ReSTOR® Intraocular Lens Gives Patients Full Range of Vision
May 9, 2005
Unique technology provided 80% of cataract patients freedom from glasses for all activities
DES MOINES, IOWA (May 9, 2005) – U.S. Food and Drug Administration (FDA) granted approval of the AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia on March 21, 2005. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly decreases their dependence on glasses after surgery.
Wolfe Eye Clinic was part of the FDA study initiated March 8, 2002 with implantations ending October 1, 2003. The Clinic was one of 16 sites, which studied 465 patients. The ReSTOR IOL has performed in spectacular fashion in Wolfe Eye Clinic patients just as it has for all the investigators throughout the country. Dr. Davison has been involved in the ReSTOR introduction and training of international surgeons in Paris, Munich, Puerto Rico, Chile, as well as in courses and training via satellite broadcasts to US surgeons throughout the country.
The first ReSTOR implantation in the US after FDA approval was granted in a live surgery demonstration at the ASCRS meeting in Washington DC on April 16, 2005. Dr. Davison performed the second implantation in the country on a local neonatologist. The patient is very happy and has 20/20 uncorrected distance and J2 uncorrected near vision. Near visual acuity of 20/32, or J2, means patients can read the very small stock quotes in the newspaper.
The clinical studies supporting the approval showed that 80 percent of patients who received the AcrySof® ReSTOR® lens did not use glasses for any activities after cataract surgery. The clinical results also showed that 84 percent of patients who received the AcrySof® ReSTOR® lens in both eyes achieved distance visual acuity of 20/25 or better and near visual acuity of 20/32 or better without correction by contacts or glasses while only 23 percent of the conventional or monofocal control group achieved this level. Patient satisfaction was very high with nearly 94 percent of patients reporting that they would have the procedure again.
The ReSTOR lens is currently available, for an additional out-of-pocket charge, to patients with cataracts covered by private insurance. As of May 10, 2005, it has become available as a non-covered upgrade for Medicare patients who have cataracts. The ReSTOR lens is also available for a refractive lens exchange in patients without cataracts.