View Clinical Trial (Medical Research Study)
SBIR II Instrument for Glaucoma Early Detection and Monitoring
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06510 |
| Conditions: |
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Glaucoma |
| Purpose: |
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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.
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| Study Summary: |
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The clinical study will evaluate a novel instrument designed to record visual evoked
potentials elicited by stimuli determined in prior research (Greenstein et al., 1998; Badr
et al., 2003) to drive select visual pathways that exhibit glaucomatous damage in an
efficient and automated manner. The results obtained with this novel device will be
compared with results obtained using an existing commercial device. Statistical results,
sensitivity and specificity, will be generated for the assessment of the accuracy of the
test to discriminate glaucoma patients from controls. Repeatability of the test will also
be analyzed based on the test-retest results.
Visual evoked potential (VEP) is a measure of neural function in the eye and brain. Three
skin electrodes are placed on the surface of the scalp to record the electrical activity
from the brain while the subject is observing a flickering stimulus with isolated-check/dot
pattern. The whole procedure is non-invasive and the risks are negligible.
Isolated-Check/dot Stimuli of about 10 Hz with luminance contrast of 10%, 15%, -10%, and
-15% will be used to test each eye. Eight samples for each stimulus will be recorded. Each
experimental run takes 2 seconds. The T-circ statistical method is performed to process the
data, and the VEP signal to noise ratio (SNR) is calculated in order to obtain an optimized
condition (stimulus and threshold) to separate glaucoma patients and normal group.
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| Criteria: |
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Inclusion Criteria:
- Age: 40 - 75 years old
- Visual acuity: 20/30 or better
Exclusion Criteria:
- Eye disease other than glaucoma
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| NCT ID: |
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NCT00578110 |
| Primary Contact: |
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Principal Investigator
George Hu, Ph.D.
Synabridge Corp.
George Hu, Ph.D.
Phone: (908) 725-5213
Email: georgehu@synabridge.com
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| Backup Contact: |
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Email: vepman@aol.com
Vance Zemon, Ph.D.
Phone: (845) 627-0320
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| Location Contact: |
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New Haven, Connecticut 06510
United States
Ann Leone
Phone: 203-785-6150
Email: ann.leone@yale.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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