Journal
JAMA OPHTHALMOLOGY
Volume 137, Issue 2, Pages 185-193Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/jamaophthalmol.2018.5669
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Funding
- National Eye Institute/National Institutes of Health [EY20797, EY20798]
- Eye Bank Association of America
- 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
- SightLife
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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/mm(2)), lower screening ECD (-234 [-331 to -137] per 500 cells/mm(2)), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm(2)), and operative complications (-324 [-516 to -133] in cells/mm(2)). 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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