<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/NCT02246556</url>
  </required_header>
  <id_info>
    <org_study_id>14-14212</org_study_id>
    <secondary_id>093955</secondary_id>
    <nct_id>NCT02246556</nct_id>
  </id_info>
  <brief_title>Dichoptic Virtual Reality Therapy for Amblyopia in Adults</brief_title>
  <official_title>Dichoptic Virtual Reality Therapy for Amblyopia in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a randomized, masked, controlled study of the effect of a virtual reality,&#xD;
      binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with&#xD;
      amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new&#xD;
      subjects for enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment inadequate and investigators leaving the study institution for new positions.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual acuity</measure>
    <time_frame>3 weeks, 6 weeks, and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in stereopsis</measure>
    <time_frame>3 weeks, 6 weeks, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 weeks, 6 weeks, and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Amblyopia</condition>
  <condition>Anisometropia</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>Patching therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dioptic (non-dichoptic) therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dichoptic therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dichoptic therapy</intervention_name>
    <description>Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system</description>
    <arm_group_label>Dichoptic therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patching therapy</intervention_name>
    <description>Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software</description>
    <arm_group_label>Patching therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dioptic (non-dichoptic) therapy</intervention_name>
    <description>Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software</description>
    <arm_group_label>Dioptic (non-dichoptic) therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Interpupillary distance of 60-66 mm&#xD;
&#xD;
          -  Age 15-40&#xD;
&#xD;
          -  Anisometropic amblyopia or strabismic amblyopia&#xD;
&#xD;
          -  Best corrected visual acuity of 20/30 or worse in the amblyopic eye&#xD;
&#xD;
          -  No prior therapeutic use of the software&#xD;
&#xD;
          -  No other ongoing therapies including patching or recent eye muscle surgery&#xD;
&#xD;
          -  No vested interest in the product&#xD;
&#xD;
          -  Ability attend visits and complete the training session, and to stop the intervention&#xD;
             after the specified intervention period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stimulus-deprivation amblyopia.&#xD;
&#xD;
          -  Organic lesions of the eye preventing the establishment of good vision (eg. media&#xD;
             opacities, abnormalities in the fundus or optic nerve).&#xD;
&#xD;
          -  Lesions of the brain preventing the establishment of good vision (eg. cortical visual&#xD;
             impairment).&#xD;
&#xD;
          -  Establishment of normal vision by refractive adaptation (wearing glasses after&#xD;
             presentation).&#xD;
&#xD;
          -  Patients diagnosed with Photosensitive Epilepsy.&#xD;
&#xD;
          -  Inability to comply with the follow-up visits required.&#xD;
&#xD;
          -  History of pathologic nystagmus (congenital or sensory).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Marc Levin</investigator_full_name>
    <investigator_title>Assistant Professor, Neuro-ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Amblyopia</keyword>
  <keyword>Dichoptic</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>Stereopsis</keyword>
  <keyword>Stereo vision</keyword>
  <keyword>Visual acuity</keyword>
  <keyword>Binocular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
    <mesh_term>Strabismus</mesh_term>
    <mesh_term>Anisometropia</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/NCT02246556
org study id: 14-14212
secondary id: 093955
nct id: NCT02246556
lead sponsor: 
has dmc: No
This was a randomized, masked, controlled study of the effect of a virtual reality,
      binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with
      amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new
      subjects for enrollment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in visual acuity
time frame: 3 weeks, 6 weeks, and 6 months
measure: Change in stereopsis
time frame: 3 weeks, 6 weeks, and 6 months
measure: Quality of life
time frame: 3 weeks, 6 weeks, and 6 months
arm group label: Patching therapy
arm group type: Active Comparator
description: Patching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.
arm group label: Dioptic (non-dichoptic) therapy
arm group type: Active Comparator
description: Dioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.
arm group label: Dichoptic therapy
arm group type: Experimental
description: Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.
intervention type: Device
intervention name: Dichoptic therapy
description: Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system
arm group label: Dichoptic therapy
intervention type: Other
intervention name: Patching therapy
description: Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
arm group label: Patching therapy
intervention type: Device
intervention name: Dioptic (non-dichoptic) therapy
description: Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
arm group label: Dioptic (non-dichoptic) therapy
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Marc Levin
investigator title: Assistant Professor, Neuro-ophthalmology
mesh term: Amblyopia
mesh term: Strabismus
mesh term: Anisometropia