Clinical Trial: Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
Study Status: Active, not recruiting
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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Adverse events [ Time Frame: Any time during follow-up period (5 years) ]
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