First Stand-Alone Prosthetic Iris Wins FDA Approval
Orange County, CA - June 4th, 2018 - The U.S. Food and Drug Administration approved an artificial iris transplant. It is the first stand-alone prosthetic iris in the United States. The iris is a surgically implanted device that treats patients with congenital Aniridia (absence of an iris) or other possible eye damage.
Congenital Aniridia is a rare genetic disorder (usually involves both eyes) to which the iris is partially or completely absent. The iris is a thin, circular structure in the eye that is responsible for controlling the diameter and size of the pupil and thus the amount of light reaching the retina.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye. Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduce sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with Aniridia.” stated Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA's Center for Devices and Radiological Health.
HumanOptics, a firm located in Germany has named this thin, foldable medical-grade silicone, CustomFlex. CustomFlex is inserted through a small incision in the eye, it is unfolded in place, and the edges are smoothed out using surgical instruments. The anatomical structure of the eye or stitches would be able to hold it in place.
It has been proven to be effective and safe in the non-randomized clinical trial of 389 adult and pediatric patients with iris defects. The study measured patients’ health-related quality of life, decrease in severe sensitivity to light and glare after the procedure was done, and the satisfaction with the cosmetic improvement or appearance of the prosthesis. 94 percent of the patients were satisfied with the appearance of the artificial iris, and more than 70 percent reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure.
It has affected about 1 in 50,000-100,000 people in the United States. It is made to treat people with eye damage caused by Aniridia. For these patients and those who have experienced other eye trauma, the CustomFlex offers an opportunity to improve how they see and is not for people who want a different eye color.
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First Stand-Alone Prosthetic Iris Wins FDA Approval Orange County, CA – June 4th, 2018 – The U.S. Food and Drug Administration approved an artificial iris transplant. It is the first stand-alone prosthetic iris in the United States. The iris is a surgically implanted device that treats patients with congenital Aniridia (absence of an iris) or other possible […]