View Clinical Trial (Medical Research Study)
Instrument for Glaucoma Early Detection and Monitoring - NCT00578110-06510(Clinical Trial 195916)
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| City: |
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New Haven |
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State:
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CT |
| 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. |
| 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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| Study is available at: |
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Yale Eye Center, Yale University New Haven, CT 06510 United States
Primary Contact: Ann Leone Email: ann.leone@yale.edu Phone: 203-785-6150
Secondary Contact: George Hu, Ph.D. Email: georgehu@synabridge.com Phone: (908) 725-5213 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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