BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
NCT ID: NCT03318549
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
115 participants
INTERVENTIONAL
2018-10-29
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Glaucoma group
Patients with diagnosed glaucoma will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface
The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Suspicious of having glaucoma group
Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface
The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Non-glaucomatous optic neuropathies group
Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Age-related macular degeneration (AMD) group
Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Retinal degenerations group
Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Other diseases of visual pathways group
Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Healthy control group
Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface
The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Interventions
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Visual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface
The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Eligibility Criteria
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Inclusion Criteria
* Both males and females will be included.
* Be able and willing to provide signed informed consent and follow study instructions
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
University of Miami
OTHER
Responsible Party
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Felipe Andrade Medeiros
Professor
Principal Investigators
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Felipe A Medeiros, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Henry Tseng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Bascom Palmer Eye Institute
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00088016
Identifier Type: OTHER
Identifier Source: secondary_id
20240020
Identifier Type: -
Identifier Source: org_study_id
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