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Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

NCT01357122 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-05-20

No results posted yet for this study

Summary

This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.

Conditions

  • Fuchs' Corneal Endothelial Dystrophy

Interventions

DEVICE

NCI Insertion

DSAEK surgery will be performed using the NCI to insert the donor tissue.

PROCEDURE

Standard Forceps Insertion

DSAEK surgery will be performed using forceps to insert the donor tissue. This is our long-established technique for DSAEK, with well-documented excellent results.

Sponsors & Collaborators

  • Devers Eye Institute

    collaborator OTHER

  • Lions Eye Bank of Oregon Vision Research Laboratory

    collaborator UNKNOWN

  • Fischer Surgical, Inc.

    collaborator INDUSTRY

  • Legacy Health System

    lead OTHER

Principal Investigators

  • Mark A Terry, MD · Devers Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT01357122 on ClinicalTrials.gov