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

Sponsor

Legacy Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT01357122

Collaborator

Devers Eye Institute (Other), Lions Eye Bank of Oregon Vision Research Laboratory (Other), Fischer Surgical, Inc. (Industry)

100

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Corneal Endothelial Dystrophy	Device: NCI Insertion Procedure: Standard Forceps Insertion	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Observer-masked, Clinical Trial Comparing the Neusidl Corneal Inserter Corneal Transplant Technique to the Standard Forceps Insertion Technique for Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NCI Insertion	Device: NCI Insertion DSAEK surgery will be performed using the NCI to insert the donor tissue.
Active Comparator: Standard Forceps Insertion	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.

Arm

Intervention/Treatment

Experimental: NCI Insertion

Device: NCI Insertion

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

Active Comparator: Standard Forceps Insertion

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.

Outcome Measures

Primary Outcome Measures

Decrease in Endothelial Cell Density From Baseline Over Time [6, 12, 24, and 60 Months]
Endothelial cell density (ECD) will be captured at each follow-up visit using a non-contact specular microscope. % Cell reduction from pre-operative baseline ECD will be calculated for each patient, and compared between treatment arms to evaluate each instrument's effect on long-term post-operative endothelial cell density.

Secondary Outcome Measures

Adverse events [Any time during follow-up period (5 years)]
Each patient will be monitored for incidence of graft dislocation, primary graft failure, immunologic graft rejection, and late endothelial failure. Rates will be compared between groups to ensure that the NCI does not increase the risk of these adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Devers Eye Institute	Portland	Oregon	United States	97266

Sponsors and Collaborators

Legacy Health System
Devers Eye Institute
Lions Eye Bank of Oregon Vision Research Laboratory
Fischer Surgical, Inc.

Investigators

Principal Investigator: Mark A Terry, MD, Devers Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01357122

Other Study ID Numbers:

LEBO-2009-1

First Posted:

May 20, 2011

Last Update Posted:

May 20, 2011

Last Verified:

May 1, 2011

Study Results

No Results Posted as of May 20, 2011