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

NCT ID: NCT01357122

Last Updated: 2011-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fuchs' Corneal Endothelial Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NCI Insertion

Group Type EXPERIMENTAL

NCI Insertion

Intervention Type DEVICE

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

Standard Forceps Insertion

Group Type ACTIVE_COMPARATOR

Standard Forceps Insertion

Intervention Type PROCEDURE

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.

Interventions

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NCI Insertion

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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 21 and over
* A diagnosis of Fuchs' Corneal Endothelial Dystrophy

Exclusion Criteria

* Under age 21
* Diagnosis of advanced glaucomatous disease
* Diagnosis of significant retinal disease
* Diagnosis of any other corneal dystrophy
* Previous corneal transplant surgery
* Previous glaucoma surgery
* Previous retinal surgery
* Previous refractive surgery
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Devers Eye Institute

OTHER

Sponsor Role collaborator

Lions Eye Bank of Oregon Vision Research Laboratory

UNKNOWN

Sponsor Role collaborator

Fischer Surgical, Inc.

INDUSTRY

Sponsor Role collaborator

Legacy Health System

OTHER

Sponsor Role lead

Responsible Party

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Deverse Eye Institute

Principal Investigators

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Mark A Terry, MD

Role: PRINCIPAL_INVESTIGATOR

Devers Eye Institute

Locations

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Devers Eye Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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LEBO-2009-1

Identifier Type: -

Identifier Source: org_study_id

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