For a study, researchers sought to assess the safety and efficacy of a custom-made artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for treating congenital and acquired iris abnormalities. Patients with photophobia, sensitivity due to congenital or acquired iris abnormalities, or both were included. From November 26, 2013, to December 1, 2017, eyes were implanted with a bespoke, foldable artificial iris using one of four distinct surgical procedures. Patients were examined one day, week, one, three, six, and twelve months following surgery. Slit-lamp results, intraocular pressure, implant location, subjective visual complaints, and complications were noted at each visit. As an additional safety examination, corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were assessed at 3, 6, and 12 months. The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to evaluate vision-related health-related quality of life. Cosmetic results were evaluated using the Global Aesthetic Improvement Scale. About 12 months after surgery, photosensitivity, glare, visual complaints, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events
A 59.7% reduction in marked to severe daytime light sensitivity (P<0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P<0.0001), a 53.1% reduction in marked to severe daytime glare (P<0.0001), and a 48.5% reduction in severe nighttime glare (P <0.0001) were discovered at the 12-month postoperative examination. The NEI VFQ-25 total score improved by 15.4 points (P<0.0001), and 93.8% of patients reported an improvement in cosmesis as judged by the Global Aesthetic Improvement Scale 12 months following surgery. There was no loss of CDVA of more than two lines associated with the device. At six months following surgery, the median ECD loss was 5.3%, and at 12 months, it was 7.2%. All important safety end objectives for adverse events related to the device, IOL, or implant procedure were exceeded, and all key effectiveness endpoints, such as decreased light and glare sensitivity, better health-related quality of life, and satisfaction with cosmesis, were reached. The device is safe and effective for treating symptoms and an unattractive aesthetic appearance caused by iris abnormalities, whether hereditary or acquired.