Expired Study
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Indianapolis, Indiana 46260


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.


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


Study is Available At:


Original ID:

2005-10


NCT ID:

NCT00624221


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cornea Research Foundation of America


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Francis W Price, Jr, MD
Principal Investigator
Cornea Research Foundation of America

Study Dates

Start Date:January 2006
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 21, 2010
First Received Date:February 19, 2008
First Results Date:February 2, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Graft Dislocation
Time Frame:1 day to 1 month after grafting
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Best Corrected Vision
Time Frame:6 months and 1 year after grafting
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Endothelial Cell Loss
Time Frame:6 months after grafting
Safety Issues:False
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 baselin

Study Interventions

Intervention Type:Procedure
Name:Descemet's stripping endothelial keratoplasty
Description:Small incision corneal transplant procedure to treat dysfunctional endothelium.
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:The surgeon dissected the donor grafts used for the transplant procedures.
Study Arm Type:Active Comparator
Arm Name:1
Description:An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Cornea Research Foundation of America
Agency Class:Other
Agency Type:Collaborator
Agency Name:North Carolina Lion's Eye Bank

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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