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Cornea Donor Study (CDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006411
Recruitment Status : Completed
First Posted : October 16, 2000
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
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 (Responsible Party):
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1090 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Cornea Donor Study: The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease
Actual Study Start Date : January 10, 2000
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
cornea assigned from donor age group <66.0 years
Other: corneas assigned by donor age group
A web-based computer program was used to select and assign a cornea by donor age group 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 assigned from donor age group >= 66.0 years
Other: corneas assigned by donor age group
A web-based computer program was used to select and assign a cornea by donor age group 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 [ Time Frame: Baseline to 10 Years of Follow Up ]
    # eyes with 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. Only one eye per participant was included in the study.


Secondary Outcome Measures :
  1. Endothelial Cell Density (ECD) [ Time Frame: 10 year ECD ]
    ECD (cells/mm2)was measured on a subset of the overall Cornea Donor Study cohort who participated in the Specular Microscopy Ancillary Study



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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

Inclusion

  1. Age range 40-80 years
  2. Corneal disease: Presence of a condition associated with endothelial dysfunction, including pseudophakic/aphakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, interstitial keratitis (nonherpetic) or perforating corneal injury
  3. Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)

Exclusion

  1. Patients are to be excluded when there is:

    • a high risk of graft failure, including failed prior penetrating keratoplasty in the eye to be transplanted, chemical burns or other significant cicatricial conjunctivitis (ocular surface disease), herpes simplex/zoster, temporary keratoprosthesis, iridocorneal endothelial syndrome or any corneal condition in which there are two or more quadrants of stromal neovascularization

      • A quadrant is considered vascularized if there is at least one patent stromal vessel >2.0 mm in length crossing the limbus within a quadrant. Two quadrants are considered vascularized if there are at least two stromal vessels 90º or more apart. Enrollment will be restricted to no more than 20% of the total cohort having stromal neovascularization.
      • Patients should be excluded if there are PAS or other abnormalities that, in the view of the investigator, place the patient at high risk for graft failure.
    • a very high probability of success including keratoconus, stromal dystrophies, stromal scars without edema or post-refractive surgery with healthy endothelium
  2. Uncontrolled glaucoma or prior filtering surgery with placement of a shunt in the eye to be grafted (Note: eyes requiring a filtering procedure combined with the PK are considered to have uncontrolled glaucoma and are ineligible. Eyes which have undergone filtering surgery (without a shunt) in which glaucoma is currently considered under control are eligible)
  3. Uncontrolled uveitis in the eye to be grafted
  4. Fellow eye visual acuity <20/200
  5. Fellow eye already included in the study

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
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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
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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
Publications of Results:

Other Publications:
Powe A, Gal RL, Beck RW, Mannis MJ, Holland EJ on behalf of the Cornea Donor Study Investigator Group. The Cornea Donor Study. Vision Pan-America 2009; 8:134-137.

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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00006411    
Other Study ID Numbers: NEI-80
5U10EY012358 ( U.S. NIH Grant/Contract )
3U10EY012358-11S1 ( U.S. NIH Grant/Contract )
5U10EY012728 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2000    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public dataset access: http://cds.jaeb.org/Studies.aspx?RecID=185
Keywords provided by National Eye Institute (NEI):
cornea transplant
corneal endothelial cell density
moderate risk corneal diseases
corneal transplantation
Additional relevant MeSH terms:
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Corneal Diseases
Corneal Edema
Fuchs' Endothelial Dystrophy
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn