Letters

material and had posterior surface radial grooves and peripheral triangular tabs. Postoperatively, visual acuity was 20/20 OU with normal intraocular pressure in each eye. The anterior chambers were quiet and the irides showed patchy, midperipheral anterior iris pigment loss. Discussion | Cosmetic iris implants are a subset of artificial iris implants designed to change the natural iris color, and they require surgical implantation.4 The NewColorIris is an artificial iris implant from Panama; it has a well-documented set of complications, including glaucoma, endothelial cell loss, and uveitis-glaucoma-hyphema syndrome.4,5 Removal of the device is required for definitive management6 and additional surgery may be necessary. Removal of the device also carries risks. This case demonstrates a new anterior chamber cosmetic iris implant being marketed under the name BrightOcular. This device is promoted as safe and made from US Food and Drug Administration–approved material, but the device is not approved by the US Food and Drug Administration. It is implanted anterior to the iris, similar to the NewColorIris. The main difference in the design of the BrightOcular implant compared with the NewColorIris appears to be the posterior surface grooves, which are intended to minimize iris implant contact and allow the flow of aqueous around the implant. We believe the endothelial damage evident on the initial presentation was likely the result of the implantation procedure and the instability of the device. With the findings of angle crowding, iris-implant contact, and pigment dispersion, we believe that anterior chamber angle damage and glaucoma are likely sequelae. The midperipheral anterior iris pigment loss was likely the result of iris chafing related to direct implantiris touch. Given our past experiences with similar cosmetic iris devices, our recommendation was for immediate removal, which has not led to additional complications. Conclusions | We believe that cosmetic artificial iris devices should be avoided owing to potentially serious complications, including permanent vision loss. Removal of the cosmetic iris implant may be necessary. Alla Kelly, MD Stephen C. Kaufman, MD, PhD Author Affiliations: St Paul Eye Clinic, St Paul, Minnesota (Kelly); Department of Ophthalmology and Visual Neurosciences, University of Minnesota, St Paul (Kelly, Kaufman); Department of Ophthalmology, State University of New York Downstate, Brooklyn (Kaufman). Corresponding Author: Alla Kelly, MD, St Paul Eye Clinic, 110 Midwest Eye and Ear Institute, 2080 Woodwinds Dr, Woodbury, MN 55125 ([email protected]). Published Online: March 26, 2015. doi:10.1001/jamaophthalmol.2015.0488. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Funding/Support: This work was supported by an unrestricted grant from Research to Prevent Blindness. Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data;

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preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. 1. Hoguet A, Ritterband D, Koplin R, et al. Serious ocular complications of cosmetic iris implants in 14 eyes. J Cataract Refract Surg. 2012;38(3):387-393. 2. Sikder S, Davis SW, Holz H, Moshirfar M. Complications of NewColorIris implantation in phakic eyes: a review. Clin Ophthalmol. 2011;5:435-438. 3. 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(5):790-793. 4. Veldman PB, Behlau I, Soriano E, Starling JC, Pineda R. Two cases of cosmetic iris implant explantation secondary to uveitis, glaucoma, and corneal decompensation. Arch Ophthalmol. 2012;130(6):787-789. 5. George MK, Tsai JC, Loewen NA. Bilateral irreversible severe vision loss from cosmetic iris implants. Am J Ophthalmol. 2011;151(5):872-875, e1. 6. Hull S, Jayaram H, Mearza AA. Complications and management of cosmetic anterior chamber iris implants. Cont Lens Anterior Eye. 2010;33(5):235-238.

COMMENT & RESPONSE

Descemet Membrane Endothelial Keratoplasty: To Do or Not to Do? To the Editor We read with great interest the article by Monnereau et al1 in which the authors reported the clinical outcomes of the initial Descemet membrane endothelial keratoplasty (DMEK) procedures performed by experienced corneal surgeons using a standardized “no-touch” surgical technique.2 They concluded that DMEK was feasible in most hands, with graft detachment being the most common complication (34.5% of 431 eyes). Since this study provides a realistic idea of the learning curve involved, an important question that needs to be asked is whether the results justify a switch to DMEK in the first place. Currently, most corneal surgeons perform either penetrating keratoplasty (PK) or Descemet stripping endothelial keratoplasty (DSEK) for corneal endothelial diseases. In the last decade there has been a shift from PK to DSEK primarily because of the increased availability of precut donor tissue and the lack of suture-related problems in DSEK.3 Unlike DSEK, a DMEK graft does not contain any corneal stromal element, therefore theoretically reducing the risk of interface haze and immunological rejection. Novelty aside, the possible reasons for a corneal surgeon experienced in DSEK to consider performing DMEK instead include better postoperative best-corrected visual acuity, greater graft survival, and lesser endothelial cell loss. On these 3 counts the authors may not have had reliable data. Data are missing for more than one-third of the cases (156 of 431). Furthermore, data showing superiority of DMEK to DSEK are not provided. Of the 176 eyes (40.8%) for which data at 6 months were available, only 43.8% recovered bestcorrected visual acuity of 20/25 or better. Another potential limitation to their conclusion appears to be the mean decrease in endothelial cell density of 47% at 6 months, which is almost similar to what is noted in DSEK at 5 years (53%).4 Furthermore, 18.3% of the eyes needed a second keratoplasty within the same period; it would be helpful if the authors could indicate whether they believe that is an acceptable failure rate and, if not, why not. A recent editorial in Ophthalmology has questioned the very argument in favor of lamellar corneal surgery.5 Long-term out-

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comes seem to indicate that PK may still hold the edge over endothelial keratoplasties.3 Therefore, it would be of value to have the authors’ response to our viewpoint. It seems to us that unless easier methods of donor attachment involving lesser endothelial cell loss are described, DMEK may never evolve into the accepted standard for treatment of corneal endothelial dysfunction. Swapna S. Shanbhag, MS Abhishek Hoshing, DNB Sayan Basu, MBBS, MS Author Affiliations: Cornea and Anterior Segment Services, L V Prasad Eye Institute, Hyderabad, India. Corresponding Author: Sayan Basu, MBBS, MS, L V Prasad Eye Institute, Room 606A, Sixth Floor, Hyderabad 500034, Andhra Pradesh, India (sayanbasu @lvpei.org). Published Online: April 2, 2015. doi:10.1001/jamaophthalmol.2015.0475. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Monnereau C, Quilendrino R, Dapena I, et al. Multicenter study of Descemet membrane endothelial keratoplasty: first case series of 18 surgeons. JAMA Ophthalmol. 2014;132(10):1192-1198. 2. Dapena I, Moutsouris K, Droutsas K, Ham L, van Dijk K, Melles GR. Standardized “no-touch” technique for Descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2011;129(1):88-94. 3. Coster DJ, Lowe MT, Keane MC, Williams KA; Australian Corneal Graft Registry Contributors. A comparison of lamellar and penetrating keratoplasty outcomes: a registry study. Ophthalmology. 2014;121(5):979-987. 4. Price MO, Fairchild KM, Price DA, Price FW Jr. Descemet’s stripping endothelial keratoplasty five-year graft survival and endothelial cell loss. Ophthalmology. 2011;118(4):725-729. 5. Patel SV, Armitage WJ, Claesson M. Keratoplasty outcomes: are we making advances? Ophthalmology. 2014;121(5):977-978.

In Reply We thank Shanbhag et al for commenting on our study. In short, they question whether, based on our article describing the learning curve for 18 novel DMEK surgeons,1 the procedure would be a better alternative to DSEK and PK. The main concerns expressed are that the study does not contain reliable data on best-corrected visual acuity, the decrease in endothelial cell density would be higher than in earlier techniques, and about one-fifth of eyes required a secondary intervention. Furthermore, according to long-term studies PK would still be preferable over endothelial keratoplasty, and unless technique improvements are reached, DMEK may not hold potential to become a preferred method for treatment of endothelial disorders.2 From their comment it is our understanding that they compared learning curve results of DMEK with large PK and DSEK study groups described by experienced surgeons. However, to get more accurate information on all of these techniques, it would seem mandatory to compare either learning curve results with each other or large study groups by established centers (instead of short-term learning curve outcomes with long-term results of experienced surgeons). Expanding on this, the cited publications in Ophthalmology read different to us: recently introduced techniques for lamellar keratoplasty showed better outcomes than PK in single-center studies,2-4 but these results would not (yet) be jamaophthalmology.com

reached by nationwide evaluations. In other words, DMEK as a technique may have been shown to surpass DSEK and PK, but the results on a larger-scale implementation lag behind. We have learned from techniques previously designed by us, like deep lamellar endothelial keratoplasty and DSEK, that starting with a new technique may be more challenging than one would anticipate. Therefore, we have tried to standardize as much as possible the surgical technique for DMEK as well as its technique for donor tissue preparation, into what we now refer to as “standardized no-touch DMEK.”5,6 Still, surgeons in various countries will be facing challenges as a result of different clinical settings, such as surgical facilities, donor tissue availability, or support of an eye bank or lack thereof. In an attempt to better identify these problems, we performed our retrospective study that may aid corneal surgeons in starting with DMEK, while it allowed us to fine-tune our educational program. So to answer the question in the title of whether “to do or not to do” DMEK, since additional training in the various techniques may be obtained through instructional courses at international meetings, wetlab courses, textbooks on DMEK, or live-surgery video-streaming sessions, we encourage all our colleagues to consider DMEK for the management of corneal endothelial disorders. Claire Monnereau, MSc Isabel Dapena, MD, PhD Gerrit R. J. Melles, MD, PhD Author Affiliations: Netherlands Institute for Innovative Ocular Surgery (NIIOS), Rotterdam, the Netherlands (Monnereau, Dapena, Melles); Melles CorneaClinic Rotterdam, Rotterdam, the Netherlands (Dapena, Melles); Amnitrans Eyebank Rotterdam, Rotterdam, the Netherlands (Melles). Corresponding Author: Gerrit R. J. Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery (NIIOS), Laan op Zuid 88, 3071 AA Rotterdam, the Netherlands ([email protected]). Published Online: April 2, 2015. doi:10.1001/jamaophthalmol.2015.0486. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Melles is a consultant for DORC International/Dutch Ophthalmic USA and SurgiCube International. No other disclosures were reported. 1. Monnereau C, Quilendrino R, Dapena I, et al. Multicenter study of descemet membrane endothelial keratoplasty: first case series of 18 surgeons. JAMA Ophthalmol. 2014;132(10):1192-1198. 2. Coster DJ, Lowe MT, Keane MC, Williams KA; Australian Corneal Graft Registry Contributors. A comparison of lamellar and penetrating keratoplasty outcomes: a registry study. Ophthalmology. 2014;121(5): 979-987. 3. Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet’s membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011;118(12): 2368-2373. 4. Rodríguez-Calvo-de-Mora M, Quilendrino R, Ham L, et al. Clinical outcome of 500 consecutive cases undergoing Descemet's membrane endothelial keratoplasty [published online October 22, 2014]. Ophthalmology. doi:10.1016/j .ophtha.2014.09.004. 5. Dapena I, Moutsouris K, Droutsas K, Ham L, van Dijk K, Melles GR. Standardized “no-touch” technique for descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2011;129(1):88-94. 6. Groeneveld-van Beek EA, Lie JT, van der Wees J, Bruinsma M, Melles GR. Standardized ‘no-touch’ donor tissue preparation for DALK and DMEK: harvesting undamaged anterior and posterior transplants from the same donor cornea. Acta Ophthalmol. 2013;91(2):145-150. (Reprinted) JAMA Ophthalmology June 2015 Volume 133, Number 6

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