(NUI) - The U.S. Food and Drug Administration recently approved new claims for Pfizer's Tecnis, making it the first eye lens implant for cataract patients with the potential to improve the safety of older drivers with cataracts and the people with whom they share the road.
About 60 percent of people over age 65, and 70 percent of those over 75, have some degree of cataract development, a clouding of the lens in the eye that affects vision. Approximately 2.5 million older people undergo cataract surgery each year in the United States.
The Tecnis lens was specifically designed to improve the functional vision of cataract surgery patients. Functional vision is the ability to see objects clearly under varying levels of light and in conditions such as rain, snow, fog and at night.
According to the AAA Foundation for Traffic Safety, drivers over age 65 are more likely to be involved in car crashes than people in their 30s, 40s and 50s. Providing elderly cataract patients with improved vision is critical to their safety and to the safety of others.
"The ability of the Tecnis lens to improve functional vision sets a new standard in the treatment of cataract patients," said Dr. Mark Packer, 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."
In a clinical study comparing Tecnis to the leading, traditional acrylic lens implant, patients' ability to detect and identify objects was tested using a night driving simulator. Although Tecnis did not show a significant improvement over the acrylic lens in contrast sensitivity, patients' reaction times were improved when using the Tecnis lens in the night driving simulator.
One of the most significant benefits of the Tecnis lens was improved detection and identification of pedestrians at night. Tecnis patients consistently identified pedestrians at a greater distance in all settings.
Adverse events associated with the Tecnis lens are consistent with the implantation of intraocular lenses in cataract surgery patients and include, but are not limited to: corneal edema, iritis, hyphema, macular edema, retinal detachment and lens dislocation.
Prescribing information is available by calling the Pfizer Ophthalmics customer service number, 1-800-423-4866.
Media Release Date: 5/19/04
