Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Eye Institute (NEI) Eye Bank Association of America Bausch & Lomb, Inc. Tissue Banks International Vision Share, Inc. San Diego Eye Bank The Cornea Society Katena Products, Inc. ViroMed Laboratories, Inc. Midwest Eye-Banks (Michigan Eye-Bank, Illinois Eye-Bank) Konan Medical, Inc. Eye Bank for Sight Restoration SightLife Sight Society of Northeastern New York (Lions Eye Bank of Albany) Lions Eye Bank of Oregon |
---|---|
Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00006411 |
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).
Condition | Intervention |
---|---|
Corneal Disease Fuch's Dystrophy Pseudophakic Corneal Edema |
Other: corneas assigned by donor age group |
Study Type: | Interventional |
Study Design: | Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Bio-equivalence Study |
Official Title: | Cornea Donor Study |
Enrollment: | 1101 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | July 2013 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
cornea from donor <66.0 years
|
Other: corneas assigned by donor age group
A web-based computer program was used to select a cornea from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
|
2: Active Comparator
cornea from donor >= 66.0 years
|
Other: corneas assigned by donor age group
A web-based computer program was used to select a cornea from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
|
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Florida | |
Jaeb Center for Health Research, Inc. | |
Tampa, Florida, United States, 33647 |
Study Chair: | Edward J Holland, MD | University of Cincinnati and Cincinnati Eye Institute |
Study Chair: | Mark J Mannis, MD | University of California, Davis |
Principal Investigator: | Roy W Beck, MD, PhD | Jaeb Center for Health Research |
Principal Investigator: | Jonathan H Lass, MD | (PI of Specular Microscopy Ancillary Study), Case Western Reserve University and University Hospitals Case Medical Center |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D. ) |
Study ID Numbers: | NEI-80, 5U10EY012358 |
Study First Received: | October 13, 2000 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00006411 History of Changes |
Health Authority: | United States: Federal Government |
cornea transplant corneal endothelial cell density moderate risk corneal diseases requiring corneal transplantation corneal transplantation |
Corneal Diseases Corneal Dystrophy Fuchs' Endothelial 1 Genetic Diseases, Inborn Corneal Dystrophy Corneal Dystrophies, Hereditary |
Eye Diseases Fuchs' Endothelial Dystrophy Corneal Edema Eye Diseases, Hereditary Edema |
Corneal Diseases Genetic Diseases, Inborn Corneal Dystrophies, Hereditary Eye Diseases |
Fuchs' Endothelial Dystrophy Corneal Edema Eye Diseases, Hereditary |