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Effect of Corneal Preservation Time on Long-Term Graft Success
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.
Age
30 - 90 years
Sex
ALL
Healthy Volunteers
No
Keck Medical Center
Beverly Hills, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
Eye Care of San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Center for Sight
Sarasota, Florida, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Eye Consultants of Atlanta
Atlanta, Georgia, United States
University of Illinois Eye and Eye
Chicago, Illinois, United States
NorthShore University Health System
Glenview, Illinois, United States
Start Date
April 16, 2012
Primary Completion Date
June 30, 2017
Completion Date
June 30, 2017
Last Updated
April 23, 2018
1,174
ACTUAL participants
Cornea tissue transplant
BIOLOGICAL
Cornea tissue transplant
BIOLOGICAL
Lead Sponsor
Case Western Reserve University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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