<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/NCT03780868</url>
  </required_header>
  <id_info>
    <org_study_id>Ebsar ophthalmic Center</org_study_id>
    <nct_id>NCT03780868</nct_id>
  </id_info>
  <brief_title>External DCR Versus Canalicular SI With MMC in NLDO</brief_title>
  <official_title>External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia 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>
      While external DCR is the gold standard procedure for primary NLDO as well as complicated&#xD;
      cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence&#xD;
      should be considered as an alternative as a safe and minimally invasive procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation&#xD;
      with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).&#xD;
&#xD;
      Methods: the study was carried out at the department of Ophthalmology, Menoufia university&#xD;
      Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with&#xD;
      primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases&#xD;
      underwent external DCR and twenty-six cases underwent silicone intubation with MMC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">July 31, 2014</completion_date>
  <primary_completion_date type="Actual">July 1, 2014</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>
    <intervention_model_description>compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>external DCR</measure>
    <time_frame>2 years</time_frame>
    <description>patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).</description>
  </primary_outcome>
  <other_outcome>
    <measure>canalicular silicone intubation with MMC</measure>
    <time_frame>2 years</time_frame>
    <description>patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Primary Acquired Nasolacrimal Duct Obstruction</condition>
  <arm_group>
    <arm_group_label>external DCR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A curvilinear incision of 10-15 mm length was made along the anterior lacrimal crest .&#xD;
The smaller end of the blunt dissector was used to fracture Lamina papyracea, the parchment like bone of the posterior half of the lacrimal fossa. the nasal mucosa was stripped from lacrimal bone with the help of Traquair's periosteal elevator, An osteotomy of approximately 12.5 x10mm was created with successive punching of bone by Cittelli's punch. Lacrimal sac and nasal mucosa were opened in a 'H' fashion with the no.11 Bard-Parker blade and Bowman's probe was in place, to form a large anterior and smaller posterior flap.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>silicone intubation with MMC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bowman's probe was gently inserted into the inferior canalicular system, until a hard stop was felt in the lacrimal sac, after which it was rotated into the NLD to reach below the inferior concha. The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus.&#xD;
After irrigation with normal saline to confirm duct patency, irrigation was performed by introducing 1 ml of MMC (0.5 mg/ml) into the duct with a syringe, the ocular surface then irrigatedby normal saline. Intubation was done by a silicone tube connected by each of its end to a malleable steel guide. A grooved director was placed under the inferior turbinate to guide the probe out of the nose, after which the steel guide was cut from the silicone tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>external dacryocystorhinostomy</intervention_name>
    <description>external DCR under general anesthesia with standard sterilization procedures.</description>
    <arm_group_label>external DCR</arm_group_label>
    <arm_group_label>silicone intubation with MMC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>canalicular silicone intubation with MMC</intervention_name>
    <description>canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.</description>
    <arm_group_label>external DCR</arm_group_label>
    <arm_group_label>silicone intubation with MMC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary acquired NLDO&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All other secondary causes of NLDO&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Amin Faisal Ellakwa</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>External DCR, canalicular silicone intubation, Mitomycin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacrimal Duct Obstruction</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/NCT03780868
org study id: Ebsar ophthalmic Center
nct id: NCT03780868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While external DCR is the gold standard procedure for primary NLDO as well as complicated
      cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence
      should be considered as an alternative as a safe and minimally invasive procedure.
Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation
      with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).

      Methods: the study was carried out at the department of Ophthalmology, Menoufia university
      Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with
      primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases
      underwent external DCR and twenty-six cases underwent silicone intubation with MMC.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).
primary purpose: Treatment
masking: Single (Participant)
measure: external DCR
time frame: 2 years
description: patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).
measure: canalicular silicone intubation with MMC
time frame: 2 years
description: patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).
arm group label: external DCR
arm group type: Active Comparator
description: A curvilinear incision of 10-15 mm length was made along the anterior lacrimal crest .
The smaller end of the blunt dissector was used to fracture Lamina papyracea, the parchment like bone of the posterior half of the lacrimal fossa. the nasal mucosa was stripped from lacrimal bone with the help of Traquair's periosteal elevator, An osteotomy of approximately 12.5 x10mm was created with successive punching of bone by Cittelli's punch. Lacrimal sac and nasal mucosa were opened in a 'H' fashion with the no.11 Bard-Parker blade and Bowman's probe was in place, to form a large anterior and smaller posterior flap.
arm group label: silicone intubation with MMC
arm group type: Active Comparator
description: Bowman's probe was gently inserted into the inferior canalicular system, until a hard stop was felt in the lacrimal sac, after which it was rotated into the NLD to reach below the inferior concha. The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus.
After irrigation with normal saline to confirm duct patency, irrigation was performed by introducing 1 ml of MMC (0.5 mg/ml) into the duct with a syringe, the ocular surface then irrigatedby normal saline. Intubation was done by a silicone tube connected by each of its end to a malleable steel guide. A grooved director was placed under the inferior turbinate to guide the probe out of the nose, after which the steel guide was cut from the silicone tube
intervention type: Procedure
intervention name: external dacryocystorhinostomy
description: external DCR under general anesthesia with standard sterilization procedures.
arm group label: external DCR
arm group label: silicone intubation with MMC
intervention type: Procedure
intervention name: canalicular silicone intubation with MMC
description: canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.
arm group label: external DCR
arm group label: silicone intubation with MMC
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Amin Faisal Ellakwa
investigator title: assistant professor
mesh term: Lacrimal Duct Obstruction
sharing ipd: No