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Clinical Trials/NCT03318549
NCT03318549
Completed
Not Applicable

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

University of Miami1 site in 1 country115 target enrollmentOctober 29, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
University of Miami
Enrollment
115
Locations
1
Primary Endpoint
Visual Impairment Measured by Visual Functioning Test
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
May 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Felipe Andrade Medeiros

Professor

University of Miami

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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)

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

  • 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 Sites (1)

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