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FDA To Review Lasik Complications and Quality of Life

Lasik complications prompt joint task force with ophthalmic and medical organizations to review patient quality of life.

Food and Drug Administration to review Lasik quality of life issues.

WASHINGTON DC, March 17, 2008 -- In 2006, in response to complaints received from concerned citizens regarding LASIK complications affecting patient's quality of life (QOL), FDA re-evaluated symptom and QOL data submitted to the agency for the approval of LASIK lasers and reviewed the medical literature for similar information.

See FDA Lasik Complication and Quality of Life for additional details.

The FDA noted that the available clinical data failed to suggest significant problems following LASIK surgery. The data showed that the vast majority of patients were satisfied with their outcomes; however, a small percentage of patients were dissatisfied. The FDA also noted that QOL issues related to LASIK had not been evaluated consistently, and there were few reports of well-designed studies of QOL post-LASIK.

To accurately quantitate the small proportion of dissatisfied LASIK patients and evaluate the reasons for their dissatisfaction, a large, national, prospective study was needed to help the FDA address this important public health issue. The FDA solicited the cooperation of the National Eye Institute (NEI) of the National Institutes of Health and two large ophthalmic professional societies, the American Society of Cataract and Refractive Surgeons (ASCRS) and the American Academy of Ophthalmology (AAO). As a result of FDA's outreach efforts, FDA, NEI, ASCRS, and AAO formed the joint LASIK Study Task Force. This task force is designing and facilitating a clinical trial to investigate QOL after LASIK that will be conducted by refractive surgeons across the country.

As a preliminary step of this project, a pilot study is currently underway at NEI Clinical Center. This pilot will assist FDA and NEI to further develop adequate tools for the assessment of QOL related to Lasik outcomes.

The results of all studies will be made publicly available. FDA's LASIK website will continue to be updated to reflect any new risks found to be supported by adequate scientific evidence.

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