the study in the general popular through a multi-center clinical trial.
FDA initially conceived this study with great expectations. From the results of the LASIK Quality of Life Collaboration Project, factors potentially affecting post-LASIK quality of life can be published. As a result, those potential risk factors can be decreased to some degree. The study is also expected to enhance the public understanding of the risks of LASIK procedure.
FDA has also inspected many LASIK surgery centers in the country. The result is that some centers have inadequate adverse event reporting systems. These centers use improper ways to collect and report adverse events about their LASIK cases. Since there are potential risks of the surgery, ambulatory LASIK centers in US are required by law to maintain a robust reporting system. And those inadequate centers have received warning letters sent by FDA.