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N/A N=136 Randomized Diagnostic

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

Glaucoma Diagnosis

Bottom Line

View on ClinicalTrials.gov: NCT02622178 ↗
Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Visual Evoked Potential (VEP) — 6.7; 7.1; 4.1 microvolts (uV) (amplitude)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Optical Coherence Tomography (Diagnostic_test); Visual evoked potential (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wills Eye
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Evoked Potential (VEP)		 6.7; 7.1; 4.1 —
SECONDARY
Retinal Nerve Fiber Layer Thickness		 95.1; 87.5; 71.2 —

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.

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
View full record on ClinicalTrials.gov →

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.

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