This article reports on the numerous complications that occurred in seven patients (14 eyes) who presented at one medical center in New York City after placement of NewColorIris cosmetic iris implants in Panama City, Panama. These include corneal edema, increased IOP, pigment dispersion, uveitis, depressed endothelial cell count (ECC), uveitis-glaucoma-hyphema (UGH) syndrome, glaucomatous optic neuropathy, cystoid macular edema (CME), trabecular meshwork damage and suprachoroidal hemorrhage. The implants were removed from all eyes after between four and 33 months, with subsequent surgeries required in most eyes and more expected. The authors recommend that this product not be used as a cosmetic implant in phakic eyes.
Use of these devices is really unbelievable. This is a cosmetic procedure, and the complications can be very severe.
The NewColorIris implant is a one-piece annular silicone iris diaphragm that is placed directly in the anterior chamber anterior to the iris. The patients in the study ranged in age from 22 to 60. Seventy-one percent were men.
The authors note the troubling rapidity of the presentation of symptoms and the subsequent ocular morbidity despite explantation. Five patients (10 eyes) were seen within four months of implantation and had elevated IOP and corneal edema, but without characteristic signs of acute angle-closure glaucoma. Overall, nine eyes (64 percent) presented with decreased visual acuity, seven (50 percent) with elevated IOP, five (36 percent) with corneal edema and five (36 percent) with anterior uveitis.
Suprachoroidal hemorrhage occurred during explantation in one eye. Patients were followed for between two and 28 months after implant removal. Postoperative complications included corneal edema (eight eyes), cataract (nine eyes) and increased IOP/glaucoma (seven eyes).
Secondary surgeries were performed in nine eyes, including Descemet-stripping automated endothelial keratoplasty (five eyes), cataract extraction with IOL placement (seven eyes), trabeculectomy (three eyes), glaucoma drainage implant placement (three eyes) and penetrating keratoplasty (one eye).
In the setting of depressed ECCs and elevated IOP, the authors say it is paramount to counsel all patients that explantation may lead to worsening ocular disease and/or an exacerbation of symptoms and further surgery might be required.
Given the patients' life expectancy and their depressed ECCs, the authors expect that some or all of them will require endokeratoplasty surgery and will have a lifelong risk of worsening glaucoma and optic neuropathy.