<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/NCT03240107</url>
  </required_header>
  <id_info>
    <org_study_id>hhim123</org_study_id>
    <nct_id>NCT03240107</nct_id>
  </id_info>
  <brief_title>Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis</brief_title>
  <official_title>Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heba Hamdy Ibrahim Mohammed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation&#xD;
      levator aponeurosis Tucking for Congenital Ptosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Target population for the study is children under twelve years old presenting to&#xD;
      ophthalmology clinic at Cairo university specialized pediatric hospital with congenital&#xD;
      ptosis.&#xD;
&#xD;
      Patients will be randomly divided into two groups First group (A) will contain 20 patients&#xD;
      who will undergo standard levator aponeurosis resection Second group (B) will contain 20&#xD;
      patient who will undergo two point fixation levator tucking&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1</measure>
    <time_frame>6 to 9 months</time_frame>
    <description>MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Congenital Ptosis</condition>
  <arm_group>
    <arm_group_label>levator resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 patients who will undergo levator aponeurosis resection technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>levator tucking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 patients who will undergo two point fixation levator tucking technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>levator resection</intervention_name>
    <description>The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.&#xD;
The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.&#xD;
The skin incision closed by continuous suture with 6-0 prolene.</description>
    <arm_group_label>levator resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>levator tucking</intervention_name>
    <description>The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.&#xD;
. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.</description>
    <arm_group_label>levator tucking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Unilateral or bilateral simple isolated congenital ptosis.&#xD;
&#xD;
          2. Levator function more than 4mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital ptosis associated with other ocular syndromes.&#xD;
&#xD;
          2. Recurrent ptosis following any attempt for repair.&#xD;
&#xD;
          3. Traumatic ptosis or acquired ptosis&#xD;
&#xD;
          4. -ve bell's phenomenon.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RANIA AS EL ASSAWY, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sameh HA ABDEL BAKY, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DINA HO HASSANIEN, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HEBA</name>
      <address>
        <city>Cairo City</city>
        <state>Zahraa AL Maadi</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Heba Hamdy Ibrahim Mohammed</investigator_full_name>
    <investigator_title>Doctor heba hamdy ibrahim</investigator_title>
  </responsible_party>
  <keyword>levator resection</keyword>
  <keyword>levator tucking</keyword>
  <keyword>Fair levator function</keyword>
  <keyword>Eyelid contour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharoptosis</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 3, 2017</submitted>
    <returned>October 30, 2017</returned>
    <submitted>January 19, 2018</submitted>
    <returned>October 25, 2018</returned>
  </pending_results>
  <!-- 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/NCT03240107
org study id: hhim123
nct id: NCT03240107
lead sponsor: 
has dmc: Yes
to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation
      levator aponeurosis Tucking for Congenital Ptosis
Target population for the study is children under twelve years old presenting to
      ophthalmology clinic at Cairo university specialized pediatric hospital with congenital
      ptosis.

      Patients will be randomly divided into two groups First group (A) will contain 20 patients
      who will undergo standard levator aponeurosis resection Second group (B) will contain 20
      patient who will undergo two point fixation levator tucking
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1
time frame: 6 to 9 months
description: MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler
arm group label: levator resection
arm group type: Active Comparator
description: 20 patients who will undergo levator aponeurosis resection technique
arm group label: levator tucking
arm group type: Active Comparator
description: 20 patients who will undergo two point fixation levator tucking technique
intervention type: Procedure
intervention name: levator resection
description: The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.
The skin incision closed by continuous suture with 6-0 prolene.
arm group label: levator resection
intervention type: Procedure
intervention name: levator tucking
description: The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.
arm group label: levator tucking
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: RANIA AS EL ASSAWY, PhD
role: Study Chair
affiliation: Cairo University
last name: Sameh HA ABDEL BAKY, MD
role: Study Director
affiliation: Cairo University
last name: DINA HO HASSANIEN, MD
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Heba Hamdy Ibrahim Mohammed
investigator title: Doctor heba hamdy ibrahim
mesh term: Blepharoptosis
mesh term: Prolapse
sharing ipd: Undecided
submitted: October 3, 2017
returned: October 30, 2017
submitted: January 19, 2018
returned: October 25, 2018