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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Fuchs' Corneal Endothelial Dystrophy

Intervention / Treatment
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* Device: NCI Insertion
* Procedure: Standard Forceps Insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCI Insertion<br> | Device: NCI Insertion<br>* DSAEK surgery will be performed using the NCI to insert the donor tissue.<br>|
| Active Comparator: Standard Forceps Insertion<br> | Procedure: Standard Forceps Insertion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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. | Any time during follow-up period (5 years) |