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Ophthalmology. 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.

Collaborators (260)

Chow CY, Dunn SP, Heidemann DG, MacLeod T, Price T, Belin MW, Schultze RL, Semeiks C, Sutherland C, Oliva MS, Rotkis WM, Huddleston C, McDonald R, Taylor J, Verdier DD, Johnson P, Lass JH, Reinhart WJ, Singh A, Thomas JM, Trocme SD, Brown L, Mines K, Murray M, Norell M, Shaffer S, Washington K, Hamilton SM, Jayawant GC, Lee WB, Larson J, Simner M, Gross RH, Shaw EL, Blackburn P, Maskin SL, Eggers E, Lutzk H, Wagner S, Ayres BD, Nagra PK, Raber IM, DiCicco J, Spanelis-Diaz I, Sugar J, Tu E, Byrne D, Gorovoy MS, Glinos D, Lehet R, Nolan B, Manning FJ, Shelly B, Boland TS, Pascucci SE, Kunz D, Farjo QA, Meyer RF, Mian SI, Soong HK, Sugar A, Hussain M, Knowlton J, Pope C, Radenbaugh P, Galentine PG, Rosen GB, Ugland DN, Schafer M, Hannush SB, Bokosky JE, Riner D, Caudill JW, Coleman L, Feder RS, Kaminski L, Affeldt JC, Blanton CL, Cancino M, Holland EJ, Jost A, Meyer A, Bowman RW, Cavanagh HD, El-Agha MS, McCulley JP, Molai M, Gillette TE, Buchan I, Corrigan M, Leahey AB, Malinowski A, Croasdale CR, Blaser S, DeBaufer J, Moudry L, Eiferman RA, Durham P, Shields S, Soukiasian SH, Brown K, Morse PA, Sexton P, Dholakia BK, Randleman JB, Stulting RD, Brown J, Larson P, Loupe D, Stark WJ, Pratzer K, Kenyon KR, Rodman RC, Crompton K, Beebe WE, Gelender H, Heinle S, Ching SS, Plotnik RD, Anstey J, Fedick N, MacDowell P, Skrine K, Stoutenburg A, Goldberg MA, Owen K, Sumers K, Spentz L, Wykle A, Chern KC, Fynn-Thompson NA, McColgin AZ, Raizman MB, Healy P, Pereira J, Rosenfeld SI, Salvati E, Davis EA, Hardten DR, Lindstrom RL, DeMarchi J, Jordan A, Lindstrom R, Mork S, Rockvam A, Mannis MJ, Imson K, Saya M, Sponzo M, Wallace C, Ford JG, Meisler DM, Holody L, Dobbins K, Price FW Jr, Zeh WG, Quillin C, Berkowitz PJ, Zubik L, Lindquist TD, Sims L, Goodman DF, Yang M, Ali AM, Beatty RF, Kavanagh M, Salinas E, Varela J, Sutphin JE, Farjo AA, Goins KM, Mullinnix C, Burris TE, Crowell D, Johnson S, Kerns D, Powell J, Swenson P, Shriver PA, Williams D, Perry K, Wells M, Self CA, Wilbanks GA, Chute C, Hart C, Chuck RS, Gaster RN, Bradley M, Chamberlain W, Cohen A, Eghbali K, Farid M, Garg S, Grijalva J, Lomazow W, Kielty DW, Davis GH, Bourg JM, Nolen R, Solis T, Van Meter WS, Webb J, Smith PW, Bradshaw R, Mewborn T, Sanchez J, Schaeffer AR, Owens C, Price C, Cohen EJ, Laibson PR, Rapuano CJ, Gardiner A, Baratz KH, Halpern B, Pavilack MA, Rosen GB, Doughman DJ, Kaufman SC, Cook S, Holleschau A, Perl T, Pak SM, Fornelos A, Cowden JW, Mussatt S, Perlman EM, Cozzo J, Gallagher-Sylvia M, Olson LE, Skoog ED, Dobbs E, Gruzensky WD, Groos EB Jr, Alexander D, Mifflin MD, Lundergan MK, Harrison D, Berger ST, Hyszczak S, Solomon KD, Bradham C, Dennis RF, Rubenstein JB, Levine S, Khan H, Sheth N, Voskull-Marre D, Kostick AM, Santander SH, Roth AS, Bealer LA, Macy JI, O'Day DG, Maynard L, Terry MA, Sossi NP, Walter KA, Fish J.

Author information

Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio. Electronic address:
Jaeb Center for Health Research, Tampa, Florida.
Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio.
Price Vision Group, Indianapolis, Indiana.
W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.
Devers Eye Institute, Portland, Oregon.
Indiana Lions Eye Bank, Indianapolis, Indiana.



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.


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


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.


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.


Time to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD.


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.


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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