NearVision CK Shows Benefits For Post-LASIK Baby Boomers With ‘Aging Eyes’

During the American Academy of Ophthalmology (AAO) meeting, to be held in Las Vegas from Nov. 11-14, ophthalmic device manufacturer Refractec, Inc., today announced promising interim results for evaluating the effectiveness of NearVision CK (conductive keratoplasty) for post-LASIK patients will be presented.

Three-month clinical data shows post-LASIK baby boomers achieved improved vision after NearVision CK.

“Post-LASIK patients who had NearVision CK showed improvements in both their near and intermediate uncorrected visual acuity, and patients’ subjective satisfaction ratings exceeded 85 percent,” Michael Gordon, M.D., of the Gordon, Binder & Weiss Vision Institute in San Diego. “The NearVision CK procedure is exceptionally safe, and could be very promising for the millions of post-LASIK patients who do not wish to rely upon corrective lenses as they age.”

Clinical study data to be presented show positive three-month post-operative results on a cohort of 60 patients ranging in age from 41 to 63 who had undergone NearVision CK, including:

– 95 percent of patients able to read phonebook-sized print (uncorrected visual acuity [UCVA] of J3);

– 83 percent of patients achieving 20/32 or better intermediate vision; and

– More than 90 percent of patients reporting satisfaction with quality of vision and depth perception.

Additionally, the NearVision CK procedure was found to be safe and effective, with no adverse events or flap complications and the technology was shown to fulfill all FDA safety limits, and to meet or exceed FDA’s targets for outcome predictability.

“The fact is that more than four million Americans have had LASIK with the expectation of being glasses-free for a lifetime. But, what they’re realizing is that they can’t escape their ‘aging eyes’ and the subsequent loss of near vision, which has them once again reaching for glasses. We’re very encouraged by the three-month data being presented at AAO,” said Tom Frinzi, Refractec CEO.

Slated to speak at the AAO’s Refractive Subspecialty Day on Nov. 11, Dr. Gordon will present his findings in a presentation entitled, “FDA Expanded Indication Study on Conductive Keratoplasty for the Improvement of NearVision in Post-LASIK Emmetropes.” Physician Erin Stahl, M.D. from Overland Park, Kansas also will report interim study results during her Nov. 13 presentation, entitled “Results of Conductive Keratoplasty to Improve Near Vision in Presbyopic Emmetropes Who Underwent Previous LASIK.”

The multi-center clinical trial currently underway will involve 150 patients, who, other than suffering from presbyopia, had normal vision. Data will be submitted to the FDA in the third quarter of 2007 and clinical enrollment is expected to be completed later this month.

How NearVision CK Works:

With one of the highest safety profiles in the refractive market, NearVision CK was the first procedure approved by the U.S. Food and Drug Administration for treating both presbyopia (a.k.a. “aging eyes”) and hyperopia (farsightedness). Using gentle radio waves instead of a laser or scalpel, NearVision CK brings near vision back into focus without cutting or removing tissue during a painless, three-minute procedure.

Using a probe thinner than a strand of human hair, NearVision CK applies radio waves in a circular pattern on the outer cornea to shrink small areas of collagen. This shrinkage pattern creates a constrictive band (like the tightening of a belt), increasing the overall curvature of the cornea to bring near-vision back into focus for Baby Boomers. Radiofrequency (RF) energy is one of today’s most advanced surgical technologies. In addition to its use in NearVision CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular procedures.

About Refractec

Refractec, Inc. is a privately held ophthalmic technology company that develops and markets minimally invasive procedures for ophthalmologists and their baby boomer patients. Based in Irvine, Calif., Refractec provides “Corrective Solutions for Near Vision” with its proprietary NearVision CK (Conductive Keratoplasty) technology. Patients can visit (http://www.refractec.com) or call 1-800-752-9544 for more information on NearVision CK and to obtain a list of physicians.

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