Instrument for Glaucoma Early Detection and Monitoring (IGDM)

April 1, 2010 updated by: Synabridge Corporation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Vance Zemon, Ph.D.
  • Phone Number: (845) 627-0320
  • Email: vepman@aol.com

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0010
        • Recruiting
        • School of Optometry, University of Alabama at Birmingham
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eugenie Hartmann, Ph.D.
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Eye Center, Yale University
        • Contact:
        • Principal Investigator:
          • James C Tsai, M.D. MBA
    • New Jersey
      • Raritan, New Jersey, United States, 08869
        • Recruiting
        • Synabridge Corp.
        • Contact:
        • Principal Investigator:
          • George Hu, Ph.D.
    • New York
      • New York, New York, United States, 10032
        • Completed
        • Edward S. Harkness Eye Institute, Columbia University
    • Tennessee
      • Memphis, Tennessee, United States, 38103-3452
        • Recruiting
        • Hamilton Eye Institute, The University of Tennessee
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter A Netland, MD, Ph.D.
        • Principal Investigator:
          • Sarwat Salim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Eye disease other than glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sensitivity and specificity
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
repeatability
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synabridge Corporation

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTH_DEV_GLAU_02
  • 1R43EY015015-01 (U.S. NIH Grant/Contract)
  • 1R43EY015015-02 (U.S. NIH Grant/Contract)
  • 1R43EY015015-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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