Oct. 14, 2023
Managing iris defects can be challenging, whether the defects are congenital or acquired through traumatic events. These defects can lead to many visual symptoms including decreased visual acuity and disability glare. "When necessary, an iris implant can mimic a natural iris and help improve visual symptoms that have been affecting a patient's quality of life," says Keith H. Baratz, M.D., an ophthalmologist at Mayo Clinic in Rochester, Minnesota.
Within the last few years, the efficacy of a custom-made artificial iris device was studied by the United States Food and Drug Administration. Participants included people with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. The study found that the artificial iris surpassed all key safety endpoints for adverse events related to the device, intraocular lens or implant surgery and met all key efficacy endpoints, including decreased glare, improved health-related quality of life and satisfaction with physical appearance. Study results were published in the June 2022 issue of Ophthalmology.
To prepare for this type of surgery at Mayo Clinic, the patient undergoes an evaluation, special photography of both irises to create a match between the prosthesis and healthy iris, and examination of the eye. "We give a comprehensive examination of the eye and discuss the plan for the surgery itself," says Dr. Baratz. Once the plan is discussed, and a surgery is scheduled for about 2 to 3 months after the initial appointment, the photos of the eye are sent to Germany for the custom-made prosthesis.
The iris prosthesis is a thin disk of biocompatible medical-grade silicone and the first of its kind. Each iris is custom-made for each patient using photos of the patient's eyes to aid in mimicking the patient's natural iris.
"There is some versatility to this procedure as well, including a sutureless and a sutured iris prosthesis, depending on the anatomy of the eye," says Sanjay V. Patel, M.D., an ophthalmologist at Mayo Clinic in Rochester, Minnesota. "The prosthesis can be implanted into the capsular bag at primary cataract surgery or placed secondarily in the sulcus with or without scleral fixation."
Once the procedure is complete, little specialized follow-up care is typically needed. Long-term studies have shown that the device has been well tolerated. While the artificial pupil is fixed, it is the sufficient size for posterior examination and surgery. If a need should arise after surgery, Mayo Clinic has the resources to manage them.
Overall, this newer technology has shown positive results for patients seeking to ameliorate their conditions. "While this iris prosthesis brings important functional improvements, such as improvement in glare and vision, it can also bring cosmetic improvements, which can contribute to a patient's overall improved health and happiness. There's an art to the design of these implants, and when it's successful, a patient can feel more at ease with the function and appearance of their eye," says Dr. Baratz.
For more information
Results of the United States Food and Drug Administration clinical trial of the CustomFlex Artificial Iris. Ophthalmology. 2022;129:614.
Refer a patient to Mayo Clinic.