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/NCT05999058</url>
    </required_header>
    <id_info>
      <org_study_id>YK-2023038</org_study_id>
      <nct_id>NCT05999058</nct_id>
    </id_info>
    <brief_title>Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy</brief_title>
    <official_title>Clinical Characteristics and Treatment Outcomes of Nasolacrimal Duct Obstruction Using Dacryoendoscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Eye Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Eye Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nasolacrimal duct obstruction (NLDO) can manifest as epiphora or recurrent infections with&#xD;
        mucopurulent discharge and may even cause social embarrassment. Dacryoendoscopic-assisted&#xD;
        laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed&#xD;
        site, leading to minimal collateral damage external to the target zone. Although the silicone&#xD;
        intubation using dacryoendoscopy has increased the success rates, the success rates vary from&#xD;
        a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of&#xD;
        obstruction, differences in the surgical technique, stringency of definitions of success, and&#xD;
        duration of follow-up. The aim of our study was to report the results of DLDI for the&#xD;
        management of NLDO, and to identify factors associated with DLDI failure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lacrimal drainage obstruction can manifest as epiphora or recurrent infections with&#xD;
        mucopurulent discharge and may even cause social embarrassment. Obstruction can occur at any&#xD;
        level along the lacrimal drainage system: punctum, canaliculus, nasolacrimal duct, or nasal&#xD;
        ostium. It is seen more often in females, especially in postmenopausal women. The&#xD;
        etiopathogenesis of lacrimal passage obstruction appears to be multifactorial. Chronic&#xD;
        inflammation has been suggested to be the most causal. Dacryocystorhinostomy (DCR) is a&#xD;
        standard surgical procedure used to treat nasolacrimal duct obstruction (NLDO), with a&#xD;
        reported success rate of more than 90%.&#xD;
  &#xD;
        Knowledge concerning the morphological characteristics of lacrimal passage obstruction using&#xD;
        traditional diagnostic methods (e.g., lacrimal irrigation, probing, dacryocystography) is&#xD;
        limited. Dacryoendoscopy was originally described in 1979 and has recently matured for use in&#xD;
        lacrimal drainage system imaging. It has been proved to be a useful instrument not only for&#xD;
        understanding differences in the etiology of obstructions but also for treating LD&#xD;
        obstructions. On the other hand, semiconductor diode laser can achieve more effective tissue&#xD;
        dissection than direct probing technique with minimal hemorrhage and improved intraoperative&#xD;
        view. Hence, dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI)&#xD;
        offers direct therapy to the obstructed site, leading to minimal collateral damage external&#xD;
        to the target zone. In addition, this procedure can be performed under local anesthesia as an&#xD;
        outpatient procedure in the office, and it has advantages such as short surgery time and less&#xD;
        risk of bleeding during surgery, resulting in its increasingly widespread use in China.&#xD;
        Although the silicone intubation using dacryoendoscopy has increased the success rates, the&#xD;
        success rates vary from a low of 51% to a high of 90%. The difference in success rates seems&#xD;
        to depend on the site of obstruction, differences in the surgical technique, stringency of&#xD;
        definitions of success, and duration of follow-up.&#xD;
  &#xD;
        A greater understanding of factors associated with treatment failure may allow us to glean&#xD;
        insights regarding patient selection and ultimately improve treatment outcome. The aim of our&#xD;
        study was to report the results of DLDI for the management of NLDO, and to identify factors&#xD;
        associated with DLDI failure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2019</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative success rate</measure>
      <time_frame>2 years</time_frame>
      <description>The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">522</enrollment>
    <condition>Lacrimal Duct Obstruction</condition>
    <arm_group>
      <arm_group_label>group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group A higher nasolacrimal duct obstruction</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group B: lower nasolacrimal duct obstruction</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group C: nasolacrimal duct stenosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation</intervention_name>
      <description>The dacryoendoscopy was inserted into the lacrimal duct through the upper or lower lacrimal punctum. When the dacryoendoscopy reached the postsaccal obstruction, laser dacryoplasty (FOX diode laser, A.R.C. Laser, Nürnberg, Germany) was performed by widening the stenotic or obstructed section. After removing the dacryoendoscopy, a silicone tube inserted into lacrimal passage. Double bicanalicular silicone intubation was performed as previously described.</description>
      <arm_group_label>group A</arm_group_label>
      <arm_group_label>group B</arm_group_label>
      <arm_group_label>group C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (1) confirmed diagnosis of nasolacrimal duct obstruction or stenosis, based on&#xD;
          dacryoendoscopic examination with or without radiologic confirmation on dacryocystogram;&#xD;
          (2) recurrent or persistent and symptomatic epiphora; (3) follow-up of longer than 6 months&#xD;
          after removal of the silicone stent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1) congenital or traumatic lacrimal duct obstruction; (2) previous acute dacryocystitis;&#xD;
          (3) facial nerve palsy; (4) lower eyelid or punctal malposition or laxity of sufficient&#xD;
          severity to contribute to epiphora; (5) previous dacryocystorhinostomy; (6) incomplete&#xD;
          medical records.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hongxun Li, MD</last_name>
      <phone>+86 18722665027</phone>
      <email>lihongxun_0522@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tianjin Eye Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chenshu Bo, MD</last_name>
        <phone>+86 02227313336</phone>
        <email>sykyykjk@tj.gov.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lacrimal Duct Obstruction</keyword>
    <keyword>Dacryoendoscopy</keyword>
    <keyword>Dacryoplasty</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>
  
  
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/NCT05999058
  org study id: YK-2023038
  nct id: NCT05999058
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Nasolacrimal duct obstruction (NLDO) can manifest as epiphora or recurrent infections with
        mucopurulent discharge and may even cause social embarrassment. Dacryoendoscopic-assisted
        laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed
        site, leading to minimal collateral damage external to the target zone. Although the silicone
        intubation using dacryoendoscopy has increased the success rates, the success rates vary from
        a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of
        obstruction, differences in the surgical technique, stringency of definitions of success, and
        duration of follow-up. The aim of our study was to report the results of DLDI for the
        management of NLDO, and to identify factors associated with DLDI failure.
  Lacrimal drainage obstruction can manifest as epiphora or recurrent infections with
        mucopurulent discharge and may even cause social embarrassment. Obstruction can occur at any
        level along the lacrimal drainage system: punctum, canaliculus, nasolacrimal duct, or nasal
        ostium. It is seen more often in females, especially in postmenopausal women. The
        etiopathogenesis of lacrimal passage obstruction appears to be multifactorial. Chronic
        inflammation has been suggested to be the most causal. Dacryocystorhinostomy (DCR) is a
        standard surgical procedure used to treat nasolacrimal duct obstruction (NLDO), with a
        reported success rate of more than 90%.
  
        Knowledge concerning the morphological characteristics of lacrimal passage obstruction using
        traditional diagnostic methods (e.g., lacrimal irrigation, probing, dacryocystography) is
        limited. Dacryoendoscopy was originally described in 1979 and has recently matured for use in
        lacrimal drainage system imaging. It has been proved to be a useful instrument not only for
        understanding differences in the etiology of obstructions but also for treating LD
        obstructions. On the other hand, semiconductor diode laser can achieve more effective tissue
        dissection than direct probing technique with minimal hemorrhage and improved intraoperative
        view. Hence, dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI)
        offers direct therapy to the obstructed site, leading to minimal collateral damage external
        to the target zone. In addition, this procedure can be performed under local anesthesia as an
        outpatient procedure in the office, and it has advantages such as short surgery time and less
        risk of bleeding during surgery, resulting in its increasingly widespread use in China.
        Although the silicone intubation using dacryoendoscopy has increased the success rates, the
        success rates vary from a low of 51% to a high of 90%. The difference in success rates seems
        to depend on the site of obstruction, differences in the surgical technique, stringency of
        definitions of success, and duration of follow-up.
  
        A greater understanding of factors associated with treatment failure may allow us to glean
        insights regarding patient selection and ultimately improve treatment outcome. The aim of our
        study was to report the results of DLDI for the management of NLDO, and to identify factors
        associated with DLDI failure.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cumulative success rate
  time frame: 2 years
  description: The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.
  arm group label: group A
  arm group type: Active Comparator
  description: group A higher nasolacrimal duct obstruction
  arm group label: group B
  arm group type: Experimental
  description: group B: lower nasolacrimal duct obstruction
  arm group label: group C
  arm group type: Experimental
  description: group C: nasolacrimal duct stenosis
  intervention type: Procedure
  intervention name: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation
  description: The dacryoendoscopy was inserted into the lacrimal duct through the upper or lower lacrimal punctum. When the dacryoendoscopy reached the postsaccal obstruction, laser dacryoplasty (FOX diode laser, A.R.C. Laser, Nürnberg, Germany) was performed by widening the stenotic or obstructed section. After removing the dacryoendoscopy, a silicone tube inserted into lacrimal passage. Double bicanalicular silicone intubation was performed as previously described.
  arm group label: group A
  arm group label: group B
  arm group label: group C
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hongxun Li, MD
  phone: +86 18722665027
  email: lihongxun_0522@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Lacrimal Duct Obstruction
  sharing ipd: No