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Cornea Donor Study (CDS)

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ClinicalTrials.gov Identifier: NCT00006411
Recruitment Status : Unknown
Verified April 2008 by National Eye Institute (NEI).
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2000
Last Update Posted : March 24, 2010
Sponsor:
Collaborators:
Eye Bank Association of America
Bausch & Lomb Incorporated
Tissue Banks International
Vision Share, Inc.
San Diego Eye Bank
The Cornea Society
Katena Products, Inc.
ViroMed Laboratories, Inc.
Midwest Eye Banks
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)

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).


Condition or disease Intervention/treatment Phase
Corneal Disease Fuch's Dystrophy Pseudophakic Corneal Edema Other: corneas assigned by donor age group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1101 participants
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Cornea Donor Study
Study Start Date : July 2002
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
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.

Active Comparator: 2
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. endothelial cell density [ Time Frame: enrollment through end of follow up ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patients must be in the age range of 40 to 80 years.
  • Patients with corneal disease associated with endothelial dysfunction, including pseudophakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, endothelial failure from another cause, interstitial keratitis (non-herpetic), or perforating corneal injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006411


Locations
United States, Florida
Jaeb Center for Health Research, Inc.
Tampa, Florida, United States, 33647
Sponsors and Collaborators
National Eye Institute (NEI)
Eye Bank Association of America
Bausch & Lomb Incorporated
Tissue Banks International
Vision Share, Inc.
San Diego Eye Bank
The Cornea Society
Katena Products, Inc.
ViroMed Laboratories, Inc.
Midwest Eye Banks
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
Investigators
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

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00006411     History of Changes
Other Study ID Numbers: NEI-80
5U10EY012358 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2000    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: April 2008

Keywords provided by National Eye Institute (NEI):
cornea transplant
corneal endothelial cell density
moderate risk corneal diseases requiring corneal transplantation
corneal transplantation

Additional relevant MeSH terms:
Corneal Diseases
Corneal Edema
Fuchs' Endothelial Dystrophy
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn