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Assessment of Visual Function With a Portable Brain-computer Interface

NCT03760055 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-02-27

No results posted yet for this study

Summary

1. The purpose of this study is to evaluate the nGoggle's accuracy and repeatability in detecting visual function loss. In addition, the ability to stage glaucomatous damage and investigate the relationship between nGoggle metrics and neural damage in glaucoma will also be evaluated.
2. Longitudinal study, including 200 patients with: glaucoma, suspected of having glaucoma, nonglaucomatous optic neuropathies, AMD, retinal degenerations, other diseases involving the visual pathways, besides healthy controls. Subjects will perform standard ophthalmological exams, and the following research tests: electroencephalogram, visual evoked potentials, and questionnaires.
3. Statistical analyses will be performed by the PI using the software Stata, MATLAB, and MPLUS. Risks are low, consisting of some discomfort, fatigue, dizziness or motion sickness.

Conditions

  • Glaucoma
  • Age Related Macular Degeneration
  • Optic Neuropathy
  • Retinal Degeneration

Interventions

DEVICE

nGoggle

The nGoggle is a portable visual evoked potential system that uses an EEG to acquire visual evoked potentials in response to visual stimuli presented on a virtual reality goggle. The investigators will assess the ability of the nGoggle to detect visual field loss in patients with glaucoma, as well as to discriminate among the different stages of the disease, its repeatability and reliability for patient self-testing and patient satisfaction compared to standard automated perimetry (SAP), optical coherence tomography (OCT) metrics and Diopsys NOVA (Diopsys, Inc.). In addition, patients with other diseases affecting the visual system will also be tested in order to assess whether the nGoggle can differentiate glaucoma from them.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • National Eye Institute (NEI)

    collaborator NIH

  • NGoggle

    lead INDUSTRY

Principal Investigators

  • Henry Tseng, PhD · Duke University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760055 on ClinicalTrials.gov