May 31 (UPI) -- The Food and Drug Administration has approved the first stand-alone artificial iris in the United States to treat adults and children.
The surgically implanted device is for people with an iris -- the colored part of the eye around the pupil -- that is completely missing or damaged due to a congenital condition called aniridia, or other damage.
On Wednesday, the FDA approved the artificial iris after a successful non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. More than 70 percent of patients reported significant decreases in light sensitivity and glare and improved health-related quality of life. Also, 94 percent of patients were satisfied with the artificial iris' appearance.
"Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye," said Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "Approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia."
Congenital aniridia, a genetic disorder, affects approximately 1 in 50,000 to 100,000 people in the United States, according to the FDA.
The CustomFlex Artificial Iris also was approved to treat iris defects due to albinism, traumatic injury or surgical removal because of melanoma.
HumanOptics of Germany, which formerly was called Dr. Schmidt Intraocularlinsen, developed the lens with Dr. Hans-Reinhard Koch. It earlier was approved in Europe where it is called HumanOptics Artificial Iris.
The artificial iris is made of thin, foldable medical-grade silicone. It is custom-sized and colored for each individual patient.
In the procedure, a surgeon makes a small incision, inserts the device under the incision, unfolds it and uses surgical instruments to smooth out the edges. The anatomical structures of the eye, or sutures, if needed, hold the prosthetic iris in place.
Low rates of complications were associated with the device or the surgical procedure during the drug trial
The FDA said the device should not be used in eyes with uncontrolled or severe chronic inflammation, abnormally small eye size, untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris, certain kinds of damaged blood vessels in the retina and intraocular infections. It also is not recommended for pregnant patients.