Glaucoma Clinical Trial
Official title:
Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Verified date | February 2024 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bascom Palmer Eye Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Eye Institute (NEI) |
United States,
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 |
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