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IGDM: Instrument for Glaucoma Early Detection and Monitoring

Sponsor
Synabridge Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00578110
Collaborator
Yale University (Other), University of Alabama at Birmingham (Other), University of Tennessee (Other)
180
Enrollment
5
Locations
3
Arms
27
Duration (Months)
36
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Glaucoma Diagnosis, Name: Neucodia
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
SBIR II Instrument for Glaucoma Early Detection and Monitoring
Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Apr 1, 2010
Anticipated Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Glaucoma Patients

Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Names:
  • NEUCODIA

    		•
    Experimental: Group 2

    Glaucoma suspects

    Device: Glaucoma Diagnosis, Name: Neucodia
    Sensitivity and Specificity
    Other Names:
  • NEUCODIA

    		•
    Active Comparator: Group 3

    Controls

    Device: Glaucoma Diagnosis, Name: Neucodia
    Sensitivity and Specificity
    Other Names:
  • NEUCODIA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sensitivity and specificity [one year]

    Secondary Outcome Measures

    1. repeatability [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age: 40 - 75 years old

    • Visual acuity: 20/30 or better

    Exclusion Criteria:
    • Eye disease other than glaucoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Optometry, University of Alabama at Birmingham Birmingham Alabama United States 35294-0010
    2 Yale Eye Center, Yale University New Haven Connecticut United States 06510
    3 Synabridge Corp. Raritan New Jersey United States 08869
    4 Edward S. Harkness Eye Institute, Columbia University New York New York United States 10032
    5 Hamilton Eye Institute, The University of Tennessee Memphis Tennessee United States 38103-3452

    Sponsors and Collaborators

    • Synabridge Corporation
    • Yale University
    • University of Alabama at Birmingham
    • University of Tennessee

    Investigators

    • 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
    • Principal Investigator: Sarwat Salim, MD, University of Tennessee
    • Study Director: Mark Swanson, OD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00578110
    Other Study ID Numbers:
    • OPTH_DEV_GLAU_02
    • 1R43EY015015-01
    • 1R43EY015015-02
    • 1R43EY015015-03
    First Posted:
    Dec 20, 2007
    Last Update Posted:
    Apr 2, 2010
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    glaucoma VEP detection device diagnosis vision
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Apr 2, 2010