Business Release

For More Information:
Kimberly Goolsby
(949) 464-0187
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FOR IMMEDIATE RELEASE

FDA APPROVES REFRACTEC's® CKSM (Conductive KeratoplastySM)
NON-LASER PROCEDURE FOR FARSIGHTEDNESS

CK Uses Radiofrequency Energy, Instead of a Laser, to Reshape the Cornea
Without Cutting or Removing Tissue

IRVINE, Calif., April 16, 2002 ? Ophthalmic device manufacturer Refractec Inc. today announced that the U.S. Food and Drug Administration has approved CK (Conductive Keratoplasty), a procedure for farsightedness (hyperopia) in people over age 40. CK utilizes the controlled release of radiofrequency (RF) energy, instead of a laser or scalpel, to reshape the cornea. The minimally invasive CK procedure takes less than three minutes and is done in-office with only topical (eye drop) anesthesia.
Farsightedness, which occurs when the cornea is too flat or the eye is too short, is the most common vision disorder in America and affects more than 60 million people over age 40. Symptoms include difficulty reading menus, a computer screen and seeing to drive at night, or the need to constantly reposition reading material to find the right focus.
"For years, the farsighted have been left behind as vision correction progressed: RK (radial keratonomy), PRK (photorefractive keratectomy) even LASIK (Laser In-situ Keratomileusis) initially, were all treatments designed specifically for the nearsighted," said world-renowned ophthalmologist Marguerite B. McDonald, MD, medical monitor for the FDA clinical trials, director of the Southern Vision Institute and clinical professor of ophthalmology at Tulane University, New Orleans, La. "CK is one of the first procedures designed specifically for the millions of people with ...
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