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

Glaucoma Diagnosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622178
• Other study ID #: 11-125E
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Diagnosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & Publications (1)

Waisbourd M, Gensure RH, Aminlari A, Shah SB, Khanna N, Sood N, Molineaux J, Gonzalez A, Myers JS, Katz LJ. Short-duration transient visual evoked potentials and color reflectivity discretization analysis in glaucoma patients and suspects. Int J Ophthalmo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 examination, one hour
Secondary	Retinal Nerve Fiber Layer Thickness	Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.	1 examination, one hour