<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/NCT02970708</url>
  </required_header>
  <id_info>
    <org_study_id>YFZX2016001</org_study_id>
    <nct_id>NCT02970708</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia</brief_title>
  <official_title>Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Eye Disease Prevention and Treatment Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Eye Disease Prevention and Treatment Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating&#xD;
      anisometropic amblyopia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to&#xD;
      receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker&#xD;
      Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct&#xD;
      square-wave alternating occlusion, will be used at a pre-programmed temporal frequency.&#xD;
      Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast&#xD;
      sensitivity, binocular function,visual evoked potential and functional MRI will be measured&#xD;
      at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information&#xD;
      from the questionnaires will be used to evaluate the compliance and adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>best corrected visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>have an improvement of best corrected visual acuity in the amblyopic eyes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stereocuity</measure>
    <time_frame>6 months</time_frame>
    <description>have an improvement of stereocuity in the amblyopic eyes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>contrast sensitivity function</measure>
    <time_frame>6 months</time_frame>
    <description>have an improvement of contrast sensitivity in the amblyopic eyes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual evoked potential</measure>
    <time_frame>6 months</time_frame>
    <description>P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional MRI</measure>
    <time_frame>6 months</time_frame>
    <description>the visual cortex activity have an improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>best corrected visual acuity</measure>
    <time_frame>a year and a half</time_frame>
    <description>have an improvement of best corrected visual acuity in the amblyopic eyes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Amblyopia, Anisometropic</condition>
  <arm_group>
    <arm_group_label>EFG group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patching group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>amblyopia in patching group will receive patching treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EFG group</intervention_name>
    <description>88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.</description>
    <arm_group_label>EFG group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Patching group</intervention_name>
    <description>88 anisometropic amblyopia will be recruited to receive patching treatment.</description>
    <arm_group_label>Patching group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged from 4 to 13 years old&#xD;
&#xD;
          2. the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with&#xD;
             two lines or more of difference between the two eyes&#xD;
&#xD;
          3. anisometropia is defined as an inter-ocular spherical refractive error difference of&#xD;
             1.00 D or more or a cylindrical difference of 1.50 D or more.&#xD;
&#xD;
          4. no amblyopia treatment one month prior to the study except refractive correction.&#xD;
&#xD;
          5. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than&#xD;
             20 prism diopters&#xD;
&#xD;
          6. willing to participate in this study and be able to follow up on time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ocular disease and other disease that have an influence on the visual acuity&#xD;
&#xD;
          2. history of ocular surgery that have an influence on the visual acuity&#xD;
&#xD;
          3. the patient is receiving other amblyopia treatment except refractive correction&#xD;
&#xD;
          4. a family or personal history of seizures&#xD;
&#xD;
          5. the patient is using some medicine that may have an influence on visual acuity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</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/NCT02970708
org study id: YFZX2016001
nct id: NCT02970708
lead sponsor: 
has dmc: No
To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating
      anisometropic amblyopia.
A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to
      receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker
      Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct
      square-wave alternating occlusion, will be used at a pre-programmed temporal frequency.
      Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast
      sensitivity, binocular function,visual evoked potential and functional MRI will be measured
      at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information
      from the questionnaires will be used to evaluate the compliance and adverse effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: best corrected visual acuity
time frame: 6 months
description: have an improvement of best corrected visual acuity in the amblyopic eyes
measure: stereocuity
time frame: 6 months
description: have an improvement of stereocuity in the amblyopic eyes
measure: contrast sensitivity function
time frame: 6 months
description: have an improvement of contrast sensitivity in the amblyopic eyes
measure: visual evoked potential
time frame: 6 months
description: P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.
measure: functional MRI
time frame: 6 months
description: the visual cortex activity have an improvement
measure: best corrected visual acuity
time frame: a year and a half
description: have an improvement of best corrected visual acuity in the amblyopic eyes
arm group label: EFG group
arm group type: Experimental
description: amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.
arm group label: Patching group
arm group type: Active Comparator
description: amblyopia in patching group will receive patching treatment.
intervention type: Device
intervention name: EFG group
description: 88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
arm group label: EFG group
intervention type: Device
intervention name: Patching group
description: 88 anisometropic amblyopia will be recruited to receive patching treatment.
arm group label: Patching group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 13 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Amblyopia
sharing ipd: Undecided