<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/NCT04487249</url>
  </required_header>
  <id_info>
    <org_study_id>20-08</org_study_id>
    <nct_id>NCT04487249</nct_id>
  </id_info>
  <brief_title>Trial of Vision Therapy for Intermittent Exotropia</brief_title>
  <acronym>VT-IXT</acronym>
  <official_title>A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern California College of Optometry at Marshall B. Ketchum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Salus University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southern College of Optometry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Academy of Optometry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southern California College of Optometry at Marshall B. Ketchum University</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>
      The main objective of this randomized trial comparing vision therapy to observation is to&#xD;
      determine the short-term effectiveness of vision therapy on distance intermittent exotropia&#xD;
      control. The results will help determine whether to proceed to a full-scale, long-term&#xD;
      randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vision therapy (VT) is a commonly prescribed treatment for children with intermittent&#xD;
      exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is&#xD;
      unknown because previous studies have largely limited observational or retrospective case&#xD;
      series without comparison groups. The objective of this multi-centered pilot randomized trial&#xD;
      of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT&#xD;
      on distance intermittent exotropia and 2) determine the feasibility of recruitment and&#xD;
      retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of&#xD;
      20 weeks of in-office VT. The results of this trial will provide the needed information to&#xD;
      plan and conduct a large-scale randomized trial to determine short-term and long-term&#xD;
      effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill&#xD;
      in the gaps in scientific knowledge concerning VT as a treatment for IXT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Mean Distance Control Score</measure>
    <time_frame>21 weeks</time_frame>
    <description>The primary analysis will be an intent-to-treat comparison of mean distance control score, determine by the intermittent exotropia office control scale, at outcome using an analysis of covariance model, which will adjust for baseline distance control. The intermittent exotropia office control scale grades the control on a scale of 0 (best control; phoria) to 5 (worst control; constant exotropia).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>No Spontaneous Tropia</measure>
    <time_frame>21 weeks</time_frame>
    <description>The proportion of participants with no spontaneous tropia at outcome will be compared between treatment groups.No spontaneous tropia is defined as control score of 2 or less on all three assessments of control at distance and near and no exotropia lasting more than 5 seconds throughout the examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Distance Control</measure>
    <time_frame>21 weeks</time_frame>
    <description>The proportion of participants with &gt;= 1 point change in control and &gt;= 2 points change in control will be compared between treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Vergence and Accommodative Measures</measure>
    <time_frame>21 weeks</time_frame>
    <description>The near point of convergence, positive and negative fusional vergence ranges at distance and near, vergence facility, accommodative amplitude, and accommodative facility at outcome will be compared between treatment groups adjusting for the corresponding baseline value. The analysis will be completed separately for each vergence and accommodative measures.</description>
  </other_outcome>
  <other_outcome>
    <measure>Suppression Status</measure>
    <time_frame>21 weeks</time_frame>
    <description>Suppression status will be compared at outcome between treatment groups, adjusting for baseline suppression status. Suppression status when the participant's eyes are in tropic position will be assessed using the suppression scale ranging from 0 (negligible suppression) to 4 (dense suppression).</description>
  </other_outcome>
  <other_outcome>
    <measure>Objective Eye Movement Recordings</measure>
    <time_frame>21 weeks</time_frame>
    <description>Frequency of intermittent exotropia by objective eye movement recordings will be compared between treatment groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Intermittent Exotropia</condition>
  <arm_group>
    <arm_group_label>Vision Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vision Therapy</intervention_name>
    <description>20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion.</description>
    <arm_group_label>Vision Therapy</arm_group_label>
    <other_name>Orthoptics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria-&#xD;
&#xD;
          -  Age 8 - 16 years&#xD;
&#xD;
          -  Intermittent exotropia meeting all of the following:&#xD;
&#xD;
               -  Distance exodeviation of 15∆ to 35∆ by prism alternating cover test (PACT)&#xD;
&#xD;
               -  IXT, exophoria, or orthophoria at near&#xD;
&#xD;
               -  Near exodeviation that does not exceed the distance exodeviation by more than 10∆&#xD;
&#xD;
               -  Mean distance control score of 2 points or more with at least one measure being 3&#xD;
                  points or higher&#xD;
&#xD;
               -  Mean near control score less than 5 points&#xD;
&#xD;
          -  Random dot stereopsis of 200&quot; or better on Preschool Randot Stereotest&#xD;
&#xD;
          -  Willingness to accept randomization and no plan to relocate in the next 6 months&#xD;
&#xD;
        Major Exclusion Criteria-&#xD;
&#xD;
          -  Treatment for IXT or amblyopia (other than refractive correction) within 3 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Office-based vision therapy for IXT within 6 months prior to enrollment&#xD;
&#xD;
          -  Prior office-based vision therapy for IXT of ≥10 sessions&#xD;
&#xD;
          -  Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Chen, OD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Southern California College of Optometry at Marshall B. Ketchum University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angela Chen, OD, MS</last_name>
    <phone>714-463-7569</phone>
    <email>angelachen@ketchum.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama in Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristine Hopkins, OD, MSPH</last_name>
      <phone>205-996-1678</phone>
      <email>kbhopkins@uab.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southern California College of Optometry at Marshall B. Ketchum University</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92831</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Chen, OD, MS</last_name>
      <phone>714-463-7569</phone>
      <email>angelachen@ketchum.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tawna Roberts, OD, PhD</last_name>
      <phone>650-723-1143</phone>
      <email>tawnar@stanford.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Morrison, OD, MS</last_name>
      <phone>614-247-0010</phone>
      <email>morrison.421@osu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Salus University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Jenewein, OD, MS</last_name>
      <phone>215-276-6053</phone>
      <email>ejenewein@salus.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southern College of Optometry</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Bodack, OD</last_name>
      <phone>901-722-3349</phone>
      <email>mbodack@sco.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intermittent Exotropia</keyword>
  <keyword>Vision Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exotropia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04487249
org study id: 20-08
nct id: NCT04487249
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective of this randomized trial comparing vision therapy to observation is to
      determine the short-term effectiveness of vision therapy on distance intermittent exotropia
      control. The results will help determine whether to proceed to a full-scale, long-term
      randomized trial.
Vision therapy (VT) is a commonly prescribed treatment for children with intermittent
      exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is
      unknown because previous studies have largely limited observational or retrospective case
      series without comparison groups. The objective of this multi-centered pilot randomized trial
      of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT
      on distance intermittent exotropia and 2) determine the feasibility of recruitment and
      retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of
      20 weeks of in-office VT. The results of this trial will provide the needed information to
      plan and conduct a large-scale randomized trial to determine short-term and long-term
      effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill
      in the gaps in scientific knowledge concerning VT as a treatment for IXT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Distance Control Score
time frame: 21 weeks
description: The primary analysis will be an intent-to-treat comparison of mean distance control score, determine by the intermittent exotropia office control scale, at outcome using an analysis of covariance model, which will adjust for baseline distance control. The intermittent exotropia office control scale grades the control on a scale of 0 (best control; phoria) to 5 (worst control; constant exotropia).
measure: No Spontaneous Tropia
time frame: 21 weeks
description: The proportion of participants with no spontaneous tropia at outcome will be compared between treatment groups.No spontaneous tropia is defined as control score of 2 or less on all three assessments of control at distance and near and no exotropia lasting more than 5 seconds throughout the examination.
measure: Change in Distance Control
time frame: 21 weeks
description: The proportion of participants with >= 1 point change in control and >= 2 points change in control will be compared between treatment groups.
measure: Change in Vergence and Accommodative Measures
time frame: 21 weeks
description: The near point of convergence, positive and negative fusional vergence ranges at distance and near, vergence facility, accommodative amplitude, and accommodative facility at outcome will be compared between treatment groups adjusting for the corresponding baseline value. The analysis will be completed separately for each vergence and accommodative measures.
measure: Suppression Status
time frame: 21 weeks
description: Suppression status will be compared at outcome between treatment groups, adjusting for baseline suppression status. Suppression status when the participant's eyes are in tropic position will be assessed using the suppression scale ranging from 0 (negligible suppression) to 4 (dense suppression).
measure: Objective Eye Movement Recordings
time frame: 21 weeks
description: Frequency of intermittent exotropia by objective eye movement recordings will be compared between treatment groups.
arm group label: Vision Therapy
arm group type: Experimental
description: Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
arm group label: Observation
arm group type: No Intervention
description: Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.
intervention type: Other
intervention name: Vision Therapy
description: 20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion.
arm group label: Vision Therapy
other name: Orthoptics
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Angela Chen, OD, MS
role: Study Chair
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
last name: Angela Chen, OD, MS
phone: 714-463-7569
email: angelachen@ketchum.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Exotropia
sharing ipd: No