xml: <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/NCT05980962</url>
    </required_header>
    <id_info>
      <org_study_id>N-97-2018</org_study_id>
      <nct_id>NCT05980962</nct_id>
    </id_info>
    <brief_title>Inferior Oblique Muscle Anteriorization Versus Anteriorization and Resection in DVD With IOOA</brief_title>
    <official_title>Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kasr El Aini Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kasr El Aini Hospital</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 goal of this clinical trial is to compare the results of two surgical modalities in&#xD;
        patients with Dissociated vertical deviation with inferior oblique muscle overaction . The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  How much does the magnitude of DVD improve after each modality?&#xD;
  &#xD;
          -  Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers&#xD;
             will compare the efficacy of symmetrical anteriorization of the inferior oblique and&#xD;
             adding an additional rescetion to one eye in the second group to see which group had&#xD;
             more signifcant reduction in the magnitude of DVD and IOOA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective study was performed on patients with bilateral symmterical dissociated vertical&#xD;
        deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University&#xD;
        hospitals starting from February 2018 through December 2021. Patients wetre included in the&#xD;
        study if they had a minimum follow up period of 6 months. The study included 54 patients (108&#xD;
        eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups.&#xD;
        The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while&#xD;
        the patients in group 2 underwent ayymmetrical surgery , where inferior oblique&#xD;
        anteriorization was performed in one eye the same manner is in group 1, and the eye with the&#xD;
        larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with&#xD;
        anteriorization according to the measured DVD difference between both eyes, whether less than&#xD;
        or more than 5 prism diopters respectively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2018</start_date>
    <completion_date type="Actual">July 15, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</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>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>reduction of the magnitude of DVD</measure>
      <time_frame>1 week ,1 month, three months, six months</time_frame>
      <description>degree of reduction of the deviation measured in prism diopters</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reduction of magnitude of IOOA</measure>
      <time_frame>1 week ,1 month, three months, six months</time_frame>
      <description>redctuon in the measured degree of IOOA</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Dissociated Vertical Deviation</condition>
    <condition>Inferior Oblique Overaction</condition>
    <arm_group>
      <arm_group_label>Group 1 (Anteriorization group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Symmetrical Anteriorization of the inferior oblique muscle</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (Resction group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Inferior oblique anteriorization</intervention_name>
      <description>symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion</description>
      <arm_group_label>Group 1 (Anteriorization group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Inferior oblique anteriorization together with unliateral resction</intervention_name>
      <description>asymmterical surgery, anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion in one eye, and an additional 3-5 mm resction of the inferior oblique in the eye with the larger devation</description>
      <arm_group_label>Group 2 (Resction group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Manifest DVD decompensated to a tropia with free ocular motility&#xD;
  &#xD;
            -  Cases with or without horizontal misalignment&#xD;
  &#xD;
            -  Cases with or without previous horizontal muscle surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Incomitant, Paralytic or restrictive strabismus&#xD;
  &#xD;
            -  Eyes with previous inferior oblique muscle surgery&#xD;
  &#xD;
            -  Recurrent DVD after surgical treatment&#xD;
  &#xD;
            -  Eyes with previous scleral buckling for retinal deatchment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hala M. Elhiliali</last_name>
      <role>Study Chair</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Magda S. Abdel-Aziz</last_name>
      <role>Study Director</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Heba M. Fouad</last_name>
      <role>Study Director</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ghada O. Mohamed</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kasr Alainy School of Medicine, Cairo University</name>
        <address>
          <city>Cairo</city>
          <zip>35855</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
      <investigator_full_name>Ghada Osama Mohamed</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <keyword>DVD</keyword>
    <keyword>IOOA</keyword>
    <keyword>IO Anteriorization</keyword>
    <keyword>IO Anteriorization with rescetion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Strabismus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980962
  org study id: N-97-2018
  nct id: NCT05980962
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the results of two surgical modalities in
        patients with Dissociated vertical deviation with inferior oblique muscle overaction . The
        main questions it aims to answer are:
  
          -  How much does the magnitude of DVD improve after each modality?
  
          -  Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers
             will compare the efficacy of symmetrical anteriorization of the inferior oblique and
             adding an additional rescetion to one eye in the second group to see which group had
             more signifcant reduction in the magnitude of DVD and IOOA.
  A prospective study was performed on patients with bilateral symmterical dissociated vertical
        deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University
        hospitals starting from February 2018 through December 2021. Patients wetre included in the
        study if they had a minimum follow up period of 6 months. The study included 54 patients (108
        eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups.
        The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while
        the patients in group 2 underwent ayymmetrical surgery , where inferior oblique
        anteriorization was performed in one eye the same manner is in group 1, and the eye with the
        larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with
        anteriorization according to the measured DVD difference between both eyes, whether less than
        or more than 5 prism diopters respectively.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: reduction of the magnitude of DVD
  time frame: 1 week ,1 month, three months, six months
  description: degree of reduction of the deviation measured in prism diopters
  measure: reduction of magnitude of IOOA
  time frame: 1 week ,1 month, three months, six months
  description: redctuon in the measured degree of IOOA
  arm group label: Group 1 (Anteriorization group)
  arm group type: Active Comparator
  description: Symmetrical Anteriorization of the inferior oblique muscle
  arm group label: Group 2 (Resction group)
  arm group type: Experimental
  description: Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation
  intervention type: Procedure
  intervention name: Inferior oblique anteriorization
  description: symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion
  arm group label: Group 1 (Anteriorization group)
  intervention type: Procedure
  intervention name: Inferior oblique anteriorization together with unliateral resction
  description: asymmterical surgery, anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion in one eye, and an additional 3-5 mm resction of the inferior oblique in the eye with the larger devation
  arm group label: Group 2 (Resction group)
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: N/A
  healthy volunteers: No
  last name: Hala M. Elhiliali
  role: Study Chair
  affiliation: Cairo University
  last name: Magda S. Abdel-Aziz
  role: Study Director
  affiliation: Cairo University
  last name: Heba M. Fouad
  role: Study Director
  affiliation: Cairo University
  last name: Ghada O. Mohamed
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Kasr El Aini Hospital
  investigator full name: Ghada Osama Mohamed
  investigator title: Dr.
  mesh term: Strabismus
  sharing ipd: No