FDA to Oversee LASIK Procedure Results

The Food and Drug Administration, along with the Defense Department and the National Eye Institute, has recently announced that it will be looking more closely into LASIK surgery and procedures amid certain reports regarding safety and its effectiveness. FDA says that it will be launching a three-year study to determine the number of patients who undergo the said procedure for correcting vision may be experiencing troubling symptoms as a result of the surgery.

The said study was formed as a result of inspections made by the FDA on several LASIK ambulatory surgical centers that showed a serious lack of adverse event reporting systems at the said centers. By law, such user facilities as well as outpatient clinics and nursing homes are required to report device-related deaths to the FDA and the device manufacturer. One of the requirements is to establish a written protocol for adverse event reporting. This is aimed to identify problems and ensure the safety and effectiveness of such devices and procedures used in various medical facilities.

LASIK, or Laser Assisted In Situ Keratomileusis, is a procedure wherein vision is corrected by changing the shape of the cornea, the clear covering found in front of the eye, by using a laser. The said procedure has been first developed around two decades ago by Dr. Gholam A. Peyman, who was granted the patent for the method of correcting vision in patients. The LASIK procedure has become a billion dollar industry annually, thanks to aggressive marketing that may have downplayed the relative risks that may be associated with the procedure.

In this manner, the FDA, in collaboration with the National Eye Institute and the Defense Department is launching a study in order to examine the impact on the quality of life of patients who have undergone LASIK procedures. The main objective of the collaborative study is to determine the percentage of patients who experience problems as a result of the said surgical procedure to correct their vision and to identify what these problems are.

The study project launched by the three government agencies is composed of three phases. Phase One was started last July 2009and involves developing and implementing a Web-based questionnaire designed for LASIK procedure patients to help assess and evaluate quality of life issues regarding post-procedure outcomes. This phase would also help answer some key fact regarding the safety of lasers used in LASIK procedures.

Phase Two of the said study will involve evaluating the quality of life and satisfaction after undergoing LASIK surgery by a select group. The participants would be patients treated by the said vision correcting procedure at the Navy Refractive Surgery Center. Phase Three of the project would involve a national and multi-clinical trial that aims to study the impact of the procedure on the quality of life after LASIK from a general population. The last phase of the study is expected to end by 2012.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186858.htm



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