Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 13, 2000
March 23, 2010
July 2002
December 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00006411 on ClinicalTrials.gov Archive Site
endothelial cell density [ Time Frame: enrollment through end of follow up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Cornea Donor Study
Cornea Donor Study

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).

The study enrolled 1101 subjects with a corneal disease considered to be at moderate risk for failure (principally Fuchs' dystrophy and pseudophakic corneal edema). A donor cornea meeting the following criteria was assigned to the subject by one of 43 participating eye banks:

  • donor age 10 to 75 years
  • endothelial cell count 2300 to 3300
  • tissue quality very good to excellent
  • death to preservation time <12 hrs if body refrigerated or eyes on ice and <8 hrs if not
  • death to surgery time <5 days

The cornea surgeon (investigator) and patient were masked to donor age and characteristics of the donor cornea. Preoperative management, surgical technique, and postoperative care, including prescription of medications, were provided according to each investigator's customary routine. The follow-up visit schedule for the initial six months was left to each investigator's discretion and after this time the minimum follow-up visit schedule included a visit between six and 12 months and then one visit every 12 months through five years. The primary study outcome was graft survival at five years. The definition of graft failure, based on the definition used in Collaborative Corneal Transplantation Studies, was a regraft or, in the absence of regraft, a cloudy cornea in which there was loss of central graft clarity sufficient to compromise vision for a minimum of three consecutive months. Follow-up in the initial phase of the study continued for five years unless the patient had a regraft of the study eye.

For the ABO compatibility study, the ABO blood type of both the donor and recipient were determined in order to compare the rate of graft failure for ABO-compatible cases with the rate for ABO-incompatible cases.

For the Specular Microscopy Ancillary Study, endothelial cell counts were determined from specular images by a central reading center, and the relationship of the cell counts to donor age were assessed. In the initial phase of the study, specular images were obtained at 6 months, and then annually through five years post-transplant.

Five-year follow up was completed in November 2007. The 5-year cumulative probability of success was 86%: 86% in the <66.0 year donor age group and 86% in the >=66.0 year donor age group (difference = 0%, upper limit of one-sided 95% confidence interval = 4%). Adjusting for baseline endothelial cell density had no appreciable effect on these results. In a statistical model with donor age as a continuous variable, there was not a significant relationship between donor age and outcome (P=0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation, and 30 to other causes. At least one probable or definite graft rejection episode preceded graft failure in 23 of the 46 failures attributed to endothelial decompensation (4 definite and 19 probable) and in 18 of the 30 failures attributed to other causes (4 definite and 14 probable). The distribution of causes of failure between the donor age groups did not substantially differ.

Although the 5-year results indicated no difference in the success rate of moderate-risk transplants according to donor age, results from the SMAS indicated that among the successful cases, there was a slight association between donor age and endothelial cell loss, with the cell loss after 5 years being slightly lower in corneas from younger donors (r adjusted for baseline endothelial cell density = -0.19, 95% confidence interval -0.29 to -0.08). Whether this slight association between cell loss and donor age is of clinical importance is not known. Of perhaps even greater importance, however, was the finding that irrespective of donor age, endothelial cell loss was substantial over the first five years after transplant even when the graft had been successful. Half of the successful cases experienced a cell loss of 70% or more, and at five years more than half had an endothelial cell density <800 cells/mm2.

The CDS will continue and patients will be followed annually through 2012 in order to to determine the overall 10-year survival rate for moderate risk grafts and to determine whether the graft-failure rate is related to donor age. Additional objectives include determining the value of endothelial cell density in predicting graft failure and evaluating donor and recipient characteristics that may be predictive of late graft failure. All CDS subjects who are active at the 5-year exam are eligible for the extended follow-up phase.

As part of the Specular Microscopy Ancillary Study, follow-up images will be obtained during the extended follow-up phase at 7-8 years and again at 10-years. The same procedures used during the first 5 years will be followed for the grading of the 7-8 year and 10-year images.

Interventional
Not Provided
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Corneal Disease
  • Fuch's Dystrophy
  • Pseudophakic Corneal Edema
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: 1
    cornea from donor <66.0 years
    Intervention: Other: corneas assigned by donor age group
  • Active Comparator: 2
    cornea from donor >= 66.0 years
    Intervention: Other: corneas assigned by donor age group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1101
July 2013
December 2007   (final data collection date for primary outcome measure)
  • 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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006411
NEI-80, 5U10EY012358
Yes
Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
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 (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
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
National Eye Institute (NEI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP