Clinical trial NCT02622178: How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Official title: Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma Diagnosis
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Evoked Potential (VEP)
timeFrame: 1 examination, one hour
Secondary outcomes:
measure: Retinal Nerve Fiber Layer Thickness
timeFrame: 1 examination, one hour
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: L J Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Ophthalmol. 2017 Feb 18;10(2):254-261. doi: 10.18240/ijo.2017.02.12. eCollection 2017.