Clinical Trial: Cornea Donor Study
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Cornea Donor Study
Brief Summary:
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives:
To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when using corneal tissue from donors older than 65 years of age compared with tissue from younger donors.
To assess the relationship between donor/recipient ABO blood type compatibility and graft failure due to rejection.
To assess corneal endothelial cell density as an indicator of the health of the cornea and as a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).
Detailed Summary:
The study enrolled 1101 subjects with a corneal disease considered to be at moderate risk for failure (principally Fuchs' dystrophy and pseudophakic corneal edema). A donor cornea meeting the following criteria was assigned to the subject by one of 43 participating eye banks:
- donor age 10 to 75 years
- endothelial cell count 2300 to 3300
- tissue quality very good to excellent
- death to preservation time <12 hrs if body refrigerated or eyes on ice and <8 hrs if not
- death to surgery time <5 days
The cornea surgeon (investigator) and patient were masked to donor age and characteristics of the donor cornea. Preoperative management, surgical technique, and postoperative care, including prescription of medications, were provided according to each investigator's customary routine. The follow-up visit schedule for the initial six months was left to each investigator's discretion and after this time the minimum follow-up visit schedule included a visit between six and 12 months and then one visit every 12 months through five years. The primary study outcome was graft survival at five years. The definition of graft failure, based on the definition used in Collaborative Corneal Transplantation Studies, was a regraft or, in the absence of regraft, a cloudy cornea in which there was loss of central graft clarity sufficient to compromise vision for a minimum of three consecutive months. Follow-up in the initial phase of the study continued for five years unless the patient had a regraft of the study eye.
For the ABO compatibility study, the ABO blood type of both the donor and recipient were determined in o
Sponsor: National Eye Institute (NEI)
Current Primary Outcome: Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of three consecutive months. [ Time Frame: enrollment through end of follow up ]
Original Primary Outcome:
Current Secondary Outcome: endothelial cell density [ Time Frame: enrollment through end of follow up ]
Original Secondary Outcome:
Information By: National Eye Institute (NEI)
Dates:
Date Received: October 13, 2000
Date Started: July 2002
Date Completion: July 2013
Last Updated: March 23, 2010
Last Verified: April 2008
