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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318549
• Other study ID #: 20240020
• Secondary ID: Pro00088016R01EY
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Glaucoma Suspect
• Macular Degeneration
• Optic Nerve Diseases
• Optic Neuropathy
• Retinal Degeneration
• Visual Pathway Disorder

Intervention

Diagnostic Test:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 higher scores indicating worse visual impairment.	5 years
Primary	Proportion of eyes showing progression	The proportion of eyes showing progression will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry), matched by specificity.	5 years
Primary	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).	5 years
Secondary	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.	5 years
Secondary	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.	5 years