<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/NCT02980445</url>
  </required_header>
  <id_info>
    <org_study_id>SHEH-M001</org_study_id>
    <nct_id>NCT02980445</nct_id>
  </id_info>
  <brief_title>Time Outdoors as an Intervention for Myopia in Children</brief_title>
  <official_title>Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Eye Disease Prevention and Treatment Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brien Holden Vision</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Eye Disease Prevention and Treatment Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether improved outdoor time has an effect on the&#xD;
      onset and progression of myopia in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To evaluate the effect of increased time outdoors on the incidence of myopia in&#xD;
           non-myopic children;&#xD;
&#xD;
        2. To evaluate the effect of increased time outdoors on the progression of myopia in myopic&#xD;
           children;&#xD;
&#xD;
        3. To explore if there is dose-response effect of time outdoors on the incidence and&#xD;
           progression of myopia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cycloplegic refractive power（auto-refractor instrument）</measure>
    <time_frame>1 year</time_frame>
    <description>The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Axial length(IOL Master instrument)</measure>
    <time_frame>6 months</time_frame>
    <description>The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">7200</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Outdoor Activity 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40min outdoor time in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outdoor Activity 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80min outdoor time in total</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outdoor activity 1</intervention_name>
    <description>40-minute outdoor activity</description>
    <arm_group_label>Outdoor Activity 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outdoor activity 2</intervention_name>
    <description>Dose 1 plus an additional 40-minute outdoor activities during recesses</description>
    <arm_group_label>Outdoor Activity 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. at baseline be enrolled in grade 1 and 2 of primary schools;&#xD;
&#xD;
          2. have a parent or guardian who is able to read and comprehend Mandarin and give&#xD;
             informed consent as demonstrated by signing a record of informed consent;&#xD;
&#xD;
          3. Children verbally consent when registration for examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any systemic or ocular pathology that may affect the refractive error status of the&#xD;
             eye;&#xD;
&#xD;
          2. Strabismus and amblyopia;&#xD;
&#xD;
          3. Intellectual disability;&#xD;
&#xD;
          4. Using any anti-myopia treatments (orthokeratology, atropine, accommodation function&#xD;
             training, acupuncture, auricular point sticking, progressive addition spectacle lenses&#xD;
             or other anti-myopia contact lenses).&#xD;
&#xD;
          5. Not suitable for inclusion in the study as deemed by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xun Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Eye Disease Prevention and Treatment Center</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myopia</keyword>
  <keyword>Outdoor time</keyword>
  <keyword>Children</keyword>
  <keyword>Intervention</keyword>
  <keyword>Prevention</keyword>
  <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 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/NCT02980445
org study id: SHEH-M001
nct id: NCT02980445
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether improved outdoor time has an effect on the
      onset and progression of myopia in children.
1. To evaluate the effect of increased time outdoors on the incidence of myopia in
           non-myopic children;

        2. To evaluate the effect of increased time outdoors on the progression of myopia in myopic
           children;

        3. To explore if there is dose-response effect of time outdoors on the incidence and
           progression of myopia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cycloplegic refractive power（auto-refractor instrument）
time frame: 1 year
description: The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
measure: Axial length(IOL Master instrument)
time frame: 6 months
description: The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).
arm group label: Control
arm group type: No Intervention
arm group label: Outdoor Activity 1
arm group type: Experimental
description: 40min outdoor time in total.
arm group label: Outdoor Activity 2
arm group type: Experimental
description: 80min outdoor time in total
intervention type: Behavioral
intervention name: Outdoor activity 1
description: 40-minute outdoor activity
arm group label: Outdoor Activity 1
intervention type: Behavioral
intervention name: Outdoor activity 2
description: Dose 1 plus an additional 40-minute outdoor activities during recesses
arm group label: Outdoor Activity 2
criteria: 
gender: All
minimum age: 6 Years
maximum age: 9 Years
healthy volunteers: No
last name: Xun Xu, MD
role: Principal Investigator
affiliation: Shanghai Eye Disease Prevention and Treatment Center
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No