Cornea Donor Study

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).

Conditions

• Corneal Disease
• Fuch's Dystrophy
• Pseudophakic Corneal Edema

Interventions

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.

Sponsors & Collaborators

• Eye Bank Association of America

  collaborator OTHER

• Bausch & Lomb Incorporated

  collaborator INDUSTRY

• Tissue Banks International

  collaborator UNKNOWN

• Vision Share, Inc.

  collaborator INDUSTRY

• San Diego Eye Bank

  collaborator OTHER

• The Cornea Society

  collaborator OTHER

• Katena Products, Inc.

  collaborator INDUSTRY

• ViroMed Laboratories, Inc.

  collaborator INDUSTRY

• Midwest Eye Banks

  collaborator OTHER

• Konan Medical, Inc.

  collaborator INDUSTRY

• Eye Bank for Sight Restoration

  collaborator UNKNOWN

• SightLife

  collaborator OTHER

• Sight Society of Northeastern New York (Lions Eye Bank of Albany)

  collaborator UNKNOWN

• Lions Eye Bank of Oregon

  collaborator UNKNOWN

• National Eye Institute (NEI)

  lead NIH

Principal Investigators

• Edward J Holland, MD · University of Cincinnati and Cincinnati Eye Institute

• Mark J Mannis, MD · University of California, Davis

• Roy W Beck, MD, PhD · Jaeb Center for Health Research

• Jonathan H Lass, MD · (PI of Specular Microscopy Ancillary Study), Case Western Reserve University and University Hospitals Case Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-01-10

Primary Completion

2012-12-31

Completion

2014-07-31

Countries

• United States

Study Locations