Complications of Cosmetic Artificial Iris Implantation and Post Explantation Outcomes

Abstract

To report complications of cosmetic artificial iris implantation and explantation outcomes.• DESIGN: Retrospective case series.• METHODS: Medical records of 12 patients (24 eyes) who presented to us after being implanted with cosmetic artificial irises elsewhere were reviewed. Data collected included baseline demographics, presenting symptoms, examination findings, and management outcomes.• RESULTS: Eight eyes had NewColorIris implants and 16 had BrightOcular implants. The mean interval from cosmetic iris implantation to presentation was 61.7 ± 60.0 months. The mean follow-up after explantation was 35.5 ± 38.1 months. Complications at presentation included iris abnormalities (11 eyes, 45.8%), elevated intraocular pressure (8 eyes, 33.3%), corneal edema (6 eyes, 25%), intraocular inflammation (5 eyes, 20.8%), and cataract (4 eyes, 16.7%). Surgical interventions included cosmetic iris removal (19 eyes, 79.2%), cataract extraction (7 eyes, 29.2%), corneal transplantation (7 eyes, 29.2%), and glaucoma surgery (4 eyes, 16.7%). Complications at the last follow-up examination included native iris defects (11 eyes, 45.8%), persistent glaucoma (7 eyes, 29.2%), cataract (5 eyes, 20.8%), corneal edema (4 eyes, 16.7%), and intraocular inflammation (2 eyes, 8.3%). The mean logarithm of the minimum angle of resolution was 0.56 ± 0.47 at presentation and 0.78 ± 0.88 at the last examination ( P = .30). The mean intraocular pressure was 22.7 ± 15.8 mm Hg at presentation and 13.4 ± 6.99 mm Hg at the last examination ( P = .02).• CONCLUSION: Cosmetic iris implantation was associated with serious complications at the time of presentation, and adverse sequelae persisted for years after explantation.

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

“…13 Furthermore, it is recognized that asymptomatic patients are likely to delay explantation until significant pain or visual loss is experienced. 9 This case highlights the sight-threatening complications of cosmetic anterior chamber iris implants. In an unregulated market of medical tourism, patients need a greater awareness of the surgical risks associated with cosmetic iris implants prior to consenting for this procedure.…”

“…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.…”

“…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. 10 Explanation of the anterior chamber iris implant is required for approximately 80% of eyes 9,10 and occurs 2 years after implantation on average.…”

Anterior segment reconstruction due to cosmetic iris implants placed in the anterior chamber

“…James Landreneau, MD Arthur van den Berg, MD Karolinne Maia Rocha, MD, PhD Charleston, South Carolina Several postoperative complications have been reported with cosmetic artificial iris implants, including cataract, recurrent uveitis, iris atrophy, uveitis-glaucoma-hyphema syndrome, ectopia uvea, endothelial cell loss, and corneal decompensation. 1 These complications can occur concomitantly requiring explantation of the implant.…”

“…This case highlights many of the complications associated with these non-FDA-approved devices. 1 For this patient, I would first focus on the right eye, which fortunately has reasonably controlled IOP, although the status of the optic nerve was not mentioned. If the previously documented keratometry in the PKP was reasonable, my preference is endothelial keratoplasty (EK) and to consider repeat PKP only if keratometric astigmatism is high or there are major issues with the graft-host junction.…”