ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Visual Function With a Portable Brain-computer Interface

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03760055
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
Duke University
National Eye Institute (NEI)
Information provided by (Responsible Party):
NGoggle

Brief Summary:
  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. 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. 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.

Condition or disease Intervention/treatment
Glaucoma Age Related Macular Degeneration Optic Neuropathy Retinal Degeneration Device: nGoggle

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Visual Function With a Portable Brain-computer Interface
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
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
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.
Other Name: Portable brain-computer interface

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
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.
Other Name: Portable brain-computer interface

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
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.
Other Name: Portable brain-computer interface

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
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.
Other Name: Portable brain-computer interface




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. Patients' satisfaction [ Time Frame: from date of enrollment and every 6 months, up to 5 years ]
    The investigators will obtain a survey regarding patients' satisfaction with testing, including easiness of placement, comfort, and user-interface.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  1. Subjects must be between the ages of 18 and 90 years old;
  2. Both males and females will be included.
  3. Be able and willing to provide signed informed consent and follow study instructions

Exclusion Criteria:

1. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760055


Contacts
Contact: Eric Cabezas 9196840201 eric.cabezas@duke.edu

Locations
United States, North Carolina
Duke University Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Eric Cabezas    919-684-0201    eric.cabezas@duke.edu   
Principal Investigator: Henry Tseng, PhD         
Sub-Investigator: Felipe A Medeiros, PhD         
Sponsors and Collaborators
NGoggle
Duke University
National Eye Institute (NEI)
Investigators
Principal Investigator: Henry Tseng, PhD Duke University

Responsible Party: NGoggle
ClinicalTrials.gov Identifier: NCT03760055     History of Changes
Other Study ID Numbers: Pro00100894
R42EY027651 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Optic Nerve Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cranial Nerve Diseases
Nervous System Diseases