Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
This trial is active, not recruiting.
|Condition||fuchs' corneal endothelial dystrophy|
|Treatments||nci insertion, standard forceps insertion|
|Sponsor||Legacy Health System|
|Collaborator||Devers Eye Institute|
|Start date||July 2009|
|End date||November 2015|
|Trial size||100 participants|
|Trial identifier||NCT01357122, LEBO-2009-1|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Decrease in Endothelial Cell Density From Baseline Over Time
time frame: 6, 12, 24, and 60 Months
time frame: Any time during follow-up period (5 years)
Male or female participants at least 21 years old.
Inclusion Criteria: - Age 21 and over - A diagnosis of Fuchs' Corneal Endothelial Dystrophy Exclusion Criteria: - Under age 21 - Diagnosis of advanced glaucomatous disease - Diagnosis of significant retinal disease - Diagnosis of any other corneal dystrophy - Previous corneal transplant surgery - Previous glaucoma surgery - Previous retinal surgery - Previous refractive surgery
|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)|
|Principal investigator||Mark A Terry, MD|
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