Washington, DC - The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.
Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. According to the National Eye Institute, more than 20 percent of Americans will have cataracts by the age of 65, and the prevalence increases with age. In cataract surgery, the clouded natural lens is removed and replaced with an IOL.
“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances.”
Traditional monofocal IOLs have been limited to improving distance vision. The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery.
The approval is based on a review of results from a randomized clinical trial comparing 148 cataract patients implanted with the Tecnis Symfony IOL to 151 cataract patients implanted with a monofocal IOL. The study evaluated visual acuity at near, intermediate and far ranges; contrast sensitivity (the ability to distinguish small differences between light and dark); and adverse events for six months after implantation. Of the patients implanted with the Tecnis Symfony IOL, 77 percent had good vision (20/25), without glasses at intermediate distances, compared to 34 percent of those with the monofocal IOL. For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL. Both sets of patients had comparable results for good distance vision.
Patients implanted with the Tecnis Symfony IOL may experience worsening of or blurred vision, bleeding or infection. The device may cause reduced contrast sensitivity that becomes worse under poor visibility conditions such as dim light or fog. Some patients may experience visual halos, glare or starbursts. The device is not intended for use on patients who have had previous trauma to their eye.
The Tecnis Symfony IOL is also available in four toric models, which are indicated for the reduction of residual refractive astigmatism or imperfections in the curvature of the eye.
The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, and dietary supplements, for products that give off electronic radiation, and for regulating tobacco products.