How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?

Wills Eye136 enrolled

Overview

Evaluate sensitivity and specificity of NOVA-DN visually evoked potentials (VEP) protocol and new software method (Corda) for glaucoma detection using optical coherence tomography (OCT) images to differentiate between normal subjects and glaucoma suspects.

The aim of this study was to evaluate the ability of NOVA-DN VEP protocol and Corda parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous visual field loss. We will evaluate measurements of the NOVA-DN VEP protocol, Corda software and Cirrus spectral domain (SD) OCT software in order to compare and correlate. Hypotheses is that NOVA-DN VEP protocol and Corda analysis results in a high sensitivity, specificity and area under the Receiver Operating Characteristic (ROC) curves (ROC area) for glaucoma detection. Second hypothesis is NOVA-DN VEP protocol and Corda parameters can differentiate between normal and glaucoma suspects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Conditions

Glaucoma Diagnosis

Interventions

Optical Coherence TomographyDIAGNOSTIC_TEST

Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.

Visual evoked potentialDIAGNOSTIC_TEST

Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Group 1: Healthy Subjects * intraocular pressure less than 22 millimeters of mercury (mmHg) * normal appearing optic discs and retinal nerve fiber layer (RNFL) * normal optical coherence tomography (OCT) RNFL thickness * normal visual field (VF) results in both eyes. Group 2: Glaucoma Suspects * glaucomatous appearance of optic discs and/or RNFL in at least one eye * normal OCT * normal VF results in both eyes. Group3: Glaucoma Patients * Glaucomatous optic disc appearance (cup to disc ratio, rim thinning or RNFL defects) * Repeatable intraocular pressure (IOP) of 23 mmHg or more, in at least one eye * Repeatable abnormal VF tests Exclusion Criteria: * inability to perform reliable VF or OCT * visual acuity worse than 20/40 * refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder

Locations (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Visual Evoked Potential (VEP)

Diopsys Visual evoked potential (VEP) (Diopsys, Inc. Pine Brook, NJ) is used to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex. This is the strength of the signal recorded from the back of the head near where vision is processed in the brain while a visual stimulus is presented to patient.

Time frame: 1 examination, one hour

Secondary Outcomes

Retinal Nerve Fiber Layer Thickness

Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.

Time frame: 1 examination, one hour

Data from ClinicalTrials.gov

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