FDA Approves First Artificial Iris

The U.S. Food and Drug Administration (FDA) has approved the world’s first artificial iris, a breakthrough development for those suffering with severe vision loss. The iris is the colored part of the eye that surrounds the central pupil.

The iris plays an important role in the function of the eye. It controls the diameter and size of the pupil, and the amount of light reaching the retina. The retina is the camera lens of the eye and the amount of light that reaches it is essential for sight. Consequently, when the iris is damaged or missing it can result in severely impaired vision.

The artificial iris is surgically implanted. The FDA says it can be used on adults and children “whose iris is missing, has been damaged by a congenital condition called aniridia, or has been injured”.  It can also be used to treat defects of the iris caused by albinism or to replace irises that have been surgically removed because of melanoma. Aniridia is a rare genetic disorder. It’s estimated that one in 50,000 to 100,000 people in the United States suffer from it.

The artificial iris can improve appearance and some vision difficulties. For those with a missing iris, it can improve the cosmetic appearance of the eye. For those with aniridia, the implant can reduce sensitivity to bright light and glare.

According to the FDA, “The artificial iris is made of thin, foldable silicone and is custom-fitted and colored for each patient. To insert it, a surgeon makes a small incision, places the device under the incision, then unfolds it and smoothes out the edges using surgical instruments”.

During clinical trials, more than 70 percent of the patients who had the artificial iris implanted said they experienced “significant decreases” in light sensitivity and glare. Ninety-four percent of the study participants said they were pleased with the appearance of the implant. Importantly, the artificial iris also improved their quality of life.

Quality of life is something that we strive to improve for our patients through the use of medical devices that enhance low vision. We believe that life with low vision does not have to be a life of isolation. Through medical devices like IrisVision, microscopic and telescopic lenses, our patients can see the faces of their loved ones, read, watch TV, participate in their favorite hobbies, and in some cases, drive a car.

Many of our patients have been told that nothing more can be done to enhance their low vision. We don’t accept that. When low vision is caused by eye diseases like macular degeneration, we can enhance remaining sight. If you or a loved one lives with low vision call us. We can help.