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

Legacy Health System

Status and phase: Unknown; Phase 4

Conditions: Fuchs' Corneal Endothelial Dystrophy

Treatments: Procedure: Standard Forceps Insertion; Device: NCI Insertion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01357122

LEBO-2009-1

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

NCI Insertion

Experimental group

Treatment:

Device: NCI Insertion

Standard Forceps Insertion

Active Comparator group

Treatment:

Procedure: Standard Forceps Insertion