Clinical trial NCT00578110: Instrument for Glaucoma Early Detection and Monitoring
Official title: SBIR II Instrument for Glaucoma Early Detection and Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma VEP detection device diagnosis vision
Lead sponsor: Synabridge Corporation
Sponsor class: INDUSTRY
Collaborators: name: Yale University
name: University of Alabama at Birmingham
name: University of Tennessee
First posted: 2007-12-20
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Eye disease other than glaucoma

Primary outcomes:
measure: sensitivity and specificity
timeFrame: one year
Secondary outcomes:
measure: repeatability
timeFrame: one year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: School of Optometry, University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale Eye Center, Yale University
state: Connecticut
city: Raritan
country: United States
facility: Synabridge Corp.
state: New Jersey
city: New York
country: United States
facility: Edward S. Harkness Eye Institute, Columbia University
state: New York
city: Memphis
country: United States
facility: Hamilton Eye Institute, The University of Tennessee
state: Tennessee
Study officials:
affiliation: Synabridge Corp.
name: George Hu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: James Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Max Forbes, M.D.
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Vivienne Greenstein, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Eugenue Hartmann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Peter Netland, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Leo Pau Semes, O.D.
role: STUDY_DIRECTOR
affiliation: Yeshiva University
name: Vance M Zemon, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Tennessee
name: Sarwat Salim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Mark Swanson, OD
role: STUDY_DIRECTOR
References: