Assessment of Visual Function With a Portable Brain-computer Interface

NCT03760055 | Unknown

• 2 other identifiers: Pro00100894R42EY027651
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.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.
2. 2.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.
3. 3.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.

Conditions

Glaucoma; Age Related Macular Degeneration; Optic Neuropathy; Retinal Degeneration

Outcome Measures

Primary Outcomes (4)

• Device accuracy to detect visual field loss

  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.

  from date of enrollment and every 6 months, up to 5 years

• Device accuracy to detect structural neural loss

  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.

  from date of enrollment and every 6 months, up to 5 years

• Device accuracy to detect objective functional loss

  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.

  from date of enrollment and every 6 months, up to 5 years

• Assessment of repeatability

  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.

  6 weeks

Secondary Outcomes (1)

• Patients' satisfaction

  from date of enrollment and every 6 months, up to 5 years

Study Arms (4)

Glaucoma and glaucoma suspects

Patients with at least two consecutive and reliable standard automated perimetry (SAP) examinations with either a pattern standard deviation (PSD) outside the 95% normal limits or a glaucoma hemifield test (GHT) result outside the 99% normal limits. Patients considered suspects for glaucoma must have an intraocular pressure (IOP) greater than 21 millimeters of mercury (mmHg) or suspicious appearance of the optic nerve head but with reliable normal visual fields, defined as a PSD within 95% confidence limits and a GHT result within normal limits.

Device: nGoggle

Age-related macular degeneration

Patients will be considered as having AMD if one or more of the following are present on posterior biomicroscopy (fundoscopy), indirect ophthalmoscopy or Optical Coherence Tomography (OCT) exams: 1. Presence of at least intermediate-size drusen (63µm or larger in diameter) 2. Retinal pigment epithelium (RPE) abnormalities such as hypopigmentation or hyperpigmentation 3. Reticular pseudodrusen (also called sub retinal drusenoid deposit) 4. Presence of any of the following features: geographic atrophy of the RPE, choroidal neovascularization (exudative, wet), polypoidal choroidal vasculopathy, or retinal angiomatous proliferation.

Device: nGoggle

Other eye diseases

Patients with other retinal degenerations such as retinitis pigmentosa or with other diseases affecting the visual pathways such as tumors, ischemic neuropathy or optic neuritis may also be included. Their diagnosis will be extracted from their clinical visits.

Device: nGoggle

Healthy subjects

To be considered healthy, subjects have to have IOP \< 22 mmHg with no history of elevated IOP and with at least two reliable normal visual fields, defined as a PSD within 95% confidence limits and a GHT result within normal limits.

Device: nGoggle

Interventions

nGoggle DEVICE

The nGoggle is a portable visual evoked potential system that uses an EEG to acquire visual evoked potentials in response to visual stimuli presented on a virtual reality goggle. The investigators will assess the ability of the nGoggle to detect visual field loss in patients with glaucoma, as well as to discriminate among the different stages of the disease, its repeatability and reliability for patient self-testing and patient satisfaction compared to standard automated perimetry (SAP), optical coherence tomography (OCT) metrics and Diopsys NOVA (Diopsys, Inc.). In addition, patients with other diseases affecting the visual system will also be tested in order to assess whether the nGoggle can differentiate glaucoma from them.

Also known as: Portable brain-computer interface

Age-related macular degeneration; Glaucoma and glaucoma suspects; Healthy subjects; Other eye diseases

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The following patients will be recruited from Dr. Tseng's clinic by verbal communication. Staff members at the Duke Eye Center will also be invited to recommend potential participants for the study, in conformance with the Duke Human Subjects Committee Guidelines. 1. Glaucoma; 2. Suspicion of having glaucoma; 3. Non-glaucomatous optic neuropathies; 4. Age-related macular degeneration (AMD); 5. Retinal degenerations; 6. Other diseases involving the visual pathways such as optic neuritis, tumors or ischemic neuropathy. 7. Healthy subjects

You may qualify if:

• 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

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• NGoggle: lead
• Duke University: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma; Macular Degeneration; Optic Nerve Diseases; Retinal Degeneration

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases, Hereditary

Study Officials

• Henry Tseng, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 30, 2018
• Study Start: February 11, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

US (1)