<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/NCT04474041</url>
  </required_header>
  <id_info>
    <org_study_id>EYEQUE - 006</org_study_id>
    <nct_id>NCT04474041</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus a Standard Eyechart.</brief_title>
  <official_title>A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EyeQue Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eye Boutique Optometry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>EyeQue Corp.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open label exploratory study of the EyeQue Insight in healthy volunteers &gt;=7 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual&#xD;
      acuity test) yields results similar to the standard ETDRS eyechart in the office.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">December 24, 2020</completion_date>
  <primary_completion_date type="Actual">December 24, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acuity Visit 1</measure>
    <time_frame>Visit 1: Day 0</time_frame>
    <description>Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acuity Visit 1 and 2</measure>
    <time_frame>Visit 1 (Day 0) and Visit 2 (Day 7)</time_frame>
    <description>Variance of the best-corrected VA (BCVA) of each participant's OD, OS, and OU measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1 and Visit 2.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>Visual Acuity with a Hand-held Device Supported by Mobile App.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Insight will be compared to a standard ETDRS eyechart</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EyeQue Insight</intervention_name>
    <description>The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.</description>
    <arm_group_label>Visual Acuity with a Hand-held Device Supported by Mobile App.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female&#xD;
&#xD;
          2. Ages =&gt;7 y.o.&#xD;
&#xD;
          3. Subjects that are minors (&lt;18 years old) must have a parent or legal guardian.&#xD;
&#xD;
          4. Binocular vision&#xD;
&#xD;
          5. Willing and able to give informed consent and follow all study procedures and&#xD;
             requirements&#xD;
&#xD;
          6. Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.&#xD;
&#xD;
          2. Has traveled outside the country within the last 4 weeks&#xD;
&#xD;
          3. Medications:&#xD;
&#xD;
             a. Taking medications that may affect ability to follow instructions.&#xD;
&#xD;
          4. Eye Disease:&#xD;
&#xD;
             a. Subjects with eye disease deemed by the Investigator to be inappropriate for the&#xD;
             study such as an active eye infection.&#xD;
&#xD;
          5. Subjects that:&#xD;
&#xD;
               1. Lack physical dexterity to properly operate the EyeQue App on the smartphone&#xD;
&#xD;
               2. Lack the ability to follow instruction&#xD;
&#xD;
               3. Lack binocular vision&#xD;
&#xD;
               4. Lack the ability to maintain both eyes open&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EyeQue</name>
      <address>
        <city>Newark</city>
        <state>California</state>
        <zip>94560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>visual acuity</keyword>
  <keyword>screening</keyword>
  <keyword>vision</keyword>
  <keyword>eye care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04474041
org study id: EYEQUE - 006
nct id: NCT04474041
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.
The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual
      acuity test) yields results similar to the standard ETDRS eyechart in the office.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Acuity Visit 1
time frame: Visit 1: Day 0
description: Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1.
measure: Acuity Visit 1 and 2
time frame: Visit 1 (Day 0) and Visit 2 (Day 7)
description: Variance of the best-corrected VA (BCVA) of each participant's OD, OS, and OU measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1 and Visit 2.
arm group label: Visual Acuity with a Hand-held Device Supported by Mobile App.
arm group type: Experimental
description: The Insight will be compared to a standard ETDRS eyechart
intervention type: Device
intervention name: EyeQue Insight
description: The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.
arm group label: Visual Acuity with a Hand-held Device Supported by Mobile App.
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No