Artificial iris device proven safe, effective for iris defects

A custom-manufactured artificial iris device has exceeded all safety outcomes for adverse events associated with the device, intraocular lens (IOL), or implant surgery, reports a study. It has also shown its efficacy as indicated by decreased light and glare sensitivity, better health-related quality of life, and cosmetic satisfaction among patients with iris defects.

“The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects,” the researchers said.

A multicentre, prospective, unmasked, nonrandomized, interventional clinical trial was conducted to assess the safety and efficacy of CustomFlex Artificial Iris (Human Optics AG) for the treatment of iris defects. Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both, were included.

From 26 November 2013 to 1 December 2017, eyes were implanted using a custom, foldable artificial iris by one of four different surgical techniques. The researchers evaluated patients 1 day, 1 week, and 1, 3, 6, and 12 months after the procedure. They recorded slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications at each examination.

The researchers also measured corrected distance visual acuity (CDVA) and endothelial cell density (ECD) at 3, 6, or 12 months as additional safety evaluations. They used the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) to assess health-related quality of life affected by vision. Cosmetic results were evaluated using the Global Aesthetic Improvement Scale.

A 59.7-percent decrease in marked to severe daytime light sensitivity (p<0.0001), a 41.5-percent reduction in marked to severe night-time light sensitivity (p<0.0001), a 53.1-percent decrease in marked to severe daytime glare (p<0.0001), and a 48.5-percent reduction in severe night-time glare (p<0.0001) were observed at the 12-month postoperative examination. [Ophthalmology 2022;129:614-625]

The NEI VFQ-25 total score also improved by 15.4 points (p<0.0001). At 12 months after surgery, majority of the patients (93.8 percent) saw an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale.

The researchers found no loss of CDVA of >2 lines related to the device. Furthermore, median ECD loss stood at 5.3 percent at 6 months following surgery and 7.2 percent at 12 months after the procedure.

“The artificial iris surpassed all key safety endpoints for adverse events related to the device, IOL, or implant surgery and met all key efficacy endpoints, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis,” the researchers said.

Iris diaphragm

A 2016 study that evaluated the safety and efficacy of Morcher 50F iris diaphragm implantation found the device to be relatively safe and effective for reducing light and glare sensitivity in eye with iris defects when used in combination with cataract extraction and intraocular lens implantation. [J Cataract Refract Surg 2016;42:870-878]

Likewise, a study published in 2018 confirmed the safety and efficacy of the Morcher 67B black iris diaphragm IOL for managing large iris defects and aphakia. Implantation of the device improved CDVA and reduced light and glare sensitivity. [J Cataract Refract Surg 2018;44:686-700]