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Study Topics
Glossary
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| Sponsors and Collaborators: |
Synabridge Corporation Yale University Columbia University University of Alabama at Birmingham University of Tennessee |
|---|---|
| Information provided by: | Synabridge Corporation |
| ClinicalTrials.gov Identifier: | NCT00578110 |
Purpose
To introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Device: Glaucoma Diagnosis, Name: Neucodia |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | SBIR II Instrument for Glaucoma Early Detection and Monitoring |
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Glaucoma Patients
|
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
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2: Experimental
Glaucoma suspects
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Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
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3: Active Comparator
Controls
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Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
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Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: George Hu, Ph.D. | (908) 725-5213 | georgehu@synabridge.com |
| Contact: Vance Zemon, Ph.D. | (845) 627-0320 | vepman@aol.com |
| United States, Connecticut | |
| Yale Eye Center | |
| New Haven, Connecticut, United States, 06510 | |
| United States, New Jersey | |
| Synabridge Corp. | |
| Raritan, New Jersey, United States, 08869 | |
| Principal Investigator: | George Hu, Ph.D. | Synabridge Corp. |
| Principal Investigator: | James Tsai, M.D. | Yale University |
| Study Director: | Max Forbes, M.D. | Columbia University |
| Study Director: | Vivienne Greenstein, Ph.D. | Columbia University |
| Principal Investigator: | Eugenue Hartmann, Ph.D. | University of Alabama at Birmingham |
| Principal Investigator: | Peter Netland, M.D. Ph.D. | University of Tennessee |
| Study Director: | Leo Pau Semes, O.D. | University of Alabama at Birmingham |
| Study Director: | Vance M Zemon, Ph.D. | Yeshiva University |
More Information
| Responsible Party: | Synabridge Corp. ( George Hu, President ) |
| Study ID Numbers: | OPTH_DEV_GLAU_02, 1R43EY015015-01, 1R43EY015015-02 |
| Study First Received: | December 11, 2007 |
| Last Updated: | December 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00578110 |
| Health Authority: | United States: Institutional Review Board |
|
glaucoma VEP detection device diagnosis vision |
|
Glaucoma Eye Diseases Hypertension Ocular Hypertension |
