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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Endothe

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 Summary:
Sponsor: Legacy Health System

Current Primary Outcome: Decrease in Endothelial Cell Density From Baseline Over Time [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Legacy Health System

Dates:
Date Received: May 16, 2011
Date Started: July 2009
Date Completion: November 2015
Last Updated: May 19, 2011
Last Verified: May 2011