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

Not Applicable

Completed

• Conditions: Glaucoma Diagnosis

• Registration Number: NCT02622178
• Lead Sponsor: Wills Eye

Brief Summary

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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-04
• Results First Submitted: 2017-12-18
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-18
• Last Update Submitted: 2018-10-18
• Results First Posted: 2018-11-15
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Evoked Potential (VEP)	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 Outcome Measures

Name	Time	Method
Retinal Nerve Fiber Layer Thickness	1 examination, one hour	Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.

Trial Locations

Locations (1)

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States