TY - JOUR
T1 - Real-World Outcomes of DMEK: A Prospective Dutch registry study
AU - Dunker, Suryan L.
AU - Veldman, Manon H. J.
AU - Winkens, Bjorn
AU - van den Biggelaar, Frank J. H. M.
AU - Nuijts, Rudy M. M. A.
AU - Dutch Cornea Consortium
AU - Kruit, Pieter Jan
AU - Dickman, Mor M.
N1 - Funding Information: All authors have completed and submitted the ICMJE form for Disclosure of Potential Conflicts of Interest and none were reported. Funding/Support: None. Financial disclosures: R.M.M.A.N. is a consultant for Alcon, Asico, and Th?aPharma; and has received research support from Acufocus, Alcon, Bausch & Lomb, HumanOptics, and Ophtec; and has received lecture fees from Alcon. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The authors thank Cynthia Konijn, Dutch Transplant Foundation, for processing data application and members of the Dutch Corneal Workgroup for their dedication and precise data registration. The authors acknowledge the Dutch Cornea Consortium (excluding writing committee): Marjolijn C. Bartels, MD, PhD; Yanny Y. Cheng, MD, PhD; Bart T.H. van Dooren, MD, PhD; Cathrien A. Eggink, MD, PhD; Annette J.M. Geerards, MD; Tom A. van Goor, MD; Ype P. Henry, MD; Ruth Lapid-Gortzak, MD, PhD; Chantal M. van Luijk, MD; Ivanka J. van der Meulen, MD, PhD; Carla P. Nieuwendaal, MD; SiamakNobacht, MD; Monica T.P. Odenthal, MD, PhD; Lies Remeijer, MD, PhD; Jeroen van Rooij, MD; Nathalie T.Y. Santana, MD, PhD; Remco Stoutenbeek, MD, PhD; Mei L. Tang, MD; ThijsVaessen, MD; NienkeVisser, MD, PhD; Robert H.J. Wijdh, MD; Robert P.L. Wisse, MD, PhD; and Michel J.W. Zaal, MD, PhD. Publisher Copyright: © 2020 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Purpose: This study analyzed real-world practice patterns, graft survival, and outcomes of Descemet membrane endothelial keratoplasty (DMEK) in the Netherlands. Design: Population-based interventional clinical study. Methods: In this prospective registry study, all consecutive primary DMEK procedures registered in the Netherlands Organ Transplant Registry were identified. Short-term graft survival and outcomes of primary transplants for Fuchs' endothelial dystrophy (FED) were analyzed using Kaplan-Meier survival curves with log-rank test and Cox regression. Linear mixed model analyses were used for best spectacle-corrected visual acuity (BSCVA), spherical equivalent, hyperopic shift, and endothelial cell density. Results: 752 DMEKs were identified between 2011 and 2018. In 90% of cases, the indication for DMEK was FED. Graft survival measured 87% at 3 months, 85% at 6 months, 85% at 1 year, and 78% at 2 years. DMEK procedures after 2015 showed better survival compared to previous years (Hazard ratio = 0.4; P < .001). Baseline BSCVA in primary transplants with FED measured on average 0.45 logarithm of the minimum angle of resolution (logMAR) (95% confidence interval [CI], 0.41-0.49), and significantly improved (overall P < .001) to 0.17 logMAR (95% CI, 0.14-0.21) at 3 months, 0.15 logMAR (95% CI, 0.11-0.18) at 6 months, 0.12 logMAR (95% CI, 0.08-0.16) at 1 year, and 0.08 (95% CI, 0.05-0.12) at 2 years. At 3 months, a hyperopic shift of +0.36 diopters (P < .001) was observed and endothelial cell loss measured 33%. Conclusion: Our findings provide real-world support that DMEK is an effective treatment for FED with respect to vision restoration, inducing a small hyperopic shift with an acceptable endothelial cell loss. Graft survival improved over time, suggesting a learning curve on a national level.
AB - Purpose: This study analyzed real-world practice patterns, graft survival, and outcomes of Descemet membrane endothelial keratoplasty (DMEK) in the Netherlands. Design: Population-based interventional clinical study. Methods: In this prospective registry study, all consecutive primary DMEK procedures registered in the Netherlands Organ Transplant Registry were identified. Short-term graft survival and outcomes of primary transplants for Fuchs' endothelial dystrophy (FED) were analyzed using Kaplan-Meier survival curves with log-rank test and Cox regression. Linear mixed model analyses were used for best spectacle-corrected visual acuity (BSCVA), spherical equivalent, hyperopic shift, and endothelial cell density. Results: 752 DMEKs were identified between 2011 and 2018. In 90% of cases, the indication for DMEK was FED. Graft survival measured 87% at 3 months, 85% at 6 months, 85% at 1 year, and 78% at 2 years. DMEK procedures after 2015 showed better survival compared to previous years (Hazard ratio = 0.4; P < .001). Baseline BSCVA in primary transplants with FED measured on average 0.45 logarithm of the minimum angle of resolution (logMAR) (95% confidence interval [CI], 0.41-0.49), and significantly improved (overall P < .001) to 0.17 logMAR (95% CI, 0.14-0.21) at 3 months, 0.15 logMAR (95% CI, 0.11-0.18) at 6 months, 0.12 logMAR (95% CI, 0.08-0.16) at 1 year, and 0.08 (95% CI, 0.05-0.12) at 2 years. At 3 months, a hyperopic shift of +0.36 diopters (P < .001) was observed and endothelial cell loss measured 33%. Conclusion: Our findings provide real-world support that DMEK is an effective treatment for FED with respect to vision restoration, inducing a small hyperopic shift with an acceptable endothelial cell loss. Graft survival improved over time, suggesting a learning curve on a national level.
UR - http://www.scopus.com/inward/record.url?scp=85096662162&partnerID=8YFLogxK
UR - https://research.vumc.nl/ws/files/18818330/1_s2.0_S0002939420303196_main.pdf
U2 - https://doi.org/10.1016/j.ajo.2020.06.023
DO - https://doi.org/10.1016/j.ajo.2020.06.023
M3 - Article
C2 - 32621899
SN - 0002-9394
VL - 222
SP - 218
EP - 225
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
M1 - 222
ER -