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Corneal Endothelium Delivery Instrument

NCT00874835 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-05-07

No results posted yet for this study

Summary

The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Conditions

  • Corneal Transplantation

Interventions

DEVICE

EndoSaver™ Corneal Endothelium Delivery Instrument

Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.

Sponsors & Collaborators

  • Wake Forest University

    collaborator OTHER

  • Ocular Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Keith A Walter, MD · Wake Forest University Eye Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

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 NCT00874835 on ClinicalTrials.gov