Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2008-01-31
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1
Glaucoma Patients
Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Group 2
Glaucoma suspects
Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Group 3
Controls
Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Interventions
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Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity: 20/30 or better
Exclusion Criteria
40 Years
75 Years
ALL
Yes
Sponsors
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Yale University
OTHER
University of Alabama at Birmingham
OTHER
University of Tennessee
OTHER
Synabridge Corporation
INDUSTRY
Responsible Party
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Synabridge Corp.
Principal Investigators
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George Hu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Synabridge Corp.
James Tsai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Max Forbes, M.D.
Role: STUDY_DIRECTOR
Columbia University
Vivienne Greenstein, Ph.D.
Role: STUDY_DIRECTOR
Columbia University
Eugenue Hartmann, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Peter Netland, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Leo Pau Semes, O.D.
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Vance M Zemon, Ph.D.
Role: STUDY_DIRECTOR
Yeshiva University
Sarwat Salim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Mark Swanson, OD
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Locations
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School of Optometry, University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale Eye Center, Yale University
New Haven, Connecticut, United States
Synabridge Corp.
Raritan, New Jersey, United States
Edward S. Harkness Eye Institute, Columbia University
New York, New York, United States
Hamilton Eye Institute, The University of Tennessee
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPTH_DEV_GLAU_02
Identifier Type: -
Identifier Source: org_study_id
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