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

NCT03318549 | Completed Results

• 3 other identifiers: 20240020Pro00088016R01EY029885
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

virtual reality; glaucoma; age related macular degeneration; quality of life; visual field; optical coherence tomography; brain-computer interface

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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).

  4.5 years

Secondary Outcomes (2)

• Standard Automated Perimetry Will be Assessed by the C-index

  4.5 years

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

  4.5 years

Study Arms (7)

Glaucoma group

OTHER

Patients with diagnosed glaucoma will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests; Device: Brain-computer interface

Suspicious of having glaucoma group

OTHER

Patients with suspicious of having glaucoma will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests; Device: Brain-computer interface

Non-glaucomatous optic neuropathies group

OTHER

Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests

Age-related macular degeneration (AMD) group

OTHER

Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests

Retinal degenerations group

OTHER

Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests

Other diseases of visual pathways group

OTHER

Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.

Diagnostic Test: Visual Performance tests

Healthy control group

OTHER

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.

Diagnostic Test: Visual Performance tests; Device: Brain-computer interface

Interventions

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.

Age-related macular degeneration (AMD) group; Glaucoma group; Healthy control group; Non-glaucomatous optic neuropathies group; Other diseases of visual pathways group; Retinal degenerations group; Suspicious of having glaucoma group

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.

Glaucoma group; Healthy control group; Suspicious of having glaucoma group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Glaucoma; Macular Degeneration; Ocular Hypertension; Optic Nerve Diseases; Retinal Degeneration

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases, Hereditary

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Limitations and Caveats

No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group. A limited number of patients reached the 5-year follow-up mark, which did not provide enough power for progression analysis.

Results Point of Contact

• Title: Vice Chair of Research
• Organization: University of Miami

fmedeiros@med.miami.edu

305-326-6373

Study Officials

• Felipe A Medeiros, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Henry Tseng, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: October 29, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)