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

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ClinicalTrials.gov Identifier: NCT00624221
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : March 12, 2010
Last Update Posted : April 27, 2016
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Fuchs Endothelial Dystrophy Corneal Edema Procedure: Descemet's stripping endothelial keratoplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2006
Primary Completion Date : October 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Endothelial Cell Loss [ Time Frame: 6 months after grafting ]
    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 :
  1. Best Corrected Vision [ Time Frame: 6 months and 1 year after grafting ]
  2. Graft Dislocation [ Time Frame: 1 day to 1 month after grafting ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 27, 2008    Key Record Dates
Results First Posted: March 12, 2010
Last Update Posted: April 27, 2016
Last Verified: October 2010

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