Assessment of Visual Function With a Portable Brain-computer Interface
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Device accuracy to detect visual field loss
Study Overview
Brief Summary
- The purpose of this study is to evaluate the nGoggle's accuracy and repeatability in detecting visual function loss. In addition, the ability to stage glaucomatous damage and investigate the relationship between nGoggle metrics and neural damage in glaucoma will also be evaluated.
- Longitudinal study, including 200 patients with: glaucoma, suspected of having glaucoma, nonglaucomatous 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: electroencephalogram, visual evoked potentials, and questionnaires.
- Statistical analyses will be performed by the PI using the software Stata, MATLAB, and MPLUS. Risks are low, consisting of some discomfort, fatigue, dizziness or motion sickness.
Detailed Description
Background & Significance
Assessment of functional loss in glaucoma has been traditionally made with standard automated perimetry (SAP). Despite the significant progress achieved with the development of SAP, assessment of visual field loss still has significant drawbacks. SAP testing is limited by subjectivity of patient responses and high test-retest variability, frequently requiring many tests for effective detection of change over time. Moreover, as these tests are generally conducted in clinic-based settings, limited patient availability and health care resources often result in an insufficient number of tests acquired over time, with delayed diagnosis and detection of disease progression. The requirement for highly trained technicians, cost, complexity, and lack of portability of SAP also preclude its use for screening of visual field loss in underserved populations. Furthermore, current SAP testing as performed in clinical practice frequently results in delayed detection of progression, with potential late initiation/escalation of treatment and irreversible functional damage.
As a part of a funded Phase I project, the nGoggle (nGoggle Inc., San Diego, CA), the first device of its kind, allowed a portable and objective brain-based assessment of visual function deficits in glaucoma. The nGoggle integrates a wearable, wireless, no-prep EEG system and a head-mounted display (HMD) to allow users to routinely monitor electrical brain activities associated with visual field stimulation. A recent study comparing the diagnostic accuracies of an earlier version of the nGoggle and SAP in discriminating patients with glaucoma from healthy subjects found that the nGoggle performed at least as well, if not better than, SAP with the additional advantage of portability and objectivity.
The overall goal of this proposal is to test the nGoggle's accuracy and repeatability in detecting visual function loss. In addition, its ability to stage glaucomatous damage, by discriminating patients at different stages of the disease will be evaluated. Finally, the relationship between nGoggle metrics and neural damage in glaucoma as detected by other objective techniques such as optical coherence tomography will also be investigated. Patients with other diseases affecting the visual system will also be included in order to assess whether the nGoggle can differentiate glaucoma from them.
Study Design & Procedures
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 or ocular conditions that in the opinion of the Principal Investigator may prevent them from completing the tests (e.g. history of seizures or other coexistent ocular pathologies).
Outcomes
Primary Outcomes
Device accuracy to detect visual field loss
Time Frame: from date of enrollment and every 6 months, up to 5 years
Comparison of diagnostic accuracies will be performed by analyzing areas under the receiver operating characteristic (ROC) curves for each nGoggle and SAP metric by assessment of partial areas under the ROC curves (targeting high specificity\>90% region), sensitivities at matched specificities and diagnostic likelihood ratios (LRs). The investigators will also evaluate the correlation between nGoggle multifocal steady-state visual evoked potentials (mfSSVEP) metrics and SAP parameters throughout the disease spectrum.
Device accuracy to detect objective functional loss
Time Frame: from date of enrollment and every 6 months, up to 5 years
Comparison of diagnostic accuracies will be performed by analyzing areas under the receiver operating characteristic (ROC) curves for each nGoggle and Diopsys NOVA parameters, as well as by assessment of partial areas under the ROC curves (targeting high specificity\>90% region), sensitivities at matched specificities and diagnostic likelihood ratios (LRs). The investigators will also evaluate the correlation between nGoggle mfSSVEP metrics and those parameters throughout the disease spectrum. SDOCT testing will be performed with Spectralis OCT (Heidelberg Engineering, Germany). SDOCT parameters to be investigated will include retinal nerve fiber layer (RNFL) thickness, minimum rim width (MRW) and macular thickness.
Device accuracy to detect structural neural loss
Time Frame: from date of enrollment and every 6 months, up to 5 years
Comparison of diagnostic accuracies will be performed by analyzing areas under the receiver operating characteristic (ROC) curves for each nGoggle and OCT parameters, as well as by assessment of partial areas under the ROC curves (targeting high specificity\>90% region), sensitivities at matched specificities and diagnostic likelihood ratios (LRs). The investigators will also evaluate the correlation between nGoggle mfSSVEP metrics and SDOCT parameters throughout the disease spectrum. SDOCT testing will be performed with Spectralis OCT (Heidelberg Engineering, Germany). SDOCT parameters to be investigated will include retinal nerve fiber layer (RNFL) thickness, minimum rim width (MRW) and macular thickness.
Assessment of repeatability
Time Frame: 6 weeks
Assessment of repeatability of the device parameters will be evaluated through intra-class correlation coefficient (ICC). A subgroup of subjects will undergo 5 visits over a short period of time (6 weeks). A sample size of 35 subjects will provide a width of 0.1 for the 95% for ICC, allowing assessment of repeatability of the devices parameters.
Secondary Outcomes
- Patients' satisfaction(from date of enrollment and every 6 months, up to 5 years)