<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/NCT03748654</url>
  </required_header>
  <id_info>
    <org_study_id>E001</org_study_id>
    <nct_id>NCT03748654</nct_id>
  </id_info>
  <brief_title>Feasibility of Visual Field Testing With a Virtual Reality Headset</brief_title>
  <official_title>Feasibility of Visual Field Testing With a Virtual Reality Headset</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brennan Eadie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC&#xD;
      Vive) to test the visual field. The VR headset test will be compared to a conventional visual&#xD;
      field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy&#xD;
      patients without visual field defect, 10 patients with early glaucomatous visual field&#xD;
      defect, and 10 patients with advanced visual field defect. Each patient will perform the&#xD;
      conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month&#xD;
      period. The results of the tests (sensitivity thresholds) will be compared. The investigators&#xD;
      hypothesize that the results of the conventional and VR tests will be similar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2022</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual field differential light sensitivity threshold</measure>
    <time_frame>Three weeks</time_frame>
    <description>Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of sensitivity values</measure>
    <time_frame>Three weeks</time_frame>
    <description>Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual Field Testing</intervention_name>
    <description>Visual field test using the protocol 24-2 Threshold Test</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous visual field test with Humphrey Field Analyzer indicating normal field, early&#xD;
             glaucomatous field damage, or advanced glaucomatous field damage, according to&#xD;
             Canadian Glaucoma Society Guidelines.&#xD;
&#xD;
          -  Ability to understand and consent to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of non-glaucomatous pathology that could influence the visual field test,&#xD;
             such as media opacities.&#xD;
&#xD;
          -  Previous intraocular surgery less than 6 months from inclusion.&#xD;
&#xD;
          -  Difficulty to execute a reliable visual field test.&#xD;
&#xD;
          -  Potential contra-indications to use of virtual reality headset, including: anxiety&#xD;
             disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device,&#xD;
             severe vertigo or balance disturbance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brennan Eadie, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Victoria General Hopsital - Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Brennan Eadie</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03748654
org study id: E001
nct id: NCT03748654
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC
      Vive) to test the visual field. The VR headset test will be compared to a conventional visual
      field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy
      patients without visual field defect, 10 patients with early glaucomatous visual field
      defect, and 10 patients with advanced visual field defect. Each patient will perform the
      conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month
      period. The results of the tests (sensitivity thresholds) will be compared. The investigators
      hypothesize that the results of the conventional and VR tests will be similar.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Visual field differential light sensitivity threshold
time frame: Three weeks
description: Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
measure: Reproducibility of sensitivity values
time frame: Three weeks
description: Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset
arm group label: Single Arm
arm group type: Experimental
description: Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset
intervention type: Diagnostic Test
intervention name: Visual Field Testing
description: Visual field test using the protocol 24-2 Threshold Test
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brennan Eadie, MD, PhD
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Brennan Eadie
investigator title: Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC
mesh term: Glaucoma