<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760055</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100894</org_study_id>
    <secondary_id>R42EY027651</secondary_id>
    <nct_id>NCT03760055</nct_id>
  </id_info>
  <brief_title>Assessment of Visual Function With a Portable Brain-computer Interface</brief_title>
  <official_title>Assessment of Visual Function With a Portable Brain-computer Interface</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NGoggle</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NGoggle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. The purpose of this study is to evaluate the nGoggle's accuracy and repeatability in&#xD;
           detecting visual function loss. In addition, the ability to stage glaucomatous damage&#xD;
           and investigate the relationship between nGoggle metrics and neural damage in glaucoma&#xD;
           will also be evaluated.&#xD;
&#xD;
        2. Longitudinal study, including 200 patients with: glaucoma, suspected of having glaucoma,&#xD;
           nonglaucomatous optic neuropathies, AMD, retinal degenerations, other diseases involving&#xD;
           the visual pathways, besides healthy controls. Subjects will perform standard&#xD;
           ophthalmological exams, and the following research tests: electroencephalogram, visual&#xD;
           evoked potentials, and questionnaires.&#xD;
&#xD;
        3. Statistical analyses will be performed by the PI using the software Stata, MATLAB, and&#xD;
           MPLUS. Risks are low, consisting of some discomfort, fatigue, dizziness or motion&#xD;
           sickness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background &amp; Significance&#xD;
&#xD;
      Assessment of functional loss in glaucoma has been traditionally made with standard automated&#xD;
      perimetry (SAP). Despite the significant progress achieved with the development of SAP,&#xD;
      assessment of visual field loss still has significant drawbacks. SAP testing is limited by&#xD;
      subjectivity of patient responses and high test-retest variability, frequently requiring many&#xD;
      tests for effective detection of change over time. Moreover, as these tests are generally&#xD;
      conducted in clinic-based settings, limited patient availability and health care resources&#xD;
      often result in an insufficient number of tests acquired over time, with delayed diagnosis&#xD;
      and detection of disease progression. The requirement for highly trained technicians, cost,&#xD;
      complexity, and lack of portability of SAP also preclude its use for screening of visual&#xD;
      field loss in underserved populations. Furthermore, current SAP testing as performed in&#xD;
      clinical practice frequently results in delayed detection of progression, with potential late&#xD;
      initiation/escalation of treatment and irreversible functional damage.&#xD;
&#xD;
      As a part of a funded Phase I project, the nGoggle (nGoggle Inc., San Diego, CA), the first&#xD;
      device of its kind, allowed a portable and objective brain-based assessment of visual&#xD;
      function deficits in glaucoma. The nGoggle integrates a wearable, wireless, no-prep EEG&#xD;
      system and a head-mounted display (HMD) to allow users to routinely monitor electrical brain&#xD;
      activities associated with visual field stimulation. A recent study comparing the diagnostic&#xD;
      accuracies of an earlier version of the nGoggle and SAP in discriminating patients with&#xD;
      glaucoma from healthy subjects found that the nGoggle performed at least as well, if not&#xD;
      better than, SAP with the additional advantage of portability and objectivity.&#xD;
&#xD;
      The overall goal of this proposal is to test the nGoggle's accuracy and repeatability in&#xD;
      detecting visual function loss. In addition, its ability to stage glaucomatous damage, by&#xD;
      discriminating patients at different stages of the disease will be evaluated. Finally, the&#xD;
      relationship between nGoggle metrics and neural damage in glaucoma as detected by other&#xD;
      objective techniques such as optical coherence tomography will also be investigated. Patients&#xD;
      with other diseases affecting the visual system will also be included in order to assess&#xD;
      whether the nGoggle can differentiate glaucoma from them.&#xD;
&#xD;
      Study Design &amp; Procedures&#xD;
&#xD;
      This will be a longitudinal study in which patients will be examined approximately&#xD;
      biannually. The following patients will be recruited:&#xD;
&#xD;
        1. Glaucoma;&#xD;
&#xD;
        2. Suspicion of having glaucoma;&#xD;
&#xD;
        3. Non-glaucomatous optic neuropathies;&#xD;
&#xD;
        4. Age-related macular degeneration (AMD);&#xD;
&#xD;
        5. Retinal degenerations;&#xD;
&#xD;
        6. Other diseases involving the visual pathways such as optic neuritis, tumors or ischemic&#xD;
           neuropathy.&#xD;
&#xD;
        7. Healthy subjects&#xD;
&#xD;
      General evaluation:&#xD;
&#xD;
      As part of the study all participants will undergo the following general evaluation:&#xD;
&#xD;
        1. Review of medical history;&#xD;
&#xD;
        2. Comprehensive ophthalmologic examination&#xD;
&#xD;
        3. Questionnaires: a. Cognitive function using the Montreal Cognitive Assessment (MoCA); b.&#xD;
           A short structured interview to obtain vision-related quality of life information using&#xD;
           the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25); c. A&#xD;
           questionnaire to assess patient's satisfaction with the nGoggle testing, including&#xD;
           easiness of placement, comfort, and user-interface.&#xD;
&#xD;
        4. Electroencephalogram (EEG) and Visual Evoked Potentials (VEP): Visual evoked potentials&#xD;
           (VEP) will be evaluated with Diopsys NOVA (Diopsys, Inc.), which is a well-established&#xD;
           conventional multifocal VEP device to assess brain functioning following visual stimuli&#xD;
           from a computer screen. Subjects will also be monitored with an EEG system integrated&#xD;
           with a head-mounted display (nGoggle, Inc.). The nGoggle is a portable visual evoked&#xD;
           potential system that uses an EEG to acquire visual evoked potentials in response to&#xD;
           visual stimuli presented on a virtual reality goggle.&#xD;
&#xD;
      Risk/Benefit Assessment&#xD;
&#xD;
      Risks:&#xD;
&#xD;
      Risks from participating in the study are very low. The primary risks for all participants&#xD;
      are some discomforts, which are similar to those encountered in any complete eye examination.&#xD;
      Participants will undergo non-invasive procedures used for diagnostic purposes that are used&#xD;
      in standard clinical care. Eventually, it will be necessary to use numbing or dilating drops&#xD;
      for fundus examination, as is done in standard clinical care. Some risks of those drops&#xD;
      include: dry eye, mild headache, blurred vision, drowsiness, burning eyes, tearing, light&#xD;
      sensitivity, redness, and allergy reactions. The only non-FDA approved device used in this&#xD;
      study is the nGoggle (nGoggle Inc.), which is an investigational diagnostic device qualified&#xD;
      as a non-significant risk device. The subject may experience mild discomfort due to drying of&#xD;
      the eye during the study. Should a patient note drying, a drop of artificial tears will be&#xD;
      placed over the eye by the study key personnel. In very rare cases, artificial eye tear drops&#xD;
      may cause irritation or allergy. There are no known risks associated with the EEG test other&#xD;
      than discomfort and fatigue. Subjects might become bored, fatigued or distressed while&#xD;
      participating. To minimize these potential effects, the tasks will be kept short and subjects&#xD;
      will be instructed that they may request to interrupt the test anytime. All assessments,&#xD;
      software, instruments that are not FDA approved will be used as tools to assess disability&#xD;
      and device efficacy, and will not be used as a diagnostic procedure without confirmation of&#xD;
      the diagnosis by another, medically established diagnostic product or procedure. There is,&#xD;
      however, the potential risk of loss of confidentiality. Every effort will be made to keep the&#xD;
      information confidential; however, this cannot be guaranteed. Some of the questions that will&#xD;
      be asked as part of this study may make the patients feel uncomfortable. Patients may refuse&#xD;
      to answer any of the questions and may take a break at any time during the study. Patient may&#xD;
      stop their participation in this study at any time.&#xD;
&#xD;
      Unknown/unforeseeable risks&#xD;
&#xD;
      In addition to the risks and discomforts listed here, there may be other risks that are&#xD;
      currently not known. Subjects will be informed if any other potential risk becomes known&#xD;
      through the duration of the study. Also, the risks and discomforts may occur more often or be&#xD;
      more severe than have been seen before and written in this form.&#xD;
&#xD;
      Benefits:&#xD;
&#xD;
      Subjects will be referred from the Duke Eye Center care providers after a comprehensive&#xD;
      clinical eye examination from a routine visit. If the last clinical eye examination is not&#xD;
      within 6 months of the study visit, the participant will be examined by the PI, with no&#xD;
      additional cost to the patient.&#xD;
&#xD;
      Participants will also undergo tests that will allow the validation and development of a&#xD;
      transformative device for diagnosing and monitoring ocular diseases, and could be suited for&#xD;
      home-based testing of visual function in the future, which could benefit patients with eye&#xD;
      diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Device accuracy to detect visual field loss</measure>
    <time_frame>from date of enrollment and every 6 months, up to 5 years</time_frame>
    <description>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&gt;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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device accuracy to detect structural neural loss</measure>
    <time_frame>from date of enrollment and every 6 months, up to 5 years</time_frame>
    <description>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&gt;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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device accuracy to detect objective functional loss</measure>
    <time_frame>from date of enrollment and every 6 months, up to 5 years</time_frame>
    <description>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&gt;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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of repeatability</measure>
    <time_frame>6 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' satisfaction</measure>
    <time_frame>from date of enrollment and every 6 months, up to 5 years</time_frame>
    <description>The investigators will obtain a survey regarding patients' satisfaction with testing, including easiness of placement, comfort, and user-interface.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Glaucoma</condition>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Optic Neuropathy</condition>
  <condition>Retinal Degeneration</condition>
  <arm_group>
    <arm_group_label>Glaucoma and glaucoma suspects</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Age-related macular degeneration</arm_group_label>
    <description>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:&#xD;
Presence of at least intermediate-size drusen (63µm or larger in diameter)&#xD;
Retinal pigment epithelium (RPE) abnormalities such as hypopigmentation or hyperpigmentation&#xD;
Reticular pseudodrusen (also called sub retinal drusenoid deposit)&#xD;
Presence of any of the following features: geographic atrophy of the RPE, choroidal neovascularization (exudative, wet), polypoidal choroidal vasculopathy, or retinal angiomatous proliferation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other eye diseases</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>To be considered healthy, subjects have to have IOP &lt; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nGoggle</intervention_name>
    <description>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.</description>
    <arm_group_label>Age-related macular degeneration</arm_group_label>
    <arm_group_label>Glaucoma and glaucoma suspects</arm_group_label>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Other eye diseases</arm_group_label>
    <other_name>Portable brain-computer interface</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The following patients will be recruited from Dr. Tseng's clinic by verbal communication.&#xD;
        Staff members at the Duke Eye Center will also be invited to recommend potential&#xD;
        participants for the study, in conformance with the Duke Human Subjects Committee&#xD;
        Guidelines.&#xD;
&#xD;
          1. Glaucoma;&#xD;
&#xD;
          2. Suspicion of having glaucoma;&#xD;
&#xD;
          3. Non-glaucomatous optic neuropathies;&#xD;
&#xD;
          4. Age-related macular degeneration (AMD);&#xD;
&#xD;
          5. Retinal degenerations;&#xD;
&#xD;
          6. Other diseases involving the visual pathways such as optic neuritis, tumors or&#xD;
             ischemic neuropathy.&#xD;
&#xD;
          7. Healthy subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be between the ages of 18 and 90 years old;&#xD;
&#xD;
          2. Both males and females will be included.&#xD;
&#xD;
          3. Be able and willing to provide signed informed consent and follow study instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subjects will be excluded if they present with any systemic or ocular conditions that in&#xD;
        the opinion of the Principal Investigator may prevent them from completing the tests (e.g.&#xD;
        history of seizures or other coexistent ocular pathologies).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Henry Tseng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Optic Nerve Diseases</mesh_term>
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Retinal Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760055
org study id: Pro00100894
secondary id: R42EY027651
nct id: NCT03760055
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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

      This will be a longitudinal study in which patients will be examined approximately
      biannually. The following patients will be recruited:

        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

      General evaluation:

      As part of the study all participants will undergo the following general evaluation:

        1. Review of medical history;

        2. Comprehensive ophthalmologic examination

        3. Questionnaires: a. Cognitive function using the Montreal Cognitive Assessment (MoCA); b.
           A short structured interview to obtain vision-related quality of life information using
           the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25); c. A
           questionnaire to assess patient's satisfaction with the nGoggle testing, including
           easiness of placement, comfort, and user-interface.

        4. Electroencephalogram (EEG) and Visual Evoked Potentials (VEP): Visual evoked potentials
           (VEP) will be evaluated with Diopsys NOVA (Diopsys, Inc.), which is a well-established
           conventional multifocal VEP device to assess brain functioning following visual stimuli
           from a computer screen. Subjects will also be monitored with an EEG system integrated
           with a head-mounted display (nGoggle, Inc.). 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.

      Risk/Benefit Assessment

      Risks:

      Risks from participating in the study are very low. The primary risks for all participants
      are some discomforts, which are similar to those encountered in any complete eye examination.
      Participants will undergo non-invasive procedures used for diagnostic purposes that are used
      in standard clinical care. Eventually, it will be necessary to use numbing or dilating drops
      for fundus examination, as is done in standard clinical care. Some risks of those drops
      include: dry eye, mild headache, blurred vision, drowsiness, burning eyes, tearing, light
      sensitivity, redness, and allergy reactions. The only non-FDA approved device used in this
      study is the nGoggle (nGoggle Inc.), which is an investigational diagnostic device qualified
      as a non-significant risk device. The subject may experience mild discomfort due to drying of
      the eye during the study. Should a patient note drying, a drop of artificial tears will be
      placed over the eye by the study key personnel. In very rare cases, artificial eye tear drops
      may cause irritation or allergy. There are no known risks associated with the EEG test other
      than discomfort and fatigue. Subjects might become bored, fatigued or distressed while
      participating. To minimize these potential effects, the tasks will be kept short and subjects
      will be instructed that they may request to interrupt the test anytime. All assessments,
      software, instruments that are not FDA approved will be used as tools to assess disability
      and device efficacy, and will not be used as a diagnostic procedure without confirmation of
      the diagnosis by another, medically established diagnostic product or procedure. There is,
      however, the potential risk of loss of confidentiality. Every effort will be made to keep the
      information confidential; however, this cannot be guaranteed. Some of the questions that will
      be asked as part of this study may make the patients feel uncomfortable. Patients may refuse
      to answer any of the questions and may take a break at any time during the study. Patient may
      stop their participation in this study at any time.

      Unknown/unforeseeable risks

      In addition to the risks and discomforts listed here, there may be other risks that are
      currently not known. Subjects will be informed if any other potential risk becomes known
      through the duration of the study. Also, the risks and discomforts may occur more often or be
      more severe than have been seen before and written in this form.

      Benefits:

      Subjects will be referred from the Duke Eye Center care providers after a comprehensive
      clinical eye examination from a routine visit. If the last clinical eye examination is not
      within 6 months of the study visit, the participant will be examined by the PI, with no
      additional cost to the patient.

      Participants will also undergo tests that will allow the validation and development of a
      transformative device for diagnosing and monitoring ocular diseases, and could be suited for
      home-based testing of visual function in the future, which could benefit patients with eye
      diseases.
observational model: Cohort
time perspective: Prospective
measure: Device accuracy to detect visual field loss
time frame: from date of enrollment and every 6 months, up to 5 years
description: 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.
measure: Device accuracy to detect structural neural loss
time frame: from date of enrollment and every 6 months, up to 5 years
description: 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.
measure: Device accuracy to detect objective functional loss
time frame: from date of enrollment and every 6 months, up to 5 years
description: 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.
measure: Assessment of repeatability
time frame: 6 weeks
description: 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.
measure: Patients' satisfaction
time frame: from date of enrollment and every 6 months, up to 5 years
description: The investigators will obtain a survey regarding patients' satisfaction with testing, including easiness of placement, comfort, and user-interface.
arm group label: Glaucoma and glaucoma suspects
description: 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.
arm group label: Age-related macular degeneration
description: 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:
Presence of at least intermediate-size drusen (63µm or larger in diameter)
Retinal pigment epithelium (RPE) abnormalities such as hypopigmentation or hyperpigmentation
Reticular pseudodrusen (also called sub retinal drusenoid deposit)
Presence of any of the following features: geographic atrophy of the RPE, choroidal neovascularization (exudative, wet), polypoidal choroidal vasculopathy, or retinal angiomatous proliferation.
arm group label: Other eye diseases
description: 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.
arm group label: Healthy subjects
description: 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.
intervention type: Device
intervention name: nGoggle
description: 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.
arm group label: Age-related macular degeneration
arm group label: Glaucoma and glaucoma suspects
arm group label: Healthy subjects
arm group label: Other eye diseases
other name: Portable brain-computer interface
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Henry Tseng, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Optic Nerve Diseases
mesh term: Macular Degeneration
mesh term: Retinal Degeneration
sharing ipd: Undecided
ipd description: Undecided.