<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/NCT01702727</url>
  </required_header>
  <id_info>
    <org_study_id>10OY006</org_study_id>
    <nct_id>NCT01702727</nct_id>
  </id_info>
  <brief_title>I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia</brief_title>
  <acronym>I-BiT</acronym>
  <official_title>Evaluation and Development of a Novel Binocular Treatment (I-BiTTM) System Using Video Clips and Interactive Games to Improve Vision in Children With Amblyopia ('Lazy Eye').</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to determine whether 30 minutes of treatment playing an interactive computer&#xD;
      game weekly for 6 weeks, improves visual acuity. The game has been specially configured to&#xD;
      ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses&#xD;
      which manipulate the image seen by each eye in order to provide more information to the&#xD;
      amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM&#xD;
      technology, play the computer game but without the I-BiTTM technology, or watch a DVD using&#xD;
      the I-BiTTM technology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</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>Change from baseline in visual acuity</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in visual acuity</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>I-BiTTM game</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes intervention weekly for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-I-BiTTM game</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 minutes intervention weekly for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-BiTTM DVD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes intervention weekly for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-BiTTM game</intervention_name>
    <description>30 minutes intervention weekly for 6 weeks.</description>
    <arm_group_label>I-BiTTM game</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-I-BiTTM game</intervention_name>
    <description>30 minutes intervention weekly for 6 weeks.</description>
    <arm_group_label>Non-I-BiTTM game</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-BiTTM DVD</intervention_name>
    <description>30 minutes intervention weekly for 6 weeks.</description>
    <arm_group_label>I-BiTTM DVD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Aged 4 - 8 years inclusive.&#xD;
&#xD;
          -  Participant's parent or guardian is willing and able to give informed consent for&#xD;
             participation in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Stimulus deprivation amblyopia.&#xD;
&#xD;
          -  Organic lesions of the eye preventing the establishment of good vision (e.g. media&#xD;
             opacities, abnormalities in the fundus or optic nerve).&#xD;
&#xD;
          -  Lesions of the brain preventing the establishment of good vision (e.g. cortical visual&#xD;
             impairment).&#xD;
&#xD;
          -  Patients diagnosed with Photosensitive Epilepsy&#xD;
&#xD;
          -  Patients diagnosed with or suspected of having Conjunctivitis&#xD;
&#xD;
          -  Loss of suppression at filter 4 or less as measured with the Sbisa Bar&#xD;
&#xD;
          -  Establishment of normal vision by refractive adaptation (wearing glasses after&#xD;
             presentation).&#xD;
&#xD;
          -  Inability to comply with the follow up visits required&#xD;
&#xD;
          -  Refusal to accept randomisation&#xD;
&#xD;
          -  Have participated in a previous study examining I-BiT treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Foss, BA BMBCh MRCP MRCOphth FRC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Ophthalmologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 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>
  <keyword>Amblyopia</keyword>
  <keyword>I-BiT TM</keyword>
  <keyword>Interactive games</keyword>
  <keyword>Binocular</keyword>
  <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/NCT01702727
org study id: 10OY006
nct id: NCT01702727
lead sponsor: 
collaborator: 
has dmc: No
The study aims to determine whether 30 minutes of treatment playing an interactive computer
      game weekly for 6 weeks, improves visual acuity. The game has been specially configured to
      ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses
      which manipulate the image seen by each eye in order to provide more information to the
      amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM
      technology, play the computer game but without the I-BiTTM technology, or watch a DVD using
      the I-BiTTM technology.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in visual acuity
time frame: 6 weeks
measure: Change from baseline in visual acuity
time frame: 10 weeks
arm group label: I-BiTTM game
arm group type: Experimental
description: 30 minutes intervention weekly for 6 weeks.
arm group label: Non-I-BiTTM game
arm group type: Active Comparator
description: 30 minutes intervention weekly for 6 weeks.
arm group label: I-BiTTM DVD
arm group type: Experimental
description: 30 minutes intervention weekly for 6 weeks.
intervention type: Device
intervention name: I-BiTTM game
description: 30 minutes intervention weekly for 6 weeks.
arm group label: I-BiTTM game
intervention type: Device
intervention name: Non-I-BiTTM game
description: 30 minutes intervention weekly for 6 weeks.
arm group label: Non-I-BiTTM game
intervention type: Device
intervention name: I-BiTTM DVD
description: 30 minutes intervention weekly for 6 weeks.
arm group label: I-BiTTM DVD
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: No
last name: Alexander Foss, BA BMBCh MRCP MRCOphth FRC
role: Principal Investigator
affiliation: Consultant Ophthalmologist
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Amblyopia