Bottom images: Three months later the color match is excellent and the iris is perfectly centered. She then underwent cataract extraction with intraocular lens implantation and passive fixation of a dark brown custom artificial iris in the ciliary sulcus. Top images: This patient suffered a blunt injury to her left eye following phakic intraocular lens implantation the iris and the implantable contact lens were expelled, leaving her aniridic with a cataract. Complication rates were low they included dislocation, strands of device fiber in the eye, increased IOP, iritis and the need for additional surgery to reposition, remove or replace the device.Īn example of an excellent outcome.
Furthermore, 94 percent reported satisfaction with the outcome. More than 70 percent of subjects receiving the implant reported a significant decrease in light sensitivity and glare, and significant improvements in health-related quality of life.
The FDA approval followed a nonrandomized clinical trial involving 389 patients.
The former design allows suturing of the device, if needed the latter design does not. (The company notes that the device can also be implanted in the capsular bag.) It comes in two formats: with or without fiber. The CustomFlex can be inserted into the ciliary sulcus using a sclerocorneal approach, or via “open sky” during penetrating keratoplasty. When implanting the device, the outside diameter is cut to the appropriate size for the patient’s eye using a trephine. The pupil opening has an undulated edge resembling that of a natural iris. The prosthesis is custom-designed to mimic the appearance of the patient’s other (undamaged) iris, based on photographs approved by the patient and surgeon. The Customflex can also improve an individual’s cosmetic appearance by eliminating visible iris defects. Compared to vision with a damaged or missing iris, this improves contrast sensitivity, reduces glare and light sensitivity and eliminates transillumination defects. It has a black, opaque back surface that completely absorbs light, only allowing light to pass through the fixed, central 3.35-mm aperture. The CustomFlex ArtificialIris is a flexible, biocompatible silicone device indicated for use in adults or children with congenital aniridia and/or iris defects. Here, surgeons who have implanted the device share some of their experience and advice.
To date, there’s still no billing code allowing financial reimbursement for implanting the device, but surgeons are nevertheless pleased to have something to offer patients who need an iris prosthesis. A lthough customized intraocular replacements for a damaged iris have been available for some time outside the United States, it’s only recently that the CustomFlex ArtificialIris, created by HumanOptics in Germany, became the first stand-alone prosthetic iris to receive approval from the U.S.