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Instrument for Glaucoma Early Detection and Monitoring (IGDM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Synabridge Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Yale University
University of Alabama at Birmingham
University of Tennessee
Information provided by:
Synabridge Corporation
ClinicalTrials.gov Identifier:
NCT00578110
First received: December 11, 2007
Last updated: April 1, 2010
Last verified: April 2010

December 11, 2007
April 1, 2010
January 2008
April 2010   (final data collection date for primary outcome measure)
sensitivity and specificity [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00578110 on ClinicalTrials.gov Archive Site
repeatability [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Instrument for Glaucoma Early Detection and Monitoring
SBIR II Instrument for Glaucoma Early Detection and Monitoring

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Glaucoma
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
  • Experimental: Group 1
    Glaucoma Patients
    Intervention: Device: Glaucoma Diagnosis, Name: Neucodia
  • Experimental: Group 2
    Glaucoma suspects
    Intervention: Device: Glaucoma Diagnosis, Name: Neucodia
  • Active Comparator: Group 3
    Controls
    Intervention: Device: Glaucoma Diagnosis, Name: Neucodia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 40 - 75 years old
  • Visual acuity: 20/30 or better

Exclusion Criteria:

  • Eye disease other than glaucoma
Both
40 Years to 75 Years
Yes
Contact: George Hu, Ph.D. (908) 725-5213 georgehu@synabridge.com
Contact: Vance Zemon, Ph.D. (845) 627-0320 vepman@aol.com
United States
 
NCT00578110
OPTH_DEV_GLAU_02, 1R43EY015015-01, 1R43EY015015-02, 1R43EY015015-03
No
George Hu, President, Synabridge Corp.
Synabridge Corporation
  • Yale University
  • University of Alabama at Birmingham
  • University of Tennessee
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
Synabridge Corporation
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP