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Completed

NCT Number: NCT03318549

BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.

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Key information

Conditions

Glaucoma Cranial Nerve Diseases Eye Diseases Eye Diseases, Hereditary Glaucoma Suspect Macular Degeneration Nervous System Diseases Ocular Hypertension Optic Nerve Diseases Optic Neuropathy Retinal Degeneration Retinal Diseases Visual Pathway Disorder

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be between the ages of 18 and 90 years old;
  • Both males and females will be included.
  • Be able and willing to provide signed informed consent and follow study instructions

Exclusion criteria

  • Subjects will be excluded if they present with any systemic conditions that in the opinion of the Principal Investigator may prevent them from completing the tests.

Treatment and study plan

Visual Performance tests

Diagnostic Test

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

Device

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.

Primary outcomes

  1. Visual Impairment Measured by Visual Functioning Test

    Time frame: 4.5 years

    The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment.

  2. Number of Eyes Showing Progression

    Time frame: 4.5 years

    The number of eyes showing progression (expressed in percentage) will be compared between the home-based Brain-computer interface (BCI) testing and standard clinical testing (standard automated perimetry, SAP)

  3. Time to Detect Progression Measured in Years

    Time frame: 4.5 years

    The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).

Secondary outcomes

  1. Standard Automated Perimetry Will be Assessed by the C-index

    Time frame: 4.5 years

    c-index will be calculated by the proportion of concordant pairs divided by the total number of possible evaluation pairs for progression. c-index is unitless.

  2. Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25

    Time frame: 4.5 years

    The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2017
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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