The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty
Jonathan H Lass, Tonya D Riddlesworth, Robin L Gal, Craig Kollman, Beth A Benetz, Francis W Price Jr, Alan Sugar, Mark A Terry, Mark Soper, Roy W Beck, Cornea Donor Study Research Group, Christopher Y Chow, Steven P Dunn, David G Heidemann, Tina MacLeod, Theresa Price, Michael W Belin, Robert L Schultze, Cassandra Semeiks, Charity Sutherland, Matthew S Oliva, Walter M Rotkis, Cindy Huddleston, Richard McDonald, Joy Taylor, David D Verdier, Paula Johnson, Jonathan H Lass, William J Reinhart, Annapurna Singh, Joseph M Thomas, Stefan D Trocme, Lauren Brown, Kristee Mines, Megin Murray, Marie Norell, Stephanie Shaffer, Kalisha Washington, Stephen M Hamilton, Gina C Jayawant, W Barry Lee, Jacqueline Larson, Melanie Simner, Robert H Gross, Edward L Shaw, Pamela Blackburn, Steven L Maskin, Eloise Eggers, Harriet Lutzk, Sherry Wagner, Brandon D Ayres, Parveen K Nagra, Irving M Raber, Joy DiCicco, Irene Spanelis-Diaz, Joel Sugar, Elmer Tu, Dolores Byrne, Mark S Gorovoy, Deborah Glinos, Robert Lehet, Bernadette Nolan, Francis J Manning, Brenda Shelly, Thomas S Boland, Stephen E Pascucci, Donna Kunz, Qais A Farjo, Roger F Meyer, Shahzad I Mian, H Kaz Soong, Alan Sugar, Munira Hussain, Jessica Knowlton, Cindy Pope, Paulina Radenbaugh, Paul G Galentine, Gerald B Rosen, David N Ugland, Mara Schafer, Sadeer B Hannush, John E Bokosky, Donna Riner, James W Caudill, Lea Coleman, Robert S Feder, Lori Kaminski, John C Affeldt, Christopher L Blanton, Monica Cancino, Edward J Holland, Amy Jost, Aimee Meyer, R Wayne Bowman, H Dwight Cavanagh, Mohamed-Sameh H El-Agha, James P McCulley, Mike Molai, Thomas E Gillette, Isabel Buchan, Michelle Corrigan, Alan B Leahey, Ann Malinowski, Christopher R Croasdale, Stephanie Blaser, Jane DeBaufer, LuAnne Moudry, Richard A Eiferman, Pamela Durham, Shannon Shields, Sarkis H Soukiasian, Ken Brown, Patti-Ann Morse, Patricia Sexton, Bhairavi K Dholakia, James B Randleman, R Doyle Stulting, Jayne Brown, Paul Larson, Donna Loupe, Walter J Stark, Kimberly Pratzer, Kenneth R Kenyon, Richard C Rodman, Kari Crompton, Walter E Beebe, Henry Gelender, Sidney Heinle, Steven S Ching, Ronald D Plotnik, Jennifer Anstey, Nancy Fedick, Peter MacDowell, Karen Skrine, Ann Stoutenburg, Marc A Goldberg, Kathy Owen, Karen Sumers, Lisa Spentz, Amanda Wykle, Kenneth C Chern, Nicoletta A Fynn-Thompson, Ann Z McColgin, Michael B Raizman, Patricia Healy, Jacqueline Pereira, Steven I Rosenfeld, Ellen Salvati, Elizabeth A Davis, David R Hardten, Richard L Lindstrom, Janet DeMarchi, Alexander Jordan, Richard Lindstrom, Sara Mork, Allison Rockvam, Mark J Mannis, Katrina Imson, Michael Saya, Marilyn Sponzo, Cindy Wallace, Jerry G Ford, David M Meisler, Laura Holody, Kendall Dobbins, Francis W Price Jr, William G Zeh, Clorissa Quillin, Peter J Berkowitz, Lori Zubik, Thomas D Lindquist, Linda Sims, Daniel F Goodman, Minah Yang, Abdulfatah M Ali, Richard F Beatty, Michaela Kavanagh, Elizabeth Salinas, Jackie Varela, John E Sutphin, Ayad A Farjo, Kenneth M Goins, Connie Mullinnix, Terry E Burris, Desiree Crowell, Susan Johnson, Dawn Kerns, Jenni Powell, Portia Swenson, Peter A Shriver, Dennis Williams, Kelly Perry, Monica Wells, Cynthia A Self, Garth A Wilbanks, Courtney Chute, Cheryl Hart, Roy S Chuck, Ronald N Gaster, Michael Bradley, Winston Chamberlain, Andre Cohen, Kouroush Eghbali, Marjan Farid, Sumit Garg, Jeff Grijalva, Whitney Lomazow, David W Kielty, Garvin H Davis, J Mike Bourg, Rhonda Nolen, Teresa Solis, Woodford S Van Meter, Jane Webb, Patricia W Smith, Robin Bradshaw, Tineta Mewborn, Jorge Sanchez, Alan R Schaeffer, Chasity Owens, Charlisha Price, Elisabeth J Cohen, Peter R Laibson, Christopher J Rapuano, Andrea Gardiner, Keith H Baratz, Barton Halpern, Mark A Pavilack, Gerald B Rosen, Donald J Doughman, Stephen C Kaufman, Sally Cook, Ann Holleschau, Theodore Perl, Soo Mee Pak, Angelina Fornelos, John W Cowden, Sue Mussatt, Elliot M Perlman, Joanie Cozzo, Margaret Gallagher-Sylvia, Lance E Olson, Erik D Skoog, Elaine Dobbs, William D Gruzensky, Erich B Groos Jr, Denise Alexander, Mark D Mifflin, Maureen K Lundergan, Deborah Harrison, Steven T Berger, Sandy Hyszczak, Kerry D Solomon, Carol Bradham, Richard F Dennis, Jonathan B Rubenstein, Sarah Levine, Heena Khan, Nisha Sheth, Denise Voskull-Marre, Alexandra M P Kostick, Samuel H Santander, Allen S Roth, Laura A Bealer, Jonathan I Macy, David G O'Day, Linda Maynard, Mark A Terry, Nunzio P Sossi, Keith A Walter, Joan Fish, Jonathan H Lass, Tonya D Riddlesworth, Robin L Gal, Craig Kollman, Beth A Benetz, Francis W Price Jr, Alan Sugar, Mark A Terry, Mark Soper, Roy W Beck, Cornea Donor Study Research Group, Christopher Y Chow, Steven P Dunn, David G Heidemann, Tina MacLeod, Theresa Price, Michael W Belin, Robert L Schultze, Cassandra Semeiks, Charity Sutherland, Matthew S Oliva, Walter M Rotkis, Cindy Huddleston, Richard McDonald, Joy Taylor, David D Verdier, Paula Johnson, Jonathan H Lass, William J Reinhart, Annapurna Singh, Joseph M Thomas, Stefan D Trocme, Lauren Brown, Kristee Mines, Megin Murray, Marie Norell, Stephanie Shaffer, Kalisha Washington, Stephen M Hamilton, Gina C Jayawant, W Barry Lee, Jacqueline Larson, Melanie Simner, Robert H Gross, Edward L Shaw, Pamela Blackburn, Steven L Maskin, Eloise Eggers, Harriet Lutzk, Sherry Wagner, Brandon D Ayres, Parveen K Nagra, Irving M Raber, Joy DiCicco, Irene Spanelis-Diaz, Joel Sugar, Elmer Tu, Dolores Byrne, Mark S Gorovoy, Deborah Glinos, Robert Lehet, Bernadette Nolan, Francis J Manning, Brenda Shelly, Thomas S Boland, Stephen E Pascucci, Donna Kunz, Qais A Farjo, Roger F Meyer, Shahzad I Mian, H Kaz Soong, Alan Sugar, Munira Hussain, Jessica Knowlton, Cindy Pope, Paulina Radenbaugh, Paul G Galentine, Gerald B Rosen, David N Ugland, Mara Schafer, Sadeer B Hannush, John E Bokosky, Donna Riner, James W Caudill, Lea Coleman, Robert S Feder, Lori Kaminski, John C Affeldt, Christopher L Blanton, Monica Cancino, Edward J Holland, Amy Jost, Aimee Meyer, R Wayne Bowman, H Dwight Cavanagh, Mohamed-Sameh H El-Agha, James P McCulley, Mike Molai, Thomas E Gillette, Isabel Buchan, Michelle Corrigan, Alan B Leahey, Ann Malinowski, Christopher R Croasdale, Stephanie Blaser, Jane DeBaufer, LuAnne Moudry, Richard A Eiferman, Pamela Durham, Shannon Shields, Sarkis H Soukiasian, Ken Brown, Patti-Ann Morse, Patricia Sexton, Bhairavi K Dholakia, James B Randleman, R Doyle Stulting, Jayne Brown, Paul Larson, Donna Loupe, Walter J Stark, Kimberly Pratzer, Kenneth R Kenyon, Richard C Rodman, Kari Crompton, Walter E Beebe, Henry Gelender, Sidney Heinle, Steven S Ching, Ronald D Plotnik, Jennifer Anstey, Nancy Fedick, Peter MacDowell, Karen Skrine, Ann Stoutenburg, Marc A Goldberg, Kathy Owen, Karen Sumers, Lisa Spentz, Amanda Wykle, Kenneth C Chern, Nicoletta A Fynn-Thompson, Ann Z McColgin, Michael B Raizman, Patricia Healy, Jacqueline Pereira, Steven I Rosenfeld, Ellen Salvati, Elizabeth A Davis, David R Hardten, Richard L Lindstrom, Janet DeMarchi, Alexander Jordan, Richard Lindstrom, Sara Mork, Allison Rockvam, Mark J Mannis, Katrina Imson, Michael Saya, Marilyn Sponzo, Cindy Wallace, Jerry G Ford, David M Meisler, Laura Holody, Kendall Dobbins, Francis W Price Jr, William G Zeh, Clorissa Quillin, Peter J Berkowitz, Lori Zubik, Thomas D Lindquist, Linda Sims, Daniel F Goodman, Minah Yang, Abdulfatah M Ali, Richard F Beatty, Michaela Kavanagh, Elizabeth Salinas, Jackie Varela, John E Sutphin, Ayad A Farjo, Kenneth M Goins, Connie Mullinnix, Terry E Burris, Desiree Crowell, Susan Johnson, Dawn Kerns, Jenni Powell, Portia Swenson, Peter A Shriver, Dennis Williams, Kelly Perry, Monica Wells, Cynthia A Self, Garth A Wilbanks, Courtney Chute, Cheryl Hart, Roy S Chuck, Ronald N Gaster, Michael Bradley, Winston Chamberlain, Andre Cohen, Kouroush Eghbali, Marjan Farid, Sumit Garg, Jeff Grijalva, Whitney Lomazow, David W Kielty, Garvin H Davis, J Mike Bourg, Rhonda Nolen, Teresa Solis, Woodford S Van Meter, Jane Webb, Patricia W Smith, Robin Bradshaw, Tineta Mewborn, Jorge Sanchez, Alan R Schaeffer, Chasity Owens, Charlisha Price, Elisabeth J Cohen, Peter R Laibson, Christopher J Rapuano, Andrea Gardiner, Keith H Baratz, Barton Halpern, Mark A Pavilack, Gerald B Rosen, Donald J Doughman, Stephen C Kaufman, Sally Cook, Ann Holleschau, Theodore Perl, Soo Mee Pak, Angelina Fornelos, John W Cowden, Sue Mussatt, Elliot M Perlman, Joanie Cozzo, Margaret Gallagher-Sylvia, Lance E Olson, Erik D Skoog, Elaine Dobbs, William D Gruzensky, Erich B Groos Jr, Denise Alexander, Mark D Mifflin, Maureen K Lundergan, Deborah Harrison, Steven T Berger, Sandy Hyszczak, Kerry D Solomon, Carol Bradham, Richard F Dennis, Jonathan B Rubenstein, Sarah Levine, Heena Khan, Nisha Sheth, Denise Voskull-Marre, Alexandra M P Kostick, Samuel H Santander, Allen S Roth, Laura A Bealer, Jonathan I Macy, David G O'Day, Linda Maynard, Mark A Terry, Nunzio P Sossi, Keith A Walter, Joan Fish
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.
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.
Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Source: PubMed