<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/NCT03242681</url>
  </required_header>
  <id_info>
    <org_study_id>IR.TUMS.VCR.REC.1395.1200</org_study_id>
    <nct_id>NCT03242681</nct_id>
  </id_info>
  <brief_title>Endoscopy Assisted Probing Versus Simple Probing in Primary Congenital Nasolacrimal Duct Obstruction</brief_title>
  <acronym>Non</acronym>
  <official_title>Endoscopy Assisted Probing Versus Simple Probing in Patients With Primary Congenital Nasolacrimal Duct Obstruction: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with&#xD;
      the standard simple probing in cases with congenital nasolacrimal duct obstruction .&#xD;
      Furthermore, investigators will identify associated anatomical anomalies. Investigators&#xD;
      believe results of this study can be valuable in better understanding of this disease and&#xD;
      provide a high evidence level necessary to propose a classification and management algorithm.&#xD;
&#xD;
      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,&#xD;
      no past surgical management, with one or more of the below criteria will be included:&#xD;
&#xD;
        1. Non-resolving symptoms of epiphora and/or discharge.&#xD;
&#xD;
        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical&#xD;
           antibiotics.&#xD;
&#xD;
        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and&#xD;
           patients will undergo lacrimal tests before and after operation in one week, one month&#xD;
           and 3months based on a special record form. Patients will be randomly assigned to&#xD;
           &quot;simple probing&quot; group or &quot;endoscopy assisted probing&quot; group.&#xD;
&#xD;
      All operations will be performed in operative theater and under general anesthesia. Pre- and&#xD;
      post-operative examinations will be performed in plastic clinic in Farabi hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital nasolacrimal duct obstruction is the most common cause of epiphora in infancy that&#xD;
      can occur in 5% of newborn infants. It may resolve spontaneously in 95% of patients during&#xD;
      the first year of life.(1) After that time surgical intervention is justified. Epiphora after&#xD;
      birth is most commonly secondary to a developmental anomaly of imperforated membrane (Hasner&#xD;
      valve) in distal part of nasolacrimal duct. Patients with congenital nasolacrimal duct&#xD;
      obstruction (CNLDO) may show epiphora, eye discharge, acute dacryocystitis and cellulitis and&#xD;
      dacryocele. Currently the management of primary CNLDO includes conservative treatment&#xD;
      including lacrimal sac massage and topical antibiotics until 12 months of age.&#xD;
&#xD;
      The standard intervention for non-complicated, unresolved cases is simple blind probing of&#xD;
      nasolacrimal duct. The overall success rate of one time simple probing is 75%-95 %. Simple&#xD;
      probing is performed through a blind passage of a malleable metallic probe through punctum to&#xD;
      nasolacrimal duct and inferior meatal space in nasal cavity.Although effective, probing may&#xD;
      be associated with traumatic nasal bleeding, nasal mucosal damage,punctal and canalicular&#xD;
      injury and false passage. The trauma is further concerned during stent insertion.In the past&#xD;
      decade improvement in endoscopic instruments and techniques enabled us to visualize and&#xD;
      smoothly manipulate anomalies in the nasal cavity and especially in the inferior meatus.&#xD;
      Endoscopic assisted probing has been proposed as a measure to increase accuracy, efficacy and&#xD;
      safety of nasolacrimal probing. Furthermore, by this method intranasal pathologies associated&#xD;
      with failure of probing could be accurately diagnosed and specifically treated. To the best&#xD;
      of our knowledge literature addressing this issue is limited to few limited case series.&#xD;
&#xD;
      The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with&#xD;
      the standard simple probing in cases with congenital nasolacrimal duct obstruction .&#xD;
      Furthermore, investigators will identify associated anatomical anomalies. Investigators&#xD;
      believe results of this study can be valuable in better understanding of this disease and&#xD;
      provide a high evidence level necessary to propose a classification and management algorithm.&#xD;
&#xD;
      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,&#xD;
      no past surgical management, with one or more of the below criteria will be included:&#xD;
&#xD;
        1. Non-resolving symptoms of epiphora and/or discharge.&#xD;
&#xD;
        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical&#xD;
           antibiotics.&#xD;
&#xD;
        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and&#xD;
           patients will undergo lacrimal tests before and after operation in one week, one month&#xD;
           and 3months based on a special record form. Patients will be randomly assigned to&#xD;
           &quot;simple probing&quot; group or &quot;endoscopy assisted probing&quot; group.&#xD;
&#xD;
      All operations will be performed in operative theater and under general anesthesia. Pre- and&#xD;
      post-operative examinations will be performed in plastic clinic in Farabi hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success rate</measure>
    <time_frame>6 months</time_frame>
    <description>absence of epiphora and discharge and negative dye disappearance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>6 month</time_frame>
    <description>Incidence of complications related to the treatment including epistaxis, nasal stuffiness, injury to the nasolacrimal system or the eye, canalicular stenosis, keratopathy, nasal mucosa scar, synechia, tightening of inferior meatus (not reported at the time first intervention) to be described in those who need re-probing and nasal endoscopy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Congenital Nasolacrimal Duct Obstruction</condition>
  <arm_group>
    <arm_group_label>Endoscopy Assisted Probing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopy Assisted Probing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simple Probing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Simple Probing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopy Assisted Probing procedure</intervention_name>
    <description>The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system</description>
    <arm_group_label>Endoscopy Assisted Probing</arm_group_label>
    <arm_group_label>Simple Probing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age: 3 weeks&lt;Age&lt;6 years&#xD;
&#xD;
          2. epiphora or discharge since birth or within 8 weeks after birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Follow up less than 3 months&#xD;
&#xD;
          2. Epiphora secondary to etiologies than congenital naso-lacrimal duct obstruction such&#xD;
             as puncta/canalicular aplasia/dysgenesis;midfacial anomalies; congenital eyelid&#xD;
             malposition;epiblepharon; trichiasis; congenital glaucoma, tumors; blepharitis; trauma&#xD;
             Treatment success: defined success absence of epiphora/lacrimation and discharge 6&#xD;
             months after intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Weeks</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farzad Pakdel, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Farabi Hospital, Tehran University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Farzad Pakdel</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT03242681
org study id: IR.TUMS.VCR.REC.1395.1200
nct id: NCT03242681
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with
      the standard simple probing in cases with congenital nasolacrimal duct obstruction .
      Furthermore, investigators will identify associated anatomical anomalies. Investigators
      believe results of this study can be valuable in better understanding of this disease and
      provide a high evidence level necessary to propose a classification and management algorithm.

      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,
      no past surgical management, with one or more of the below criteria will be included:

        1. Non-resolving symptoms of epiphora and/or discharge.

        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical
           antibiotics.

        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and
           patients will undergo lacrimal tests before and after operation in one week, one month
           and 3months based on a special record form. Patients will be randomly assigned to
           "simple probing" group or "endoscopy assisted probing" group.

      All operations will be performed in operative theater and under general anesthesia. Pre- and
      post-operative examinations will be performed in plastic clinic in Farabi hospital.
Congenital nasolacrimal duct obstruction is the most common cause of epiphora in infancy that
      can occur in 5% of newborn infants. It may resolve spontaneously in 95% of patients during
      the first year of life.(1) After that time surgical intervention is justified. Epiphora after
      birth is most commonly secondary to a developmental anomaly of imperforated membrane (Hasner
      valve) in distal part of nasolacrimal duct. Patients with congenital nasolacrimal duct
      obstruction (CNLDO) may show epiphora, eye discharge, acute dacryocystitis and cellulitis and
      dacryocele. Currently the management of primary CNLDO includes conservative treatment
      including lacrimal sac massage and topical antibiotics until 12 months of age.

      The standard intervention for non-complicated, unresolved cases is simple blind probing of
      nasolacrimal duct. The overall success rate of one time simple probing is 75%-95 %. Simple
      probing is performed through a blind passage of a malleable metallic probe through punctum to
      nasolacrimal duct and inferior meatal space in nasal cavity.Although effective, probing may
      be associated with traumatic nasal bleeding, nasal mucosal damage,punctal and canalicular
      injury and false passage. The trauma is further concerned during stent insertion.In the past
      decade improvement in endoscopic instruments and techniques enabled us to visualize and
      smoothly manipulate anomalies in the nasal cavity and especially in the inferior meatus.
      Endoscopic assisted probing has been proposed as a measure to increase accuracy, efficacy and
      safety of nasolacrimal probing. Furthermore, by this method intranasal pathologies associated
      with failure of probing could be accurately diagnosed and specifically treated. To the best
      of our knowledge literature addressing this issue is limited to few limited case series.

      The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with
      the standard simple probing in cases with congenital nasolacrimal duct obstruction .
      Furthermore, investigators will identify associated anatomical anomalies. Investigators
      believe results of this study can be valuable in better understanding of this disease and
      provide a high evidence level necessary to propose a classification and management algorithm.

      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,
      no past surgical management, with one or more of the below criteria will be included:

        1. Non-resolving symptoms of epiphora and/or discharge.

        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical
           antibiotics.

        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and
           patients will undergo lacrimal tests before and after operation in one week, one month
           and 3months based on a special record form. Patients will be randomly assigned to
           "simple probing" group or "endoscopy assisted probing" group.

      All operations will be performed in operative theater and under general anesthesia. Pre- and
      post-operative examinations will be performed in plastic clinic in Farabi hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: success rate
time frame: 6 months
description: absence of epiphora and discharge and negative dye disappearance test
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 6 month
description: Incidence of complications related to the treatment including epistaxis, nasal stuffiness, injury to the nasolacrimal system or the eye, canalicular stenosis, keratopathy, nasal mucosa scar, synechia, tightening of inferior meatus (not reported at the time first intervention) to be described in those who need re-probing and nasal endoscopy.
arm group label: Endoscopy Assisted Probing
arm group type: Experimental
description: Endoscopy Assisted Probing
arm group label: Simple Probing
arm group type: Active Comparator
description: Simple Probing
intervention type: Procedure
intervention name: Endoscopy Assisted Probing procedure
description: The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system
arm group label: Endoscopy Assisted Probing
arm group label: Simple Probing
criteria: 
gender: All
minimum age: 3 Weeks
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farzad Pakdel, M.D.
role: Principal Investigator
affiliation: Farabi Hospital, Tehran University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Lacrimal Duct Obstruction
sharing ipd: Undecided