<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/NCT03248336</url>
  </required_header>
  <id_info>
    <org_study_id>HMS1312</org_study_id>
    <nct_id>NCT03248336</nct_id>
  </id_info>
  <brief_title>Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children</brief_title>
  <official_title>Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salus University</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>
      This study is designed to evaluate changes in objective measures of disparity vergence after&#xD;
      office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in&#xD;
      children 12-17 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 participants with normal binocular vision and 30 with CI will be recruited for this&#xD;
      prospective study. All participants with CI will be treated with 12 weeks of office-based&#xD;
      vergence/accommodative therapy. The primary outcome measure will be the average peak velocity&#xD;
      for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence&#xD;
      will be time to peak velocity, latency, and accuracy. Changes in clinical measures [near&#xD;
      point of convergence (NPC), positive fusional vergence at near (PFV)] and symptoms will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Eligible participants received 12 weeks of office vergence/accommodative therapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and the primary outcome measures will be the change in average peak velocity for 4° symmetrical convergence steps</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in time to peak velocity for 4° symmetrical convergence steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in accuracy for 4° symmetrical convergence steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in settling time for 4° symmetrical convergence steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the near point of convergence</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>The near point of convergence will be measured using the Near Point Rule at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the positive fusional vergence</measure>
    <time_frame>After 12 weeks of therapy</time_frame>
    <description>Positive fusional vergence will be measured using a handheld target placed 40 cm from the participant and using a horizontal prism bar. Positive fusional vergence will be measured at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Convergence Insufficiency</condition>
  <arm_group>
    <arm_group_label>Vision therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve, 60-minute, weekly visits of office-based vergence/accommodation therapy will be administered by a trained therapist combined with procedures to practice at home (15 minutes, 5 times per week). This treatment sequence is a well-accepted approach for treatment of CI and has been successfully implemented in previous studies. Fifteen minutes of home-based therapy was prescribed to be performed 5 days per week, and compliance with home-based therapy was monitored at each visit by the therapist</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>office-based vergence/accommodative therapy</intervention_name>
    <description>one -to-one treatment by a trained therapists. The subject is asked to perform 5-6 therapy procedures during a 60 minute therapy session. The subject is also asked to perform 15 minutes per day of home-based therapy.</description>
    <arm_group_label>Vision therapy group</arm_group_label>
    <other_name>optometric vision therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CI Symptom Survey score ≥ 16&#xD;
&#xD;
          -  Exophoria at near at least 4 greater than at far&#xD;
&#xD;
          -  Receded near point of convergence (NPC) of 6 cm break&#xD;
&#xD;
          -  Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's&#xD;
             criterion or PFV ≤15 base-out break)&#xD;
&#xD;
          -  Best-corrected distance visual acuity of 20/25 or better in each eye&#xD;
&#xD;
          -  Random dot stereopsis appreciation of 500 seconds of arc or better&#xD;
&#xD;
          -  Wearing appropriate refractive correction (spectacles of contact lenses) for at least&#xD;
             2 weeks prior to final determination of eligibility for any of the following&#xD;
             uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)&#xD;
&#xD;
          -  No use of BI prism or plus add at near for 2 weeks prior to study and for duration of&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Constant strabismus at distance or near&#xD;
&#xD;
          -  Esophoria of ≥ 2∆ at distance&#xD;
&#xD;
          -  Vertical heterophoria ≥ 2∆ at distance or near&#xD;
&#xD;
          -  ≥ 2 line interocular difference in best-corrected visual acuity&#xD;
&#xD;
          -  Near point of accommodation &gt;20 cm in either eye as measured by push-up method&#xD;
&#xD;
          -  Manifest or latent nystagmus&#xD;
&#xD;
          -  History of strabismus surgery or refractive surgery&#xD;
&#xD;
          -  CI associated with head trauma or known disease of the brain&#xD;
&#xD;
          -  Diseases known to affect accommodation, vergence, or ocular motility&#xD;
&#xD;
          -  Inability to comprehend and/or perform any study-related test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mitchell Scheiman, OD, PhD</last_name>
    <phone>215-692-0897</phone>
    <email>scheiman@comcast.net</email>
  </overall_contact>
  <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>Mitchell Scheiman, OD, PhD</last_name>
      <phone>215-692-0897</phone>
      <email>mscheiman@salus.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Salus University</investigator_affiliation>
    <investigator_full_name>Mitchell Scheiman</investigator_full_name>
    <investigator_title>Dean of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Motility Disorders</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/NCT03248336
org study id: HMS1312
nct id: NCT03248336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to evaluate changes in objective measures of disparity vergence after
      office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in
      children 12-17 years old.
30 participants with normal binocular vision and 30 with CI will be recruited for this
      prospective study. All participants with CI will be treated with 12 weeks of office-based
      vergence/accommodative therapy. The primary outcome measure will be the average peak velocity
      for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence
      will be time to peak velocity, latency, and accuracy. Changes in clinical measures [near
      point of convergence (NPC), positive fusional vergence at near (PFV)] and symptoms will be
      evaluated.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Eligible participants received 12 weeks of office vergence/accommodative therapy
primary purpose: Treatment
masking: None (Open Label)
measure: Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
time frame: After 12 weeks of therapy
description: The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and the primary outcome measures will be the change in average peak velocity for 4° symmetrical convergence steps
measure: Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
time frame: After 12 weeks of therapy
description: The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in time to peak velocity for 4° symmetrical convergence steps
measure: Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy
time frame: After 12 weeks of therapy
description: The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps
measure: Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy
time frame: After 12 weeks of therapy
description: The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in accuracy for 4° symmetrical convergence steps
measure: Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy
time frame: After 12 weeks of therapy
description: The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in settling time for 4° symmetrical convergence steps
measure: Change in the near point of convergence
time frame: After 12 weeks of therapy
description: The near point of convergence will be measured using the Near Point Rule at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.
measure: Change in the positive fusional vergence
time frame: After 12 weeks of therapy
description: Positive fusional vergence will be measured using a handheld target placed 40 cm from the participant and using a horizontal prism bar. Positive fusional vergence will be measured at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.
arm group label: Vision therapy group
arm group type: Experimental
description: Twelve, 60-minute, weekly visits of office-based vergence/accommodation therapy will be administered by a trained therapist combined with procedures to practice at home (15 minutes, 5 times per week). This treatment sequence is a well-accepted approach for treatment of CI and has been successfully implemented in previous studies. Fifteen minutes of home-based therapy was prescribed to be performed 5 days per week, and compliance with home-based therapy was monitored at each visit by the therapist
intervention type: Procedure
intervention name: office-based vergence/accommodative therapy
description: one -to-one treatment by a trained therapists. The subject is asked to perform 5-6 therapy procedures during a 60 minute therapy session. The subject is also asked to perform 15 minutes per day of home-based therapy.
arm group label: Vision therapy group
other name: optometric vision therapy
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchell Scheiman, OD, PhD
phone: 215-692-0897
email: scheiman@comcast.net
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Salus University
investigator full name: Mitchell Scheiman
investigator title: Dean of Research
mesh term: Ocular Motility Disorders
sharing ipd: No