FDA approves new intraocular lens for distance and reading correction

March 25, 2005. 
Alcon Laboratories, Inc. (Fort Worth, TX), received FDA approval of the company's Acrysof Restor IOL for use in cataract patients with and without presbyopia. The lens incorporates an apodized diffractive technology that provides patients with a quality range of vision and freedom from spectacles. The principle of apodization is commonly used in microscopy and astronomy as the radial treatment of a lens system to manage light and optimize image quality.

According to a company press release, in clinical studies, 80% of patients who received the Acrysof Restor lens did not need to use spectacles for any activities following cataract surgery. Furthermore, 84% of patients who received the lens bilaterally achieved a distance visual acuity of 20/25 or better and a near visual acuity of 20/32 or better without correction by contacts or spectacles. Only 23% of the conventional or monofocal control group achieved this level of visual acuity.

"During the past 37 years, the three most important technological developments in ophthalmic surgery have been phacoemulsification, the IOL, and the Acrysof Restor IOL," stated Richard J. Mackool, MD, a principle investigator for the Acrysof Restor IOL, during an interview with CRSToday. "Phacoemulsification was a revolutionary way to remove cataracts, and the IOL was the innovative way to replace the human lens. The Acrysof Restor IOL is not only a revolutionary way to replace the human lens, but it most accurately mimics the normal functioning of the natural lens. The last piece of the puzzle is better vision without glasses, and the Acrysof Restor IOL can achieve that for the vast majority of patients," Dr. Mackool said.

If you are a member of the media and want to schedule an interview with Drs. Yankelove, call Michele Adriance at 713 82708311 or e-mail michele@yankelove.com.