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

University of Miami115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

115

Conditions

Glaucoma Macular Degeneration Glaucoma Suspect Optic Neuropathy Retinal Degeneration Visual Pathway Disorder

Interventions

Visual Performance testsDIAGNOSTIC_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 interfaceDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bascom Palmer Eye Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

Visual Impairment Measured by Visual Functioning Test

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.

Time frame: 4.5 years

Number of Eyes Showing Progression

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)

Time frame: 4.5 years

Time to Detect Progression Measured in 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).

Time frame: 4.5 years

Secondary Outcomes

Standard Automated Perimetry Will be Assessed by the C-index

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.

Time frame: 4.5 years

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

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

Time frame: 4.5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.