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

March 28, 2016 updated by: Cornea Research Foundation of America

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Cornea Research Foundation of America

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after grafting

Secondary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Vision
Time Frame: 6 months and 1 year after grafting
6 months and 1 year after grafting
Graft Dislocation
Time Frame: 1 day to 1 month after grafting
1 day to 1 month after grafting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornea Research Foundation of America

Collaborators

Price Vision Group
North Carolina Lion's Eye Bank

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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