No abstract

Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.

; 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.