Hope for Aniridia patients as USFDA approves first artificial iris

Imagine a camera without a shutter. That is exactly how it is with a human eye that does not have an 'iris' . There is too much light falling on the retina within the eye and normal vision does not develop. The reason for this could be either congenital or an accident. There is hope now for those suffering with this condition.

The US Food and Drug Administration (USFDA) has just approved (on May 30) the "first stand-alone prosthetic iris" in the United States. It is being described by the regulator as "a surgically implanted device to treat adults and children whose iris (the coloured part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye."

A note issued by the USFDA describes 'congenital aniridia' as "a rare genetic disorder in which the iris is completely or partially absent. It affects approximately 1 in 50,000 to 100,000 people in the US". The numbers could be higher in India and more common in communities where marriages are held within families, says Dr Virender Singh Sangwan, Director, Centre for Ocular Regeneration, at the L V Prasad Eye Institute in Hyderabad. This practice of marriages within the family or between close relatives, he says, is a big factor for all inherited genetic conditions.

Though unable to spell out the number of patients affected with aniridia in India, he does say it is an area of concern. For the moment, the treatment may be expensive but there could be hope given India's strong ophthalmic industry, says Sangwan.  

The CustomFlex Artificial Iris, the USFDA note says, is made of thin, foldable medical-grade silicone and is custom-sized and coloured for each individual patient. A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures.

The note further adds that the safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. The study measured patients' self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis. More than 70 percent of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure. In addition, 94 percent of patients were satisfied with the artificial iris' appearance.