When it comes to using the artificial iris, “patients will appreciate this more than anything else you do,” said Kevin M. Miller, MD, during the 15th annual Charles D. Kelman Lecture at Monday’s Cataract Spotlight session.
Dr. Miller has considerable experience with several artificial iris implants, notably the CustomFlex (HumanOptics), which received FDA approval last year. (Several other implants are available elsewhere in the world.) As part of this, he has worked to streamline and expedite the compassionate use protocols.
Unexpected benefits. “Cosmetically, these devices are over the top,” Dr. Miller said. And not only do they convey practical benefits, such as reducing light sensitivity and glare, but they also have a significant impact on patients’ emotional health and their ability to interact with others, he said. As one of his patients put it, “I have fewer inhibitions about meeting random strangers.”
Considerations and outcomes. The artificial iris can be placed with either forceps or an injector. “You’ll need an older-style injector and larger incisions,” given their size, Dr. Miller said. He also noted that the color match is not always perfect—and that the iris doesn’t always center. With regard to sequelae, “glaucoma will be an issue if they had it preoperatively,” but new-onset cases do not seem to be a problem. Other possible sequelae include the postimplantation need for PRK or strabismus surgery. “On a positive note, the view of the retina and optic nerve is excellent through the artificial pupil.”
How to qualify for use. U.S. surgeons who are interested in bringing the CustomFlex into their practices should contact VEO Ophthalmics, the company that distributes the implant in the United States. The company requires the completion of online training models and a dry lab. Moreover, the surgeon must meet several prerequisites, including having performed at least 1,000 cataract surgeries.
With regard to the financial angle, “I lose money with virtually every artificial iris I implant,” Dr. Miller said. “There’s no reimbursement, as there are no codes, and no clinical trials reimburse their investigators.”
A last caution. Above all, don’t implant a cosmetic anterior chamber artificial iris (NewColorIris and others), Dr. Miller said. “And if you’re using them, please stop.” They cause myriad problems, including corneal decompensation, uveitis, glaucoma, iris atrophy, and premature cataracts. —Jean Shaw
Financial disclosures. Dr. Miller: Alcon: C; Bausch + Lomb: O; ianTech/Zeiss: C; Johnson & Johnson Vision: C.
Disclosure key. C = Consultant/Advisor; E = Employee; L = Speakers bureau; O = Equity owner; P = Patents/Royalty; S = Grant support.
Watch a 5-minute interview with Dr. Miller. Lisa B. Arbisser, MD, interviews Dr. Miller about his Charles D. Kelman Lecture. Dr. Miller discusses the HumanOptics ArtificialIris, the first stand-alone prosthetic iris to receive approval from the FDA. He describes specifications of the prosthesis, the cases most likely to benefit from artificial iris implantation, and lessons learned from the first year of the iris' availability in the United States.
Read more news from AAO 2019 and the Subspecialty Day meetings.