Mark J Mannis1, Edward J Holland2, Robin L Gal3, Mariya Dontchev3, Craig Kollman3, Dan Raghinaru3, Steven P Dunn4, Robert L Schultze5, David D Verdier6, Jonathan H Lass7, Irving M Raber8, Joel Sugar9, Mark S Gorovoy10, Alan Sugar11, R Doyle Stulting12, Monty M Montoya13, Jeffrey G Penta14, Beth Ann Benetz7, Roy W Beck3. 1. University of California Davis, Sacramento, California. Electronic address: cds@jaeb.org. 2. Cincinnati Eye Institute, Department of Ophthalmology and Visual Sciences, Cincinnati, Ohio. 3. Jaeb Center for Health Research, Tampa, Florida. 4. Michigan Cornea Consultants, P.C., Southfield, Michigan. 5. Cornea Consultants of Albany, Albany, New York. 6. Verdier Eye Center, Grand Rapids, Michigan. 7. Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio. 8. Ophthalmic Partners of Pennsylvania, Bala Cynwyd, Pennsylvania. 9. University of Illinois at Chicago, Chicago, Illinois. 10. Gorovoy Eye Specialists, Ft. Meyers, Florida. 11. W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. 12. Emory University (now at Woolfson Eye Institute), Atlanta, Georgia. 13. SightLife, Seattle, Washington. 14. San Diego Eye Bank, San Diego, California.
Abstract
OBJECTIVE: To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age. DESIGN: Multicenter, prospective, double-masked clinical trial. PARTICIPANTS: A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years. METHODS:Forty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines. MAIN OUTCOME MEASURES: Graft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months. RESULTS: In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, -1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P<0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6. CONCLUSIONS: Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease.
RCT Entities:
OBJECTIVE: To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age. DESIGN: Multicenter, prospective, double-masked clinical trial. PARTICIPANTS: A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years. METHODS: Forty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines. MAIN OUTCOME MEASURES: Graft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months. RESULTS: In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, -1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P<0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6. CONCLUSIONS: Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease.
Authors: R W Beck; R L Gal; M J Mannis; E J Holland; H D Cavanagh; G N Foulks; E L Heck; T Lindquist; M S Macsai; R E Smith; W J Stark; R D Stulting; J Sugar Journal: Cornea Date: 1999-09 Impact factor: 2.651
Authors: Mark J Mannis; Edward J Holland; Roy W Beck; Michael W Belin; Marc A Goldberg; Robin L Gal; Andrea D Kalajian; Kenneth R Kenyon; Craig Kollman; Katrina J Ruedy; Patricia Smith; Joel Sugar; Walter J Stark Journal: Cornea Date: 2006-02 Impact factor: 2.651
Authors: Keryn A Williams; Adrian J Esterman; Christine Bartlett; Helene Holland; Ngaere B Hornsby; Douglas J Coster Journal: Transplantation Date: 2006-03-27 Impact factor: 4.939
Authors: Alan Sugar; Robin L Gal; roy W Beck; Katrina J Ruedy; Christopher L Blanton; Robert S Feder; David R Hardten; Edward J Holland; Jonathan H Lass; Mark J Mannis; Michael B O'Keefe Journal: Cornea Date: 2005-05 Impact factor: 2.651
Authors: Jonathan H Lass; Robin L Gal; Katrina J Ruedy; Beth Ann Benetz; Roy W Beck; Keith H Baratz; Edward J Holland; Andrea Kalajian; Craig Kollman; Francis J Manning; Mark J Mannis; Kristen McCoy; Monty Montoya; Doyle Stulting; Dongyuan Xing Journal: Ophthalmology Date: 2005-03 Impact factor: 12.079
Authors: Robin L gal; Mariya Dontchev; Roy W Beck; Mark J Mannis; Edward J Holland; Craig Kollman; Steven P Dunn; Ellen L Heck; Jonathan H Lass; 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
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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
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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