<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/NCT03242226</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-OPH-001</org_study_id>
    <nct_id>NCT03242226</nct_id>
  </id_info>
  <brief_title>The Effect of +3.00ADD on Myopia Progression in Chinese Children</brief_title>
  <official_title>The Effect of +3.00ADD on Myopia Progression in Chinese Children: A Cluster Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on&#xD;
      the progression of myopia in children. Many studies applying bifocals or multifocal&#xD;
      spectacles to intervene the progression have been carried out based on the idea that myopia&#xD;
      was caused by excessive accommodation, however, the effect was limited. The possible reason&#xD;
      is that bifocal or multifocal spectacles still not fully adjust the accommodative error in&#xD;
      myopia children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The optical intervention has been extensively explored for the intervention of myopia&#xD;
      progression.&#xD;
&#xD;
      Based on the theory that myopia was caused by the excessive accommodative, bifocal or&#xD;
      multifocal spectacles for slowing the progression of myopia have been fully studied. Although&#xD;
      some studies' results showed statistically significant for slowing myopia progression with&#xD;
      multifocal spectacles, few had clinically meaningful, even in children with high&#xD;
      accommodative lag or near-point esophoria. The investigators think that the possible reason&#xD;
      for this clinical un-meaningful maybe that daily wearing bifocal or multifocal spectacles&#xD;
      still not fully adjust the accommodative error in children.&#xD;
&#xD;
      The aim of this randomized clinical trial is to evaluate myopic progression in children using&#xD;
      two spectacles (single-vision spectacles for distant vision, and +3.00ADD spectacle for near&#xD;
      vision), compared with control subjects wearing one spectacles (single-vision spectacles).&#xD;
      Myopia progression quantified by changes in axial length (AL) and cycloplegic spherical&#xD;
      equivalent refraction will be monitored for 3 years. The spectacles for intervention group&#xD;
      children will be adjusted based on the cycloplegic spherical equivalent and the extent of&#xD;
      accommodation lag for schedule time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 11, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>spherical equivalent refraction (SER) change</measure>
    <time_frame>3 years</time_frame>
    <description>SE was measured by autorefractometer with cycloplegic once a year at scheduled time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>axial length</measure>
    <time_frame>3 years</time_frame>
    <description>Axial length is measured by IOMaster once a year at scheduled time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corneal curvature</measure>
    <time_frame>3 years</time_frame>
    <description>Corneal curvature is measured by IOMaster once a year at scheduled time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>binocular vision</measure>
    <time_frame>3 years</time_frame>
    <description>the binocular vision was measured by an ophthalmologist every six month at scheduled time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>two spectacles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>single vision spectacles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>two spectacles</intervention_name>
    <description>single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision</description>
    <arm_group_label>two spectacles</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>single vision spectacles</intervention_name>
    <description>Wear single vision spectacle only</description>
    <arm_group_label>single vision spectacles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Children who are aged 8 to 12 years (grade 3 and grade 4) from Huadu district of&#xD;
             Guangzhou in China.&#xD;
&#xD;
          2. Refractive error meeting all the following, obtained by cycloplegic autorefraction:&#xD;
             spherical equivalent -1.00 to -6.00D in both eyes, astigmatism ≤2.00 D in both eyes,&#xD;
             and spherical equivalent anisometropia ≤1.50 D.&#xD;
&#xD;
          3. The best corrected visual acuity is ≥ 6/9.5&#xD;
&#xD;
          4. The parents are willing to provide consent to participation in the study, and the&#xD;
             children are willing to wear the only provided spectacles&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Children who are allergy to tropicamide or topical anesthetic drugs.&#xD;
&#xD;
          2. Children who had other eye diseases that cause the visual impairment including&#xD;
             strabismus, amblyopia, ocular surface related disease, cataract, traumas, ocular&#xD;
             fundus diseases, and ocular surgery.&#xD;
&#xD;
          3. Children who were wearing rigid gas permeable contact lenses, progressive-addition&#xD;
             lenses, bifocal spectacles lens, Peripheral defocus modifying contact lenses;&#xD;
&#xD;
          4. Children who are receiving visual function training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yizhi LIU, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yangfa ZENG, MD,Master</last_name>
    <role>Study Director</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuting LI, Master</last_name>
    <phone>+86-020-87334687</phone>
    <email>ytdorothy@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qianyun Chen, Bachelor</last_name>
    <phone>+86-020-87334687</phone>
    <email>torunchen@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center, Sun Yet-san University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuting LI, Master</last_name>
      <phone>+86-020-87334687</phone>
      <email>ytdorothy@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Qianyun Chen, bachelor</last_name>
      <phone>+86-020-87334687</phone>
      <email>torunchen@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yizhi Liu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>+3.00ADD</keyword>
  <keyword>single vision spectacle</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>Undecided</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/NCT03242226
org study id: SYSU-OPH-001
nct id: NCT03242226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on
      the progression of myopia in children. Many studies applying bifocals or multifocal
      spectacles to intervene the progression have been carried out based on the idea that myopia
      was caused by excessive accommodation, however, the effect was limited. The possible reason
      is that bifocal or multifocal spectacles still not fully adjust the accommodative error in
      myopia children.
The optical intervention has been extensively explored for the intervention of myopia
      progression.

      Based on the theory that myopia was caused by the excessive accommodative, bifocal or
      multifocal spectacles for slowing the progression of myopia have been fully studied. Although
      some studies' results showed statistically significant for slowing myopia progression with
      multifocal spectacles, few had clinically meaningful, even in children with high
      accommodative lag or near-point esophoria. The investigators think that the possible reason
      for this clinical un-meaningful maybe that daily wearing bifocal or multifocal spectacles
      still not fully adjust the accommodative error in children.

      The aim of this randomized clinical trial is to evaluate myopic progression in children using
      two spectacles (single-vision spectacles for distant vision, and +3.00ADD spectacle for near
      vision), compared with control subjects wearing one spectacles (single-vision spectacles).
      Myopia progression quantified by changes in axial length (AL) and cycloplegic spherical
      equivalent refraction will be monitored for 3 years. The spectacles for intervention group
      children will be adjusted based on the cycloplegic spherical equivalent and the extent of
      accommodation lag for schedule time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: spherical equivalent refraction (SER) change
time frame: 3 years
description: SE was measured by autorefractometer with cycloplegic once a year at scheduled time
measure: axial length
time frame: 3 years
description: Axial length is measured by IOMaster once a year at scheduled time
measure: corneal curvature
time frame: 3 years
description: Corneal curvature is measured by IOMaster once a year at scheduled time
measure: binocular vision
time frame: 3 years
description: the binocular vision was measured by an ophthalmologist every six month at scheduled time.
arm group label: two spectacles
arm group type: Experimental
arm group label: single vision spectacles
arm group type: Active Comparator
intervention type: Device
intervention name: two spectacles
description: single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision
arm group label: two spectacles
intervention type: Device
intervention name: single vision spectacles
description: Wear single vision spectacle only
arm group label: single vision spectacles
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
last name: Yizhi LIU, MD,PhD
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Yangfa ZENG, MD,Master
role: Study Director
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Yuting LI, Master
phone: +86-020-87334687
email: ytdorothy@163.com
last name: Qianyun Chen, Bachelor
phone: +86-020-87334687
email: torunchen@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
investigator full name: Yizhi Liu
investigator title: Professor
mesh term: Myopia
sharing ipd: Undecided