Articles about Eye Health and Disease 2004

 

FDA Approves Tecnis Lens Implant for Potential Improvement of Night Vision following Cataract Surgery

Tecnis has Potential to Improve Driving Safety for Millions Of Elderly Cataract Patients

4/20/2004

     Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling claims for Tecnis Lens Implant. This is the first lens implant (intraocular lens/IOLs) to receive such claims for reduction of postoperative spherical aberrations and improved night driving simulator performance. Approximately 60 percent of adults over 65 have some degree of cataract development, and cataract surgery is the most common operation in the U.S. Due to the expected doubling in the number of people over age 65 from 35 million in 2000 to 71 million in 2030, and because drivers over age 65 are more likely to be involved in car crashes than people in their 30's, 40's and 50's; providing elderly cataract patients with improved visual capability and driving safety represents a growing healthcare imperative

     The Tecnis lens was specifically designed to improve the functional vision of cataract surgery patients. Functional vision is the ability to see objects in varying light conditions. In a clinical study, Tecnis demonstrated improved functional vision. Improving the functional vision of elderly drivers with the Tecnis lens in less than ideal conditions, such as nighttime, rain, snow, fog and twilight may increase the safety of all drivers and pedestrians on the road. "The ability of the Tecnis lens to improve functional vision sets a new standard in the treatment of cataract patients," said Mark Packer, MD, Clinical Assistant Professor, Casey Eye Institute, Department of Ophthalmology, Oregon Health & Science University, and Principal Investigator for the Tecnis clinical study. "Many Tecnis patients see very well in low light conditions and tell me they feel comfortable driving at night for the first time in years."

     Clinical Study Results: A controlled, multi-center, intra-individual clinical investigation of the Tecnis lens and a traditional acrylic lens (with a spherical optic) was conducted.

• The results of the postoperative ocular spherical aberration measurements and the night driving simulation results are both statistically and clinically significant in favor of the Tecnis lens.

• Spherical aberrations (undesirable scattering of light which negatively affects vision) were significantly less with the Tecnis lens than with the traditional lens with the spherical optic.

• The simulated night driving results (functional vision) under several of the conditions tested and the visual acuity (i.e., 20/20, 20/40, etc.) results were statistically significantly better in eyes implanted with the Tecnis lens (Tecnis eyes).

     "Over the past five years, research about the eye has shown that the cornea and the young lens in the eye interact to produce a very high quality vision," said Jack Holladay, MD, MSEE, FACS, and Clinical Professor of Ophthalmology at Baylor College of Medicine. "The ability of the Tecnis IOL to mimic this interaction in the young eye is the most important advance in the design of intraocular lenses in over two decades."

     A subset of patients was randomly selected from all investigational sites to participate in testing in a validated night driving simulator. Patients were tested in four nighttime conditions: normal city, city with glare, normal rural and rural with glare. In each setting, patients were asked to detect and identify targets including white-on-green information highway signs, black-on-yellow warning signs and pedestrian hazards. They were asked to respond when the sign or the hazard was first detected, and the detection distances were recorded. Patients were then asked to respond when the sign or hazard could first be identified, i.e., what did the sign say, what direction was the pedestrian walking, and the identification distances were recorded. The Tecnis eyes performed functionally better than the control eyes in 21 of the 24 conditions tested. This means the Tecnis lens improves both detection and identification distances across the driving scenes (city and rural) and visibility conditions (with and without glare) compared to the control lens. Tecnis eyes performed statistically significantly better than the control eyes in nine of the test conditions.

The Tecnis Lens Implant is being used by D. Alan Chandler, MD of Richmond Eye Associates. 

The Cataract / Implant Page offers more information about cataracts and cataract surgery.

 

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