<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/NCT04415684</url>
  </required_header>
  <id_info>
    <org_study_id>eSpec Phase III</org_study_id>
    <nct_id>NCT04415684</nct_id>
  </id_info>
  <brief_title>Projected Peripheral Defocus Using a Wearable Device</brief_title>
  <official_title>Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kubota Vision Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kubota Vision Inc.</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic&#xD;
      progression, which is a significant public health concern across the world, especially in&#xD;
      Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will&#xD;
      have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in&#xD;
      order to alter retinal physiology leading to myopia regulation. This study will establish the&#xD;
      changes seen during a proof-of-concept that projected defocus in the periphery utilizing a&#xD;
      wearable device will stimulate physiological changes similar to those in the literature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Axial length (AL)</measure>
    <time_frame>1 hour</time_frame>
    <description>Change in AL from baseline in the test eye vs. control eye</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Choroidal thickness (CT)</measure>
    <time_frame>1 hour</time_frame>
    <description>Change in CT from baseline in the test eye vs. control eye</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Test Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)</intervention_name>
    <description>For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image</description>
    <arm_group_label>Test Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)</intervention_name>
    <description>For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.</description>
    <arm_group_label>Test Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spherical equivalent +2.00 to -4.00 diopters&#xD;
&#xD;
          -  Refractive cylinder ≤ 0.75 diopters&#xD;
&#xD;
          -  Visual acuity 20/20 -3 or better&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Active ocular infection&#xD;
&#xD;
          -  History of dry eye, strabismus, or amblyopia&#xD;
&#xD;
          -  Previous or planned ocular surgery&#xD;
&#xD;
          -  Use of medication known to affect vision or accommodation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arkady Selenow, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manhattan Vision Associates/Institute of Vision Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manhattan Vision Associates/institute of Vision Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <disposition_first_submitted>August 16, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>August 16, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 20, 2021</disposition_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</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>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04415684
org study id: eSpec Phase III
nct id: NCT04415684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic
      progression, which is a significant public health concern across the world, especially in
      Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will
      have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in
      order to alter retinal physiology leading to myopia regulation. This study will establish the
      changes seen during a proof-of-concept that projected defocus in the periphery utilizing a
      wearable device will stimulate physiological changes similar to those in the literature.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Axial length (AL)
time frame: 1 hour
description: Change in AL from baseline in the test eye vs. control eye
measure: Choroidal thickness (CT)
time frame: 1 hour
description: Change in CT from baseline in the test eye vs. control eye
arm group label: Test Arm
arm group type: Experimental
intervention type: Device
intervention name: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
description: For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
arm group label: Test Arm
intervention type: Device
intervention name: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
description: For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
arm group label: Test Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arkady Selenow, OD
role: Principal Investigator
affiliation: Manhattan Vision Associates/Institute of Vision Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No