Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Primary Purpose
Fuchs Endothelial Dystrophy, Corneal Edema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Descemet's stripping endothelial keratoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs Endothelial Dystrophy
Eligibility 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
Sites / Locations
- Cornea Research Foundation of America
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
The surgeon dissected the donor grafts used for the transplant procedures.
Outcomes
Primary Outcome Measures
Endothelial Cell Loss
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
Graft Dislocation
Full Information
NCT ID
NCT00624221
First Posted
February 19, 2008
Last Updated
March 28, 2016
Sponsor
Cornea Research Foundation of America
Collaborators
North Carolina Lion's Eye Bank, Price Vision Group
1. Study Identification
Unique Protocol Identification Number
NCT00624221
Brief Title
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
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 Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cornea Research Foundation of America
Collaborators
North Carolina Lion's Eye Bank, Price Vision Group
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs Endothelial Dystrophy, Corneal Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
Arm Title
2
Arm Type
Active Comparator
Arm Description
The surgeon dissected the donor grafts used for the transplant procedures.
Intervention Type
Procedure
Intervention Name(s)
Descemet's stripping endothelial keratoplasty
Intervention Description
Small incision corneal transplant procedure to treat dysfunctional endothelium.
Primary Outcome Measure Information:
Title
Endothelial Cell Loss
Description
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.
Time Frame
6 months after grafting
Secondary Outcome Measure Information:
Title
Best Corrected Vision
Time Frame
6 months and 1 year after grafting
Title
Graft Dislocation
Time Frame
1 day to 1 month after grafting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr, MD
Organizational Affiliation
Cornea Research Foundation of America
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornea Research Foundation of America
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
We'll reach out to this number within 24 hrs