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

We report the case of a 27-year-old Middle Eastern woman who travelled to India for bilateral cosmetic anterior chamber iris implant surgery. Within 8 years of implantation, both iris implants required removal, and extensive ophthalmic surgery has been required for visual rehabilitation.

The use of anterior chamber iris implants to alter eye colour for cosmetic reasons carries a significant risk of visual loss owing to secondary complications. Both the NewColourIris (Khan Medical Devices Corp, Panama) and BrightOcular (Stellar Devices LLC, New York, NY) anterior chamber iris implant models are associated with visually threatening complications that may continue to cause ocular morbidity after removal.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.

A 27-year-old phakic woman underwent bilateral anterior chamber iris implant (NewColorIris) surgery in Chennai, India, in 2012 to change the colour of her brown irises to olive green. Surgery was completed at a total cost of $2000 for both eyes. The patient completed a routine course of topical prednisolone acetate 1.0% following surgery and had no preexisting ocular or medical history.

At 4 weeks following surgery, the patient presented with a red, painful, photophobic right eye in Hamilton, New Zealand. On examination, uncorrected visual acuity (UCVA) was 6/6–2 OD and 6/5 OS, and intraocular pressure (IOP) was 17 mm Hg OU. An acute anterior uveitis was confirmed OD with 1+ cells identified in the anterior chamber. The uveitis settled with topical prednisolone acetate 1.0% eye drops. The cup-to-disc ratio was 0.1 bilaterally, and gonioscopy revealed that her angles were open (grade C35r) OU. The iris implants were noted to be contacting the trabecular meshwork. Treatment was started with topical corticosteroid and was associated with an IOP rise to 26 mm Hg, but the IOP normalized after cessation of steroids.

One year following surgery, a chronic bilateral low-grade uveitis developed that settled after prolonged treatment with dexamethasone eye drops. The patient was discharged back to her primary care physician following an extended period of quiescence without regular treatment. At 5 years following surgery, the patient re-presented with bilateral anterior uveitis and an IOP of 29 and 22 mm Hg OD and OS, respectively. Slit-lamp examination confirmed 1+ cells in the anterior chamber, clear corneas with fine keratic precipitates, and no evidence of cataract or optic neuropathy at this time. Gonioscopy revealed pigment in the angle, worse on the right. Topical prednisolone acetate 1.0% and brimonidine were started in both eyes with a plan to remove the right iris implant. While awaiting iris explantation surgery, the patient discontinued topical brimonidine, presenting acutely with IOPs of 57 mm Hg OD and 24 mm Hg OS. Over the next 2 years, UCVA dropped to 6/180 in both eyes secondary to decompensated corneas, which was then followed by cataract development.

After a discussion of the risk and benefits, both anterior chamber iris implants were explanted via a 2.4 mm temporal incision (Video 1, available online). Following explanation, large iris defects were visible at the location of the implant fixation points (Fig. 1). The iris defects correspond to the fixation points on the periphery of the prosthesis (Fig. 2; see also Video 1, available online). Combined cataract extraction and Descemet's membrane endothelial keratoplasty has been completed OD and planned for OS. The IOP has remained poorly controlled on maximal medical treatment, and the patient is currently awaiting trabeculectomy surgery OD.Fig 1

Fig. 1Right and left eyes (upper panel) prior to explantation of iris implants. After explantation, both eyes have significant iris defects corresponding to the location of the peripheral fixation points of the prosthesis. The right cornea (bottom left) is clear following endothelial keratoplasty and cataract surgery. The left cornea (bottom right) is decompensated.

Fig 2

Fig. 2Explanted anterior chamber iris prosthesis demonstrating five peripheral fixation points that correspond to five large residual iris defects evident in both eyes after explantation.

Iris implant surgery designed to treat aniridia, coloboma, or trauma resulting in damage or absence of a normal iris typically involves implantation of a device into the posterior chamber or in the capsular bag of a pseudophakic eye. In contrast to cosmetic anterior chamber iris implants, these devices have proven to be a safe and effective strategy for the treatment of visual and cosmetic defects and do not carry the same risk of glaucoma, cataract, and corneal decompensation as anterior chamber implants.Koch KR Heindl LM Cursiefen C Koch HR. Artificial iris devices: benefits, limitations, and management of complications. The CustomFlex artificial iris implant (HumanOptics AG, Erlangen, Germany) was the first device with specific medical indications approved U.S. Food and Drug Administration in 2018. The device is a foldable, custom-designed silicone implant placed within the capsular bag or ciliary sulcus or sutured in the posterior chamber.U.S. Food and Drug AdministrationIris implants placed in the posterior chamber or capsular bag should not be confused with anterior chamber iris implants, which are used to change iris colour for cosmetic reasons. Anterior chamber iris implants are readily available in several countries that are popular as medical tourism destinations. In this context, there is a significant danger for patients that surgical risks may be understated and that the relatively low prices for cosmetic surgery may encourage poorly informed decisions to proceed with surgery.Wilde C Ross AR Maharajan S. Health tourism and the need for occasional strong paternalism: complications and management of cosmetic anterior chamber iris implantation. Despite concerns from the ophthalmic community, there remains no patient registry to capture all patients who have had this procedure and associated complications.Bore M Choudhari N Chaurasia S. Management of complications of cosmetic iris implants in a phakic eye: a case report and literature review. In these circumstances, patients may have no follow-up or support from the surgeon when they return to their country of origin.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.Angle closure, endothelial damage, iris atrophy, uveitis, and pigment dispersion are likely owing to the iris implant fixation points inside the eye and/or poor sizing of the iris implant.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.,Koaik MK Mansour AM Saad A Farah SG. BrightOcular cosmetic iris implant: a spectrum from tolerability to severe morbidity. This case demonstrates significant iris defects that correspond to the implant fixation points. It is possible that the fixation point-related trauma to the iris is the underlying stimulus for the chronic uveitis and secondary pressure rise.The onset of complications following anterior chamber iris implant surgery may vary from weeks to years.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.,Arjmand P Gooi P Ahmed IIK. Surgical technique for explantation of cosmetic anterior chamber iris implants. The current patient presented initially with uveitis that failed to completely settle with medical treatment. Pigment dispersion and elevated IOP developed at 5 years after implantation. Further complications including IOP elevation, cataract, and corneal decompensation followed relatively quickly. Visual rehabilitation has required bilateral explantation of the iris implants, cataract surgery, corneal endothelial transplantation, and glaucoma surgery. A total of 6 or more major ophthalmic surgeries spanning a 2-year period will be required for visual rehabilitation. 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.Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes.Secondary glaucoma, uveitis, corneal decompensation, and cataract are the most commonly reported complications, with many patients requiring surgical treatment.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants. 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.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.,Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes.,Ghaffari R Aldave AJ Al-Hashimi S Miller KM. Complications of cosmetic artificial iris implantation and postexplantation outcomes. From the largest case series, corneal decompensation may be the most common complication (78.5% of eyes).Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes. Corneal transplant surgery was performed in up to 20% of eyes, with most patients undergoing endothelial keratoplasty.Galvis V Tello A Corrales MI. Postoperative results of cosmetic iris implants.,Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes.,Ghaffari R Aldave AJ Al-Hashimi S Miller KM. Complications of cosmetic artificial iris implantation and postexplantation outcomes. Peripheral anterior synechiae is an important surgical consideration, with some patients developing broad peripheral anterior synechiae, which can limit a more selective endothelial keratoplasty.Anshu A Price MO Tan DTH Price Jr., FW Endothelial keratoplasty: a revolution in evolution.Explanation of the anterior chamber iris implant is required for approximately 80% of eyesGhaffari R Aldave AJ Al-Hashimi S Miller KM. Complications of cosmetic artificial iris implantation and postexplantation outcomes.,Anshu A Price MO Tan DTH Price Jr., FW Endothelial keratoplasty: a revolution in evolution. and occurs 2 years after implantation on average.Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes. Progressive complications are common, and long-term follow up is recommended in many cases.Chehab EL Gatinel D Baudouin C et al.Complications of cosmetic iris implants: French series of 87 eyes. A similar case report from India documents a patient presenting with raised IOP and uveitis following (BrightOcular) device implantation. Cataract, glaucoma, and corneal decompensation developed following explantation completed at 3 months of follow-up.Hoguet A Ritterband D Koplin R et al.Serious ocular complications of cosmetic iris implants in 14 eyes.,Mansour AM Ahmed IIK Eadie B et al.Iritis, glaucoma and corneal decompensation associated with BrightOcular cosmetic iris implant. Implant explantation for the current patient was planned 5 years following the initial surgery, after development of anterior segment complications. Interestingly, a previous report noted that a patient with implant-related uveitis refused explantation because the perceived cosmetic benefits outweighed the adverse effects of uveitis.Devastating complication of cosmetic iris implants. Furthermore, it is recognized that asymptomatic patients are likely to delay explantation until significant pain or visual loss is experienced.Ghaffari R Aldave AJ Al-Hashimi S Miller KM. Complications of cosmetic artificial iris implantation and postexplantation outcomes.

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. Ophthalmologists should be aware of the potential risks associated with these implants, monitor patients closely, and elect for early removal in the event of complications.

Footnotes and Disclosure

The authors have no proprietary or commercial interest in any materials discussed in this communication.

Appendix. Supplementary materialsReferencesGalvis V Tello A Corrales MI.

Postoperative results of cosmetic iris implants.

J Cataract Refract Surg. 42: 1518-1526Koch KR Heindl LM Cursiefen C Koch HR.

Artificial iris devices: benefits, limitations, and management of complications.

J Cataract Refract Surg. 40: 376-382U.S. Food and Drug AdministrationPMA P170039: FDA Summary of Safety and Effectiveness Data, Bethesda, MD () Wilde C Ross AR Maharajan S.

Health tourism and the need for occasional strong paternalism: complications and management of cosmetic anterior chamber iris implantation.

Eye (Lond). 32: 1915-1916Bore M Choudhari N Chaurasia S.

Management of complications of cosmetic iris implants in a phakic eye: a case report and literature review.

Int Ophthalmol. 39: 1141-1146Koaik MK Mansour AM Saad A Farah SG.

BrightOcular cosmetic iris implant: a spectrum from tolerability to severe morbidity.

Case Rep Ophthalmol. 9: 395-400Arjmand P Gooi P Ahmed IIK.

Surgical technique for explantation of cosmetic anterior chamber iris implants.

Cataract Refract Surg. 41: 18-22Chehab EL Gatinel D Baudouin C et al.

Complications of cosmetic iris implants: French series of 87 eyes.

J Cataract Refract Surg. 46: 34-39Ghaffari R Aldave AJ Al-Hashimi S Miller KM.

Complications of cosmetic artificial iris implantation and postexplantation outcomes.

Am J Ophthalmol. 226: 156-164Anshu A Price MO Tan DTH Price Jr., FW

Endothelial keratoplasty: a revolution in evolution.

Surv Ophthalmol. 57: 236-252Hoguet A Ritterband D Koplin R et al.

Serious ocular complications of cosmetic iris implants in 14 eyes.

J Cataract Refract Surg. 38: 387-393Mansour AM Ahmed IIK Eadie B et al.

Iritis, glaucoma and corneal decompensation associated with BrightOcular cosmetic iris implant.

Br J Ophthalmol. 100: 1098-1101

Devastating complication of cosmetic iris implants.

Indian J Ophthalmol. 65: 771-772Article InfoPublication History

Published online: July 03, 2021

Publication stageIn Press Uncorrected ProofIdentification

DOI: https://doi.org/10.1016/j.jcjo.2021.05.019

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© 2021 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

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