Evaluation of Visual and Task Performance

Study Overview
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Brief Summary
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Better understand the impact of visual impairment on daily task performance in patients with eye diseases of the visual pathways, such as glaucoma and age-related macular degeneration (AMD). Longitudinal study, with biannual visits, including patients with: glaucoma, suspected of having glaucoma, non-glaucomatous optic neuropathies, AMD, retinal degenerations, other diseases involving the visual pathways, besides healthy controls. Subjects will perform standard ophthalmological exams, and the following research tests: psychophysical, eye tracking, electroencephalogram, driving simulator, virtual reality, balance assessment, and questionnaires. This proposal also includes an investigation of the ability of longitudinal brain-computer interface (BCI) multifocal steady-state visual-evoked potentials (mfSSVEP) parameters in detecting glaucoma progression. We hypothesize that BCI mfSSVEP data will be able to successfully detect progression and measure rates of change, as compared to functional assessment by standard automated perimetry (SAP) and structural assessment by optical coherence tomography.

Official Title
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Evaluation of Visual and Task Performance in Subjects With Eye Diseases

Conditions
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Glaucoma, Macular Degeneration, Glaucoma Suspect, Optic Neuropathy, Retinal Degeneration, Visual Pathway Disorder

Intervention / Treatment
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* Diagnostic Test: Visual Performance tests
* Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glaucoma<br>Patients with diagnosed glaucoma | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials<br>* The brain-computer interface (BCI) device 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.<br>|
| Other: Suspicious of having glaucoma<br>Patients with suspicious of having glaucoma based on intra-ocular pressure or optic nerve photographs with glaucoma appearance | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials<br>* The brain-computer interface (BCI) device 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.<br>|
| Other: Non-glaucomatous optic neuropathies;<br>Patients with optic neuropathies that do not look glaucomatous-like | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>|
| Other: Age-related macular degeneration (AMD)<br>Patients with diagnosed age-related macular degeneration | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>|
| Other: Retinal degenerations<br>Patients with other retinal degenerations excluding AMD | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>|
| Other: Other diseases of visual pathways<br>Other diseases of the visual pathway not included in the previous groups | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>|
| Other: Healthy control group<br>Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups | Diagnostic Test: Visual Performance tests<br>* The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.<br>Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials<br>* The brain-computer interface (BCI) device 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual impairment measured by a composite of scores | The study team will evaluate visual impairment through the following scores obtained from the following composite tests: ophthalmological evaluation, questionnaires, psychophysics tests, eye tracking devices, electroencephalogram exams, driving simulator, virtual reality tests, and balance assessment. | 5 years | 
| 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 | 
| Time to detect progression | The time to detect progression will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive ability to detect progression (c-index) | The ability of home-based BCI testing to predict future progression on standard automated perimetry will be assessed by the c-index. | 5 years | 
| Ability to predict changes in patient-reported quality of life (c-index) | The ability of home-based BCI testing to predict changes in patient-reported quality of life data as assessed by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be assessed by the c-index. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, glaucoma, age related macular degeneration, quality of life, visual field, optical coherence tomography, brain-computer interface