Study of Eye Bank Pre-Cut Donor Grafts for Endothelial Keratoplasty - Full Text View

Sponsors and Collaborators:	Cornea Research Foundation of America North Carolina Lion's Eye Bank Price Vision Group
Information provided by:	Cornea Research Foundation of America
ClinicalTrials.gov Identifier:	NCT00624221

Purpose

Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.

Condition	Intervention
Fuchs Endothelial Dystrophy Corneal Edema	Procedure: Descemet's stripping endothelial keratoplasty

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-Prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Edema Surgery

U.S. FDA Resources

Further study details as provided by Cornea Research Foundation of America:

Primary Outcome Measures:

Endothelial Cell Loss [ Time Frame: 6 months after grafting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

best corrected vision [ Time Frame: 6 months and 1 year after grafting ] [ Designated as safety issue: Yes ]
graft dislocation [ Time Frame: 1 day to 1 month after grafting ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.	Procedure: Descemet's stripping endothelial keratoplasty Small incision corneal transplant procedure to treat dysfunctional endothelium.
2: Active Comparator The surgeon dissected the donor grafts used for the transplant procedures.	Procedure: Descemet's stripping endothelial keratoplasty Small incision corneal transplant procedure to treat dysfunctional endothelium.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

candidate for Descemet's stripping with endothelial keratoplasty
at least 21 years old
willing and able to return for scheduled follow-up visits
reads and signs Informed Consent document

Exclusion Criteria:

visual acuity of less than 20/400 in fellow eye
known sensitivity to planned study concomitant medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624221

Locations

United States, Indiana
Cornea Research Foundation of America
Indianapolis, Indiana, United States, 46260

Sponsors and Collaborators

Cornea Research Foundation of America

North Carolina Lion's Eye Bank

Price Vision Group

Investigators

Principal Investigator:

Francis W Price, Jr, MD

Cornea Research Foundation of America

More Information

No publications provided

Responsible Party:	Cornea Research Foundation of America ( Francis W. Price, Jr. MD )
Study ID Numbers:	2005-10
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00624221 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Corneal Diseases
Corneal Dystrophy Fuchs' Endothelial 1
Genetic Diseases, Inborn
Corneal Dystrophy
Corneal Dystrophies, Hereditary

Eye Diseases
Fuchs' Endothelial Dystrophy
Corneal Edema
Eye Diseases, Hereditary
Edema

Additional relevant MeSH terms:

Corneal Diseases
Genetic Diseases, Inborn
Corneal Dystrophies, Hereditary
Eye Diseases

Fuchs' Endothelial Dystrophy
Corneal Edema
Eye Diseases, Hereditary

ClinicalTrials.gov processed this record on September 04, 2009