FDA Approves New Lens Implant Technology for Patients With Extreme Nearsightedness

Procedure Offers Long-awaited Alternative for Patients with Thick Corrective
Lenses

Clinical Trials Conducted Locally over Past Four Years

OVERLAND PARK, Kansas (September 13, 2004) -- ­ A newly approved vision-correcting procedure offers hope for persons with extreme nearsightedness who were not candidates for familiar laser-based vision surgery.

The U.S. Food and Drug Administration announced its approval of a patented lens that is surgically implanted to reduce or eliminate myopia (nearsightedness) in adults.

The Overland Park-based Durrie Vision conducted the initial clinical trials for this refractive surgery procedure, with the first patients receiving the implanted lenses in November of 1999.

Dr. Daniel Durrie, the clinic's founding ophthalmologist and a leading researcher in vision correction, says, "This procedure is truly a breakthrough for patients who could not be helped by the familiar laser-based technologies like LASIK, especially those whose vision correction typically requires 'pop-bottle' thick lenses. For these patients, this technology is an alternative that enables them to achieve near normal vision without bulky glasses or contact lenses."

The most recent patients treated in the clinical trials had their surgery performed by co-investigator Jason Stahl, MD of Durrie Vision.  Linda Smith, who participated in the clinical study recently had her follow up visit and calls the procedure a "miracle."

The procedure is desirable for highly nearsighted patients because it does not disrupt the normal function of the eye. All tissue and natural lenses remain intact. In this new refractive surgical procedure, the lens is implanted near the iris, but at a distance from the eye's natural lens and the cornea. The lens has been safely implanted in more than 150,000 eyes
worldwide.  

FDA approval means that the patented lens will be released this fall for use by ophthalmologic surgeons who have been specifically trained in this procedure.