Vanity is the quicksand of reason.
— George Sand
Iris prosthetic implants or devices were developed to treat pathologic conditions such as iris colobomas, traumatic iris defects, aniridia, and other processes that can lead to loss of iris tissue. They have been effective in reducing glare and decreasing light sensitivity. Contact lenses with an artificial iris painted on them were also developed for the treatment of these conditions. However, a trend to use contact lenses or iris implants strictly for cosmetic purposes to change the color of a patient's iris has recently arisen.
The NewColorIris (Kahn Medical Devices) has been touted as a way to safely and permanently change the iris color following placement in the anterior chamber. Patients have traveled to Panama City, Panama, for insertion of this device as a result of an advertising campaign carried out primarily online.
Over the past several years, scattered reports of serious complications in eyes with this cosmetic iris implant have been reported. The complications were sometimes quite severe, with significant visual loss, uveitis-glaucoma-hyphema (UGH) syndrome, corneal endothelial damage, and subsequent bullous keratopathy, as well as elevated intraocular pressure (IOP) with significant glaucomatous optic nerve damage.
In this issue, Hoguet et al. (pages 387-393) present the largest case series to date of patients with significant complications secondary to this cosmetic iris implant—7 patients (14 eyes). The patients ranged in age from a young 22 years up to 60 years. Nine eyes (64%) initially presented with decreased visual acuity, 7 eyes (50%) showed elevated IOP, and 5 eyes (36%) showed corneal edema. Another 5 eyes (36%) had signs of anterior uveitis. All 14 eyes had subsequent explantation of the iris prosthesis from 4 to 33 months after the initial surgical procedure. Although the surgical removal was uneventful in most eyes, a suprachoroidal hemorrhage occurred during the explantation procedure in 1 eye. Postoperative complications were seen commonly, with corneal edema noted in 8 eyes, cataract formation in 9 eyes, and increased IOP/glaucoma in 7 eyes. A more disturbing finding was that significant secondary surgeries were required in most patients: Descemet-stripping automated endothelial keratoplasty (DSAEK) in 5 eyes and a full-thickness penetrating keratoplasty in 1 eye. Cataract extraction with intraocular lens implantation was necessary in 7 eyes. In addition, the IOP and glaucomatous damage was significant enough to require trabeculectomy in 3 eyes and a glaucoma drainage implant device was placed in an additional 3 eyes.
The quest for improved cosmesis has led patients to travel outside the United States to have the cosmetic iris implant implanted. Unlike cosmetic surgery around the eye or outside the eye, placement of this device requires an intraocular procedure and leaves a device permanently in the anterior chamber of the eye. The relatively young age of many patients requires that the device be properly constructed and made of a material that will last long term without creating problems. More important, any device placed in the anterior chamber of the eye must be perfectly sized to prevent complications. The iris implant device reported here is a single size—1 size made to fit all eyes. An especially troubling aspect of the reported complications is that many occurred very rapidly after the surgical procedure, with many patients having signs of significant problems such as corneal edema or elevated IOP within 4 months of the surgical procedure.
The complications initially associated with the NewColorIris device were significant, with corneal endothelial damage causing corneal edema, chronic inflammatory changes such as UGH syndrome, and problems with increased IOP and glaucoma. An even more troubling finding was that most patients required significant surgical interventions for ongoing problems following the removal of this device. These included invasive surgical procedures such as DSAEK or corneal transplantation, trabeculectomy, or valve placement, as well as cataract removal. The potential morbidity from these procedures is significant in and of itself, but the potential long-term problems that can be associated with the complications arising from this device are an area of great concern, especially given the relatively young age of the patients.
It is important to note that this cosmetic iris implant device is quite different from the iris prosthetic devices that are used in Europe and Asia as well as in the United States under research protocols or compassionate-use protocols. These properly made, properly sized, and properly placed devices have been shown to have excellent results in patients with significant iris defects with subsequent glare and light sensitivity.
In conclusion, the cosmetic iris implant device may cause significant ocular complications that could result in visual loss, the need for further surgical interventions, and ocular morbidity. The lack of long-term adequate follow-up in patients implanted with this device, as well as the lack of safety data presented in the peer-reviewed literature, requires that both patients and physicians seriously reconsider the use of this cosmetic iris implant device in healthy phakic eyes.