<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/NCT01704729</url>
  </required_header>
  <id_info>
    <org_study_id>ZOC-WEAR-1</org_study_id>
    <nct_id>NCT01704729</nct_id>
  </id_info>
  <brief_title>The Children's WEAR Trial(Phase 1&amp;2)</brief_title>
  <acronym>WEAR</acronym>
  <official_title>The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&amp;2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase I: Focus groups on different designs of adjustable glasses and standard glasses&#xD;
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:&#xD;
      (September 2012 - August 2013)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I: Focus groups on different designs of adjustable glasses and standard glasses&#xD;
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:&#xD;
      self-refraction with adjustable glasses, receiving custom standard glasses; subjective&#xD;
      refraction by an expert refractionist after cycloplegic automated refraction and receiving&#xD;
      custom standard glasses; subjective refraction by a rural refractionist after cycloplegic&#xD;
      automated refraction, receiving custom standard glasses; and subjective refraction by an&#xD;
      expert refractionist after cycloplegic automated refraction receiving ready made glasses&#xD;
      (September 2012 - August 2013)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 1, 2016</completion_date>
  <primary_completion_date type="Actual">April 1, 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity with and without study refractive correction</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported and Supplemental visual functioning</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of glasses-wear and the reason why the frequency is low</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of spectacles given to children</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Value attached to the glasses and satisfaction to the glasses</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Breakage, damage and loss of spectacles</measure>
    <time_frame>2 months</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2300</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>group2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cycloplegic subjective refraction by a &quot;vision technician&quot; trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group1</intervention_name>
    <description>Non-cycloplegic self-refraction +conventional glasses</description>
    <arm_group_label>group1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group2</intervention_name>
    <description>Cycloplegic subjective refraction by experienced optometrist +conventional glasses</description>
    <arm_group_label>group2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group3</intervention_name>
    <description>Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses</description>
    <arm_group_label>group3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group4</intervention_name>
    <description>Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses</description>
    <arm_group_label>group4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        phase1: - aged 12-17 years&#xD;
&#xD;
          -  with &lt;= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old&#xD;
             children from two locations in Guangdong Province&#xD;
&#xD;
          -  with uncorrected vision &lt;/= 6/12 in at least one eye thought to be due to refractive&#xD;
             error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction&#xD;
             by an optometrist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those corrected VA can not up to 6/7.5 with cycloplegic subjective refraction by an&#xD;
             optometrist&#xD;
&#xD;
          -  those with significant strabismus or vision abnormality (keratopathy, cataract,&#xD;
             vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to&#xD;
             be excluded.&#xD;
&#xD;
          -  Children developing acquired vision problems other than myopia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan G Congdon, MD,MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Congdon Nathan</investigator_full_name>
    <investigator_title>MD,MPH</investigator_title>
  </responsible_party>
  <keyword>Myopia</keyword>
  <keyword>Focus groups</keyword>
  <keyword>refraction</keyword>
  <keyword>Glasses</keyword>
  <keyword>spectacles</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT01704729
org study id: ZOC-WEAR-1
nct id: NCT01704729
lead sponsor: 
has dmc: Yes
Phase I: Focus groups on different designs of adjustable glasses and standard glasses
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:
      (September 2012 - August 2013)
Phase I: Focus groups on different designs of adjustable glasses and standard glasses
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:
      self-refraction with adjustable glasses, receiving custom standard glasses; subjective
      refraction by an expert refractionist after cycloplegic automated refraction and receiving
      custom standard glasses; subjective refraction by a rural refractionist after cycloplegic
      automated refraction, receiving custom standard glasses; and subjective refraction by an
      expert refractionist after cycloplegic automated refraction receiving ready made glasses
      (September 2012 - August 2013)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Visual acuity with and without study refractive correction
time frame: 2 months
measure: Self-reported and Supplemental visual functioning
time frame: 2 months
measure: frequency of glasses-wear and the reason why the frequency is low
time frame: 2 months
measure: Accuracy of spectacles given to children
time frame: 2 months
measure: Value attached to the glasses and satisfaction to the glasses
time frame: 2 months
measure: Breakage, damage and loss of spectacles
time frame: 2 months
arm group label: group2
arm group type: Other
description: Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
arm group label: group3
arm group type: Other
description: Cycloplegic subjective refraction by a "vision technician" trained in the Zhongshan Ophthalmic Center's Rural Refractionist Program
arm group label: group4
arm group type: Other
description: Cycloplegic subjective refraction by an experienced optometrist or ophthalmologist
arm group label: group1
arm group type: Other
description: Non-cycloplegic self-refraction using First Generation, Child-Specific fluid-filled adjustable spectacles and updated self-refraction protocol
intervention type: Procedure
intervention name: group1
description: Non-cycloplegic self-refraction +conventional glasses
arm group label: group1
intervention type: Procedure
intervention name: group2
description: Cycloplegic subjective refraction by experienced optometrist +conventional glasses
arm group label: group2
intervention type: Procedure
intervention name: group3
description: Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
arm group label: group3
intervention type: Procedure
intervention name: group4
description: Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
arm group label: group4
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Nathan G Congdon, MD,MPH
role: Principal Investigator
affiliation: Department of privetive ophthalmology,zhongshan ophthamic center,Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Congdon Nathan
investigator title: MD,MPH
mesh term: Myopia