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

Completed · Not applicable

Conditions studied: Glaucoma Diagnosis

In brief

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.

Key facts

Study ID

NCT02622178

Run by

Wills Eye

People needed

136

Starts

2011-09-01

Expected to finish

2013-12-01

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wills Eye Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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