; for the Cornea Preservation Time Study Group IMPORTANCE Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. OBJECTIVE To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). INTERVENTIONS Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Graft success at 3 years. RESULTS Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). CONCLUSIONS AND RELEVANCE The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01537393

Purpose Describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS). Methods The CPTS is a randomized, clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs’ dystrophy (FECD) or pseudophakic bullous keratopathy were randomized to receive donor corneas stored ≤7 days or 8–14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor cornea stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices. Results The 1,330 CPTS donors were: 49% >60 years old, 27% diabetic, a median eye bank-determined screening ECD of 2,688 cells/mm2, and 74% eye-bank-prepared for DSAEK. 1,090 recipients (1,330 eyes including 240 bilateral cases) had: median age of 70 years, 60% female, 90% Caucasian, 18% diabetic, 52% phakic, and 94% with FECD. Prior to the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010–11; 96% were preserved ≤ 7 days. Of 305 AAO members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less. Conclusions The CPTS will increase understanding of factors related to DSAEK success and, if non-inferiority of longer PT is shown, will have a great potential to extend the available pool of endothelial keratoplasty donors.

for the Cornea Preservation Time Study Group IMPORTANCE Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty.OBJECTIVE To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT. DESIGN, SETTING, AND PARTICIPANTSA multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96% of the cohort). The study was conducted from April 16, 2012, to June 5, 2017.INTERVENTIONS DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images.RESULTS Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8% women, 93.0% white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK were included. At the initial eye bank tissue screening, mean (SD) central ECD was 2746 (297) cells/mm 2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm 2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37% (21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm 2 and 1642 (631) cells/mm 2 , respectively (mean difference, 73 cells/mm 2 ; 95% CI, 8-138 cells/mm 2 ; P = .03). When analyzed as a continuous variable (days), longer PT was associated with lower ECD (mean difference by days, 15 cells/mm 2 ; 95% CI, 4-26 cells/mm 2 ; P = .006). Endothelial cell loss (ECL) was comparable from 4 to 13 days' PT (n = 878; 36%-43% when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm 2 and mean [SD] ECL, 41% [23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm 2 and mean [SD] ECL, 44% [23%]) (mean difference, 112 cells/mm 2 ; 95% CI, 5-219 cells/mm 2 ; P = .04).CONCLUSIONS AND RELEVANCE Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days' PT. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01537393

To determine how donor health status affects the risk of infection after corneal transplant.Methods: An adverse reaction surveillance registry was used to conduct a matched case-control study among transplanted donor corneas from January 1, 1994, to December 31, 2003. Cases comprised 162 reports of endophthalmitis after penetrating keratoplasty including 121 with microbial recovery, of which 59 had concordant donor and recipient microbial isolates. Two controls were matched to each case by surgery date. Conditional logistic regression estimated adjusted odds ratios with 95% confidence intervals according to the premortem status of decedent donors.Results: Postkeratoplasty endophthalmitis was associated with recent hospitalization (odds ratio, 2.84; 95% confidence interval, 1.61-4.98) and fatal cancer (odds ra-

Purpose: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. Design: Cohort study within a multi-center, double-masked, randomized clinical trial. Methods: 1,090 individuals (1,330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N=675) or 8-14 days (N=655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre-and post-operative IOP. Pre-and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and {99% confidence intervals}. Results: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio {OR}: 2.29 {1.30, 4.02}), increased pre-lamellar dissection central corneal thickness (OR: 1.13 {1.01, 1.27} per 25μ increase), and operative complications (OR: 2.97 {1.24, 7.11}). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 Aldave et al.