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First standalone artificial iris receives green light

The FDA has approved the first standalone prosthetic iris for use in the US, which could be used to treat patients with congenitial aniridia and other iris defects.

The regulator granted the CustomFlex Artificial Iris, developed by Germany-based HumanOptics AG, with a Breakthrough Device designation following extensive evaluation and development reviews of the product.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” the FDA’s Dr Malvina Eydelman said.

“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.”

The CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone and is custom-sized and coloured for each individual patient. The device is inserted under a small incision, before being unfolded and smoothed with the use of surgical instruments. The device can be held in place by the anatomical structures of the eye or, if needed, by sutures.

"Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduce sensitivity to bright light and glare."
Malvina Eydelman, FDA

The prosthetic iris was tested through a non-randomised clinical trial of 389 adult and paediatric patients diagnosed with aniridia or other types of iris defects. It measured the 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% 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% of patients were satisfied with the artificial iris’ appearance.

The study found low rates of adverse events associated with the device or the surgical procedure.

Complications that did occur were associated with device movement or dislocation, strands of device fibre in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae) and the need for secondary surgery to reposition, remove or replace the device.

Complications associated with the surgical procedure included increased intraocular pressure, blood leakage in the eye, swelling of the center of the retina (cystoid macular oedema), secondary surgery, corneal swelling, iritis, and retinal detachment. The FDA said the device should not be used on persons with uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections. It is also contraindicated for patients who are pregnant.


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