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

Wills Eye

Status: Completed

Conditions: Glaucoma Diagnosis

Treatments: Diagnostic Test: Visual evoked potential; Diagnostic Test: Optical Coherence Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02622178

11-125E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 3 patient groups

Healthy Subjects

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Optical Coherence Tomography

Diagnostic Test: Visual evoked potential

Glaucoma Suspects

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Optical Coherence Tomography

Diagnostic Test: Visual evoked potential

Glaucoma Patients

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Optical Coherence Tomography

Diagnostic Test: Visual evoked potential