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A national prospective study is being planned to evaluate post-LASIK quality of life outcomes in a clinical setting. The trial is being coordinated by representatives from the FDA, the National Eye Institute (NEI), the American Society of Cataract & Refractive Surgery, and the American Academy of Ophthalmology, and it will be executed in accordance with the rules governing FDA and NEI clinical trials.
Atlanta-Planning is under way for a large national prospective study to evaluate postLASIK quality-of-life (QOL) outcomes in a clinical setting, said Malvina B. Eydelman, MD.
Members of a Center for Devices and Radiological Health (CDRH) action team recommended the study after an initial attempt to compare pre-market with post-market patient-reported outcomes after LASIK was found unable to fulfill its purpose, Dr. Eydelman said at refractive subspecialty day during the American Academy of Ophthalmology annual meeting.
"The job of the FDA is not over once a medical device is approved," said Dr. Eydelman, director, division of ophthalmic and ENT devices, CDRH/FDA, Rockville, MD. "Rather, we continue to monitor device performance through several different avenues with the goal of assuring public health throughout a product's life cycle.
The prospective clinical trial is being coordinated by representatives from the FDA, the National Eye Institute (NEI), the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. All four of the organizations have committed resources toward the study.
The objectives of the trial are to determine the level of postLASIK satisfaction, changes in health-related QOL after LASIK, and factors associated with the level of patient satisfaction postLASIK.
"The FDA has an integral role in the design and execution of the study, and the trial will be executed in accordance with the rules governing FDA and NEI clinical trials," Dr. Eydelman said. "Consumer representation will be included, the FDA will objectively evaluate the information collected, and all of the outcomes will be made public."
In 2006, the CDRH action team attempted to evaluate post-marketing patient-reported outcomes of LASIK by comparing pre-marketing and post-marketing data. The need to perform such a post-market evaluation was identified by the FDA based on the number of patient complaints being received and considering the popularity of the surgery.
Pre-, post-market data
"About 700,000 LASIK procedures were being performed annually and so problems relating to this surgery can potentially have a significant public health impact," Dr. Eydelman said.
The CDRH action team reviewed pre-marketing data received by the FDA from the clinical trials used for approval of the various laser platforms. The post-marketing data were extracted from articles published in the peer-reviewed literature prior to 2006, adverse event reports received by the FDA, recall information, and comments submitted to the agency's LASIK Web page, which launched in 2000. Only 15 articles published in English were identified that contained information on patient-reported outcomes that potentially could be used for the comparison.
"At the onset of this project, the action team believed that a comparison of premarketing and post-marketing data could be done," she said. "However, they concluded that it was not possible since reported patient outcomes were included in a small number of articles and the scoring methods used in those studies were significantly different from what was used in the pre-marketing clinical trials."
Based on their research, however, the action team members concluded that patient-completed surveys from both the pre-marketing and post-marketing studies showed a high level of satisfaction. In addition, the team determined that the post-marketing data in the literature did not suggest widespread problems.
"The post-marketing study surveys, however, do not adequately evaluate the effects of rare and serious events, and this limitation led to the recommendation to evaluate postLASIK QOL further in a clinical setting," Dr. Eydelman said.