<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/NCT03768362</url>
  </required_header>
  <id_info>
    <org_study_id>13112</org_study_id>
    <nct_id>NCT03768362</nct_id>
  </id_info>
  <brief_title>Comparison of Medial Rectus Resection and Plication in Exotropic Patients</brief_title>
  <official_title>Comparison of Medial Rectus Resection and Plication in Exotropic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</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>
      Purpose: To determine the surgical outcomes of the plication technique in comparison with the&#xD;
      resection method on exotropic patients.&#xD;
&#xD;
      Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%)&#xD;
      who are candidate for medial rectus strengthening will be randomly classified into plication&#xD;
      (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be&#xD;
      performed on all study subjects and they will be followed- up for three months&#xD;
      postoperatively. Plication technique is the same as resection up to muscle suturing, in the&#xD;
      next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle&#xD;
      insertion, then the muscle was folded toward inside or outside by pulling and joining the&#xD;
      sutures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Postoperative ocular deviation</measure>
    <time_frame>three months</time_frame>
    <description>Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Exotropia</condition>
  <arm_group>
    <arm_group_label>Undergoing plication strabismus surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Undergoing resection strabismus surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Plication strabismus surgery</intervention_name>
    <description>The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures. At the end, conjunctiva was repaired by vicryl 8/0.</description>
    <arm_group_label>Undergoing plication strabismus surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection strabismus surgery</intervention_name>
    <description>resection strabismus surgery</description>
    <arm_group_label>Undergoing resection strabismus surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with a residual exotropia and history of uni- or bilateral lateral rectus&#xD;
        recession or recession and resection (R &amp;R) and those exotropic patients who were going to&#xD;
        have already recession and resection (R &amp; R) operation due to unilateral constant exotropia&#xD;
        will be considered as eligible cases to be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with a history of prematurity, intellectual disability, lack of central fixation&#xD;
        (nystagmus, eccentric fixation, retinopathy of prematurity) subjects with systemic or other&#xD;
        ocular diseases, neurological disorders, uncooperative patients and participants with less&#xD;
        than three-month postoperative follow-up will be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</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>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hamideh Sabbaghi</investigator_full_name>
    <investigator_title>PhD student, Teacher Assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exotropia</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/NCT03768362
org study id: 13112
nct id: NCT03768362
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: To determine the surgical outcomes of the plication technique in comparison with the
      resection method on exotropic patients.

      Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%)
      who are candidate for medial rectus strengthening will be randomly classified into plication
      (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be
      performed on all study subjects and they will be followed- up for three months
      postoperatively. Plication technique is the same as resection up to muscle suturing, in the
      next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle
      insertion, then the muscle was folded toward inside or outside by pulling and joining the
      sutures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Postoperative ocular deviation
time frame: three months
description: Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.
arm group label: Undergoing plication strabismus surgery
arm group type: Experimental
arm group label: Undergoing resection strabismus surgery
arm group type: Active Comparator
intervention type: Procedure
intervention name: Plication strabismus surgery
description: The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures. At the end, conjunctiva was repaired by vicryl 8/0.
arm group label: Undergoing plication strabismus surgery
intervention type: Procedure
intervention name: Resection strabismus surgery
description: resection strabismus surgery
arm group label: Undergoing resection strabismus surgery
criteria: 
gender: All
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Hamideh Sabbaghi
investigator title: PhD student, Teacher Assistant
mesh term: Exotropia
sharing ipd: Undecided