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

Phase 4

• Conditions: Fuchs' Corneal Endothelial Dystrophy
• Interventions: Device: NCI Insertion; Procedure: Standard Forceps Insertion

• Registration Number: NCT01357122
• Lead Sponsor: Legacy Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Status Verified: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-19
• Last Update Submitted: 2011-05-19
• Study First Posted: 2011-05-20
• Last Update Posted: 2011-05-20
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCI Insertion	NCI Insertion	-
Standard Forceps Insertion	Standard Forceps Insertion	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Devers Eye Institute; 🇺🇸 Portland, Oregon, United States