<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/NCT03818880</url>
  </required_header>
  <id_info>
    <org_study_id>P/654/18/SG</org_study_id>
    <nct_id>NCT03818880</nct_id>
  </id_info>
  <brief_title>Choroidal Response to Novel Spectacle Lens to Control Myopia Progression</brief_title>
  <acronym>CHERRY</acronym>
  <official_title>A Sub-Study to Assess the Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SightGlass Vision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SightGlass Vision, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diurnal variations in the thickness of the choroid have been reported in the literature, and,&#xD;
      more recently, the role of the choroid has been studied with respect to its role in myopia&#xD;
      (near-sightedness) progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diurnal variations in the thickness of the choroid have been reported in the literature ,&#xD;
      and, more recently, the role of the choroid has been studied with respect to its role in&#xD;
      myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site,&#xD;
      randomized, controlled, interventional study to confirm the efficacy and safety of spectacle&#xD;
      lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral&#xD;
      vision. CORE is participating as a clinical site in this three year study which aims to&#xD;
      compare changes in ocular length and cycloplegic auto-refraction in children randomised to&#xD;
      wear one of either two test or one control spectacle lens designs; the CPRO-1802-001&#xD;
      (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements&#xD;
      only at CORE's site by inviting those participants who have already been found eligible for&#xD;
      the CPRO-1802-001 study to participate in this parallel study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2023</completion_date>
  <primary_completion_date type="Actual">April 21, 2022</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>Choroidal thickness</measure>
    <time_frame>3 years</time_frame>
    <description>Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual field</measure>
    <time_frame>3 years</time_frame>
    <description>Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Myopia, Progressive</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects wearing novel spectacle lenses will be assessed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Novel spectacle lens design</intervention_name>
    <description>Spectacle lens to control progression of myopia</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating in the CPRO-1802-001 (Cypress_SG) study at CORE&#xD;
&#xD;
          -  Read and signed an Assent and their parent/guardian has signed an information consent&#xD;
             letter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transient health condition which may affect the eye(s) (e.g. a common cold, active&#xD;
             allergies, fatigue, etc;)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD, FCOptom</last_name>
    <role>Principal Investigator</role>
    <affiliation>CORE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jill Woods, BSc, MCOptom</last_name>
    <role>Study Director</role>
    <affiliation>CORE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Ocular Research and Education</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myopia</keyword>
  <keyword>Myopia control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Myopia, Degenerative</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/NCT03818880
org study id: P/654/18/SG
nct id: NCT03818880
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Diurnal variations in the thickness of the choroid have been reported in the literature, and,
      more recently, the role of the choroid has been studied with respect to its role in myopia
      (near-sightedness) progression.
Diurnal variations in the thickness of the choroid have been reported in the literature ,
      and, more recently, the role of the choroid has been studied with respect to its role in
      myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site,
      randomized, controlled, interventional study to confirm the efficacy and safety of spectacle
      lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral
      vision. CORE is participating as a clinical site in this three year study which aims to
      compare changes in ocular length and cycloplegic auto-refraction in children randomised to
      wear one of either two test or one control spectacle lens designs; the CPRO-1802-001
      (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements
      only at CORE's site by inviting those participants who have already been found eligible for
      the CPRO-1802-001 study to participate in this parallel study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Choroidal thickness
time frame: 3 years
description: Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis
measure: Visual field
time frame: 3 years
description: Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer
arm group label: Treatment
arm group type: Experimental
description: Subjects wearing novel spectacle lenses will be assessed
intervention type: Device
intervention name: Novel spectacle lens design
description: Spectacle lens to control progression of myopia
arm group label: Treatment
criteria: 
gender: All
minimum age: 6 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lyndon Jones, PhD, FCOptom
role: Principal Investigator
affiliation: CORE
last name: Jill Woods, BSc, MCOptom
role: Study Director
affiliation: CORE
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Myopia
mesh term: Myopia, Degenerative