This trial is active, not recruiting.

Condition fuchs' corneal endothelial dystrophy
Treatments nci insertion, standard forceps insertion
Phase phase 4
Sponsor Legacy Health System
Collaborator Devers Eye Institute
Start date July 2009
End date November 2015
Trial size 100 participants
Trial identifier NCT01357122, LEBO-2009-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
nci insertion
DSAEK surgery will be performed using the NCI to insert the donor tissue.
(Active Comparator)
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.

Primary Outcomes

Decrease in Endothelial Cell Density From Baseline Over Time
time frame: 6, 12, 24, and 60 Months

Secondary Outcomes

Adverse events
time frame: Any time during follow-up period (5 years)

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

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)
Principal investigator Mark A Terry, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Legacy Health System.