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

October 18, 2018 updated by: L. Jay Katz MD, Wills Eye

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects
42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal appearing optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Diagnostic test: Optical Coherence Tomography
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
Diagnostic test: Visual evoked potential
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
Experimental: Glaucoma Suspects
45 Glaucoma suspects with glaucomatous appearance optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Diagnostic test: Optical Coherence Tomography
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
Diagnostic test: Visual evoked potential
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
Experimental: Glaucoma Patients
49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc appearance (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Diagnostic test: Optical Coherence Tomography
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
Diagnostic test: Visual evoked potential
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 examination, one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 examination, one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Investigators

  • Principal Investigator: L J Katz, MD, Wills Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-125E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Manuscript has been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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