ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
North Carolina Lion's Eye Bank
Price Vision Group
Information provided by:
Cornea Research Foundation of America

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fuchs Endothelial Dystrophy
Corneal Edema
Intervention Procedure: Descemet's stripping endothelial keratoplasty
Enrollment 40

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Hide Arm/Group 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.
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Eye Bank Pre-cut Grafts Surgeon Dissected Grafts Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
70  (12) 72  (13) 71  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
12
  60.0%
13
  65.0%
25
  62.5%
Male
8
  40.0%
7
  35.0%
15
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Endothelial Cell Loss
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percentage of endothelial cell loss
28  (20) 36  (18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eye Bank Pre-cut Grafts, Surgeon Dissected Grafts
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method paired difference t-test
Comments [Not Specified]
2.Secondary Outcome
Title Best Corrected Vision
Hide Description [Not Specified]
Time Frame 6 months and 1 year after grafting
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Graft Dislocation
Hide Description [Not Specified]
Time Frame 1 day to 1 month after grafting
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Hide Arm/Group 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.
All-Cause Mortality
Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eye Bank Pre-cut Grafts Surgeon Dissected Grafts
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      2/20 (10.00%)    
Eye disorders     
graft dislocation and reattachment   2/20 (10.00%)  2 2/20 (10.00%)  2
graft rejection episode   2/20 (10.00%)  2 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marianne O. Price, PhD
Organization: Cornea Research Foundation of America
Phone: 317-814-2990
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 Submitted: February 19, 2008
First Posted: February 27, 2008
Results First Submitted: February 2, 2010
Results First Posted: March 12, 2010
Last Update Posted: April 27, 2016