LASIK NEWSLasik Patients Satisfied Despite ConcernsFDA hears surprising data on Lasik patient quality of life - Press Release WASHINGTON DC, April 25, 2008 - More than 99% of patients report their quality of life after laser vision correction surgery is as they had expected or better, even though 2% report complications that are frequently or always problematic, according to a national patient survey conducted by the nonprofit Council or Refractive Surgery Quality Assurance (USAEyes). Preliminary results of the USAEyes Competence Opinion Relative to Expectation (CORE) patient survey are being presented to the US Food and Drug Administration during a special hearing today. "The USAEyes CORE survey is designed to determine if patients are getting what they expect from Lasik and similar eye surgery," says Glenn Hagele, Executive Director of the nonprofit patient advocacy that conducted the study. "Relevant questions ask if the patient's results were 'as expected', or degrees of 'better than expected' or 'worse than expected'." The survey is used to screen Lasik doctors for certification by USAEyes. The survey was mailed to 1,800 vision correction surgery patients of six doctors throughout the US, with a 31% response rate. "It is not surprising that the vast majority of Lasik patients are satisfied with their results, but what was unexpected was that many would have the surgery again despite reporting complications," reports Hagele. Of those who reported complications that were "seldom problematic", 91% would have the surgery again. A surprising 22% of patients who reported complications that were "frequently" or "always" problematic would have the surgery again, according to patients who responded to the survey. "Clearly some patients find the convenience of a reduced need for glasses and contacts worth occasional problems," says Hagele. NASA Approves Advanced LASIK For AstronautsAMO's Advanced CustomVue™ LASIK with the IntraLase® Method Proves Ready for the Rigors of Space Travel
SANTA ANA, Calif. Sept. 21, 2007 / PRNewswire / – Advanced Medical Optics, Inc. (AMO) (NYSE: EYE), a global leader in ophthalmic surgical devices and eye care products, today announced that the National Aeronautics and Space Agency (NASA) has approved the company's LASIK technologies for use on U.S. astronauts. The NASA decision was made following review of extensive military clinical data using AMO's Advanced CustomVue™ LASIK with the IntraLase® Method, which showed the combination of technologies provides superior safety and vision.
Approved for use on consumers almost a decade ago, more than 11 million LASIK procedures have been performed to-date, making it the most-common elective surgical procedure in the U.S. But it wasn't until LASIK developed into an all-laser procedure that NASA approved it for use on pilots, mission and payload specialists who face extreme, physically demanding conditions in space. The all-laser LASIK technologies, which utilize wavefront guided and femtosecond lasers, have also been cleared for U.S. military personnel, including most recently Air Force pilots.
"NASA's approval is further evidence that today's LASIK exceeds all established standards of safety and effectiveness," said Steven Schallhorn, M.D., retired captain of the U.S. Navy, investigator in multiple studies involving use of LASIK and other refractive surgeries for treatment of nearsightedness, farsightedness and astigmatism, and Medical Director for Optical Express. "NASA followed the Naval Aviation clinical studies closely with a particular interest in both safety and quality of vision under extreme conditions. Wavefront guided and femtosecond lasers were proven to provide excellent safety with consistent visual results of 20/20 or better. LASIK was able to withstand even the most extreme rigors of warfare and flight. All surgical procedures have risks, but with this exceptional track record, the average consumer has nothing to fear from LASIK."
LASIK is a two-step procedure. The IntraLase® FS (femtosecond) laser replaces the hand-held microkeratome blade historically used in creating LASIK corneal flaps -- the first step of the procedure. The computer guided, ultra-fast laser virtually eliminates almost all of the most severe, sight threatening LASIK complications related to microkeratomes. The laser creates an optimal corneal surface below the flap, allowing for better visual outcomes from the second step of the procedure where wavefront guided technology maps, and then custom-corrects vision based upon the unique characteristics of an individual's eye. This sophisticated measurement provides 25 times more precision than measurements using standard methods for glasses and contact lenses.
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