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CustomFlex artificial iris may be well-tolerated, improve cosmetic outcomes
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NEW YORK — The HumanOptics artificial iris may be well-tolerated with improved cosmetic results compared with previous devices, according to a speaker here.
In the past, surgeons could use fin devices inserted through a small incision, as well as IOL-iris diaphragm combinations.
“These devices were great when patients had a tremendous amount of glare and issues, but cosmetically, it wasn’t necessarily consistent with the human eye or cosmetic result that we would like,” Nicole R. Fram, MD, said at OSN New York 2015.
Therefore, FDA trials have been conducted in the U.S. over the past 5 to 6 years for the CustomFlex silicone elastomer, which is a custom-matched, pigmented, biocompatible iris prosthesis for patients who have experienced trauma, congenital aniridia or problems during surgery, she said. The artificial iris is fiber-free and placed into the capsular bag through a small-incision technique or through fiber meshwork with an open-sky technique, suturing it into the sulcus or the IOL.
Fram said she reinforces the haptics of the IOL that are in the capsular bag in the event that there are zonular issues or the sutures break in the future. Glue is also used to seal the conjunctiva, she said.
“The technology is improving, there are amazing cosmetic results, and it’s well-tolerated,” Fram said. “It’s not for use of placement in the anterior chamber, and it’s not used to change eye color.” – by Kristie L. Kahl
Disclosure: Fram reports she is a speaker for Alcon, Bausch + Lomb and Abbott Medical Optics and a consultant for Allergan and Bio-Tissue.