title: The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty.
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.
  
  
  METHODS
  Multicenter, prospective, double-masked, controlled clinical trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio. Electronic address: cds@jaeb.org.
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Lass
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Tonya D
authors.initials: TD
authors.lastname: Riddlesworth
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Gal
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Benetz
authors.affiliation: Price Vision Group, Indianapolis, Indiana.
authors.forename: Francis W
authors.initials: FW
authors.lastname: Price
authors.affiliation: W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.
authors.forename: Alan
authors.initials: A
authors.lastname: Sugar
authors.affiliation: Devers Eye Institute, Portland, Oregon.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Terry
authors.affiliation: Indiana Lions Eye Bank, Indianapolis, Indiana.
authors.forename: Mark
authors.initials: M
authors.lastname: Soper
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002452:Cell Count; D002648:Child; D003316:Corneal Diseases / Q000601:surgery; D055954:Corneal Endothelial Cell Loss / Q000175:diagnosis / Q000209:etiology*; D048909:Diabetes Complications; D004311:Double-Blind Method; D004728:Endothelium, Corneal / Q000473:pathology*; D005125:Eye Banks; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000209:etiology*; D006801:Humans; D015948:Keratoplasty, Penetrating; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D014019:Tissue Donors / Q000706:statistics & numerical data*