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| Name | Class |
|---|---|
| Devers Eye Institute | OTHER |
| Lions Eye Bank of Oregon Vision Research Laboratory | UNKNOWN |
| Fischer Surgical, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCI Insertion | Experimental |
| |
| Standard Forceps Insertion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCI Insertion | Device | DSAEK surgery will be performed using the NCI to insert the donor tissue. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Terry, MD | Devers Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Devers Eye Institute | Portland | Oregon | 97266 | United States |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| Standard Forceps Insertion | Procedure | 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. |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |