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Instrument for Glaucoma Early Detection and Monitoring

SBIR II Instrument for Glaucoma Early Detection and Monitoring

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00578110
Acronym
IGDM
Enrollment
180
Registered
2007-12-20
Start date
2008-01-31
Completion date
2010-04-30
Last updated
2010-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

glaucoma VEP detection device diagnosis vision

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.

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.

Interventions

DEVICEGlaucoma Diagnosis, Name: Neucodia

Sensitivity and Specificity

Sponsors

Yale University
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
University of Tennessee
CollaboratorOTHER
Synabridge Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Eye disease other than glaucoma

Design outcomes

Primary

MeasureTime frame
sensitivity and specificityone year

Secondary

MeasureTime frame
repeatabilityone year

Countries

United States

Contacts

Primary ContactGeorge Hu, Ph.D.
georgehu@synabridge.com(908) 725-5213
Backup ContactVance Zemon, Ph.D.
vepman@aol.com(845) 627-0320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026