Cornea Donor Study - Full Text View

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:

Genetics Home Reference related topics: Fuchs endothelial dystrophy lattice corneal dystrophy type I Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Corneal Disorders Edema

U.S. FDA Resources

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.

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

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

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

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:

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

Publications:

Sugar A, Gal RL, Beck W, Ruedy KJ, Blanton CL, Feder RS, Hardten DR, Holland EJ, Lass JH, Mannis MJ, O'Keefe MB; Cornea Donor Study Group. Baseline donor characteristics in the Cornea Donor Study. Cornea. 2005 May;24(4):389-96.

Lass JH, Gal RL, Ruedy KJ, Benetz BA, Beck RW, Baratz KH, Holland EJ, Kalajian A, Kollman C, Manning FJ, Mannis MJ, McCoy K, Montoya M, Stulting D, Xing D; Cornea Donor Study Group. An evaluation of image quality and accuracy of eye bank measurement of donor cornea endothelial cell density in the Specular Microscopy Ancillary Study. Ophthalmology. 2005 Mar;112(3):431-40. Erratum in: Ophthalmology. 2005 Aug;112(8):1394.

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.

Beck RW, Gal RL, Mannis MJ, Holland EJ, Cavanagh HD, Foulks GN, Heck EL, Lindquist T, Macsai MS, Smith RE, Stark WJ, Stulting RD, Sugar J. Is donor age an important determinant of graft survival? Cornea. 1999 Sep;18(5):503-10. Review. No abstract available.

Mannis MJ, Holland EJ, Beck RW, Belin MW, Goldberg MA, Gal RL, Kalajian AD, Kenyon KR, Kollman C, Ruedy KJ, Smith P, Sugar J, Stark WJ; Cornea Donor Study Group. Clinical profile and early surgical complications in the Cornea Donor Study. Cornea. 2006 Feb;25(2):164-70.

Benetz BA, Gal RL, Ruedy KJ, Rice C, Beck RW, Kalajian AD, Lass JH; Cornea Donor Study Group. Specular microscopy ancillary study methods for donor endothelial cell density determination of Cornea Donor Study images. Curr Eye Res. 2006 Apr;31(4):319-27.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lass JH, Beck RW, Benetz BA, Dontchev M, Gal RL, Holland EJ, Kollman C, Mannis MJ, Price F Jr, Raber I, Stark W, Stulting RD, Sugar A; Cornea Donor Study Investigator Group. Baseline factors related to endothelial cell loss following penetrating keratoplasty. Arch Ophthalmol. 2011 Sep;129(9):1149-54. Epub 2011 May 9.

Lass JH, Sugar A, Benetz BA, Beck RW, Dontchev M, Gal RL, Kollman C, Gross R, Heck E, Holland EJ, Mannis MJ, Raber I, Stark W, Stulting RD; Cornea Donor Study Investigator Group. Endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Arch Ophthalmol. 2010 Jan;128(1):63-9.

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
Edema
Fuchs' Endothelial Dystrophy
Eye Diseases

Signs and Symptoms
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 19, 2013