Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, 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 found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

Capsular bag stabilization during lens extraction and intraocular lens implantation in cases of Marfan syndrome with ectopia lentis using ultra-high-viscosity ophthalmic viscosurgical devices.

Capsule-sparing lens surgery in the setting of compromised zonular support presents several surgical challenges. One challenge has been achieving early stabilization of the capsular bag prior to cataract removal. We developed a technique that uses a high-molecular-weight viscoadaptive substance to distend and stabilize the capsular bag from within, with or without early insertion of a capsular tension ring, during lens extraction and intraocular lens (IOL) implantation in cases of zonular insufficiency. The technique obviates the use of capsule hooks or similar devices that have been used traditionally for early stabilization of the capsular bag. It has also resulted in immediate and long-term stability of the IOL-zonule-capsular bag complex, with excellent visual outcomes in both pediatric and adult patients. FINANCIAL DISCLOSURE: Dr. Rosenthal is a consultant to Abbott Medical Optics, Inc., Ophtec USA, and Bausch & Lomb/Valeant. Dr. Venkateswaran has no financial or proprietary interest in any material or method mentioned.

Transillumination defects following in-the-bag single-piece intraocular lens implantation and trabeculectomy with mini-shunt.

An 80-year-old woman of mixed ethnicity developed significant iris transillumination defects following phacoemulsification with in-the-bag implantation of a single-piece hydrophobic acrylic intraocular lens (IOL) and trabeculectomy with insertion of an Express mini-shunt. With the exception of modest anterior chamber shallowing in the first few weeks postoperatively, the surgery and postoperative course were uneventful. The observed iris defects are thought to have been caused by contact between the IOL-capsule complex and the posterior iris during shallowing of the anterior chamber. No other cases in the peer-reviewed literature have identified iris defects secondary to implantation of a single-piece monofocal hydrophobic acrylic IOL when the optic and haptics remained entirely within the capsular bag.