LASIK FOR NEARSIGHTEDNESS GAINS FDA APPROVAL AFTER TESTING AT MAJOR EYE CENTERS, INCLUDING EMORY


July 28, 1997


Media Contacts: Sarah Goodwin, 404/727-3366 - sgoodwi@emory.edu
Kathi Ovnic, 404/727-9371 - covnic@emory.edu
http://www.emory.edu/WHSC/





Today, the Ophthalmic Devices Advisory Panel of the U.S. Food & Drug Administration (FDA) recommended pre-market approval (with conditions) for LASIK, an advanced new laser procedure that corrects nearsightedness. LASIK utilizes a computer controlled excimer laser to reshape the cornea to eliminate nearsightedness. The laser reshaping is performed under a protective flap created by an automated cutting instrument. Combining the flap with the laser provides patients with a rapid recovery of vision, minimal discomfort and the ability to fine tune or adjust vision in the future, advantages not available with other techniques for refractive surgery. The approval for LASIK was gained by a team of investigators from Emory University in Atlanta led by principal investigator, George O. Waring, III, MD in collaboration with Emory professors Keith P. Thompson, MD and R. Doyle Stulting, MD, PhD. Fourteen Atlanta ophthalmologists participated in the investigation at Emory Vision Correction Center. The Emory investigators, developed a specific set of laser programs that can safely and effectively correct a low, moderate and high degree of nearsightedness up to -15.00 diopters. That encompasses some 95% of all nearsighted individuals, approximately 72 million Americans. The Emory team reported results in 1,063 eyes that had been part of an FDA investigation for the past two years. The Summit laser used by the Emory team had been previously approved by the FDA November, 1995 for the correction of smaller amounts of nearsightedness (-2.00 to -7.00 diopters) using the technique of photorefractive keratectomy (PRK) in which the laser sculpts the front surface of the eye into a new flatter shape, which eliminates the nearsightedness. However, this approach left the surface raw for a few days, with pain and blurry vision for the patient. This is followed by a period of haziness of the eye tissue as it heals, a process that can take six months or more. LASIK is a more advanced technique, which creates a thin protective flap of tissue on the anterior front of the eye. Beneath this flap, the laser sculpting and reshaping is done, but when the protective flap is replaced, vision returns painlessly and quickly. If some nearsightedness remains, the flap can be surgically lifted again, and an enhancement refinement procedure done - something that is difficult to do with PRK. The challenge for researchers has been to develop accurate laser programs that guide the laser in achieving accurate results. The Emory team worked closely with Summit Technology of Waltham, Massachusetts to develop a new set of laser programs formulas that were recommended today for approval by the FDA.

The Emory team found that after LASIK, patients had a greater than 95% chance of seeing 20/40 or better without glasses or contact lenses - vision good enough to get an unrestrictive driver's license in most states. After the surgery, only 6.5 percent of patients needed glasses for full time distance wear, although many patients elected to use glasses occasionally for special tasks, such as driving at night. As part of the trial, patients completed a personal questionnaire at one year after surgery and 90% reported high satisfaction with the procedure and 97% said they would have LASIK if they had the choice to make again.

The Emory Group has been on the forefront of development of refractive surgery techniques to eliminate the need for glasses and contact lenses since 1980. From 1980 to 1995, Dr. Waring headed the Prospective Evaluation of Radial Keratotomy (PERK) study. The National Eye Institute - funded research into the safety and effectiveness of this classic technique that makes incisions into to cornea to correct nearsightedness. Drs. Waring and Thompson directed early research in excimer laser corneal surgery, in animals at the Yerkes Primate Center in Atlanta. These experiments paved the way for human use and led in part to the FDA approval of the excimer laser. LASIK is the team's latest focus. Says Waring "In order to help develop LASIK techniques, I worked internationally two years, to develop early techniques of LASIK. I brought these techniques back to the United States and we have been refining them under FDA supervision. Fortunately, we have now been recommended for FDA approval to offer our technique of LASIK to nearsighted individuals. We will also be teaching it to other surgeons throughout the U.S. who use the Summit excimer laser." The Emory Vision Correction Center is known around the world for its leadership and high quality of refractive surgery. Details can be accessed through its worldwide web page at http://www.emory.org/vision_correction. Says Dr. Thompson, "We receive a surprisingly large number of patients coming river's license in most states. After the surgery, only 6.5 percent of patients needed glasses for full time distance wear, although many patients elected to use glasses occasionally for special tasks, such as driving at night. As part of the trial, patients completed a personal questionnaire at one year after surgery and 90% reported high satisfaction with the procedure and 97% said they would have LASIK if they had the choice to make again.

The Emory Group has been on the forefront of development of refractive surgery techniques to eliminate the need for glasses and contact lenses since 1980. From 1980 to 1995, Dr. Waring headed the Prospective Evaluation of Radial Keratotomy (PERK) study. The National Eye Institute - funded research into the safety and effectiveness of this classic technique that makes incisions into to cornea to correct nearsightedness. Drs. Waring and Thompson directed early research in excimer laser corneal surgery, in animals at the Yerkes Primate Center in Atlanta. These experiments paved the way for human use and led in part to the FDA approval of the excimer laser. LASIK is the team's latest focus. Says Waring "In order to help develop LASIK techniques, I worked internationally two years, to develop early techniques of LASIK. I brought these techniques back to the United States and we have been refining them under FDA supervision. Fortunately, we have now been recommended for FDA approval to offer our technique of LASIK to nearsighted individuals. We will also be teaching it to other surgeons throughout the U.S. who use the Summit excimer laser."

The Emory Vision Correction Center is known around the world for its leadership and high quality of refractive surgery. Details can be accessed through its worldwide web page at http://www.emory.org/vision_correction. Says Dr. Thompson, "We receive a surprisingly large number of patients coming to us internationally through information on the worldwide web.

This is the first time the FDA ophthalmologic branch has granted premarket approval directly to ophthalmologists. Previous approvals have been granted to manufacturers of ophthalmic devices. Physician-sponsored investigation is one way the FDA is exploring to decrease the time it takes to review and approve for medical technologies in the United States. "This is an extremely important for the FDA and for ophthalmologists, because it puts the practicing physician squarely in the middle of the regulatory process, rather than as a passive bystander waiting for the industry and the government to decide what the physician can and cannot do," says Waring.



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