<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/NCT03754153</url>
  </required_header>
  <id_info>
    <org_study_id>DALA1031</org_study_id>
    <nct_id>NCT03754153</nct_id>
  </id_info>
  <brief_title>Binocularly Balanced Viewing Study</brief_title>
  <acronym>BALANCE</acronym>
  <official_title>Phase 2a Two-site Randomised Controlled Trial to Determine Safety of and Adherence With a New 'Binocularly Balanced Viewing' Treatment for Unilateral Amblyopia Compared With Standard Treatment in Children Age 3-8 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moorfields Eye Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moorfields Eye Hospital NHS Foundation Trust</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>
      Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works&#xD;
      in about 70% of children, but parents and children strongly dislike these treatments which&#xD;
      may carry on for years and involve frequent clinic visits. In this pilot trial, 66 children&#xD;
      will receive, at random, either a Nintendo 3DSXL console with movies, or standard&#xD;
      patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double&#xD;
      vision), change in the balance between the two eyes and in visual acuity over 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Lazy eye&quot; (amblyopia) is the commonest sight problem in children, affecting about one in 30&#xD;
      children. It is caused by a difference in spectacle prescription between the eyes and/or a&#xD;
      squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses&#xD;
      and patches or blurring eyedrops to the good eye. This works in about 70% of children, but&#xD;
      parents and children strongly dislike these treatments which may carry on for years and&#xD;
      involve frequent clinic visits.&#xD;
&#xD;
      The Investigators have developed an exciting new treatment: children watch customized movies&#xD;
      for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture&#xD;
      that the good eye sees to match it with what the weaker eye sees. They have tested this&#xD;
      approach on 22 children, with an average improvement in vision by three lines on the test&#xD;
      chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and&#xD;
      children the Investigators have spoken with like both the idea of research in this area and&#xD;
      the engaging nature of this device. The Investigators now need to assess how the new&#xD;
      treatment compares with standard treatment, but first need to ensure that the new treatment&#xD;
      is safe and that families will use it.&#xD;
&#xD;
      In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console&#xD;
      with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor&#xD;
      adverse events (double vision), change in the balance between the two eyes and in visual&#xD;
      acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement&#xD;
      will be continued throughout the study. At study completion, children and parents will be&#xD;
      involved in deciding how best to communicate the findings on hospital websites, in&#xD;
      newsletters, at conferences and in medical journals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>
    <intervention_model_description>Two-group parallel randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>At each site, a masked orthoptist will carry out the study assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The evaluation of safety of the experimental intervention</measure>
    <time_frame>16 weeks from randomization</time_frame>
    <description>To measure changes in suppression/interocular balance (considered to precede double vision) at 16 weeks from baseline, using a novel test of interocular balance, a contrast-sensitivity test presented on a PC</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Balanced Binocular Viewing (BBV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental intervention will be BBV treatment, i.e. viewing movies for one hour or 2x30min/day on a Nintendo 3DSXL console. With this technology, the Investigators will show blurred images to the better-seeing eye and normal images to the amblyopic eye, encouraging the use of the amblyopic eye and improving acuity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Therapy - Occlusion (patching) or blurring (atropine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control intervention will be either atropine eyedrops twice a week or daily occlusion (patching) therapy of the better-seeing eye (which are the current standards). As per clinical standard, parents will be offered the choice of occlusion or eyedrop treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balanced Binocular Viewing (BBV)</intervention_name>
    <description>The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).</description>
    <arm_group_label>Balanced Binocular Viewing (BBV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Therapy - Occlusion (patching) or blurring (atropine)</intervention_name>
    <description>The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies</description>
    <arm_group_label>Standard Therapy - Occlusion (patching) or blurring (atropine)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 3.0 and less than 8.0 years&#xD;
&#xD;
          -  unilateral anisometropic, strabismic or combined mechanism amblyopia&#xD;
&#xD;
          -  best-corrected crowded logMAR visual acuity (BCVA) in the amblyopic eye worse than&#xD;
             0.2logMar&#xD;
&#xD;
          -  best corrected visual acuity in the better seeing eye 0.2 or better&#xD;
&#xD;
          -  difference in best corrected visual acuity between the two eyes of 0.2 logMAR or more&#xD;
&#xD;
          -  adapted to spectacles with no improvement in acuity in affected eye for two&#xD;
             consecutive visits&#xD;
&#xD;
          -  no previous treatment for amblyopia other than glasses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular cause for reduced visual acuity&#xD;
&#xD;
          -  inability to co-operate with assessment tests&#xD;
&#xD;
          -  other developmental disorders or learning or neurological disability that would impact&#xD;
             on adherence to treatment&#xD;
&#xD;
          -  photopic epilepsy&#xD;
&#xD;
          -  myopia with spherical equivalent of greater than -6.00DS&#xD;
&#xD;
          -  previous intraocular surgery&#xD;
&#xD;
          -  inability to perform a crowded letter logMAR visual acuity test using a clinical&#xD;
             trials standard testing method (ATS-HOTV protocol), either by naming or by matching&#xD;
             letters&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annegret Dahlmann-Noor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moorfields Eye Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 22, 2021</last_update_submitted>
  <last_update_submitted_qc>December 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual-level data will be made available on request to the principal investigator.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Will be made available after publication of the trial findings.</ipd_time_frame>
    <ipd_access_criteria>As per review by sponsor and principal investigator.</ipd_access_criteria>
  </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/NCT03754153
org study id: DALA1031
nct id: NCT03754153
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works
      in about 70% of children, but parents and children strongly dislike these treatments which
      may carry on for years and involve frequent clinic visits. In this pilot trial, 66 children
      will receive, at random, either a Nintendo 3DSXL console with movies, or standard
      patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double
      vision), change in the balance between the two eyes and in visual acuity over 16 weeks.
"Lazy eye" (amblyopia) is the commonest sight problem in children, affecting about one in 30
      children. It is caused by a difference in spectacle prescription between the eyes and/or a
      squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses
      and patches or blurring eyedrops to the good eye. This works in about 70% of children, but
      parents and children strongly dislike these treatments which may carry on for years and
      involve frequent clinic visits.

      The Investigators have developed an exciting new treatment: children watch customized movies
      for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture
      that the good eye sees to match it with what the weaker eye sees. They have tested this
      approach on 22 children, with an average improvement in vision by three lines on the test
      chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and
      children the Investigators have spoken with like both the idea of research in this area and
      the engaging nature of this device. The Investigators now need to assess how the new
      treatment compares with standard treatment, but first need to ensure that the new treatment
      is safe and that families will use it.

      In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console
      with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor
      adverse events (double vision), change in the balance between the two eyes and in visual
      acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement
      will be continued throughout the study. At study completion, children and parents will be
      involved in deciding how best to communicate the findings on hospital websites, in
      newsletters, at conferences and in medical journals.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-group parallel randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: At each site, a masked orthoptist will carry out the study assessments.
measure: The evaluation of safety of the experimental intervention
time frame: 16 weeks from randomization
description: To measure changes in suppression/interocular balance (considered to precede double vision) at 16 weeks from baseline, using a novel test of interocular balance, a contrast-sensitivity test presented on a PC
arm group label: Balanced Binocular Viewing (BBV)
arm group type: Experimental
description: The experimental intervention will be BBV treatment, i.e. viewing movies for one hour or 2x30min/day on a Nintendo 3DSXL console. With this technology, the Investigators will show blurred images to the better-seeing eye and normal images to the amblyopic eye, encouraging the use of the amblyopic eye and improving acuity.
arm group label: Standard Therapy - Occlusion (patching) or blurring (atropine)
arm group type: Active Comparator
description: The control intervention will be either atropine eyedrops twice a week or daily occlusion (patching) therapy of the better-seeing eye (which are the current standards). As per clinical standard, parents will be offered the choice of occlusion or eyedrop treatment.
intervention type: Device
intervention name: Balanced Binocular Viewing (BBV)
description: The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).
arm group label: Balanced Binocular Viewing (BBV)
intervention type: Other
intervention name: Standard Therapy - Occlusion (patching) or blurring (atropine)
description: The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies
arm group label: Standard Therapy - Occlusion (patching) or blurring (atropine)
criteria: 
gender: All
minimum age: 3 Years
maximum age: 8 Years
healthy volunteers: No
last name: Annegret Dahlmann-Noor
role: Principal Investigator
affiliation: Moorfields Eye Hospital NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Amblyopia
mesh term: Atropine
sharing ipd: Yes
ipd description: Individual-level data will be made available on request to the principal investigator.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Will be made available after publication of the trial findings.
ipd access criteria: As per review by sponsor and principal investigator.