The study found low rates of adverse events associated with the device or the surgical procedure.
The US Food and Drug Administration approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.
Iris is the coloured part of the eye around the pupil.
Director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, Malvina Eydelman, in a statement said 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 reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.” he said.
The FDA granted approval of the “CustomFlex Artificial Iris” to HumanOptics AG a Germany-based firm that produces and distributes intraocular implants of the highest quality.
The CustomFlex Artificial Iris 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, FDA said.
“The safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomised clinical trial of 389 adult and paediatric 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 per cent 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 per cent of patients were satisfied with the artificial iris’ appearance,” the regulator said with regards to the efficacy of the artificial iris.
The study found low rates of adverse events associated with the device or the surgical procedure, it added.
The FDA also suggested that the CustomFlex Artificial Iris is contraindicated, or should not be used, in eyes under certain conditions such as uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, and cataract caused by rubella virus.
It is also contraindicated for patients who are pregnant.