Objective To examine the long term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PKP) in the Cornea Donor Study Design Multi-center prospective, double-masked, controlled clinical trial Participants 1090 subjects undergoing PKP for a moderate risk condition, principally Fuchs’ dystrophy or pseudophakic/aphakic corneal edema (PACE), were enrolled by 105 surgeons from 80 clinical sites in the United States. Methods Corneas from donors 12 to 75 years old were assigned by 43 eye banks to participants without respect to recipient factors. Donor and recipient diabetes status was determined from existing medical records. Images of the central endothelium were obtained preoperatively (baseline) and at intervals for ten years postoperatively and analyzed by a central image analysis reading center to determine ECD. Main Outcome Measure(s) Time to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD. Results There was no statistically significant association of donor diabetes history with 10-year graft failure, baseline ECD, 10-year ECD or ECD values longitudinally over time in unadjusted analyses nor after adjusting for donor age and other significant covariates. The 10-year graft failure rate was 23% in the 199 cases receiving a cornea from a donor with diabetes versus 26% in the 891 cases receiving a cornea from a donor without diabetes (95% confidence interval for the difference: −10% to +6%; unadjusted p = 0.60). Baseline ECD (p=0.71), 10-year ECD (p>0.99), and changes in ECD over 10 years (p=0.86) were similar comparing donor diabetes and no-diabetes groups. Conclusions and Relevance The study results do not suggest an association between donor diabetes and PKP outcome. However, the assessment of donor diabetes was imprecise and based on historical data only. The increasing frequency of diabetes in the aging population in the United States affects the donor pool, thus the impact of donor diabetes on long term endothelial health after penetrating and/or endothelial keratoplasty warrants further study with more precise measures of diabetes and its complications. Trial Registration clinicaltrials.gov NCT00006411

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These results support the hypothesis that preconditioning by hypoxia or exposure to FG-4592 improves corneal endothelial cell survival and may also provide protection during surgical trauma.

Purpose: To describe a technique that ensures the production of a type 1 bubble when preparing pre-Descemet endothelial keratoplasty (PDEK) grafts with a high rate of predictability. Methods: Donor corneas were placed on a support disc, and a blunt instrument was used to score 360 degrees of the peripheral Descemet membrane and endothelium just inside the trabecular meshwork. Air was injected in several short bursts and several stages with a 30-gauge needle on a 3-mL syringe 2.0 mm away from the limbus to create a type 1 big bubble. The technique was tested by 2 operators (M.S. and A.S.-J.) in 26 human donor corneas, including 12 for possible transplantation, over a 9-month period. Anterior segment optical coherence tomograph (AS-OCT) was performed in 1 case proving a type 1 bubble. Results: A type 1 big bubble was successfully created in 24 of 26 attempted cases (92.3%). The technique was used successfully to obtain PDEK tissue for transplant in 9 eyes. One case was not technically acceptable because of diffuse cell loss (>10%); however, the bubble preparation itself was successful. One case had a mixed bubble because of incomplete scoring, resulting in a Descemet membrane endothelial keratoplasty graft used for transplant. One case failed to form any bubble likely because the scoring was too central. Of a total of 26 cases, 14 cases were for practice. Conclusions: The Soper technique significantly improved the success rate of creating a type 1 bubble for PDEK preparation.

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