MedTrace Logo

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

NCT02622178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-11-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Glaucoma Diagnosis

Interventions

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.

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.

Sponsors & Collaborators

  • Wills Eye

    lead OTHER

Principal Investigators

  • L J Katz, MD · Wills Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-12-31
Completion
2013-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622178 on ClinicalTrials.gov