NASA Approves Advanced Lasik for Use on Astronauts

SANTA ANA, Calif., Sept. 21 /PRNewswire-FirstCall/ -- 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(TM) 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.

Dr. Schallhorn, himself a retired naval aviator, spearheaded the majority of the Defense Department's research in laser vision correction. Some notable results of the many clinical trials conducted include:

An evaluation of Custom LASIK in 100 military personnel showed that 95 percent achieved 20/20 uncorrected vision or better; these patients, on average, were previously only able to read the first line (the big "E") of the vision assessment chart.(1)
In a study of different methods to create the LASIK flap, 370 naval personnel underwent bilateral wavefront-guided LASIK with either the femtosecond laser or microkeratome blade. One week after surgery more than 76 percent of femtosecond laser patients achieved an uncorrected visual acuity of at least 20/16 (better than 20/20) compared to 58 percent of microkeratome patients.(2)
In an evaluation of 785 aviators, 89% of Navy pilots rated their ability to land on an aircraft carrier as moderately to significantly better after laser vision correction. None said it was worse after surgery.(3)
A separate study determined that over 90 percent of marksmen had improvement in marksmanship skills after laser vision correction; a significant result given the visual precision of marksmen.(4)

SOURCE Advanced Medical Optics, Inc.

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