Jonathan H Lass1, Tonya D Riddlesworth2, Robin L Gal2, Craig Kollman2, Beth A Benetz3, Francis W Price4, Alan Sugar5, Mark A Terry6, Mark Soper7, Roy W Beck2. 1. Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio. Electronic address: cds@jaeb.org. 2. Jaeb Center for Health Research, Tampa, Florida. 3. Case Western Reserve University, Department of Ophthalmology and Visual Sciences, and University Hospitals Eye Institute, Cleveland, Ohio. 4. Price Vision Group, Indianapolis, Indiana. 5. W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. 6. Devers Eye Institute, Portland, Oregon. 7. Indiana Lions Eye Bank, Indianapolis, Indiana.
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.
RCT Entities:
OBJECTIVE: To examine the long-term effect of donordiabetes 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 donordiabetes 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 donordiabetes and PK outcome. However, the assessment of donordiabetes 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 donordiabetes 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: Jonathan H Lass; Robin L Gal; Mariya Dontchev; Roy W Beck; Craig Kollman; Steven P Dunn; Ellen Heck; Edward J Holland; Mark J Mannis; Monty M Montoya; Robert L Schultze; R Doyle Stulting; Alan Sugar; Joel Sugar; Bradley Tennant; David D Verdier Journal: Ophthalmology Date: 2008-04 Impact factor: 12.079
Authors: Mark A Greiner; Jordan J Rixen; Michael D Wagoner; Gregory A Schmidt; Christopher G Stoeger; Michael D Straiko; M Bridget Zimmerman; Anna S Kitzmann; Kenneth M Goins Journal: Cornea Date: 2014-11 Impact factor: 2.651
Authors: Jonathan H Lass; Beth Ann Benetz; Robin L Gal; Craig Kollman; Dan Raghinaru; Mariya Dontchev; Mark J Mannis; Edward J Holland; Christopher Chow; Kristen McCoy; Francis W Price; Alan Sugar; David D Verdier; Roy W Beck Journal: Ophthalmology Date: 2013-12 Impact factor: 12.079
Authors: Joel Sugar; Monty Montoya; Mariya Dontchev; Jean Paul Tanner; Roy Beck; Robin Gal; Shawn Gallagher; Ronald Gaster; Ellen Heck; Edward J Holland; Craig Kollman; Jackie Malling; Mark J Mannis; Jason Woody Journal: Cornea Date: 2009-10 Impact factor: 2.651
Authors: Mark A Terry; Anthony J Aldave; Loretta B Szczotka-Flynn; Wendi Liang; Allison R Ayala; Maureen G Maguire; Christopher Croasdale; Yassine J Daoud; Steven P Dunn; Caroline K Hoover; Marian S Macsai; Thomas F Mauger; Sudeep Pramanik; George O D Rosenwasser; Jennifer Rose-Nussbaumer; R Doyle Stulting; Alan Sugar; Elmer Y Tu; David D Verdier; Sonia H Yoo; Jonathan H Lass Journal: Ophthalmology Date: 2018-08-09 Impact factor: 12.079
Authors: Yicheng Chen; Sean W Tsao; Moonseong Heo; Patrick K Gore; Mitchell D McCarthy; Roy S Chuck; Prabjot Channa Journal: Cornea Date: 2017-03 Impact factor: 2.651
Authors: Anthony J Aldave; Mark A Terry; Loretta B Szczotka-Flynn; Wendi Liang; Allison R Ayala; Maureen G Maguire; Robert C O'Brien; Beth Ann Benetz; John E Bokosky; Steven P Dunn; Thomas E Gillette; Kristin M Hammersmith; David R Hardten; Bennie H Jeng; Marc F Jones; Richard L Lindstrom; Kenneth J Maverick; Verinder S Nirankari; Matthew S Oliva; Irving M Raber; Christopher J Rapuano; George O D Rosenwasser; Kevin W Ross; John W Seedor; Neda Shamie; Christopher G Stoeger; Shachar Tauber; Woodford S Van Meter; David D Verdier; Jonathan H Lass Journal: Am J Ophthalmol Date: 2019-03-06 Impact factor: 5.258
Authors: Jonathan H Lass; Beth Ann Benetz; Sanjay V Patel; Loretta B Szczotka-Flynn; Robert O'Brien; Allison R Ayala; Maureen G Maguire; Yassine J Daoud; Mark A Greiner; Sadeer B Hannush; W Barry Lee; Thomas F Mauger; Harry J Menegay; Mark D Mifflin; Michael B Raizman; Jennifer Rose-Nussbaumer; Robert L Schultze; Gregory A Schmidt; Alan Sugar; Mark A Terry; David D Verdier Journal: JAMA Ophthalmol Date: 2019-02-01 Impact factor: 7.389
Authors: Jonathan H Lass; Loretta B Szczotka-Flynn; Allison R Ayala; Beth A Benetz; Robin L Gal; Anthony J Aldave; Michelle M Corrigan; Steven P Dunn; Ty L McCall; Sudeep Pramanik; George O Rosenwasser; Kevin W Ross; Mark A Terry; David D Verdier Journal: Cornea Date: 2015-06 Impact factor: 2.651