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NCT00578110 Clinical Trial

Instrument for Glaucoma Early Detection and Monitoring

Glaucoma Clinical Trial

— IGDM  

Official title:
SBIR II Instrument for Glaucoma Early Detection and Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00578110
Other study ID # OPTH_DEV_GLAU_02
Secondary ID 1R43EY015015-011
Status Recruiting
Phase N/A
First received December 11, 2007
Last updated April 1, 2010
Start date January 2008
Est. completion date April 2010

Study information
Verified date April 2010
Source Synabridge Corporation
Contact George Hu, Ph.D.
Phone (908) 725-5213
Email georgehu@synabridge.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Age: 40 - 75 years old

- Visual acuity: 20/30 or better

Exclusion Criteria:

- Eye disease other than glaucoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity

Locations
Country Name City State
United States School of Optometry, University of Alabama at Birmingham Birmingham Alabama
United States Hamilton Eye Institute, The University of Tennessee Memphis Tennessee
United States Yale Eye Center, Yale University New Haven Connecticut
United States Edward S. Harkness Eye Institute, Columbia University New York New York
United States Synabridge Corp. Raritan New Jersey

Sponsors (4)
Lead Sponsor Collaborator
Synabridge Corporation University of Alabama at Birmingham, University of Tennessee, Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity and specificity one year No
Secondary repeatability one year No
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