Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
|ClinicalTrials.gov Identifier: NCT01357122|
Recruitment Status : Unknown
Verified May 2011 by Legacy Health System.
Recruitment status was: Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : May 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fuchs' Corneal Endothelial Dystrophy||Device: NCI Insertion Procedure: Standard Forceps Insertion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
|Experimental: NCI Insertion||
Device: NCI Insertion
DSAEK surgery will be performed using the NCI to insert the donor tissue.
|Active Comparator: Standard Forceps Insertion||
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357122
|United States, Oregon|
|Devers Eye Institute|
|Portland, Oregon, United States, 97266|
|Principal Investigator:||Mark A Terry, MD||Legacy Devers Eye Institute|