Cornea Preservation Time Study

Phase 4

Completed

• Conditions: Transplant Success; Endothelial Keratoplasty; Endothelial Cell Density; Cornea Preservation Time

• 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.

Study Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Study Start: 2012-04-16
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Results First Submitted: 2018-03-14
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Results First Posted: 2018-04-23
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (40)

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

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