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

NCT00624221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-04-27

Study results available
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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.

Conditions

  • Fuchs Endothelial Dystrophy
  • Corneal Edema

Interventions

PROCEDURE

Descemet's stripping endothelial keratoplasty

Small incision corneal transplant procedure to treat dysfunctional endothelium.

Sponsors & Collaborators

  • North Carolina Lion's Eye Bank

    collaborator UNKNOWN

  • Price Vision Group

    collaborator INDUSTRY

  • Cornea Research Foundation of America

    lead OTHER

Principal Investigators

  • Francis W Price, Jr, MD · Cornea Research Foundation of America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-10-31
Completion
2007-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624221 on ClinicalTrials.gov