N/A
Completed N=136
How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Glaucoma Diagnosis
Source: ClinicalTrials.gov NCT02622178 ↗
Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Visual Evoked Potential (VEP) — 6.7; 7.1; 4.1 microvolts (uV) (amplitude)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Evoked Potential (VEP) |
6.7; 7.1; 4.1 | — |
| SECONDARY Retinal Nerve Fiber Layer Thickness |
95.1; 87.5; 71.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02622178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.