<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/NCT03822806</url>
  </required_header>
  <id_info>
    <org_study_id>18-010474</org_study_id>
    <nct_id>NCT03822806</nct_id>
  </id_info>
  <brief_title>Augmenting Patching Treatment for Amblyopia With Physical Exercise</brief_title>
  <official_title>Augmenting Patching Treatment for Amblyopia With Physical Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researches are trying to establish whether moderate exercise enhances the treatment benefit&#xD;
      of patching 2 hours a day for residual amblyopia in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2018</start_date>
  <completion_date type="Actual">November 19, 2020</completion_date>
  <primary_completion_date type="Actual">November 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>1 month (3 weeks to 8 weeks) after initiating game play</time_frame>
    <description>The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Physical Exercise in addition to Patching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Exercise in addition to Patching</intervention_name>
    <description>Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game</description>
    <arm_group_label>Physical Exercise in addition to Patching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 5 to &lt; 17 years old&#xD;
&#xD;
          -  Cycloplegic refraction within past year&#xD;
&#xD;
          -  Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye&#xD;
             visual acuity by 1 or more LogMAR from best previous&#xD;
&#xD;
          -  Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine&#xD;
             treatment.&#xD;
&#xD;
          -  Stable visual acuity as defined by &lt;1 LogMAR change over 2 visits&#xD;
&#xD;
          -  Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system&#xD;
             with a version of Just Dance® already in the home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known problems with exercise tolerance&#xD;
&#xD;
          -  No gaming system in the home that supports Just Dance® Kids 2014, and no existing&#xD;
             version of Just Dance® in the home&#xD;
&#xD;
          -  Current atropine treatment for amblyopia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erick Bothun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Erick D. Bothun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</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/NCT03822806
org study id: 18-010474
nct id: NCT03822806
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Researches are trying to establish whether moderate exercise enhances the treatment benefit
      of patching 2 hours a day for residual amblyopia in children.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity
time frame: 1 month (3 weeks to 8 weeks) after initiating game play
description: The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.
arm group label: Physical Exercise in addition to Patching
arm group type: Experimental
description: Patch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise).
intervention type: Other
intervention name: Physical Exercise in addition to Patching
description: Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game
arm group label: Physical Exercise in addition to Patching
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Erick Bothun, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Erick D. Bothun
investigator title: Principal Investigator
mesh term: Amblyopia