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Serious ocular complications of cosmetic iris implants in 14 eyes
ARTICLE
Serious ocular complications of cosmetic iris implants in 14 eyes Ambika Hoguet, MD, David Ritterband, MD, Richard Koplin, MD, Elaine Wu, MD, Tal Raviv, MD, John Aljian, MD, John Seedor, MD
PURPOSE: To report the presentation and subsequent management of a series of patients presenting with cosmetic iris implants. SETTING: New York Eye and Ear Infirmary, New York, New York, USA. DESIGN: Case series. METHODS: In this evaluation of patients with NewColorIris cosmetic iris implants, data collected included patient demographics, visual acuity, intraocular pressure (IOP), endothelial cell count, and slitlamp examination findings at presentation. Medical and surgical interventions and the postoperative course were recorded. RESULTS: Fourteen eyes of 7 patients (ages 22 to 60; 71% men) were identified. Nine eyes (64%) presented with decreased visual acuity, 7 (50%) had elevated IOP, 5 (36%) had corneal edema, and 5 (36%) had anterior uveitis. All 14 eyes had explantation of the iris prosthesis (range 4 to 33 months after placement). The minimum follow-up after implant removal in all eyes was 2 months (range 2 to 28 months). Intraoperative complications included suprachoroidal hemorrhage during explantation in 1 eye. Postoperative complications included corneal edema (8 eyes), cataract (9 eyes), and increased IOP/glaucoma (7 eyes). Secondary surgeries included Descemet-stripping automated endothelial keratoplasty (5 eyes), cataract extraction with intraocular lens placement (7 eyes), trabeculectomy (3 eyes), glaucoma drainage implant placement (3 eyes), and penetrating keratoplasty (1 eye). CONCLUSIONS: The cosmetic iris implants may result in severe ocular morbidity. Complications in our series included uveitis, glaucoma, corneal edema, and decreased visual acuity. Although explantation helped stabilize symptoms, additional medical and surgical intervention to control IOP and corneal decompensation was required in many cases. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2012; 38:387–393 Q 2012 ASCRS and ESCRS
A variety of prosthetic iris implants have been used for congenital, traumatic, or functional iris abnormalities since the first prosthetic iris was implanted in 1956.1–3 Prosthetic iris–lens devices have been found to be safe and effective in reducing glare and decreasing light sensitivity in certain types of iris defects, including congenital iris colobomas, traumatic iris defects, aniridia, and ocular albinism, and in eyes with surgical iris loss.1 Iris diaphragm–type prosthetic iris implants were initially designed to correct iris defects in phakic patients.1 In 2006, an implant initially developed for the treatment of oculocutaneous albinism was marketed to patients without iris abnormalities who sought to permanently change their iris color.A The NewColorIris implant offered by Kahn Q 2012 ASCRS and ESCRS Published by Elsevier Inc.
Medical Devices in Panama City, Panama, was advertised as a safe and permanent solution with a favorable risk profile over cosmetic contact lenses and as an alternative to contact lenses.4 Patients without a history of ocular pathology were eligible for placement of this implant and could select from 3 colors (hazel, blue, or green). Since 2004, there have been 6 reports of serious complications in eyes that have had NewColorIris implants. These complications include severe vision loss, uveitis–glaucoma–hyphema (UGH) syndrome, elevated intraocular pressure (IOP), endothelial cell loss, bullous keratopathy, and end-stage glaucomatous optic neuropathy.5–10 However, information on the long-term management and visual outcomes of 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2011.09.037
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these patients is lacking. George et al.8 reported through a personal communication with Kahn Medical in 2001 that more than 700 procedures had been performed since 2002, with an incidence of chronic inflammation of 1.5% and an occurrence of raised IOP that could be adequately controlled with eyedrops. We report the initial presentation, subsequent management, and clinical outcomes in 14 eyes of 7 patients presenting with NewColorIris implants to our institution. PATIENTS AND METHODS All patients who presented to the New York Eye and Ear Infirmary between 2006 and 2010 with cosmetic iris implants were identified. All recorded patients had previously had implantation of NewColorIris cosmetic implants in Panama City, Panama. The implant was placed under topical anesthesia. Carbachol (Miostat) was first used in the anterior chamber to constrict the pupil, with subsequent injection of an ophthalmic viscosurgical device (OVD). The foldable implant was inserted in the anterior chamber through a 3.2 mm clear corneal incision (CCI), and the OVD was subsequently aspirated out of the anterior chamber.4,5 No sutures were required for this procedure. The medical records of these patients were reviewed and the patient age, sex, time of presentation, visual acuity, IOP, endothelial cell count (ECC), and slitlamp examination findings at presentation were recorded. When the images were available, slitlamp photographs and ultrasound biomicroscopy (UBM) images were also reviewed. Follow-up data were tabulated, including surgical interventions, visual acuity, IOP, ECC, and slitlamp examination findings at the most recent presentation.
RESULTS Fourteen eyes of 7 patients (5 men) were identified. The mean age at time of implantation was 39 years (range 22 to 60 years). One patient had laser in situ keratomileusis surgery in both eyes before having iris implant surgery; none of the remaining patients had previous intraocular surgery or pathology. All patients had cosmetic implants placed in both eyes in Panama City, Panama, by Kahn Medical and self-reported uneventful surgery. Submitted: July 31, 2011. Final revision submitted: September 14, 2011. Accepted: September 16, 2011. From the Department of Ophthalmology, New York Eye and Ear Infirmary, and New York Medical College, Valhalla, New York, USA. Presented in part at the annual meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, USA, May 2011. Corresponding author: David Ritterband, MD, Ophthalmic Consultants PC, 310 East 14th Street, The New York Eye and Ear Infirmary, New York, New York 10003, USA. E-mail: [email protected].
On presentation, all 7 patients (12 eyes) reported blurry vision, 4 patients (4 eyes) reported redness and pain, and 1 patient reported a foreign-body sensation. On initial ocular examination, 9 eyes (64%) presented with decreased visual acuity (%20/30), 7 eyes (50%) with elevated IOP (O22 mm Hg), 5 eyes (36%) had corneal edema, and 5 eyes (36%) with iritis. The mean initial IOP was 25 mm Hg (range 15 to 52 mm Hg), and the mean ECC was 989 cells/mm2 (range 266 to 1841 cells/mm2) (Table 1). Figure 1 shows the available slitlamp photographs of 12 eyes (7 patients). All patients received management with topical glaucoma medications and topical antiinflammatory drops as needed to address IOP elevation and anterior segment inflammation. All 14 eyes were eventually treated with explantation of the iris prosthesis (range 4 to 33 months after implant placement). Two patients (4 eyes) refused immediate explantation against medical advice but had the implants removed at a later date due to worsening vision and elevated IOP. One of these eyes developed a suprachoroidal hemorrhage during explantation and had hand-motion vision at the time of manuscript preparation. The minimum follow-up after explantation in all eyes was 2 months (range 2 to 28 months). After explantation, 9 eyes had progression of ocular disease. This progression included new-onset or persistent corneal edema (8 eyes), emerging cataract (9 eyes), increased IOP (7 eyes), and cystoid macular edema (CME) (1 eye). Secondary surgeries included Descemet-stripping automated endothelial keratoplasty (DSAEK) (5 eyes), cataract extraction/intraocular lens (IOL) placement (7 eyes), trabeculectomy (3 eyes), glaucoma drainage implant placement (3 eyes), and penetrating keratoplasty (1 eye) (Table 2). Representative Case Reports Case 1 A 60-year-old woman presented, reporting 3 months of redness, irritation, and blurred vision after having iris implant surgery in Panama 6 months previously. Her corrected distance visual acuity (CDVA) on presentation was 20/50 2 in the right eye and 20/60 in the left eye. Slitlamp examination on presentation showed bilateral peripheral corneal edema, uveitis, dense pigmentation of the peripheral corneal endothelium, and 2C nuclear sclerosis and 2C cortical cataract in both eyes. The IOP was 24 mm Hg in the right eye and 25 mm Hg in the left eye. The patient was using prednisolone acetate drops 4 times daily and brimonidine drops twice daily bilaterally. The ECC was 1146 cells/mm2 in the right eye and 266 cells/mm2 in the left eye. The iris implant in the left eye was removed 1 week after presentation. Four weeks later, the iris implant in
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Table 1. Findings on presentation.
Pt/Eye
Presenting Symptoms
CDVA
IOP (mm Hg)
Corneal Edema
Iritis
ECC (Cells/mm2)
Time from Initial Surgery to Implant Removal (Mo) 20 21 Advised: 16 Removed: 23 Advised: 16 Removed: 22 7 7 7 6 11 7 4 4 13 11
1/R 1/L 2/R
None Decreased VA Decreased VA
20/20 20/25 20/25
21 29 18
No No No
No No No
722 1841 548
2/L
Decreased VA; redness; pain
20/50
28
Yes
No
551
3/R 3/L 4/R 4/L 5/R 5/L 6/R 6/L 7/R 7/L
Decreased VA Decreased VA Decreased VA; redness; pain Decreased VA Redness; pain Decreased VA; redness; pain Decreased VA Decreased VA Decreased VA Decreased VA; foreign-body sensation
20/30 20/30 20/50 20/60 20/20 20/40 20/80 20/50 20/25 20/30
22 16 24 25 30 52 20 30 15 15
No No Yes Yes No No Yes Yes No No
Yes No Yes Yes Yes No No No No Yes
1602 1277 1146 266 1225 1376 662 1137 746 754
CDVA Z corrected distance visual acuity; ECC Z endothelial cell count; IOP Z intraocular pressure; Pt Z patient; VA Z visual acuity
the right eye was removed. One month after surgery in the left eye, the CDVA worsened to 20/200 and the corneal edema worsened. The CDVA in the left eye stabilized to 20/50 but was limited by persistent peripheral corneal edema and an emerging cataract.
Three months after initial presentation, the patient had DSAEK and cataract extraction in the left eye, which now had chronic corneal edema and poor CDVA (at the 20/400 level). Three months after DSAEK in the left eye, uncorrected distance visual
Figure 1. Slitlamp photographs taken at presentation of 7 patients with the cosmetic iris implant. A: Right eye. B: Left eye. J CATARACT REFRACT SURG - VOL 38, MARCH 2012
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Table 2. Most recent follow-up data of patients after implant explantation. Follow-up Pt/Eye (Mo After Explantation) 1/R 1/L
14 13
2/R
3
2/L 3/R 3/L 4/R 4/L 5/R
5 2 2 15 16 17
5/L 6/R
24 28
6/L 7/R
28 4
7/L
12
Complications
CDVA
IOP ECC (mm Hg) (Cells/mm2)
Cataract Cataract
20/25 20/20
16 16
576 1331
Corneal edema; cataract; glaucoma Glaucoma Peripheral corneal scar Peripheral corneal scar Cataract; corneal edema Cataract; corneal edema Corneal edema; cataract; glaucoma; CME Cataract; glaucoma Corneal edema; glaucoma
20/80
14
828
HM 20/25 20/30 20/30 20/30 20/80
34 14 14 17 16 10
652 1354 491
20/30 20/60
12 8
610 854
20/200 20/400
6 12
841
20/35
23
Corneal edema Corneal edema, cataract; glaucoma Corneal edema; cataract; glaucoma
Subsequent Surgery Cataract extraction–IOL Cataract extraction–IOL at time of explantation DSAEK/cataract extraction–IOL; PPV/goniosynechiolysis; GDI Choroidal hemorrhage drainage None None DSAEK/cataract extraction–IOL DSAEK/cataract extraction–IOL Goniosynechiolysis, trabeculectomy, DSAEK Goniosynechiolysis, trabeculectomy PKP/cataract extraction–IOL/PPV/GDI None Trabeculectomy DSAEK/cataract extraction–IOL/PPV/GDI
CDVA Z corrected distance visual acuity; CME Z cystoid macular edema; DSAEK Z Descemet-stripping automated endothelial keratoplasty; ECC Z endothelial cell count; GDI Z glaucoma drainage implant; IOL Z intraocular lens placement; IOP Z intraocular pressure; PKP Z penetrating keratoplasty; PPV Z pars plana vitrectomy; Pt Z patient; VA Z visual acuity
acuity (UDVA) improved to 20/30, the cornea was clear, and the IOP was controlled on brimonidine and timolol. Nine months after presentation, the cornea in the right eye further decompensated and the CDVA dropped to 20/400. The patient had DSAEK and cataract extraction 2 weeks later. On the most recent visit 16 months after initial presentation, the DSAEK lenticules were clear and the UDVA was 20/30 bilaterally. At the time of manuscript preparation, the patient was taking brimonidine twice daily to control IOP bilaterally. Case 2 A 36-year-old man who had iris implants
placed in Panama 6 months previously presented for consultation. He had been treated by a glaucoma specialist for the past several months and was on maximum medical therapy of topical brimonidine tartrate 0.2% 3 times daily, timolol maleate 0.5% twice daily, travoprost 0.004% at bedtime, dorzolamide 2.0% 3 times daily, and methazolamide 50 mg orally twice daily. On examination at presentation, the UDVA was 20/20 1 in the right eye and 20/25 in the left eye. The iris in the right eye was irregular and poorly reactive. There was dense pigment clumping on the endothelium bilaterally and trace posterior subcapsular cataracts, greater in the left eye than in the
right eye. The IOP was 21 mm Hg in the right eye and 29 mm Hg in the left. Although no corneal edema was present, the ECC was depressed in both eyes (722 cells/mm2 right eye; 1841 cells/mm2 left eye). Three weeks after presentation, the first implant was removed from the right eye and synechialysis was performed to sever the iris adhesions. One month later, the iris implant was removed from the left eye and cataract surgery with IOL implantation was performed. Six months after presentation, the UDVA was 20/25 in the left eye but had dropped to 20/50 2 in the right eye secondary to continued cataract development. One year after presentation, the patient had cataract extraction in the right eye. On the most recent visit 14 months after presentation, the corrected distance visual acuity (CDVA) was 20/25 in the right eye and 20/ 20 1 in the left eye. The ECC remained depressed bilaterally (576 cells/mm2 right eye; 1331 cells/mm2 left eye). At the time of manuscript preparation, the IOP was well controlled on travoprost 0.004% nightly in each eye. The patient will likely require DSAEK if the ECCs continue to decline at the same yearly rate. Case 3 A 46-year-old man presented with severe photophobia, increased IOP, and corneal swelling bilaterally 16 months after having iris implants placed in Panama. The UGH syndrome had been
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diagnosed and treated by his local ophthalmologist. The CDVA at the time was 20/25 2 in the right eye and 20/50 2 in the left eye. Despite medical therapy with topical brimonidine tartrate 0.2%–timolol maleate 0.5%, brinzolamide 1.0%, brimatoprost 0.01%, and topical steroids, the IOP was 18 mm Hg in the right eye and 28 mm Hg in the left eye. The ECC was 548 cells/mm2 in the right eye and 551 cells/ mm2 in the left eye. The patient was advised to have immediate removal of both implants and counseled that he would probably require additional corneal and/or glaucoma surgery in the future. He scheduled surgery the following week but then cancelled after he reported his vision had improved. Despite several attempts to contact the patient to have the implants removed, he was lost to follow-up. Seven months later, he returned for consultation concerning the right eye. The left eye had suffered a suprachoroidal hemorrhage during removal of the implant by another physician 1 month previously. In the left eye, the UDVA was hand motion and the cornea was diffusely edematous. The right eye had DSAEK and cataract extraction the week previously but now had a flat anterior chamber with posterior segment air, causing iris bombe with 360 degrees of peripheral anterior synechiae and a zippered anterior chamber angle. The IOP was markedly elevated (in the high 40s). The next day, the patient had a pars plana vitrectomy, goniosynechialysis, and glaucoma drainage implant placement. Six weeks later, the CDVA had improved to 20/80 and the IOP was 14 mm Hg. The lenticule was clear, the ECC was 828 cell/mm2, and the IOP was well controlled. The patient was aware that the left eye would not likely improve and the right eye might require further surgery if the DSAEK lenticule cell count continued to decrease. DISCUSSION Complications arising from implantation of NewColorIris cosmetic implants can be serious and include uveitis, hyphema, glaucoma, corneal endothelial damage, glaucomatous optic neuropathy, and profound vision loss.5–10 Clinical examination in our series of 14 eyes confirmed multiple complications from these implants, including increased IOP, pigment dispersion, uveitis, corneal edema, a depressed ECC, UGH syndrome, glaucomatous optic neuropathy, CME, and suprachoroidal hemorrhage. The NewColorIris implants are a 1-piece annular silicone iris diaphragm. The implant is placed directly in the anterior chamber anterior to the iris. The implants are not sized and have a diameter of 15.00 mm with a central opening in the pupil of
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3.50 mm and a thickness of 0.16 mm.B The implant contains 6 semicircular peripheral flaps designed to stabilize its position in the anterior chamber. A recent online inquiry as to the safety of the implants (the web site http://newcoloritis.com no longer exists) referred the authors to a new web siteC and reported that the implants are made of “ophthalmic grade silicone and manufactured by Nusil, a leader in formulating silicone worldwide for the health care industry. The implant is molded and designed in a 100 clean room laboratory which is a registered 13485 in France.” Careful slitlamp examination shows the implants are not identical and some, but not all, have peripheral iridectomy cutouts of various sizes (Figure 1, images 5B, 6B, and 7B). Anderson et al.5 report that microscopic examination of 1 explanted implant showed that only 2 of 6 footplates that were intended to support the implant in the angle were present and that more than 180 degrees of the implant had been roughly hand cut to dimensions larger than the intended machine-cut edge. In addition to the manufacturing issues, many of the eyes in our series had implants decentered in reference to the pupil. This variability was most evident when comparing centration between fellow eyes (Figure 1; images 3A, 3B, 5A, 5B, 7A, and 7B). The poor centration confirms that the implants move in the anterior chamber because of poor sizing or that the design is inadequate to accommodate varying anterior chamber anatomies. As we have learned from more than 50 years of experience with anterior segment implants, poor design can lead to chronic deleterious effects with severe visual loss and ocular morbidity.10–12 In previous case reports,5–10 several hypotheses for the high complication rate in eyes with NewColorIris implants were proposed. First, during the surgical procedure, the corneal endothelium may be damaged during insertion and opening of the folded implant into the anterior chamber. Second, the device is a single-piece silicone implant that has flaps instead of haptics, which can place pressure on the corneoscleral trabecular meshwork, Schlemm canal, and collector channels. Using anterior segment imaging (anterior segment optical coherence tomography and UBM), several studies5,7,10 found that the NewColorIris implants come in direct contact with the lens and the iris. Many authors5,8,10 also found pigment dispersion throughout the anterior segment, thus speculating that pigment dispersion may be the primary mechanism of elevated IOP. Castanera et al.13 report irregularities in the implant surface on scanning electron microscopy. They speculate that these irregularities might promote contact between the implant and the iris, thus enhancing pigment dispersion. The mobility
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of the implant might also cause mechanical irritation to the corneal endothelium, iris stroma, and angle structures, damaging these structures. Explantation of the devices is not technically challenging because they are best amputated into 2 pieces to enable their removal through a small CCI. Removal does require a paracentesis to stabilize the implant while using a commercially available lens amputator or Stern-Gills scissors (American Surgical Instruments Corp.). The use of an OVD is recommended to limit further damage to the angle structures and the endothelial mosaic. In 12 eyes of 6 patients, we successfully removed the implants without intraoperative complications. In 1 eye of 1 patient (Case 3), a suprachoroidal hemorrhage occurred during removal of an iris segment by an outside physician in a patient who delayed intervention by 6 months despite elevated IOP. In the setting of depressed ECCs and elevated IOP, it is paramount to counsel all patients that explantation may lead to worsening ocular disease and/or an exacerbation of symptoms and further surgery might be required. Additionally troubling in our series of 14 eyes was the rapidity of the presentation of the symptoms and the subsequent ocular morbidity despite implant explantation. Five patients (10 eyes) were seen within 4 months of implantation and had elevated IOP and corneal edema, but without characteristic signs of acute angle-closure glaucoma. This always occurred after the patient had returned from Panama. Thus, the implant surgeon may be unaware of the significant morbidity caused by these iris implants. We speculate most, if not all, patients remain in the United States to have their post-implant care because returning to Panama would incur additional costs. Further distressing is the continuing morbidity associated with the implants. As shown in our representative case series, all 3 patients required further surgery after implant explantation and at present, all are being treated for ocular hypertension, glaucoma, or both. In addition, these implants are generally placed in younger patients; only 1 patient was older than 45 years at the time of implantation. Given these patients' life expectancy and their depressed ECCs, we would expect that in the future some, if not all, will require endokeratoplasty surgery and will maintain a lifelong risk of worsening glaucoma and optic neuropathy. It is important to differentiate the NewColorIris implants from the more commonly used prosthetic iris devices. In general, these implants are used in aphakic or pseudophakic patients or in patients with cataract. Although the iris prosthetic devices are not U.S. Food and Drug Administration (FDA) approved, they have received Conformitee Europeenne (CE) marking. The CE marking is an indicator that a product
is compliant with European Union legislation and has satisfied a level of safety to be used in the European marketplace. Ophtec BV, Morcher GmbH, and Intraocularlinsen GmbH are the main manufacturers of these devices.14,15,D,E In the U.S., ophthalmologists who want to implant these products must obtain a compassionate-use exemption from the FDA and the approval of an institutional review board. The Ophtec BV products are available in 3 colors (blue, green, and brown) and are relatively bright and reflective. Although the color match to the native iris is not ideal, they reduce glare and light sensitivity.14,E Most products from Morcher GmbH are black poly(methyl methacrylate). They attract less attention than the Ophtec products; however, despite correcting for glare and photosensitivity, they leave the eye with the same black cosmetic iris defect that existed before surgery.15,E The Intraocularlinsen GmbH products can be placed in the sulcus or capsular bag or sutured in the absence of capsule support. The implants can be customized to color; before ordering, the manufacturer requires a quality color photograph to allow matching with the fellow eye. The device can be further customized at the time of surgery with a trephine or scissors to reduce its outer diameter or to add an iridectomy.D,E Clinical trials with some of the above devices are underway in the U.S., and the manufacturer's representatives can direct patients to these trials. In summary, cosmetic iris implantation in our series of 14 eyes resulted in numerous complications, including corneal edema, increased IOP, pigment dispersion, uveitis, corneal edema, a depressed ECC, UGH syndrome, glaucomatous optic neuropathy, CME, trabecular meshwork damage, and suprachoroidal hemorrhage. In all, at the time of manuscript preparation, 9 of 14 eyes required subsequent surgery after implant removal. We expect this number will increase as the ECCs worsen over time. We believe that all the remaining eyes will subsequently require corneal intervention or both cornea and glaucoma intervention in the near future. In the absence of clear safety data for these implants in the peer-reviewed literature, we recommend that this implant not be used or offered as a cosmetic implant in phakic eyes. REFERENCES 1. Burk SE, Da Mata AP, Snyder ME, Cionni RJ, Cohen JS, Osher RH. Prosthetic iris implantation for congenital, traumatic, or functional iris deficiencies. J Cataract Refract Surg 2001; 27:1732–1740 2. Pozdeyeva NA, Pashtayev NP, Lukin VP, Batkov YN. Artificial iris-lens diaphragm in reconstructive surgery for aniridia and aphakia. J Cataract Refract Surg 2005; 31:1750–1759 3. Burk SE, Osher RH. Surgical management of aniridia. In: Roy FH, Arzabe CW, eds, Master Techniques in Cataract and Refractive Surgery. Thorofare, NJ, Slack, 2004; 3–10
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4. Azizi RS. Cosmetic contact lens fit for traumatic aniridia. Int Contact Lens Clin 1996; 23:72–75 5. Anderson JE, Grippo TM, Sbeity Z, Rich R. Serious complications of cosmetic NewColorIris implantation. Acta Ophthalmol (Oxf) 2010; 88:700–704 6. Thiagalingam S, Tarongoy P, Hamrah P, Lobo A-M, Nagao K, Barsam C, Bellows R, Pineda R. Complications of cosmetic iris implants. J Cataract Refract Surg 2008; 34:1222–1224 7. Arthur SN, Wright MM, Kramarevsky N, Kaufman SC, Grajewski AL. Uveitis-glaucoma-hyphema syndrome and corneal decompensation in association with cosmetic iris implants. Am J Ophthalmol 2009; 148:790–793 8. George MK, Tsai JC, Loewen NA. Bilateral irreversible severe vision loss from cosmetic iris implants. Am J Ophthalmol 2011; 151:872–875 €ller MC, Ruokonen PC, Torun N, Rieck P. 9. Jonsson NJ, Sahlmu Komplikationen nach kosmetischer Irisimplantation [Complications after cosmetic iris implantation]. Ophthalmologe 2011; 108:455–458 10. Garcia-Pous M, Udaondo P, Garcia-Delpech S, Salom D, DıazLlopis M. Acute endothelial failure after cosmetic iris implants (NewIrisÒ). Clin Ophthalmol 2011; 5:721–723. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116795/pdf/ opth-5-721.pdf. Accessed October 11, 2011 11. Apple DJ, Brems RN, Park RB, Kavka-Van Norman D, Hansen SO, Tetz MR, Richards SC, Letchinger SD. Anterior chamber lens implantation. Part 1: complications and pathology and a review of designs. J Cataract Refract Surg 1987; 13:157–174 12. Huang D, Schallhorn SC, Sugar A, Farjo AA, Majmudar PA, Trattler WB, Tanzer DJ. Phakic intraocular lens implantation
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for the correction of myopia; a report by the American Academy of Ophthalmology (Ophthalmic Technology Assessment). Ophthalmology 2009; 116:2244–2258 ez G, Ten P, Pinalla B, Guevara O. 13. Castanera F, Fuentes-Pa Scanning electron microscopy of explanted cosmetic iris implants [letter]. Clin Exp Ophthalmol 2010; 38:648–651 14. Price MO, Price FW Jr, Chang DF, Kelley K, Olson MD, Miller KM. Ophtec iris reconstruction lens United States clinical trial phase I. Ophthalmology 2004; 111:1847–1852 15. Olson MD, Masket S, Miller KM. Interim results of compassionateuse clinical trial of Morcher iris diaphragm implantation: report 1. J Cataract Refract Surg 2008; 34:1674–1680
OTHER CITED MATERIAL A. Kahn DA, “Iris Diaphragm Implant (Newiris) in Oculocutaneous Albinism,” poster presented at the annual meeting of the American Academy of Ophthalmology, Las Vegas, Nevada, USA, November 2006 B. Kahn DA, “Artificial Iris Diaphragm Implant (NewIris): Report of first patients,” presented at the Xth International Congress of the Keratomileusis Study Group (KMSG), Panama, February 2004 C. BrightOcular. Available at: http://www.BrightOcular.com. Accessed October 11, 2011 D. Dr. Schmidt Intraocularlinsen GmbH. Artificial iris prosthesis reconstruction implant. Available at: http://www.artificial-iris. com. Accessed October 11, 2011 E. Miller KM, “Technology Watch. Iris Prosthetics,” Advanced Ocular Care November/December 2010, pages 20 22. Available at: http://bmctoday.net/advancedocularcare/pdfs/ aoc1110_tech.pdf. Accessed October 11, 2011
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Serious ocular complications of cosmetic iris implants in 14 eyes Ambika Hoguet, MD, David Ritterband, MD, Richard Koplin, MD, Elaine Wu, MD, Tal Raviv, MD, John Aljian, MD, John Seedor, MD
PURPOSE: To report the presentation and subsequent management of a series of patients presenting with cosmetic iris implants. SETTING: New York Eye and Ear Infirmary, New York, New York, USA. DESIGN: Case series. METHODS: In this evaluation of patients with NewColorIris cosmetic iris implants, data collected included patient demographics, visual acuity, intraocular pressure (IOP), endothelial cell count, and slitlamp examination findings at presentation. Medical and surgical interventions and the postoperative course were recorded. RESULTS: Fourteen eyes of 7 patients (ages 22 to 60; 71% men) were identified. Nine eyes (64%) presented with decreased visual acuity, 7 (50%) had elevated IOP, 5 (36%) had corneal edema, and 5 (36%) had anterior uveitis. All 14 eyes had explantation of the iris prosthesis (range 4 to 33 months after placement). The minimum follow-up after implant removal in all eyes was 2 months (range 2 to 28 months). Intraoperative complications included suprachoroidal hemorrhage during explantation in 1 eye. Postoperative complications included corneal edema (8 eyes), cataract (9 eyes), and increased IOP/glaucoma (7 eyes). Secondary surgeries included Descemet-stripping automated endothelial keratoplasty (5 eyes), cataract extraction with intraocular lens placement (7 eyes), trabeculectomy (3 eyes), glaucoma drainage implant placement (3 eyes), and penetrating keratoplasty (1 eye). CONCLUSIONS: The cosmetic iris implants may result in severe ocular morbidity. Complications in our series included uveitis, glaucoma, corneal edema, and decreased visual acuity. Although explantation helped stabilize symptoms, additional medical and surgical intervention to control IOP and corneal decompensation was required in many cases. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2012; 38:387–393 Q 2012 ASCRS and ESCRS
A variety of prosthetic iris implants have been used for congenital, traumatic, or functional iris abnormalities since the first prosthetic iris was implanted in 1956.1–3 Prosthetic iris–lens devices have been found to be safe and effective in reducing glare and decreasing light sensitivity in certain types of iris defects, including congenital iris colobomas, traumatic iris defects, aniridia, and ocular albinism, and in eyes with surgical iris loss.1 Iris diaphragm–type prosthetic iris implants were initially designed to correct iris defects in phakic patients.1 In 2006, an implant initially developed for the treatment of oculocutaneous albinism was marketed to patients without iris abnormalities who sought to permanently change their iris color.A The NewColorIris implant offered by Kahn Q 2012 ASCRS and ESCRS Published by Elsevier Inc.
Medical Devices in Panama City, Panama, was advertised as a safe and permanent solution with a favorable risk profile over cosmetic contact lenses and as an alternative to contact lenses.4 Patients without a history of ocular pathology were eligible for placement of this implant and could select from 3 colors (hazel, blue, or green). Since 2004, there have been 6 reports of serious complications in eyes that have had NewColorIris implants. These complications include severe vision loss, uveitis–glaucoma–hyphema (UGH) syndrome, elevated intraocular pressure (IOP), endothelial cell loss, bullous keratopathy, and end-stage glaucomatous optic neuropathy.5–10 However, information on the long-term management and visual outcomes of 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2011.09.037
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these patients is lacking. George et al.8 reported through a personal communication with Kahn Medical in 2001 that more than 700 procedures had been performed since 2002, with an incidence of chronic inflammation of 1.5% and an occurrence of raised IOP that could be adequately controlled with eyedrops. We report the initial presentation, subsequent management, and clinical outcomes in 14 eyes of 7 patients presenting with NewColorIris implants to our institution. PATIENTS AND METHODS All patients who presented to the New York Eye and Ear Infirmary between 2006 and 2010 with cosmetic iris implants were identified. All recorded patients had previously had implantation of NewColorIris cosmetic implants in Panama City, Panama. The implant was placed under topical anesthesia. Carbachol (Miostat) was first used in the anterior chamber to constrict the pupil, with subsequent injection of an ophthalmic viscosurgical device (OVD). The foldable implant was inserted in the anterior chamber through a 3.2 mm clear corneal incision (CCI), and the OVD was subsequently aspirated out of the anterior chamber.4,5 No sutures were required for this procedure. The medical records of these patients were reviewed and the patient age, sex, time of presentation, visual acuity, IOP, endothelial cell count (ECC), and slitlamp examination findings at presentation were recorded. When the images were available, slitlamp photographs and ultrasound biomicroscopy (UBM) images were also reviewed. Follow-up data were tabulated, including surgical interventions, visual acuity, IOP, ECC, and slitlamp examination findings at the most recent presentation.
RESULTS Fourteen eyes of 7 patients (5 men) were identified. The mean age at time of implantation was 39 years (range 22 to 60 years). One patient had laser in situ keratomileusis surgery in both eyes before having iris implant surgery; none of the remaining patients had previous intraocular surgery or pathology. All patients had cosmetic implants placed in both eyes in Panama City, Panama, by Kahn Medical and self-reported uneventful surgery. Submitted: July 31, 2011. Final revision submitted: September 14, 2011. Accepted: September 16, 2011. From the Department of Ophthalmology, New York Eye and Ear Infirmary, and New York Medical College, Valhalla, New York, USA. Presented in part at the annual meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, USA, May 2011. Corresponding author: David Ritterband, MD, Ophthalmic Consultants PC, 310 East 14th Street, The New York Eye and Ear Infirmary, New York, New York 10003, USA. E-mail: [email protected].
On presentation, all 7 patients (12 eyes) reported blurry vision, 4 patients (4 eyes) reported redness and pain, and 1 patient reported a foreign-body sensation. On initial ocular examination, 9 eyes (64%) presented with decreased visual acuity (%20/30), 7 eyes (50%) with elevated IOP (O22 mm Hg), 5 eyes (36%) had corneal edema, and 5 eyes (36%) with iritis. The mean initial IOP was 25 mm Hg (range 15 to 52 mm Hg), and the mean ECC was 989 cells/mm2 (range 266 to 1841 cells/mm2) (Table 1). Figure 1 shows the available slitlamp photographs of 12 eyes (7 patients). All patients received management with topical glaucoma medications and topical antiinflammatory drops as needed to address IOP elevation and anterior segment inflammation. All 14 eyes were eventually treated with explantation of the iris prosthesis (range 4 to 33 months after implant placement). Two patients (4 eyes) refused immediate explantation against medical advice but had the implants removed at a later date due to worsening vision and elevated IOP. One of these eyes developed a suprachoroidal hemorrhage during explantation and had hand-motion vision at the time of manuscript preparation. The minimum follow-up after explantation in all eyes was 2 months (range 2 to 28 months). After explantation, 9 eyes had progression of ocular disease. This progression included new-onset or persistent corneal edema (8 eyes), emerging cataract (9 eyes), increased IOP (7 eyes), and cystoid macular edema (CME) (1 eye). Secondary surgeries included Descemet-stripping automated endothelial keratoplasty (DSAEK) (5 eyes), cataract extraction/intraocular lens (IOL) placement (7 eyes), trabeculectomy (3 eyes), glaucoma drainage implant placement (3 eyes), and penetrating keratoplasty (1 eye) (Table 2). Representative Case Reports Case 1 A 60-year-old woman presented, reporting 3 months of redness, irritation, and blurred vision after having iris implant surgery in Panama 6 months previously. Her corrected distance visual acuity (CDVA) on presentation was 20/50 2 in the right eye and 20/60 in the left eye. Slitlamp examination on presentation showed bilateral peripheral corneal edema, uveitis, dense pigmentation of the peripheral corneal endothelium, and 2C nuclear sclerosis and 2C cortical cataract in both eyes. The IOP was 24 mm Hg in the right eye and 25 mm Hg in the left eye. The patient was using prednisolone acetate drops 4 times daily and brimonidine drops twice daily bilaterally. The ECC was 1146 cells/mm2 in the right eye and 266 cells/mm2 in the left eye. The iris implant in the left eye was removed 1 week after presentation. Four weeks later, the iris implant in
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Table 1. Findings on presentation.
Pt/Eye
Presenting Symptoms
CDVA
IOP (mm Hg)
Corneal Edema
Iritis
ECC (Cells/mm2)
Time from Initial Surgery to Implant Removal (Mo) 20 21 Advised: 16 Removed: 23 Advised: 16 Removed: 22 7 7 7 6 11 7 4 4 13 11
1/R 1/L 2/R
None Decreased VA Decreased VA
20/20 20/25 20/25
21 29 18
No No No
No No No
722 1841 548
2/L
Decreased VA; redness; pain
20/50
28
Yes
No
551
3/R 3/L 4/R 4/L 5/R 5/L 6/R 6/L 7/R 7/L
Decreased VA Decreased VA Decreased VA; redness; pain Decreased VA Redness; pain Decreased VA; redness; pain Decreased VA Decreased VA Decreased VA Decreased VA; foreign-body sensation
20/30 20/30 20/50 20/60 20/20 20/40 20/80 20/50 20/25 20/30
22 16 24 25 30 52 20 30 15 15
No No Yes Yes No No Yes Yes No No
Yes No Yes Yes Yes No No No No Yes
1602 1277 1146 266 1225 1376 662 1137 746 754
CDVA Z corrected distance visual acuity; ECC Z endothelial cell count; IOP Z intraocular pressure; Pt Z patient; VA Z visual acuity
the right eye was removed. One month after surgery in the left eye, the CDVA worsened to 20/200 and the corneal edema worsened. The CDVA in the left eye stabilized to 20/50 but was limited by persistent peripheral corneal edema and an emerging cataract.
Three months after initial presentation, the patient had DSAEK and cataract extraction in the left eye, which now had chronic corneal edema and poor CDVA (at the 20/400 level). Three months after DSAEK in the left eye, uncorrected distance visual
Figure 1. Slitlamp photographs taken at presentation of 7 patients with the cosmetic iris implant. A: Right eye. B: Left eye. J CATARACT REFRACT SURG - VOL 38, MARCH 2012
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Table 2. Most recent follow-up data of patients after implant explantation. Follow-up Pt/Eye (Mo After Explantation) 1/R 1/L
14 13
2/R
3
2/L 3/R 3/L 4/R 4/L 5/R
5 2 2 15 16 17
5/L 6/R
24 28
6/L 7/R
28 4
7/L
12
Complications
CDVA
IOP ECC (mm Hg) (Cells/mm2)
Cataract Cataract
20/25 20/20
16 16
576 1331
Corneal edema; cataract; glaucoma Glaucoma Peripheral corneal scar Peripheral corneal scar Cataract; corneal edema Cataract; corneal edema Corneal edema; cataract; glaucoma; CME Cataract; glaucoma Corneal edema; glaucoma
20/80
14
828
HM 20/25 20/30 20/30 20/30 20/80
34 14 14 17 16 10
652 1354 491
20/30 20/60
12 8
610 854
20/200 20/400
6 12
841
20/35
23
Corneal edema Corneal edema, cataract; glaucoma Corneal edema; cataract; glaucoma
Subsequent Surgery Cataract extraction–IOL Cataract extraction–IOL at time of explantation DSAEK/cataract extraction–IOL; PPV/goniosynechiolysis; GDI Choroidal hemorrhage drainage None None DSAEK/cataract extraction–IOL DSAEK/cataract extraction–IOL Goniosynechiolysis, trabeculectomy, DSAEK Goniosynechiolysis, trabeculectomy PKP/cataract extraction–IOL/PPV/GDI None Trabeculectomy DSAEK/cataract extraction–IOL/PPV/GDI
CDVA Z corrected distance visual acuity; CME Z cystoid macular edema; DSAEK Z Descemet-stripping automated endothelial keratoplasty; ECC Z endothelial cell count; GDI Z glaucoma drainage implant; IOL Z intraocular lens placement; IOP Z intraocular pressure; PKP Z penetrating keratoplasty; PPV Z pars plana vitrectomy; Pt Z patient; VA Z visual acuity
acuity (UDVA) improved to 20/30, the cornea was clear, and the IOP was controlled on brimonidine and timolol. Nine months after presentation, the cornea in the right eye further decompensated and the CDVA dropped to 20/400. The patient had DSAEK and cataract extraction 2 weeks later. On the most recent visit 16 months after initial presentation, the DSAEK lenticules were clear and the UDVA was 20/30 bilaterally. At the time of manuscript preparation, the patient was taking brimonidine twice daily to control IOP bilaterally. Case 2 A 36-year-old man who had iris implants
placed in Panama 6 months previously presented for consultation. He had been treated by a glaucoma specialist for the past several months and was on maximum medical therapy of topical brimonidine tartrate 0.2% 3 times daily, timolol maleate 0.5% twice daily, travoprost 0.004% at bedtime, dorzolamide 2.0% 3 times daily, and methazolamide 50 mg orally twice daily. On examination at presentation, the UDVA was 20/20 1 in the right eye and 20/25 in the left eye. The iris in the right eye was irregular and poorly reactive. There was dense pigment clumping on the endothelium bilaterally and trace posterior subcapsular cataracts, greater in the left eye than in the
right eye. The IOP was 21 mm Hg in the right eye and 29 mm Hg in the left. Although no corneal edema was present, the ECC was depressed in both eyes (722 cells/mm2 right eye; 1841 cells/mm2 left eye). Three weeks after presentation, the first implant was removed from the right eye and synechialysis was performed to sever the iris adhesions. One month later, the iris implant was removed from the left eye and cataract surgery with IOL implantation was performed. Six months after presentation, the UDVA was 20/25 in the left eye but had dropped to 20/50 2 in the right eye secondary to continued cataract development. One year after presentation, the patient had cataract extraction in the right eye. On the most recent visit 14 months after presentation, the corrected distance visual acuity (CDVA) was 20/25 in the right eye and 20/ 20 1 in the left eye. The ECC remained depressed bilaterally (576 cells/mm2 right eye; 1331 cells/mm2 left eye). At the time of manuscript preparation, the IOP was well controlled on travoprost 0.004% nightly in each eye. The patient will likely require DSAEK if the ECCs continue to decline at the same yearly rate. Case 3 A 46-year-old man presented with severe photophobia, increased IOP, and corneal swelling bilaterally 16 months after having iris implants placed in Panama. The UGH syndrome had been
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diagnosed and treated by his local ophthalmologist. The CDVA at the time was 20/25 2 in the right eye and 20/50 2 in the left eye. Despite medical therapy with topical brimonidine tartrate 0.2%–timolol maleate 0.5%, brinzolamide 1.0%, brimatoprost 0.01%, and topical steroids, the IOP was 18 mm Hg in the right eye and 28 mm Hg in the left eye. The ECC was 548 cells/mm2 in the right eye and 551 cells/ mm2 in the left eye. The patient was advised to have immediate removal of both implants and counseled that he would probably require additional corneal and/or glaucoma surgery in the future. He scheduled surgery the following week but then cancelled after he reported his vision had improved. Despite several attempts to contact the patient to have the implants removed, he was lost to follow-up. Seven months later, he returned for consultation concerning the right eye. The left eye had suffered a suprachoroidal hemorrhage during removal of the implant by another physician 1 month previously. In the left eye, the UDVA was hand motion and the cornea was diffusely edematous. The right eye had DSAEK and cataract extraction the week previously but now had a flat anterior chamber with posterior segment air, causing iris bombe with 360 degrees of peripheral anterior synechiae and a zippered anterior chamber angle. The IOP was markedly elevated (in the high 40s). The next day, the patient had a pars plana vitrectomy, goniosynechialysis, and glaucoma drainage implant placement. Six weeks later, the CDVA had improved to 20/80 and the IOP was 14 mm Hg. The lenticule was clear, the ECC was 828 cell/mm2, and the IOP was well controlled. The patient was aware that the left eye would not likely improve and the right eye might require further surgery if the DSAEK lenticule cell count continued to decrease. DISCUSSION Complications arising from implantation of NewColorIris cosmetic implants can be serious and include uveitis, hyphema, glaucoma, corneal endothelial damage, glaucomatous optic neuropathy, and profound vision loss.5–10 Clinical examination in our series of 14 eyes confirmed multiple complications from these implants, including increased IOP, pigment dispersion, uveitis, corneal edema, a depressed ECC, UGH syndrome, glaucomatous optic neuropathy, CME, and suprachoroidal hemorrhage. The NewColorIris implants are a 1-piece annular silicone iris diaphragm. The implant is placed directly in the anterior chamber anterior to the iris. The implants are not sized and have a diameter of 15.00 mm with a central opening in the pupil of
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3.50 mm and a thickness of 0.16 mm.B The implant contains 6 semicircular peripheral flaps designed to stabilize its position in the anterior chamber. A recent online inquiry as to the safety of the implants (the web site http://newcoloritis.com no longer exists) referred the authors to a new web siteC and reported that the implants are made of “ophthalmic grade silicone and manufactured by Nusil, a leader in formulating silicone worldwide for the health care industry. The implant is molded and designed in a 100 clean room laboratory which is a registered 13485 in France.” Careful slitlamp examination shows the implants are not identical and some, but not all, have peripheral iridectomy cutouts of various sizes (Figure 1, images 5B, 6B, and 7B). Anderson et al.5 report that microscopic examination of 1 explanted implant showed that only 2 of 6 footplates that were intended to support the implant in the angle were present and that more than 180 degrees of the implant had been roughly hand cut to dimensions larger than the intended machine-cut edge. In addition to the manufacturing issues, many of the eyes in our series had implants decentered in reference to the pupil. This variability was most evident when comparing centration between fellow eyes (Figure 1; images 3A, 3B, 5A, 5B, 7A, and 7B). The poor centration confirms that the implants move in the anterior chamber because of poor sizing or that the design is inadequate to accommodate varying anterior chamber anatomies. As we have learned from more than 50 years of experience with anterior segment implants, poor design can lead to chronic deleterious effects with severe visual loss and ocular morbidity.10–12 In previous case reports,5–10 several hypotheses for the high complication rate in eyes with NewColorIris implants were proposed. First, during the surgical procedure, the corneal endothelium may be damaged during insertion and opening of the folded implant into the anterior chamber. Second, the device is a single-piece silicone implant that has flaps instead of haptics, which can place pressure on the corneoscleral trabecular meshwork, Schlemm canal, and collector channels. Using anterior segment imaging (anterior segment optical coherence tomography and UBM), several studies5,7,10 found that the NewColorIris implants come in direct contact with the lens and the iris. Many authors5,8,10 also found pigment dispersion throughout the anterior segment, thus speculating that pigment dispersion may be the primary mechanism of elevated IOP. Castanera et al.13 report irregularities in the implant surface on scanning electron microscopy. They speculate that these irregularities might promote contact between the implant and the iris, thus enhancing pigment dispersion. The mobility
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of the implant might also cause mechanical irritation to the corneal endothelium, iris stroma, and angle structures, damaging these structures. Explantation of the devices is not technically challenging because they are best amputated into 2 pieces to enable their removal through a small CCI. Removal does require a paracentesis to stabilize the implant while using a commercially available lens amputator or Stern-Gills scissors (American Surgical Instruments Corp.). The use of an OVD is recommended to limit further damage to the angle structures and the endothelial mosaic. In 12 eyes of 6 patients, we successfully removed the implants without intraoperative complications. In 1 eye of 1 patient (Case 3), a suprachoroidal hemorrhage occurred during removal of an iris segment by an outside physician in a patient who delayed intervention by 6 months despite elevated IOP. In the setting of depressed ECCs and elevated IOP, it is paramount to counsel all patients that explantation may lead to worsening ocular disease and/or an exacerbation of symptoms and further surgery might be required. Additionally troubling in our series of 14 eyes was the rapidity of the presentation of the symptoms and the subsequent ocular morbidity despite implant explantation. Five patients (10 eyes) were seen within 4 months of implantation and had elevated IOP and corneal edema, but without characteristic signs of acute angle-closure glaucoma. This always occurred after the patient had returned from Panama. Thus, the implant surgeon may be unaware of the significant morbidity caused by these iris implants. We speculate most, if not all, patients remain in the United States to have their post-implant care because returning to Panama would incur additional costs. Further distressing is the continuing morbidity associated with the implants. As shown in our representative case series, all 3 patients required further surgery after implant explantation and at present, all are being treated for ocular hypertension, glaucoma, or both. In addition, these implants are generally placed in younger patients; only 1 patient was older than 45 years at the time of implantation. Given these patients' life expectancy and their depressed ECCs, we would expect that in the future some, if not all, will require endokeratoplasty surgery and will maintain a lifelong risk of worsening glaucoma and optic neuropathy. It is important to differentiate the NewColorIris implants from the more commonly used prosthetic iris devices. In general, these implants are used in aphakic or pseudophakic patients or in patients with cataract. Although the iris prosthetic devices are not U.S. Food and Drug Administration (FDA) approved, they have received Conformitee Europeenne (CE) marking. The CE marking is an indicator that a product
is compliant with European Union legislation and has satisfied a level of safety to be used in the European marketplace. Ophtec BV, Morcher GmbH, and Intraocularlinsen GmbH are the main manufacturers of these devices.14,15,D,E In the U.S., ophthalmologists who want to implant these products must obtain a compassionate-use exemption from the FDA and the approval of an institutional review board. The Ophtec BV products are available in 3 colors (blue, green, and brown) and are relatively bright and reflective. Although the color match to the native iris is not ideal, they reduce glare and light sensitivity.14,E Most products from Morcher GmbH are black poly(methyl methacrylate). They attract less attention than the Ophtec products; however, despite correcting for glare and photosensitivity, they leave the eye with the same black cosmetic iris defect that existed before surgery.15,E The Intraocularlinsen GmbH products can be placed in the sulcus or capsular bag or sutured in the absence of capsule support. The implants can be customized to color; before ordering, the manufacturer requires a quality color photograph to allow matching with the fellow eye. The device can be further customized at the time of surgery with a trephine or scissors to reduce its outer diameter or to add an iridectomy.D,E Clinical trials with some of the above devices are underway in the U.S., and the manufacturer's representatives can direct patients to these trials. In summary, cosmetic iris implantation in our series of 14 eyes resulted in numerous complications, including corneal edema, increased IOP, pigment dispersion, uveitis, corneal edema, a depressed ECC, UGH syndrome, glaucomatous optic neuropathy, CME, trabecular meshwork damage, and suprachoroidal hemorrhage. In all, at the time of manuscript preparation, 9 of 14 eyes required subsequent surgery after implant removal. We expect this number will increase as the ECCs worsen over time. We believe that all the remaining eyes will subsequently require corneal intervention or both cornea and glaucoma intervention in the near future. In the absence of clear safety data for these implants in the peer-reviewed literature, we recommend that this implant not be used or offered as a cosmetic implant in phakic eyes. REFERENCES 1. Burk SE, Da Mata AP, Snyder ME, Cionni RJ, Cohen JS, Osher RH. Prosthetic iris implantation for congenital, traumatic, or functional iris deficiencies. J Cataract Refract Surg 2001; 27:1732–1740 2. Pozdeyeva NA, Pashtayev NP, Lukin VP, Batkov YN. Artificial iris-lens diaphragm in reconstructive surgery for aniridia and aphakia. J Cataract Refract Surg 2005; 31:1750–1759 3. Burk SE, Osher RH. Surgical management of aniridia. In: Roy FH, Arzabe CW, eds, Master Techniques in Cataract and Refractive Surgery. Thorofare, NJ, Slack, 2004; 3–10
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4. Azizi RS. Cosmetic contact lens fit for traumatic aniridia. Int Contact Lens Clin 1996; 23:72–75 5. Anderson JE, Grippo TM, Sbeity Z, Rich R. Serious complications of cosmetic NewColorIris implantation. Acta Ophthalmol (Oxf) 2010; 88:700–704 6. Thiagalingam S, Tarongoy P, Hamrah P, Lobo A-M, Nagao K, Barsam C, Bellows R, Pineda R. Complications of cosmetic iris implants. J Cataract Refract Surg 2008; 34:1222–1224 7. Arthur SN, Wright MM, Kramarevsky N, Kaufman SC, Grajewski AL. Uveitis-glaucoma-hyphema syndrome and corneal decompensation in association with cosmetic iris implants. Am J Ophthalmol 2009; 148:790–793 8. George MK, Tsai JC, Loewen NA. Bilateral irreversible severe vision loss from cosmetic iris implants. Am J Ophthalmol 2011; 151:872–875 €ller MC, Ruokonen PC, Torun N, Rieck P. 9. Jonsson NJ, Sahlmu Komplikationen nach kosmetischer Irisimplantation [Complications after cosmetic iris implantation]. Ophthalmologe 2011; 108:455–458 10. Garcia-Pous M, Udaondo P, Garcia-Delpech S, Salom D, DıazLlopis M. Acute endothelial failure after cosmetic iris implants (NewIrisÒ). Clin Ophthalmol 2011; 5:721–723. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116795/pdf/ opth-5-721.pdf. Accessed October 11, 2011 11. Apple DJ, Brems RN, Park RB, Kavka-Van Norman D, Hansen SO, Tetz MR, Richards SC, Letchinger SD. Anterior chamber lens implantation. Part 1: complications and pathology and a review of designs. J Cataract Refract Surg 1987; 13:157–174 12. Huang D, Schallhorn SC, Sugar A, Farjo AA, Majmudar PA, Trattler WB, Tanzer DJ. Phakic intraocular lens implantation
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for the correction of myopia; a report by the American Academy of Ophthalmology (Ophthalmic Technology Assessment). Ophthalmology 2009; 116:2244–2258 ez G, Ten P, Pinalla B, Guevara O. 13. Castanera F, Fuentes-Pa Scanning electron microscopy of explanted cosmetic iris implants [letter]. Clin Exp Ophthalmol 2010; 38:648–651 14. Price MO, Price FW Jr, Chang DF, Kelley K, Olson MD, Miller KM. Ophtec iris reconstruction lens United States clinical trial phase I. Ophthalmology 2004; 111:1847–1852 15. Olson MD, Masket S, Miller KM. Interim results of compassionateuse clinical trial of Morcher iris diaphragm implantation: report 1. J Cataract Refract Surg 2008; 34:1674–1680
OTHER CITED MATERIAL A. Kahn DA, “Iris Diaphragm Implant (Newiris) in Oculocutaneous Albinism,” poster presented at the annual meeting of the American Academy of Ophthalmology, Las Vegas, Nevada, USA, November 2006 B. Kahn DA, “Artificial Iris Diaphragm Implant (NewIris): Report of first patients,” presented at the Xth International Congress of the Keratomileusis Study Group (KMSG), Panama, February 2004 C. BrightOcular. Available at: http://www.BrightOcular.com. Accessed October 11, 2011 D. Dr. Schmidt Intraocularlinsen GmbH. Artificial iris prosthesis reconstruction implant. Available at: http://www.artificial-iris. com. Accessed October 11, 2011 E. Miller KM, “Technology Watch. Iris Prosthetics,” Advanced Ocular Care November/December 2010, pages 20 22. Available at: http://bmctoday.net/advancedocularcare/pdfs/ aoc1110_tech.pdf. Accessed October 11, 2011
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