Complications of cosmetic iris implants: French series of 87 eyes

Abstract

Iris intraocular implants were developed to manage congenital or traumatic iris defects. However, they are also used to change the color of patient eyes. The aim of this retrospective series was to report complications in patients managed in France after cosmetic implantation.Setting: Ophthalmological institutions and private ophthalmologists in France.Design: Multicenter retrospective observational study.Methods: Questionnaires were sent to all ophthalmology departments in university hospitals and to private ophthalmologists. This questionnaire listed demographic and clinical data for each implanted eye with a focus on safety, the description of ocular complications (corneal edema, endothelial cell loss, increased intraocular pressure, and intraocular inflammation), and the therapeutic management implemented.Results: Forty-four questionnaires (87 eyes) were collected, and ultimately, 33 questionnaires (65 eyes) were considered complete and analyzed. Two types of implants were identified. Of the 65 eyes analyzed, only 5 eyes (7.7%) did not experience any complication and 60 eyes (92.3%) had at least 1 complication. The most commonly reported complication was corneal decompensation (78.5%). The diagnosis of glaucoma was made in over half (52.3%) of the cases. Explantation was needed in 81.5% of cases. The mean final visual acuity was 0.45 ± 0.08 logarithm of the minimum angle of resolution (logMAR) (0 to 2 logMAR).Conclusions: Several ocular complications with a decreased mean visual acuity were described in a young healthy population. In addition, patient information on the safety of this procedure appeared insufficient.

Complications of Cosmetic Artificial Iris Implantation and Post Explantation Outcomes

“…Unlike the improved visual and functional outcomes that typically follow functional iris prosthesis implantation, cosmetic iris devices have been associated with serious complications such as corneal decompensation, glaucoma, native iris trauma, intraocular inflammation, and cataract development, any of which can result in vision loss or other morbidities. [11][12][13][14][15][16][17] In 2006, a silicone anterior chamber iris implant, the NewColorIris (Kahn Medical Devices, Panama City, Panama), was introduced as a treatment for oculocutaneous albinism (Kahn, DA: poster presentation at the American Academy of Ophthalmology Annual Meeting 2006). The implant was subsequently advertised on the Internet as a cosmetic device to change eye color (from former Web site: http://www.newcoloriris.com ).…”

“…in previous studies. [11][12][13][14][15][16] However, direct comparison is confounded by different and often poorly specified criteria used to define elevated IOP and glaucoma in various studies. Underlying mechanisms of glaucoma in implanted eyes may include trabeculitis, mechanical trabecular injury, peripheral anterior synechiae, and rarely acute angle closure.…”

Cosmetic anterior chamber iris implant: a case report documenting severe complications and morbidity after 9-year follow-up

“…The extent of visual rehabilitation is variable, with an average follow-up visual acuity of 0.45 logMAR (equivalent to 6/17) for all eyes, yet half of eyes can reach 0 logMAR (6/6) visual acuity. 8 Secondary glaucoma, uveitis, corneal decompensation, and cataract are the most commonly reported complications, with many patients requiring surgical treatment. 1 The true prevalence of complications is unknown, with current estimates based on presented case series and reports in the literature.…”

“…Secondary glaucoma develops in approximately 50% of implanted eyes, with surgery (trabeculectomy and aqueous drainage device) necessary for approximately 20% of eyes. 1,8,9 From the largest case series, corneal decompensation may be the most common complication (78.5% of eyes). 8 Corneal transplant surgery was performed in up to 20% of eyes, with most patients undergoing endothelial keratoplasty.…”

“…1,8,9 From the largest case series, corneal decompensation may be the most common complication (78.5% of eyes). 8 Corneal transplant surgery was performed in up to 20% of eyes, with most patients undergoing endothelial keratoplasty. 1,8,9 Peripheral anterior synechiae is an important surgical consideration, with some patients developing broad peripheral anterior synechiae, which can limit a more selective endothelial keratoplasty.…”