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)
Sponsor study identifier
interventional
100
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 16, 2011
Actual (reported)May 20, 2011
Actual (reported)November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Decrease in Endothelial Cell Density From Baseline Over Time
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.
6, 12, 24, and 60 Months
Adverse events
Any time during follow-up period (5 years)
DSAEK surgery will be performed using the NCI to insert the donor tissue.
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.
Devers Eye Institute
Portland, Oregon, 97266, United States
Mark A Terry, MD
Devers Eye Institute
100 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2011
First Posted
May 20, 2011
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 20, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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