Preventing confusion between iris color-changing implants and therapeutic iris prostheses.

Abstract

El Chehab et al. rightly describe the well-known sight-threatening consequences of the cosmetic iris color–changing implants.1 We applaud their work in collating these European cases. They also reference a few of the now many peer-reviewed publications documenting the complications of the cosmetic color-changing iris implants. Although not stated specifically, to our knowledge, neither of the 2 referenced devices, the NewColorIris (Kahn Medical Devices) and BrightOcular (Stellar Devices), have even a single case report of safe use or retention without sequelae. Recognizing that the focus of the article was to describe the French experience with complications with those 2 non–CE (Conformité Européene)-marked and non–FDA (U.S. Food and Drug Administration)-approved color-changing devices, the discussion does not differentiate these 2 devices from the iris prostheses, which have been used successfully for therapeutic purposes and also have some cosmetic benefit of restoring the original appearance of a damaged iris (not changing iris color).2–6 Readers of the article by El Chehab et al. might inadvertently confuse the color-changing device with the therapeutic implants, which have well-documented safety and efficacy uses. Currently, several therapeutic iris prostheses made by Morcher GmbH, Ophtec BV, HumanOptics AG, and Reper NN carry the CE mark for use in Europe. The HumanOptics artificial iris is also FDA approved for use in the United States. Devices from Ophtec are made in 3 colors, whereas Reper manufactures several dozen colors, and the HumanOptics device is custom matched to an image taken from an uninjured eye. It is worth noting that all the therapeutically used devices are designed to be placed either in the capsular bag or in the ciliary sulcus, whereas the color-changing implants are placed in the anterior chamber, overlying native iris tissue. In addition to manufacturing concerns mentioned in the article, the anterior chamber placement can reasonably predict the complications seen, whereas the sulcus and capsular bag placement of therapeutic devices also predicts the favorable safety and efficacy seen by these therapeutic implants. Ironically, the iris of the patient depicted in El Chehab's Figure 1 was badly damaged by the color-changing implant, and this patient may now have photic symptoms due to the induced iris deficiency. Such a patient would likely receive relief from one of the therapeutic implants placed within the capsular bag or ciliary sulcus, as did one of our patients with trauma with a similar deficiency, treated with an in-the-bag custom, flexible iris (HumanOptics AG) (Figure 1).Figure 1.: Note the exposed IOL edges and atrophic iris remnant of the left eye preoperatively (upper left) and following custom, flexible iris implantation within the capsular bag, confirmed by the visualization of the capsulorhexis overlying the implant (upper right). The midface postoperative photograph (bottom) demonstrates the match to the fellow eye.