EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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EW CORNEA 60 May 2016 by Ellen Stodola EyeWorld Senior Staff Writer Experts highlight cosmetic iris implants and cosmetic contact lenses as well as potential concerns during the 2016 Cornea Day C osmetic procedures were a major focus of a session at the 2016 Cornea Day at the ASCRS•ASOA Sym- posium & Congress. Tal Raviv, MD, New York, spoke about ocular complications of cosmetic iris implants. There are 2 categories of iris implants, he said, functional medical devices and unstudied cos- metic implants. Functional medical devices, such as the HumanOptics iris implant (Erlangen, Germany), are placed in the ciliary sulcus or capsular bag, while cosmetic implants are placed in the anterior chamber, in contact circumferential- ly with the angle structures. There are 2 known types of cosmetic iris implants: New Color Iris, which has been supplanted by BrightOcular. The color chang- ing implants are heavily marketed online, Dr. Raviv said, and there are no safety studies or approvals. The procedure is currently performed in 10 countries, which have minimal regulatory oversight, outside of the U.S. and EU. One issue with these dangerous cosmetic iris implants, he said, is the savvy online marketing. They often feature splashy videos, celebrity endorsements, and sophisticated so- cial media marketing. The lay press often misrepresents the unapproved cosmetic iris implants as "controver- sial," Dr. Raviv said, and there has so far been no official condemnation or statements by organized ophthalmic societies. Literature has reported severe and irreversible complications, including corneal decompensation, uveitis, uncontrolled glaucoma, iris atrophy, and cataracts, he said. It has also been shown that greater than 50% of New Color Iris patients need- ed secondary surgeries. Meanwhile, 50% of BrightOcular patients devel- oped corneal decompensation, and one-third of BrightOcular patients refused to explant their implants in a recent case series, he said. Most of these patients present to their local ophthalmologists months postop, usually requesting prescrip- tion refills. "Usually they want to keep the implants and they're on multiple steroids and glaucoma drops already," Dr. Raviv said. He added that they may present with more serious complaints of red eyes, blurry vision, and pain. Dr. Raviv suggested early and immediate explantation of the implants. The most important thing is don't delay, he said. Some of the warning signs may be iritis, high IOP, pupil ovalization under the implant, corneal decompensation, and cataracts. Most patients request to be managed medically, but the longer one delays explantation, the greater the damage. Decompensa- tion of the cornea typically happens quickly in these cases, so explanta- tion shouldn't be delayed. The ini- tial surgical intervention should be primary explantation without other secondary procedures. After explan- tation, he recommended evaluating the patient for secondary procedures such as phaco, DSEK, glaucoma surgery, and iris repair. Previous descriptions of cosmet- ic iris explantation involved cutting the implant into multiple pieces intraocularly and then removing them. Dr. Raviv said there is also a no-cut technique. He presented his own preferred 1-cut technique. In order to do this, he uses ace- tylcholine chloride and dispersive OVD. He uses 23-gauge graspers 180 degrees from the primary corneal wound, and micro-scissors to make 1 radial cut into the implant close to the corneal entry. Dr. Raviv then removes the implant in 1 piece, with copious OVD placement and gentle I/A. "You want to be in the eye as little as possible," he said. "In conclusion, these are un- approved, unstudied cosmetic iris implants and are a public safety hazard," he said. Prompt remov- al of iris implants at the first sign of problems is critical to prevent irreversible complications, he said, adding that he thinks ophthalmic societies need to officially condemn these implants. Michelle Rhee, MD, New York, highlighted another cosmetic product that may cause concern. Her talk touched on complications of large-diameter cosmetic contact lenses, and she covered 3 main questions: What are large-diameter cosmetic contact lenses? What are the problems associated with them? What can be done about them? Some cosmetic procedures and lenses could prove problematic I recently saw a patient who had cosmet- ic iris implants in both eyes implanted overseas. She was told by the operating surgeon that she needed a cornea specialist back home (in Toronto, Canada) to monitor her eyes and perform endothelial cell counts every 6 months. When I discussed the long-term potential for irreversible complications related to her cosmetic iris implants and my recommendation for ex- plantation, she responded that she trusted her surgeon; she liked her turquoise-col- ored irises and did not want her natural brown eyes again Medical tourism for cosmetic proce- dures exists around the world. Tal Raviv, MD, spoke at the 2016 Cornea Day at the ASCRS•ASOA Symposium & Congress on cosmetic iris implants. In this month's "Cornea editor's corner of the world," he discusses the dangers of cosmetic iris implants, how to avoid complications, and how to manage complications that do arise. Decorative contact lenses are another cosmetic product that is unregulated, not approved as a proper medical device, and can be purchased without a prescription. Very popular in Asia and during the Hallow- een season, these large-diameter contact lenses can lead to significant problems as well. Michelle Rhee, MD, who also spoke at this year's Cornea Day, goes into further details in this month's column. Clara Chan, MD, FRCSC, FACS, cornea editor Cornea editor's corner of the world Cosmetic contact lenses can often be purchased without a prescription and come with their own set of potential risks and complications. Source: Michelle Rhee, MD