NCT01357122

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fuchs' Corneal Endothelial Dystrophy

Interventions

Type	Name	Description
DEVICE	NCI Insertion	DSAEK surgery will be performed using the NCI to insert the donor tissue.
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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-05-20
• Last updated: 2011-05-20

Locations

1 site across 1 country: United States