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Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

This study has been completed.
Sponsor:
Collaborators:
North Carolina Lion's Eye Bank
Price Vision Group
Information provided by:
Cornea Research Foundation of America
ClinicalTrials.gov Identifier:
NCT00624221
First received: February 19, 2008
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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:

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 ]
    Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.


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
Active Comparator: 1
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.
Active Comparator: 2
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: Francis W. Price, Jr. MD, Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00624221     History of Changes
Other Study ID Numbers: 2005-10
Study First Received: February 19, 2008
Results First Received: February 2, 2010
Last Updated: October 21, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Corneal Edema
Edema
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
 Signs and Symptoms
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013