N/A
N=115
BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Glaucoma · Macular Degeneration · Glaucoma Suspect · Optic Neuropathy · Retinal Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT03318549 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Visual Impairment Measured by Visual Functioning Test — 80.6; 74.2; 81.1 score on a scale — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Visual Performance tests (Diagnostic_test); Brain-computer interface (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Impairment Measured by Visual Functioning Test |
80.6; 74.2; 81.1 | 0.011 sig |
| PRIMARY Number of Eyes Showing Progression |
33; 7; 26; 0; 15; 2 | 0.303 |
| PRIMARY Time to Detect Progression Measured in Years |
3.3; 2.9; 2.7; 2.9 | — |
| SECONDARY Standard Automated Perimetry Will be Assessed by the C-index |
.652; .667 | — |
| SECONDARY Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 |
95.2; 91.3; 92.6 | 0.132 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03318549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.