Trial record 15 of 20 for:    "Fuchs endothelial dystrophy" OR "Corneal Granular Dystrophies" OR "Hereditary Corneal Dystrophies" OR "Corneal Macular Dystrophy"

Cornea Donor Study (CDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
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 (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
First received: October 13, 2000
Last updated: March 23, 2010
Last verified: April 2008
  Purpose

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: Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Cornea Donor Study

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endothelial cell density [ Time Frame: enrollment through end of follow up ] [ Designated as safety issue: No ]

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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006411

Locations
United States, Florida
Jaeb Center for Health Research, Inc.
Tampa, Florida, United States, 33647
Sponsors and 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 (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
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
  More Information

Additional Information:
Publications:
Cornea Donor Study Investigator Group. The effect of donor age on corneal transplantation outcome: results of the cornea donor study. Ophthalmology 2008; 115:620-626.
Cornea Donor Study Investigator Group. Donor age and corneal endothelial cell loss five years after successful cornea transplantation: specular microscopy ancillary study results. Ophthalmology 2008; 115:627-632.

Additional 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
Study First Received: October 13, 2000
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 19, 2014