Bilateral Irreversible Severe Vision Loss From Cosmetic Iris Implants

doi:10.1016/j.ajo.2010.11.010

American Journal of Ophthalmology

Volume 151, Issue 5, May 2011, Pages 872-875.e1

https://doi.org/10.1016/j.ajo.2010.11.010 Get rights and content

Purpose

To report a case of bilateral neovascular glaucoma with central retinal vein occlusions secondary to cosmetic iris implantation.

Design

Interventional case report.

Methods

setting: Tertiary care center; ophthalmology clinic. patient: A 25-year-old woman presented with persistent bilateral blurry vision after simultaneous bilateral cosmetic iris implantation. Examination showed best-corrected visual acuity of hand motion in the right and 20/400 in the left eye with intraocular pressures (IOP) of 48 mm Hg in the right and 40 mm Hg in the left eye on maximal medical therapy. She had bilateral neovascularization of the iris and angle with synechial angle closure, surgical aniridia, central retinal vein occlusion, and end-stage glaucomatous optic neuropathy. She was diagnosed with neovascular glaucoma in both eyes, associated with cosmetic iris implants. intervention procedures: Humphrey 24-2 visual field testing, optic nerve coherence tomography, and fundus imaging were performed. After bilateral intravitreal bevacizumab and panretinal photocoagulation, Ahmed glaucoma drainage devices were implanted in both eyes. main outcome measures: IOP, anterior chamber inflammation, neovascularization.

Results

Despite aggressive treatment, severe permanent bilateral vision loss ensued.

Conclusion

We strongly advise against the use of anterior chamber iris implants for cosmetic indications. Close monitoring of implanted individuals is necessary. Explantation should be considered at the earliest sign of adverse reaction.

Section snippets

Case Report

A 25-year-old Hispanic woman traveled to Panama and underwent simultaneous bilateral eye surgery to change the color of her irides with non-FDA-approved anterior chamber cosmetic iris diaphragm implants (NewColorIris) (Figure, Top row). Since the week following the surgery she complained of bilateral blurry vision, redness, tearing, and light sensitivity. Topical steroids for chronic iritis and IOP-lowering drops were prescribed by her surgeon during numerous postoperative visits back to

Discussion

This case highlights lessons learned from more than a half century of anterior segment implants, which appear to be simple procedures but may have complex, long-lasting, and deleterious effects. The first phakic intraocular lenses and prosthetic iris implantations were performed in the 1950s,⁵ but their use was associated with severe complications that included cataract formation, angle fibrosis, endothelial decompensation, and corectopia.⁶ There are 2 types of iris implants: iris diaphragm

Mathew K. George is a PGY-4 resident in Ophthalmology at Yale-New Haven Hospital, New Haven, Connecticut. He completed his medical school training at MS Ramaiah Medical College, Bangalore, India, and at Christian Medical College, Vellore, India prior to moving to the US for further research and training. He is currently applying for a clinical fellowship in medical retina.

References (12)

S.N. Arthur et al.
Uveitis-glaucoma-hyphema syndrome and corneal decompensation in association with cosmetic iris implants
Am J Ophthalmol
(2009)
S. Thiagalingam et al.
Complications of cosmetic iris implants
J Cataract Refract Surg
(2008)
L.-J. Chen et al.
Metaanalysis of cataract development after phakic intraocular lens surgery
J Cataract Refract Surg
(2008)
P.M. Phillips et al.
Transscleral sulcus fixation of a small-diameter iris-diaphragm intraocular lens in combined penetrating keratoplasty and cataract extraction for correction of traumatic cataract, aniridia, and corneal scarring
J Cataract Refract Surg
(2008)
S.E. Burk et al.
Prosthetic iris implantation for congenital, traumatic, or functional iris deficiencies
J Cataract Refract Surg
(2001)
J.J. Pérez-Santonja et al.
Chronic subclinical inflammation in phakic eyes with intraocular lenses to correct myopia
J Cataract Refract Surg
(1996)

There are more references available in the full text version of this article.

Cited by (29)

Flexible silicone artificial iris in cases of aniridia and iris deficiencies
2021, Journal Francais d'Ophtalmologie
To evaluate a customized silicone flexible artificial iris in cases of aniridia or iris deficiencies.
Centre Hospitalier National d’Ophtalmologie, Hôpital des Quinze-Vingts, Paris, France.
Retrospective case series investigating cosmetic result, photophobia, endothelial cell density and intraocular pressure.
Patients with iris deficiencies requiring cataract surgery or correction of aphakia, or pseudophakic patients, complaining of photophobia or cosmetic disturbances were implanted with the new flexible artificial iris.
Fifteen eyes of 14 patients were evaluated. Mean age was: 49.5 (±18.5). A total of 50% were aphakic, 22.4% pseudophakic and 28.6% phakic. Etiology was trauma (57.1%), previous surgical trauma (28.6%) and congenital aniridia (14.3%). Three months postoperatively, the mean subjective photophobia score improved by 5.2 points (P = .002) and the mean cosmesis score by 4.7 points (P = .001) on a 0 to 10 scale. Mean endothelial cell loss was 16% (P = .001). There was no further statistically significant endothelial cell loss between the 3-month follow-up and the 1-year follow-up visit (P = .320). Elevated intraocular pressure was the main complication (35.7%). Two patients with pre-existing glaucoma required cyclodestructive procedures. The artificial iris was removed in one eye because of chronic pain, elevated intraocular pressure and inflammation that resolved rapidly after removal.
Implantation of the customized artificial iris is a very good option because of its outstanding cosmetic result. However, patients with pre-existing glaucoma are not good candidates. Patients should also be warned of possible chronic inflammation necessitating explantation.
Évaluer un nouvel iris artificiel en silicone flexible en cas d’aniridie ou de déficience irienne.
Centre hospitalier national d’ophtalmologie, hôpital des Quinze-Vingts, Paris, France.
Étude retrospective étudiant le résultat cosmétique, la photophobia, la densité endothéliale et la pression intraoculaire.
Des patients, atteints de déficiences iriennes se plaignant de photophobie ou d’un probleme esthétique et nécessitant une chirurgie de cataracte, ont recu le nouvel iris artificiel en silicone flexible.
Quinze yeux de 14 patients on été evalué. L’âge moyen était de 49,5 années (±18,5). Un total de 50 % étaient aphaques, 22,4 % pseudophaques et 28,6 % phaques. L’étiologie était un traumatisme (57,1 %), un traumatisme chirugical (28,6 %) ou une aniridie congénitale (14,3 %). À 3 mois postoperatoire, sur une échelle de 0 à 10, la photophobie subjective moyenne s’est améliorée de 5,2 points (p = .002) et le résultat esthétique de 4,7 points (p = .001). la perte endothéliale était de 16 % (p = .001). Entre 3 mois et 1 an postopératoire il n’y avait plus de perte endotheliale significative (p = .320). L’ élévation de la pression intraoculaire était la complication principale (35,7 %). Deux patients souffrant d’un glaucome préexistant ont nécessité une cyclodestruction. L’iris artificiel a dû être retiré pour un patient du fait d’une pression élévée et d’une douleur associée à une inflammation chronique. Les symptomes ont disparus après l’ablation de l’iris artificiel.
L’implantation du nouvel iris artificiel est une bonne solution du fait de ses résultats esthétiques probants. Cependant, les patients atteints de glaucome préexistant ne sont pas de bons candidats. Les patients doivent être prévenus de la nécessité d’une possible explantation.
Postoperative results of cosmetic iris implants
2016, Journal of Cataract and Refractive Surgery
Citation Excerpt :
Additional data were requested from the author via e-mail, but no information was sent. Twenty-seven publications reporting complications were identified, including 20 articles in scientific journals,7–26 4 scientific meeting presentations,G–I,M and 3 videosJ–L (Table 1). The mean age of the patients in the reports was 32.6 years (range 19 to 65 years).
The purpose of this review was to evaluate the postoperative results of cosmetic iris implants. A systematic review of studies reporting postoperative outcomes of cosmetic iris implants identified 26 studies and 3 videos, comprising 128 eyes. In 88 (68.8%) of the eyes, the device required explantation due to complications. Secondary glaucoma occurred in 59 eyes, uveitis in 39 eyes, cataract in 22 eyes, and severe endothelial cell loss or corneal decompensation in 44 eyes. In 8 eyes, the final corrected distance visual acuity was counting fingers or worse. The review showed that cosmetic iris implants resulted in a substantial number of cases with severe complications. The finding strongly suggests that this cosmetic surgical technique should be avoided.
None of the authors has a financial or proprietary interest in any material or method mentioned.
Acute angle-closure attack secondary to BrightOcular<sup>©</sup> cosmetic iris implant and subsequent subluxation of contralateral iris implant
2016, Journal Francais d'Ophtalmologie
Artificial iris devices: Benefits, limitations, and management of complications
2014, Journal of Cataract and Refractive Surgery
To discuss limitations and benefits of a custom-made foldable artificial iris (Artificialiris) in the management of acquired iris defects.
Hochkreuzklinik Eye Hospital, Bonn, and the Department of Ophthalmology, University of Cologne, Germany.
Case series.
We reviewed the clinical course and surgical management in eyes with sight-compromising complications after phakic anterior chamber implantation of synthetic iris devices between November 2011 and January 2012.
Three eyes of 2 patients were reviewed. One patient developed cataract and corneal decompensation after anterior chamber artificial iris implantation in the left eye to treat post-uveitic mydriasis. Further treatment included artificial iris removal, cataract surgery, iridoplasty, and Descemet membrane endothelial keratoplasty (DMEK). By the 6-month follow-up, visual acuity had increased from 20/50 to 20/25. The second patient presented with bilateral secondary glaucoma, cataract, corneal edema, and iris atrophy after implantation of Newiris devices for cosmetic reasons. He consecutively had binocular explantation of the cosmetic devices, cataract surgery, artificial iris implantation, and DMEK in both eyes and Ahmed valve implantation in the right eye. During the 6-month follow-up, the intraocular pressure remained sufficiently adjusted in both eyes. Photophobia was eliminated, and visual acuity improved to 20/32 in the right eye and 20/20 in the left eye.
In patients with major iris defects ineligible for pupilloplasties, the artificial iris allows functionally and esthetically satisfactory anterior segment reconstruction. To prevent secondary complications, the artificial iris should only be implanted in aphakic or pseudophakic eyes and placed in the posterior chamber.
Dr. H.-R. Koch received travel grants from Humanoptics AG and Dr. Schmidt Intraocularlinsen GmbH. No other author has a financial or proprietary interest in any material or method mentioned.
Prosthetic iris devices
2014, Canadian Journal of Ophthalmology
Citation Excerpt :
We feel compelled to emphasize that this review does not address the NewColorIris, an implant that has been marketed for iris colour change in normal eyes. We are aware of no supportive reports in the world literature, although numerous authors have described severe ocular sequelae from their use.39–47 Operating on patients with congenital or traumatic aniridia often poses great challenges to the surgeons.
Congenital iris defects may usually present either as subtotal aniridia or colobomatous iris defects. Acquired iris defects are secondary to penetrating iris injury, iatrogenic after surgical excision of iris tumours, collateral trauma after anterior segment surgery, or can be postinflammatory in nature. These iris defects can cause severe visual disability in the form of glare, loss of contrast sensitivity, and loss of best corrected visual acuity. The structural loss of iris can be reconstructed with iris suturing, use of prosthetic iris implants, or by a combination of these, depending on the relative amount of residual iris stromal tissue and health of the underlying pigment epithelium. Since the first implant of a black iris diaphragm posterior chamber intraocular lens in 1994, advances in material and design technology over the last decade have led to advances in the prosthetic material, surgical technique, and instrumentation in the field of prosthetic iris implants. In this article, we review the classification of iris defects, types of iris prosthetic devices, implantation techniques, and complications.
Les malformations congénitales de l’iris présentent soit une aniridie quasi-complète ou des défauts colobomateux de l’iris. Les défauts acquis de l’iris sont secondaires à une blessure pénétrante de l’iris, iatrogéniques à la suite d’une excision chirurgicale de tumeurs de l’iris ou d’un trauma collatéral suivant une chirurgie du segment antérieur, ou encore ils peuvent être de nature post-inflammatoire. Les déficiences de l’iris peuvent causer de graves conséquences visuelles sous formes d’éblouissement, de perte de sensibilité aux contrastes et de perte de meilleure acuité visuelle corrigée. La perte de structure de l’iris peut être corrigée par la suture de l’iris, l’utilisation d’implants ou une combinaison des deux, selon la somme relative de tissus du stroma et l’état de santé de l’épithélium pigmentaire sous-jacent. Depuis la première implantation d’une lentille intraoculaire de chambre postérieure avec diaphragme irien noir en 1994, les progrès du matériel et de la technologie de la dernière décennie ont fait progresser le domaine des implants prothétiques de l’iris. Dans cet article, nous revoyons la classification des défauts de l’iris, des appareils prosthétiques de l’iris, des techniques et complications de l’implantation.
New color iris implants
2012, Ophthalmology

View all citing articles on Scopus

View full text

Original articleBilateral Irreversible Severe Vision Loss From Cosmetic Iris Implants

Purpose

Design

Methods

Results

Conclusion

Section snippets

Case Report

Discussion

Am J Ophthalmol

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Original article
Bilateral Irreversible Severe Vision Loss From Cosmetic Iris Implants