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

Not Applicable

Completed

• Conditions: Macular Degeneration; Optic Neuropathy; Glaucoma Suspect; Retinal Degeneration; Glaucoma; Visual Pathway Disorder
• Interventions: Diagnostic Test: Visual Performance tests; Device: Brain-computer interface

• Registration Number: NCT03318549
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Study Start: 2018-10-29
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Results First Submitted: 2024-05-30
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glaucoma group	Brain-computer interface	Patients with diagnosed glaucoma will be in the group for up to 5 years.
Non-glaucomatous optic neuropathies group	Visual Performance tests	Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Glaucoma group	Visual Performance tests	Patients with diagnosed glaucoma will be in the group for up to 5 years.
Retinal degenerations group	Visual Performance tests	Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Other diseases of visual pathways group	Visual Performance tests	Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Healthy control group	Visual Performance tests	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.
Healthy control group	Brain-computer interface	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.
Suspicious of having glaucoma group	Visual Performance tests	Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Suspicious of having glaucoma group	Brain-computer interface	Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Age-related macular degeneration (AMD) group	Visual Performance tests	Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.

Primary Outcome Measures

Name	Time	Method
Visual Impairment Measured by Visual Functioning Test	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.
Number of Eyes Showing Progression	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)
Time to Detect Progression Measured in Years	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 Outcome Measures

Name	Time	Method
Standard Automated Perimetry Will be Assessed by the C-index	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.
Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25	4.5 years	The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States