Implantable Contact Lens -- ICL -- Corrects Moderate to High Farsightedness; Phase III Trial...

Health/Medical Writers

SAN FRANCISCO--(BUSINESS WIRE)--April 14, 2003

Implant Can Benefit Estimated 14 Million Farsighted Americans

Ill Suited for LASIK

A Phase III FDA Trial of farsighted (i.e., hyperopic) patients treated with the Implantable Contact Lens

ICL(TM) reports one-year outcomes that provide new hope for patients who are not good candidates for LASIK and other more invasive refractive surgeries. Such patients include the estimated 14 million Americans with moderate to high degrees of farsightedness (more than 3 diopters) and/or thin corneas (less than 500 microns).

The study, titled "One Year Outcomes of FDA Trial of the ICL for Hyperopia" (ASCRS Phakic Refractive IOLs Session 1-O) was presented here, Saturday, April 12, by Paul J. Dougherty, M.D., medical director of Dougherty Laser Vision Institute (Camarillo, Calif.). The multicenter study assessed the safety and efficacy of the ICL, which is the phakic intraocular lens (IOL) manufactured by Staar Surgical Company(a) (Monrovia, Calif.).

Results from 130 patients (243 eyes) treated by 28 surgeons nationwide demonstrate that the ICL provides safe, effective and predictable correction for patients with farsightedness ranging from 1.5 to 12.0 diopters. Nearly half of the patients achieved 20/20 or better vision following implant surgery, and nearly 95 percent achieved 20/40 or better at their one-year follow-up visit. Similarly impressive results for the ICL in treating nearsighted (i.e., myopic) patients were reported previously. Final FDA approval for treating nearsighted patients is currently pending. The ICL is also being studied for the treatment of astigmatism.

"The one year outcomes for farsighted patients treated with the ICL are very promising," said Dr. Dougherty. "The lens offers stable correction with few surgical or postoperative complications."

Intraocular lenses such as the ICL improve vision much like a conventional contact lens, except that they are surgically implanted within the eye. Once implanted, the ICL requires no upkeep and is cosmetically undetectable.

During the implant procedure, a small incision is made in the cornea, through which the foldable ICL is inserted behind the iris just above the crystalline lens. The ICL is positioned to sustain a small arch so that it rests above the natural lens without making direct contact. Surgery usually takes five to 10 minutes per eye, and is performed under topical eyedrop anesthesia.

(a) Dr. Dougherty has no financial interest in the ICL, nor is he a consultant for the manufacturer.