The effect of donor age on penetrating keratoplasty for endothelial disease: Graft survival after 10 years in the cornea donor study

Mark J Mannis, Edward J. Holland, Robin L. Gal, Mariya Dontchev, Craig Kollman, Dan Raghinaru, Steven P. Dunn, Robert L. Schultze, David D. Verdier, Jonathan H. Lass, Irving M. Raber, Joel Sugar, Mark S. Gorovoy, Alan Sugar, R. Doyle Stulting, Monty M. Montoya, Jeffrey G. Penta, Beth Ann Benetz, Roy W. Beck

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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. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

Original languageEnglish (US)
Pages (from-to)2419-2427
Number of pages9
JournalOphthalmology
Volume120
Issue number12
DOIs
StatePublished - Dec 2013

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Penetrating Keratoplasty
Graft Survival
Cornea
Tissue Donors
Disclosure
Transplants
Eye Banks
Corneal Edema
Postoperative Care

ASJC Scopus subject areas

  • Ophthalmology
  • Medicine(all)

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The effect of donor age on penetrating keratoplasty for endothelial disease : Graft survival after 10 years in the cornea donor study. / Mannis, Mark J; Holland, Edward J.; Gal, Robin L.; Dontchev, Mariya; Kollman, Craig; Raghinaru, Dan; Dunn, Steven P.; Schultze, Robert L.; Verdier, David D.; Lass, Jonathan H.; Raber, Irving M.; Sugar, Joel; Gorovoy, Mark S.; Sugar, Alan; Stulting, R. Doyle; Montoya, Monty M.; Penta, Jeffrey G.; Benetz, Beth Ann; Beck, Roy W.

In: Ophthalmology, Vol. 120, No. 12, 12.2013, p. 2419-2427.

Research output: Contribution to journalArticle

Mannis, MJ, Holland, EJ, Gal, RL, Dontchev, M, Kollman, C, Raghinaru, D, Dunn, SP, Schultze, RL, Verdier, DD, Lass, JH, Raber, IM, Sugar, J, Gorovoy, MS, Sugar, A, Stulting, RD, Montoya, MM, Penta, JG, Benetz, BA & Beck, RW 2013, 'The effect of donor age on penetrating keratoplasty for endothelial disease: Graft survival after 10 years in the cornea donor study', Ophthalmology, vol. 120, no. 12, pp. 2419-2427. https://doi.org/10.1016/j.ophtha.2013.08.026
Mannis, Mark J ; Holland, Edward J. ; Gal, Robin L. ; Dontchev, Mariya ; Kollman, Craig ; Raghinaru, Dan ; Dunn, Steven P. ; Schultze, Robert L. ; Verdier, David D. ; Lass, Jonathan H. ; Raber, Irving M. ; Sugar, Joel ; Gorovoy, Mark S. ; Sugar, Alan ; Stulting, R. Doyle ; Montoya, Monty M. ; Penta, Jeffrey G. ; Benetz, Beth Ann ; Beck, Roy W. / The effect of donor age on penetrating keratoplasty for endothelial disease : Graft survival after 10 years in the cornea donor study. In: Ophthalmology. 2013 ; Vol. 120, No. 12. pp. 2419-2427.
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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. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.",
author = "Mannis, {Mark J} and Holland, {Edward J.} and Gal, {Robin L.} and Mariya Dontchev and Craig Kollman and Dan Raghinaru and Dunn, {Steven P.} and Schultze, {Robert L.} and Verdier, {David D.} and Lass, {Jonathan H.} and Raber, {Irving M.} and Joel Sugar and Gorovoy, {Mark S.} and Alan Sugar and Stulting, {R. Doyle} and Montoya, {Monty M.} and Penta, {Jeffrey G.} and Benetz, {Beth Ann} and Beck, {Roy W.}",
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T1 - The effect of donor age on penetrating keratoplasty for endothelial disease

T2 - Graft survival after 10 years in the cornea donor study

AU - Mannis, Mark J

AU - Holland, Edward J.

AU - Gal, Robin L.

AU - Dontchev, Mariya

AU - Kollman, Craig

AU - Raghinaru, Dan

AU - Dunn, Steven P.

AU - Schultze, Robert L.

AU - Verdier, David D.

AU - Lass, Jonathan H.

AU - Raber, Irving M.

AU - Sugar, Joel

AU - Gorovoy, Mark S.

AU - Sugar, Alan

AU - Stulting, R. Doyle

AU - Montoya, Monty M.

AU - Penta, Jeffrey G.

AU - Benetz, Beth Ann

AU - Beck, Roy W.

PY - 2013/12

Y1 - 2013/12

N2 - 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. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

AB - 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. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

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