Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000137
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Collaborative Corneal Transplantation Studies CCTS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether histocompatibility matching of corneal transplant donors and recipients can reduce the incidence of graft rejection in high-risk patients
Detailed Description:
Approximately 20 percent of corneal transplant patients about 6000 per year face donor tissue rejection at rates of up to 60 percent because of corneal vascularization or prior graft rejection Histocompatibility antigen matching andor crossmatching may have offered these patients an improved chance for successful outcome
The Collaborative Corneal Transplantation Studies Group conducted two controlled double-masked studies addressing distinct scientific questions about donor-recipient histocompatibility matching The Crossmatch Study was a randomized study assessing the effectiveness of crossmatching in preventing graft rejection among high-risk patients with lymphocytotoxic antibodies The Antigen Matching Study was a prospective double-masked observational study of the effectiveness of HLA-A -B and -DR donor-recipient matching in high-risk patients who had no lymphocytotoxic antibodies
Six clinical centers recruited high-risk patients and collaborated with their local eye banking and organ procurement agencies in procuring donor corneal tissue For each of the two studies a total of 400 patients were sought Blood samples from each enrolled patient were sent to the local CCTS tissue typing laboratory for HLA typing and serum samples were sent to the Central Laboratory to be screened for preformed lymphocytotoxic antibodies Depending on the results of the testing patients were entered into the Crossmatch Study or the Antigen Matching Study
As corneal donors became available donor blood samples were HLA typed at the local laboratories and crossmatched against all CCTS patients who awaited transplantation Results of the testing were entered in a national 24-hour computerized allocation system operated by the United Network for Organ Sharing UNOS Patients in the Crossmatch Study received a cornea from either a positively crossmatched donor or a negatively crossmatched donor Patients in the Antigen Matching Study received a cornea with 0 to 6 matched antigens
Transplant patients were followed intensively during the first months after surgery The number of clinic visits was tapered to 2 during the third and final year of followup resulting in a total of 17 postoperative visits Irreversible failure of the corneal allograft due to all causes was the primary outcome variable in both studies Allograft reaction episodes irreversible failure due to rejection and visual acuity were secondary outcome variables
The Collaborative Corneal Transplantation Studies Group conducted two controlled double-masked studies addressing distinct scientific questions about donor-recipient histocompatibility matching The Crossmatch Study was a randomized study assessing the effectiveness of crossmatching in preventing graft rejection among high-risk patients with lymphocytotoxic antibodies The Antigen Matching Study was a prospective double-masked observational study of the effectiveness of HLA-A -B and -DR donor-recipient matching in high-risk patients who had no lymphocytotoxic antibodies
Six clinical centers recruited high-risk patients and collaborated with their local eye banking and organ procurement agencies in procuring donor corneal tissue For each of the two studies a total of 400 patients were sought Blood samples from each enrolled patient were sent to the local CCTS tissue typing laboratory for HLA typing and serum samples were sent to the Central Laboratory to be screened for preformed lymphocytotoxic antibodies Depending on the results of the testing patients were entered into the Crossmatch Study or the Antigen Matching Study
As corneal donors became available donor blood samples were HLA typed at the local laboratories and crossmatched against all CCTS patients who awaited transplantation Results of the testing were entered in a national 24-hour computerized allocation system operated by the United Network for Organ Sharing UNOS Patients in the Crossmatch Study received a cornea from either a positively crossmatched donor or a negatively crossmatched donor Patients in the Antigen Matching Study received a cornea with 0 to 6 matched antigens
Transplant patients were followed intensively during the first months after surgery The number of clinic visits was tapered to 2 during the third and final year of followup resulting in a total of 17 postoperative visits Irreversible failure of the corneal allograft due to all causes was the primary outcome variable in both studies Allograft reaction episodes irreversible failure due to rejection and visual acuity were secondary outcome variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None