<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/NCT02186184</url>
  </required_header>
  <id_info>
    <org_study_id>2014CB504601</org_study_id>
    <nct_id>NCT02186184</nct_id>
  </id_info>
  <brief_title>Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial</brief_title>
  <official_title>Effect of Orthokeratology on Myopia Progression in Chinese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Orthokeratology is becoming popular for the treatment of myopia children. Many studies have&#xD;
      shown that orthokeratology is effective in temporarily reducing refractive error, and is also&#xD;
      helpful for controlling myopia progression. However, the mechanism for its slowing myopia&#xD;
      progression and rebound effect after the treatment have not been clearly studied. In&#xD;
      addition, the effect of orthokeratology among Chinese children has not been evaluated with&#xD;
      randomized controlled trial.This study is to assess the effect of orthokeratology versus&#xD;
      spectacles on myopia progression in school-aged Chinese children during two years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Refraction</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Axial length</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
    <description>The Lenstar will be used to measure the axial length.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Refraction</measure>
    <time_frame>Change from baseline at 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Axial length</measure>
    <time_frame>Change from baseline at 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tear film break up time(BUT)</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluation of comfortableness</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal endothelial cell density</measure>
    <time_frame>Change from baseline at 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear film break up time(BUT)</measure>
    <time_frame>Change from baseline at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluation of comfortness</measure>
    <time_frame>Change from baseline at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal endothelial cell density</measure>
    <time_frame>Change from baseline at 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Orthokeratology in the first year</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants would wear orthokeratology in the first year and then switch to spectacle in the second year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spectacle in the first year</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants would wear spectacle in the first year and then changed to orthokeratology in the second year</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orthokeratology</intervention_name>
    <arm_group_label>Orthokeratology in the first year</arm_group_label>
    <arm_group_label>Spectacle in the first year</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectacle</intervention_name>
    <arm_group_label>Orthokeratology in the first year</arm_group_label>
    <arm_group_label>Spectacle in the first year</arm_group_label>
    <other_name>Glasses</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages Eligible for Study: 7 Years to 14 Years&#xD;
&#xD;
          -  Genders Eligible for Study: Both&#xD;
&#xD;
          -  Visual acuity 20/20 or better in each eye&#xD;
&#xD;
          -  Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each&#xD;
             eye, anisometropia less than 1.0 D between the two eyes&#xD;
&#xD;
          -  No strabismus, amblyopia and any other ocular or systematic diseases that may affect&#xD;
             refractive development&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently or history using other interventions to control myopia progression&#xD;
             (acupuncture, drugs, contact lens, ear needles and so on)&#xD;
&#xD;
          -  Unable to cooperate with the ocular examination,questionnaire survey,or&#xD;
             orthokeratology wearing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ningli Wang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>December 17, 2017</last_update_submitted>
  <last_update_submitted_qc>December 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tongren Hospital</investigator_affiliation>
    <investigator_full_name>Shi-Ming Li</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Myopia progression</keyword>
  <keyword>Orthokeratology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Disease Progression</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/NCT02186184
org study id: 2014CB504601
nct id: NCT02186184
lead sponsor: 
has dmc: Yes
Orthokeratology is becoming popular for the treatment of myopia children. Many studies have
      shown that orthokeratology is effective in temporarily reducing refractive error, and is also
      helpful for controlling myopia progression. However, the mechanism for its slowing myopia
      progression and rebound effect after the treatment have not been clearly studied. In
      addition, the effect of orthokeratology among Chinese children has not been evaluated with
      randomized controlled trial.This study is to assess the effect of orthokeratology versus
      spectacles on myopia progression in school-aged Chinese children during two years.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Refraction
time frame: Change from baseline at 1 year
description: The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500.
measure: Axial length
time frame: Change from baseline at 1 year
description: The Lenstar will be used to measure the axial length.
measure: Refraction
time frame: Change from baseline at 2 years
measure: Axial length
time frame: Change from baseline at 2 years
measure: Tear film break up time(BUT)
time frame: Change from baseline at 1 year
measure: Self evaluation of comfortableness
time frame: Change from baseline at 1 year
measure: Corneal endothelial cell density
time frame: Change from baseline at 1 year
measure: Tear film break up time(BUT)
time frame: Change from baseline at 2 years
measure: Self evaluation of comfortness
time frame: Change from baseline at 2 years
measure: Corneal endothelial cell density
time frame: Change from baseline at 2 years
arm group label: Orthokeratology in the first year
arm group type: Experimental
description: The participants would wear orthokeratology in the first year and then switch to spectacle in the second year
arm group label: Spectacle in the first year
arm group type: Active Comparator
description: The participants would wear spectacle in the first year and then changed to orthokeratology in the second year
intervention type: Device
intervention name: Orthokeratology
arm group label: Orthokeratology in the first year
arm group label: Spectacle in the first year
intervention type: Device
intervention name: Spectacle
arm group label: Orthokeratology in the first year
arm group label: Spectacle in the first year
other name: Glasses
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ningli Wang, MD,PhD
role: Principal Investigator
affiliation: Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tongren Hospital
investigator full name: Shi-Ming Li
investigator title: Dr.
mesh term: Myopia
mesh term: Disease Progression