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OpenTrials
Completed

NCT Number: NCT02622178

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

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.

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Key information

Conditions

Glaucoma Diagnosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography

Diagnostic 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.

Other names: OCT

Visual evoked potential

Diagnostic 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.

Other names: VEP

Primary outcomes

  1. Visual Evoked Potential (VEP)

    Time frame: 1 examination, one hour

    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.

Secondary outcomes

  1. Retinal Nerve Fiber Layer Thickness

    Time frame: 1 examination, one hour

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

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2015
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.