<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/NCT03767985</url>
  </required_header>
  <id_info>
    <org_study_id>MEC-2016-439</org_study_id>
    <nct_id>NCT03767985</nct_id>
  </id_info>
  <brief_title>Patching or Gaming as Amblyopia Treatment?</brief_title>
  <official_title>A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lijf &amp; Leven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ODAS Stichting</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uitzicht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Applied Sciences Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 affects 3% of the children and is caused by strabismus, anisometropia or both.&#xD;
      Standard treatment is glasses and patching therapy. From North-America, behavioural training,&#xD;
      i.e. dichoptic training, perceptual learning and video gaming, has become increasingly&#xD;
      popular to improve visual acuity not only in children but also in adults. In this study we&#xD;
      aim to compare the standard occlusion therapy with dichoptic video gaming.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The&#xD;
      standard treatment is glasses and patching therapy. From North-America, behavioural training,&#xD;
      i.e. dichoptic training, perceptual learning and video gaming, has become increasingly&#xD;
      popular. The rationale behind these games is by using dichoptic stimulation, with the&#xD;
      contrast of the stimuli presented to the good eye reduced to match the appearance of the same&#xD;
      stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now&#xD;
      conducted, demonstrate improvement in visual acuity with the games, the effect however is&#xD;
      limited, but the rate of improvement is higher. In these studies, prescribed patching-time&#xD;
      was compared to realised game-time. We have demonstrated in multiple studies that&#xD;
      electronically measured compliance is low: on average only 50%.&#xD;
&#xD;
      In this study we aim to compare the effect of patching therapy, using the ODM to objectively&#xD;
      measure compliance, with the effect of a novel dichoptic action video game in children as&#xD;
      well as in adults. In addition, the adult participants will undergo fMRI scans to document&#xD;
      any changes in the visual cortex before and after either therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 18, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 24, 2020</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>Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The research orthoptist that does the orthoptic examinations is masked to the randomization.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Occlusion therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dichoptic video game therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dichoptic video game therapy</intervention_name>
    <description>Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.</description>
    <arm_group_label>Dichoptic video game therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Occlusion therapy</intervention_name>
    <description>Occlusion therapy for 2 hours per day, 7 days a week</description>
    <arm_group_label>Occlusion therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A non-comitant or large angle constant strabismus &gt;30Prism Dioptres, a neurological&#xD;
             disorder, nystagmus, other eye disorders and diminished acuity due to medication,&#xD;
             brain damage or trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johannes R Vingerling, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sjoukje E Loudon, MD, PhD</last_name>
    <phone>+31(0)624927128</phone>
    <email>s.loudon@erasmusmc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aveen Kadhum, Bsc</last_name>
    <phone>+31 (0)10 7032103</phone>
    <email>a.kadhum@erasmusmc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <state>South-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aveen Kadhum, Bsc</last_name>
      <phone>+31 (0)10 7032103</phone>
      <email>a.kadhum@erasmusmc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Emily T.C. Tan, Bsc</last_name>
      <phone>+31(0)650032078</phone>
      <email>e.tan@erasmusmc.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Sjoukje E Loudon, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Sjoukje Elizabeth Loudon</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </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/NCT03767985
org study id: MEC-2016-439
nct id: NCT03767985
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both.
      Standard treatment is glasses and patching therapy. From North-America, behavioural training,
      i.e. dichoptic training, perceptual learning and video gaming, has become increasingly
      popular to improve visual acuity not only in children but also in adults. In this study we
      aim to compare the standard occlusion therapy with dichoptic video gaming.
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The
      standard treatment is glasses and patching therapy. From North-America, behavioural training,
      i.e. dichoptic training, perceptual learning and video gaming, has become increasingly
      popular. The rationale behind these games is by using dichoptic stimulation, with the
      contrast of the stimuli presented to the good eye reduced to match the appearance of the same
      stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now
      conducted, demonstrate improvement in visual acuity with the games, the effect however is
      limited, but the rate of improvement is higher. In these studies, prescribed patching-time
      was compared to realised game-time. We have demonstrated in multiple studies that
      electronically measured compliance is low: on average only 50%.

      In this study we aim to compare the effect of patching therapy, using the ODM to objectively
      measure compliance, with the effect of a novel dichoptic action video game in children as
      well as in adults. In addition, the adult participants will undergo fMRI scans to document
      any changes in the visual cortex before and after either therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
primary purpose: Treatment
masking: Single (Care Provider)
masking description: The research orthoptist that does the orthoptic examinations is masked to the randomization.
measure: Visual Acuity improvement
time frame: 24 weeks
description: Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming
arm group label: Occlusion therapy
arm group type: Active Comparator
description: Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.
arm group label: Dichoptic video game therapy
arm group type: Experimental
description: Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.
intervention type: Other
intervention name: Dichoptic video game therapy
description: Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
arm group label: Dichoptic video game therapy
intervention type: Other
intervention name: Occlusion therapy
description: Occlusion therapy for 2 hours per day, 7 days a week
arm group label: Occlusion therapy
criteria: 
gender: All
minimum age: 4 Years
maximum age: 55 Years
healthy volunteers: No
last name: Johannes R Vingerling, MD, PhD
role: Study Director
affiliation: Erasmus Medical Center
last name: Sjoukje E Loudon, MD, PhD
phone: +31(0)624927128
email: s.loudon@erasmusmc.nl
last name: Aveen Kadhum, Bsc
phone: +31 (0)10 7032103
email: a.kadhum@erasmusmc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Sjoukje Elizabeth Loudon
investigator title: MD, PhD
mesh term: Amblyopia
sharing ipd: Undecided