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Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

Educational Objective
To evaluate the associations of donor, recipient, and operative factors with endothelial cell density 3 years after Descemet stripping automated endothelial keratoplasty in the Cornea Preservation Time Study.
1 Credit CME
Key Points

Question  What donor, recipient, and operative factors are associated with endothelial cell density 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study cohort?

Findings  In this study, donors with diabetes, diagnosis of pseudophakic/aphakic corneal edema in the recipient, and operative complications were associated with lower endothelial cell density at 3 years.

Meaning  Optimizing donor selection and minimizing surgical trauma could help minimize endothelial cell loss and improve graft survival after DSAEK. Mechanisms whereby corneal tissue from diabetes in donors and pseudophakic/aphakic corneal edema in recipients affect endothelial cell density warrant further study.

Abstract

Importance  Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival.

Objective  To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study.

Design, Setting, and Participants  This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included.

Interventions  The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days.

Main Outcomes and Measures  Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images.

Results  The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (−103 [−196 to −9] cells/mm2), lower screening ECD (−234 [−331 to −137] per 500 cells/mm2), recipient diagnosis of PACE (−257 [−483 to −31] in cells/mm2), and operative complications (−324 [−516 to −133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD.

Conclusions and Relevance  Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.

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Article Information

Corresponding Author: Jonathan H. Lass, MD, University Hospitals Cleveland Medical Center, 11100 Euclid Ave, Cleveland, OH 44106 (jonathan.lass@uhhospitals.org).

Accepted for Publication: September 26, 2018.

Correction: This article was corrected on December 13, 2018, to correct a P value in the Table. The P value for the Multivariable Model in the Diabetic donor row was presented as .01 but should be .005. The error has been corrected.

Published Online: October 26, 2018. doi:10.1001/jamaophthalmol.2018.5669

Author Contributions: Dr Lass and Ms Ayala had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lass, Benetz, Patel, Szczotka- Flynn, O'Brien, Maguire, Ayala.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Lass, Benetz, Patel, Szczotka-Flynn, O'Brien.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: O'Brien, Maguire.

Obtained funding: Lass, Ayala.

Administrative, technical, or material support: All authors.

Study supervision: Lass, Benetz, Patel, Szczotka-Flynn, Ayala.

Conflict of Interest Disclosures: Drs Terry and Lee report financial relationships with Bausch & Lomb, which manufactures corneal storage solutions (considered relevant to this work). Dr Terry reports receiving royalties for endothelial keratoplasty surgical instruments and educational grants. Dr Lee reports receiving speaker’s bureau fees. No other disclosures were reported.

Funding/Support: This study was supported by cooperative agreements with the National Eye Institute/National Institutes of Health(grants EY20797 and EY20798). Additional support was provided by Eye Bank Association of America, The Cornea Society, Vision Share, Inc, Alabama Eye Bank, Cleveland Eye Bank Foundation, Eversight, Eye Bank for Sight Restoration, Iowa Lions Eye Bank, Lions Eye Bank of Albany, San Diego Eye Bank, and SightLife.

Role of the Funder/Sponsor: The National Eye Institute had roles in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. The other sponsors had no role in the design and conduct of the study; management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication, but provided additional support for ancillary work pertaining to this study.

Group Members: The Cornea Preservation Time Study Group members are as follows: Operations Committee: Jonathan Lass, MD; Allison Ayala, MS; Beth Ann Benetz, MA; Loretta Szczotka-Flynn, OD, PhD; Roy Beck, MD, PhD; Robin Gal, MSPH; and Maryann Redford, DDS, MPH. Executive Committee: Operations Committee as well as Anthony J. Aldave, MD; Steven P. Dunn, MD; Ty L. McCall, MD; Lisa Navarro; Sudeep Pramanik, MD; Kevin W. Ross, MS, MPH; George O. Rosenwasser, MD; Mark A. Terry, MD; and David T. Verdier, MD; Eye Bank Advisory Committee: Kevin W. Ross, MS MPH (chair); Patricia Dahl, BS; Donna C. Drury, BS, MBA; Sameera M. Farazdaghi, BS, MPH; Caroline K. Hoover, CEBT; Jeffery G. Penta, AS, BS, MBA; Mark C. Soper BS, CEBT; Chris G. Stoeger, CEBT, MBA; Doyce V. Williams, CEBT, CTBS, BS, MA; Data and Safety Monitoring Committee: David C. Musch, PhD, MPH (DSMC chair), William Bourne, MD, Kathryn A. Colby, MD, PhD, Marian Fisher, PhD, Rabbi Samuel Fishman, Maryann Redford, DDS, MPH; Clinical Site Principal Investigators: Anthony Aldave, MD; Gregg Berdy, MD; John Bokosky, MD; Christopher Croasdale, MD; Yassine Daoud, MD; Steven Dunn, MD; Thomas Gillette, MD; Kenneth Goins, MD; Pankaj Gupta, MD; Kristen Hammersmith, MD; Sadeer Hannush, MD; David Hardten, MD; Bennie Jeng, MD; Marc Jones, MD; William Lahners, MD; W. Barry Lee, MD; Marian Macsai, MD; Thomas Mauger, MD; Kenneth Maverick, MD; Tyrone McCall, MD; Woodford Van Meter, MD; Shahzad Mian, MD; Mark Mifflin, MD; Verinder Nirankari, MD; Michael Nordlund, MD, PhD; Matthew Oliva, MD; Sanjay Patel, MD; Sudeep Pramanik, MD; Irving Raber, MD; Michael Raizman, MD; Jennifer Rose-Nussbaumer, MD; George Rosenwasser, MD; Robert Schultze, MD; John Seedor, MD; Neda Shamie, MD; Jonathan Song, MD; Walter Stark, MD; R. Doyle Stulting, MD, PhD; Alan Sugar, MD; Shachar Tauber, MD; Mark Terry, MD; Kristina Thomas, MD; Elmer Tu, MD; David Verdier, MD; and Sonia Yoo, MD. Eye Bank Principal Investigators: Victoria Adler, RN, BSN, CPTC, CEBT; Wilfred Caraballo; Patricia Dahl, BS; Gregory Dorn, CEBT; Donna Drury, BS, MBA; Sameera Farazdaghi, BS, MPH; Elizabeth Fout-Caraza, MHSA; Patrick Gore, RN, CEBT; Veronique Grimes, COMT, CEBT; Caroline Hoover, CEBT; Debora Van Klinken, CEBT; Nai Liang, CEBT; Tina Mays, CEBT; Kristen McCoy, BS; Wade McEntire, MPH; Eric Meinecke, BA; Jeffrey Penta, AS, BS, MBA; Kevin Ross, MS, MPH; Mikelanne Schipper; Gregory Schmidt, BS, CEBT; Chris Stoeger, CEBT, MBA; Michael Tramber, MBA, BS, CEBT, CTBS.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Eye Institute or the National Institutes of Health.

Meeting Presentation: This paper was presented at the Cornea and Eye Banking Forum; October 26, 2018; Chicago, Illinois.

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