<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/NCT03006601</url>
  </required_header>
  <id_info>
    <org_study_id>2016AC2</org_study_id>
    <nct_id>NCT03006601</nct_id>
  </id_info>
  <brief_title>Effect of Vision Therapy in Myopic Children With Poor Accommodative Response</brief_title>
  <official_title>Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the treatment effect of vision therapy on myopic children by&#xD;
      assessment of accommodative function before and after therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Specific aims of the proposed clinical trial:&#xD;
&#xD;
           1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative&#xD;
           function of myopic children by comparing the results from treatment group to placebo&#xD;
           group.&#xD;
&#xD;
           1.2 To minimize the influences of confounding variables by randomly assigning the&#xD;
           intervention.&#xD;
&#xD;
           1.3 To observe the longitudinal effects of VT on accommodation system and its effect on&#xD;
           axial length.&#xD;
&#xD;
        2. Hypothesis:&#xD;
&#xD;
      VT can improve the accommodative functions of 8-12 years old Chinese myopic children with&#xD;
      poor accommodative response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of Accommodative response is being assessed</measure>
    <time_frame>At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.</time_frame>
    <description>we will use objective measures from open-field auto refractor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the changes of Accommodative amplitude is being assessed:</measure>
    <time_frame>At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.</time_frame>
    <description>we will use subjective measures from accommodative rod(push up method)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the changes of Accommodative facility is being assessed:</measure>
    <time_frame>At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.</time_frame>
    <description>we will use subjective measures from lens flipper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the changes of Cycloplegic objective refraction is being assessed:</measure>
    <time_frame>At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.</time_frame>
    <description>we will use objective measures from open-field auto refractor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the changes of Axial length is being assessed:</measure>
    <time_frame>At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.</time_frame>
    <description>we will use objective measures from IOL-Master</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After enrollment, patients will be randomized into either treatment group or placebo group. Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) will be provided to patients of treatment group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Office-based accommodative/vergence therapy</intervention_name>
    <description>Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks)</description>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects enrolled in the trial must:&#xD;
&#xD;
          -  be within the age range of 8 to 12 years old inclusive&#xD;
&#xD;
          -  -0.75D to -4.50Dspherical equivalent by cycloplegic autorefraction in both eyes&#xD;
&#xD;
          -  astigmatism≤1.5D in both eyes&#xD;
&#xD;
          -  anisometropia≤1.0D&#xD;
&#xD;
          -  monocular accommodation lag at near(33cm)in right eye by non-cycloplegic&#xD;
             autorefraction≧1D&#xD;
&#xD;
          -  have vision correctable to at least 0.8 or better in each eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects enrolled in the trial must NOT have:&#xD;
&#xD;
          -  current or prior use of PALs, bifocals, or contact lenses in either eye( prior or&#xD;
             current use of SVLs allowed)&#xD;
&#xD;
          -  history of any of the following functional defects: strabismus, amblyopia, nystagmus&#xD;
&#xD;
          -  history of diabetes or seizures&#xD;
&#xD;
          -  history of any ocular systemic, or neuro-developmental condition that might influence&#xD;
             refractive development&#xD;
&#xD;
          -  use of ocular or systemic medications containing atropine, pirenzepine, and&#xD;
             anti-epileptic medications in recent 3 months&#xD;
&#xD;
          -  history of any ocular surgery that might influence refractive development&#xD;
&#xD;
          -  developmental disability, attention deficit hyperactivity disorder(ADHD), or learning&#xD;
             disability diagnosis in children that in the investigator's discretion would interfere&#xD;
             with office-based treatment&#xD;
&#xD;
          -  relocation anticipated for 1 year&#xD;
&#xD;
          -  birth weight lower than 1250 grams（2lbs,12oz）&#xD;
&#xD;
          -  siblings in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiang Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic 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>December 2016</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xiang Chen</investigator_full_name>
    <investigator_title>Study Principal Investigator Zhongshan Ophthalmic Center</investigator_title>
  </responsible_party>
  <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/NCT03006601
org study id: 2016AC2
nct id: NCT03006601
lead sponsor: 
has dmc: No
This study aims to determine the treatment effect of vision therapy on myopic children by
      assessment of accommodative function before and after therapy.
1. Specific aims of the proposed clinical trial:

           1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative
           function of myopic children by comparing the results from treatment group to placebo
           group.

           1.2 To minimize the influences of confounding variables by randomly assigning the
           intervention.

           1.3 To observe the longitudinal effects of VT on accommodation system and its effect on
           axial length.

        2. Hypothesis:

      VT can improve the accommodative functions of 8-12 years old Chinese myopic children with
      poor accommodative response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the change of Accommodative response is being assessed
time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
description: we will use objective measures from open-field auto refractor.
measure: the changes of Accommodative amplitude is being assessed:
time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
description: we will use subjective measures from accommodative rod(push up method)
measure: the changes of Accommodative facility is being assessed:
time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
description: we will use subjective measures from lens flipper
measure: the changes of Cycloplegic objective refraction is being assessed:
time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
description: we will use objective measures from open-field auto refractor.
measure: the changes of Axial length is being assessed:
time frame: At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT.
description: we will use objective measures from IOL-Master
arm group label: Placebo group
arm group type: Placebo Comparator
description: After enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients.
arm group label: Treatment group
arm group type: Experimental
description: After enrollment, patients will be randomized into either treatment group or placebo group. Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) will be provided to patients of treatment group.
intervention type: Other
intervention name: Office-based accommodative/vergence therapy
description: Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks)
arm group label: Placebo group
arm group label: Treatment group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiang Chen, PhD
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiang Chen
investigator title: Study Principal Investigator Zhongshan Ophthalmic Center
mesh term: Myopia
sharing ipd: Undecided