Kansas City, MO June 1, 2002 --- The Food & Drug Administration has accepted critical data  for a new procedure that may help millions of Americans with hyperopia (farsightedness) see better.

The device to improve patients' sight, called the ViewPoint TM CK System, uses radio frequency energy to shrink collagen tissue within the cornea, thus reshaping it. The FDA recently accepted a clinical module of a Pre-Market Approval (PMA), which requests approval of the device to treat spherical hyperopia between 0.75 and 3.00 diopters.
The submission marks the first introduction in the U.S. market to use radio frequency energy to reshape the cornea and correct hyperopia. More than 60 million Americans suffer from hyperopia, and until now, the treatments for the condition were LASIK or LTK. Although LASIK (where a laser is used to cut and reshape the cornea) effectively treats most types of vision problems, hyperopia is the most difficult vision problem to treat with the procedure. The ViewPointTM CK System, is already approved in most major international markets.

"This is a pivotal FDA submission because the clinical study of CK indicated that most patients continue to not need glasses," said the director of refractive surgery at HEC who also serves on the medical advisory board and is one of the investigators that conducts the studies. "The CK procedure is considered a less invasive alternative to LASIK for the treatment of hyperopia because no tissue is cut or removed from the eye. We should be able to correct most cases of hyperopia, and our initial studies indicate ultimately, presbyopia. Reading glasses won't be needed just because you turn 40."

As many as 2.15 million Americans are expected to have refractive surgery this year, an increase from 1.82 million in 2000.

If you are interested in learning more about CK, make an appointment online or call 956-423-2100.

If you are a member of the media and want to schedule an interview with Michael Laney, please e-mail him at michael@vecpa.com.