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Randomized Controlled Trial
. 2015 Mar;122(3):448-56.
doi: 10.1016/j.ophtha.2014.09.012. Epub 2014 Nov 15.

The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty

Jonathan H Lass  1 , Tonya D Riddlesworth  2 , Robin L Gal  2 , Craig Kollman  2 , Beth A Benetz  3 , Francis W Price Jr  4 , Alan Sugar  5 , Mark A Terry  6 , Mark Soper  7 , Roy W Beck  2 ; Cornea Donor Study Research Group
Collaborators, Affiliations
Randomized Controlled Trial

The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty

Jonathan H Lass et al. Ophthalmology. 2015 Mar.

Abstract

Objective: To examine the long-term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PK) in the Cornea Donor Study.

Design: Multicenter, prospective, double-masked, controlled clinical trial.

Participants: One thousand ninety subjects undergoing PK for a moderate risk condition, principally Fuchs' dystrophy or pseudophakic or aphakic corneal edema, were enrolled by 105 surgeons from 80 clinical sites in the United States.

Methods: Corneas from donors 12 to 75 years of age 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 before surgery (baseline) and at intervals for 10 years after surgery and were analyzed by a central image analysis reading center to determine ECD.

Main outcome measures: 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 patients receiving a cornea from a donor with diabetes versus 26% in the 891 patients 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 groups with and without diabetes.

Conclusions: The study results do not suggest an association between donor diabetes and PK 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 PK or endothelial keratoplasty, or both, warrants further study with more precise measures of diabetes and its complications.

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Conflict of interest statement

Conflict of Interest: Francis Price, Jr., MD serves as a consultant for Allergan, Ophtec, and Staar and receives lecture fees from Alcon, Bausch & Lomb, Oculus and Santen. Mark Soper is employed by the Indiana Lions Eye & Tissue Transplant Bank. Alan Sugar received grant support from University of Michigan. Mark Terry receives educational grant support from Moria and educational grant support and royalties from Bausch & Lomb.

Figures

Figure 1
Figure 1. Graft Failure over Time According to Donor Diabetes History
The table beneath the figure presents the number of subjects at risk in the beginning of each year along with the number of graft failures, deaths, losses to follow-up, and censored subjects during the year.
Figure 2
Figure 2
Association of Donor Diabetes History and Graft Failure within Subgroups
Figure 3
Figure 3. ECD over Time According to Donor Diabetes History
In the box plot, black dots indicate mean values; horizontal lines in the boxes, medians; and the bottom and top of the boxes, the 25th and 75th percentiles.
See this image and copyright information in PMC

References

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