Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Yale University
University of Alabama at Birmingham
University of Tennessee
Information provided by:
Synabridge Corporation Identifier:
First received: December 11, 2007
Last updated: April 1, 2010
Last verified: April 2010

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 Intervention
Device: Glaucoma Diagnosis, Name: Neucodia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: SBIR II Instrument for Glaucoma Early Detection and Monitoring

Resource links provided by NLM:

Further study details as provided by Synabridge Corporation:

Primary Outcome Measures:
  • sensitivity and specificity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • repeatability [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Glaucoma Patients
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
Experimental: Group 2
Glaucoma suspects
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
Active Comparator: Group 3
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA

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.


Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00578110

Contact: George Hu, Ph.D. (908) 725-5213
Contact: Vance Zemon, Ph.D. (845) 627-0320

United States, Alabama
School of Optometry, University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-0010
Contact: Naser T Naser    205-222-4543   
Contact: Eugenie Hartmann, Ph.D.    205-975-3143   
Principal Investigator: Eugenie Hartmann, Ph.D.         
United States, Connecticut
Yale Eye Center, Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ann Leone    203-785-6150   
Principal Investigator: James C Tsai, M.D. MBA         
United States, New Jersey
Synabridge Corp. Recruiting
Raritan, New Jersey, United States, 08869
Contact: George Hu, Ph.D.    908-725-5213   
Principal Investigator: George Hu, Ph.D.         
United States, New York
Edward S. Harkness Eye Institute, Columbia University Completed
New York, New York, United States, 10032
United States, Tennessee
Hamilton Eye Institute, The University of Tennessee Recruiting
Memphis, Tennessee, United States, 38103-3452
Contact: Sarwat Salim, MD    901-351-0777   
Contact: George Hu, Ph.D.    908-803-7040   
Principal Investigator: Peter A Netland, MD, Ph.D.         
Principal Investigator: Sarwat Salim, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: George Hu, President, Synabridge Corp. Identifier: NCT00578110     History of Changes
Other Study ID Numbers: OPTH_DEV_GLAU_02, 1R43EY015015-01, 1R43EY015015-02, 1R43EY015015-03
Study First Received: December 11, 2007
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Synabridge Corporation:
glaucoma VEP detection device diagnosis vision

Additional relevant MeSH terms:
Eye Diseases
Ocular Hypertension processed this record on February 27, 2015