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
(refractec) or call 1-800-752-9544 for more information on
NearVision CK and to obtain a list of physicians.
Refractec, Inc.
refractec