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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Fuchs' Corneal Endothelial Dystrophy
• Intervention / Treatment: Device: NCI Insertion; Procedure: Standard Forceps Insertion

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97266
      • Devers Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Endothelial Cell Density From Baseline Over Time	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.	6, 12, 24, and 60 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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.	Any time during follow-up period (5 years)

Collaborators and Investigators

• Sponsor: Legacy Health System
• Collaborators: 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 record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2011
• Last Update Submitted That Met QC Criteria: May 19, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: LEBO-2009-1