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.

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.

Unlabelled: 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.

Anterior Chamber Iris Claw Lens for the Treatment of Aphakia in a Patient with Megalocornea.

Megalocornea in isolation is a rare congenital enlargement of the cornea greater than 13 mm in diameter. Patients with megalocornea are prone to cataract formation, crystalline lens subluxation, zonular deficiencies and dislocation of the posterior chamber intraocular lens (PCIOL) within the capsular bag. A 55-year-old male with megalocornea in isolation developed subluxation of the capsular bag and PCIOL.

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.