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JAMA Ophthalmol. 2018 Oct 26. doi: 10.1001/jamaophthalmol.2018.5669. [Epub ahead of print]

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

Author information

1
Cornea Image Analysis Reading Center, Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, Case Western Reserve University, Cleveland, Ohio.
2
Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
3
Jaeb Center for Health Research, Tampa, Florida.
4
Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
5
The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
6
University of Iowa Hospitals and Clinics, Iowa City.
7
Sadeer Hannush, P. C., Langhorne, Pennsylvania.
8
Eye Consultants of Atlanta, Atlanta, Georgia.
9
The Ohio State University Wexner Medical Center-Havener Eye Institute, Columbus.
10
Moran Eye Center, University of Utah, Salt Lake City.
11
Ophthalmic Consultants of Boston, Boston, Massachusetts.
12
University of California, San Francisco.
13
Cornea Consultants of Albany, Slingerlands, New York.
14
Iowa Lions Eye Bank, Iowa City.
15
Kellogg Eye Center, University of Michigan, Ann Arbor.
16
Devers Eye Institute, Portland, Oregon.
17
Verdier Eye Center, Grand Rapids, Michigan.

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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