Original articleThe Effect of Donor Age on Corneal Transplantation Outcome: Results of the Cornea Donor Study
Section snippets
Materials and Methods
The protocol was approved by institutional review boards for all investigational sites. Each subject gave written informed consent to participate in the study. Study oversight was provided by an independent data and safety monitoring committee.
Eligible subjects were between 40 and 80 years old and had a corneal disease that placed them at moderate risk for graft failure (principally Fuchs’ dystrophy and pseudophakic corneal edema). An eye was not eligible if it was considered to be at high risk
Baseline Characteristics and Surgical Procedure
Between January 2000 and August 2002, 1090 eligible subjects were enrolled by 105 surgeons at 80 sites in the U.S. Mean age was 70±9 years; 697 (64%) were female, 1011 (93%) were Caucasian, 50 (5%) were African American, 13 (1%) were Hispanic, and 16 (1%) were of another race. Indications for corneal transplantation included Fuchs’ dystrophy in 676 (62%), pseudophakic/aphakic corneal edema in 369 (34%), and a variety of other causes in 45 (4%). Five hundred thirty-four (49%) eyes were
Discussion
In this study of 1090 moderate-risk cornea transplants, the overall 5-year success rate was 86% for grafts performed with corneas from donors 12 to 65 years old as well as for grafts performed with corneas from donors 66 to 75. The 95% CI on the observed difference was well within the study’s prespecified definition of noninferiority.
When donor age was analyzed as a continuous variable, there was not a significant donor age effect over the range of 12 to 75 years included in the study. However,
References (24)
- et al.
Risk factors of corneal graft failure
Ophthalmology
(1993) - et al.
Risk factors for corneal graft failure and rejection in the Collaborative Corneal Transplantation Studies
Ophthalmology
(1994) - et al.
Corneal graft survival and visual outcome: a multicenter study
Ophthalmology
(1994) 2006 Eye Banking Statistical Report
(2006)- Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling, Final...
Eye Banking 1995: danger and opportunity
Cornea
(1995)- et al.
Benefits of specular microscopy in evaluating eye donors aged 66 and older
Cornea
(1995) - et al.
The impact on tissue utilization of screening donor corneas by specular microscopy at the University of Texas Southwestern Medical Center
Cornea
(1995) - et al.
Tissue utilization at the Minnesota Lions’ Eye Bank
Cornea
(1995) - et al.
Quality of corneal donor tissue in the greater-than-75-year age group
Cornea
(1997)
Clinical profile and early surgical complications in the Cornea Donor Study
Cornea
Medical Standards
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Manuscript no. 2007–1568.
Supported by the National Eye Institute, Bethesda, Maryland (cooperative agreement nos. EY12728, EY12358). Additional support provided by Eye Bank Association of America, Washington, DC; Bausch & Lomb, Inc., Rochester, New York; Tissue Banks International, Baltimore, Maryland; Vision Share, Inc., Apex, North Carolina; San Diego Eye Bank, San Diego, California; Cornea Society, Fairfax, Virginia; Katena Products, Inc., Denville, New Jersey; ViroMed Laboratories, Inc., Minnetonka, Minnesota; Midwest Eye-Banks (Michigan Eye-Bank, Illinois Eye-Bank), Ann Arbor, Michigan; Konan Medical Corp., Torrance, California; Eye Bank for Sight Restoration, New York, New York; SightLife, Seattle, Washington; Sight Society of Northeastern New York (Lions Eye Bank of Albany), Albany, New York; and Lions Eye Bank of Oregon, Portland, Oregon.
E-mail: [email protected].
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See “Appendix 2” (available at http://aaojournal.org) for a list of Group members.