Instrument for Glaucoma Early Detection and Monitoring

NCT ID: NCT00578110

Last Updated: 2010-04-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

Glaucoma Patients

Group Type EXPERIMENTAL

Glaucoma Diagnosis, Name: Neucodia

Intervention Type DEVICE

Sensitivity and Specificity

Group 2

Glaucoma suspects

Group Type EXPERIMENTAL

Glaucoma Diagnosis, Name: Neucodia

Intervention Type DEVICE

Sensitivity and Specificity

Group 3

Controls

Group Type ACTIVE_COMPARATOR

Glaucoma Diagnosis, Name: Neucodia

Intervention Type DEVICE

Sensitivity and Specificity

Interventions

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Glaucoma Diagnosis, Name: Neucodia

Sensitivity and Specificity

Intervention Type DEVICE

Other Intervention Names

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NEUCODIA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Eye disease other than glaucoma
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role collaborator

Synabridge Corporation

INDUSTRY

Sponsor Role lead

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

Site Status RECRUITING

Yale Eye Center, Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Synabridge Corp.

Raritan, New Jersey, United States

Site Status RECRUITING

Edward S. Harkness Eye Institute, Columbia University

New York, New York, United States

Site Status COMPLETED

Hamilton Eye Institute, The University of Tennessee

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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George Hu, Ph.D.

Role: CONTACT

(908) 725-5213

Vance Zemon, Ph.D.

Role: CONTACT

(845) 627-0320

Facility Contacts

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Naser T Naser

Role: primary

205-222-4543

Eugenie Hartmann, Ph.D.

Role: backup

205-975-3143

Ann Leone

Role: primary

203-785-6150

George Hu, Ph.D.

Role: primary

908-725-5213

Sarwat Salim, MD

Role: primary

901-351-0777

George Hu, Ph.D.

Role: backup

908-803-7040

Other Identifiers

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1R43EY015015-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R43EY015015-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R43EY015015-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OPTH_DEV_GLAU_02

Identifier Type: -

Identifier Source: org_study_id

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