Cornea Preservation Time Study
- Conditions
- Transplant SuccessEndothelial KeratoplastyEndothelial Cell DensityCornea Preservation Time
- Interventions
- Biological: Cornea tissue transplant
- Registration Number
- NCT01537393
- Lead Sponsor
- Case Western Reserve University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1174
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8-14d Preservation Time Group Cornea tissue transplant Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant. 0-7d Preservation Time Group Cornea tissue transplant Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant.
- Primary Outcome Measures
Name Time Method Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery Study eye will be assessed for this outcome for 3 years following surgery Graft failure, defined as the occurrence of one of the following within 3 years of surgery:
* Regrafting of the study eye for any reason
* Cornea which remains cloudy without clearing, according to the following:
1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR
2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.Endothelial Cell Density (ECD) 3 years from surgery Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
NorthShore University Health System
🇺🇸Glenview, Illinois, United States
Ohio State Medical Center
🇺🇸Columbus, Ohio, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Keck Medical Center
🇺🇸Beverly Hills, California, United States
Eye Care of San Diego
🇺🇸San Diego, California, United States
Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Woolfson Eye Institute
🇺🇸Atlanta, Georgia, United States
Center for Sight
🇺🇸Sarasota, Florida, United States
Eye Consultants of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Illinois Eye and Eye
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kentucky Ophthalmology
🇺🇸Lexington, Kentucky, United States
Mid-Atlantic Cornea Consultants
🇺🇸Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Johns Hopkins/Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Eye Consultants of Maryland
🇺🇸Owings Mills, Maryland, United States
Verdier Eye Center
🇺🇸Grand Rapids, Michigan, United States
University of Michigan/Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Michigan Cornea Consultants
🇺🇸Southfield, Michigan, United States
Minnesota Eye Consultants
🇺🇸Bloomington, Minnesota, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
University Hospitals Case Medical Center Eye Institute
🇺🇸Cleveland, Ohio, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
Cornea Consultants of Albany
🇺🇸Slingerlands, New York, United States
Northeast Ohio Eye Surgeons
🇺🇸Kent, Ohio, United States
Ophthalmic Partners of PA
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Medical Eye Center
🇺🇸Medford, Oregon, United States
Central Pennsylvania Eye Institute
🇺🇸Hershey, Pennsylvania, United States
Sadeer Hannush, MD
🇺🇸Langhorne, Pennsylvania, United States
Corneal Associates, PC, Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Cornea Associates of Texas
🇺🇸Dallas, Texas, United States
Eye Associates Northwest
🇺🇸Seattle, Washington, United States
Dean Medical Center
🇺🇸Madison, Wisconsin, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
University of Utah, Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States