<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/NCT02993770</url>
  </required_header>
  <id_info>
    <org_study_id>IR.TUMS.REC.1394.853</org_study_id>
    <nct_id>NCT02993770</nct_id>
  </id_info>
  <brief_title>Endo-nasal Endoscopic DCR and External-DCR in Primary Nasolacrimal Duct Obstruction</brief_title>
  <official_title>Comparison of Endonasal-Endoscopic Dacryocystorhinostomy Versus External Dacryocystorhinostomy</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>
  <brief_summary>
    <textblock>
      All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in&#xD;
      Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary&#xD;
      nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic&#xD;
      consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR&#xD;
      and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive&#xD;
      regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo&#xD;
      comprehensive ophthalmology examinations including best corrected visual acuity (BCVA),&#xD;
      relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated&#xD;
      fundoscopy with 78 D lens. Past history and review os systems will be elicited for&#xD;
      medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries,&#xD;
      epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ&#xD;
      transplant, immunosuppressive drugs and immunodeficiency disorders.&#xD;
&#xD;
      All operations will be performed under general or local anesthesia, based on patient and&#xD;
      surgeon preferences.&#xD;
&#xD;
      Surgical Technique:&#xD;
&#xD;
      All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in&#xD;
      endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by&#xD;
      Wormold.&#xD;
&#xD;
      Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal&#xD;
      sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing&#xD;
      lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed through&#xD;
      puncta into nasal cavity and stabilized and will be kept for 2 months. After operation&#xD;
      patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop phenylephrine&#xD;
      0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily&#xD;
      for one week.&#xD;
&#xD;
      External DCR will be performed in a conventional manner [2]via a nasal side straight skin&#xD;
      incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be&#xD;
      separated using blunt dissection to expose the periosteum overlying and medial to the&#xD;
      anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm&#xD;
      in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an &quot;H&quot;&#xD;
      incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta into&#xD;
      nasal cavity of stabilized by multiple square knots at the end. The small posterior flaps&#xD;
      will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl&#xD;
      sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl sutures.&#xD;
      Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner. Nasal packing&#xD;
      will not be placed. All Ext-DCR operations will be performed by one of the two expert&#xD;
      ophthalmic plastic surgeons (F.P and A.K.).&#xD;
&#xD;
      The amount of bleeding will be estimated and recorded by the subtracting the total suction&#xD;
      reservoir from the amount of irrigated fluid through syringe during operation. Time of&#xD;
      operation will be estimated and recorded from the time of anesthetics injection to removing&#xD;
      the drape.&#xD;
&#xD;
      One week after operation patients will be asked to report post-operative pain and discomfort&#xD;
      by visual analogue score scale (0-10).&#xD;
&#xD;
      27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is&#xD;
      healed, and complications, if any, will be detected and recorded in the special data sheets.&#xD;
      Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining and&#xD;
      any complications will be detected and recorded. Dye disappearance test (DDT) will be checked&#xD;
      and recorded. Epiphora will be recorded according to modified Munk epiphora staging scale.&#xD;
&#xD;
      Two months after operation, ocular surface will be checked by fluorescein for staining of&#xD;
      cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded&#xD;
      according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye&#xD;
      test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS) visual&#xD;
      analogue scale will be checked in months 2, 6, 12, 18 and after operation. Satisfaction will&#xD;
      be checked 2 mo and 18 mo after operation by VAS. Any grade of daily epiphora or return of&#xD;
      fluid&gt;20% through opposite punctum in irrigation test or negative FDDT (absence of fluid&#xD;
      passage) will be regarded as functional or anatomic failure, respectively. Any complication&#xD;
      will be recorded in the specific forms.&#xD;
&#xD;
      All pre-operative and post-op examinations will be performed by a masked senior ophthalmology&#xD;
      resident subjective data will be checked and recorded by a trained nurse&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Anatomic success rate of endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO</measure>
    <time_frame>12 months after operation.</time_frame>
    <description>anatomic patency of lacrimal drainage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional success rate endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO</measure>
    <time_frame>12 months after operation.</time_frame>
    <description>absence of epiphora and discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general success rate</measure>
    <time_frame>12 months after operation.</time_frame>
    <description>anatomic patency of lacrimal drainage+ Functional such (absence of epiphora and discharge )</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications of operation</measure>
    <time_frame>12 months after operation.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Primary Acquired Nasolacrimal</condition>
  <arm_group>
    <arm_group_label>Endoscopic DCR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopic DCR will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by Wormold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>External DCR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>External DCR will be performed in a conventional mannervia a nasal side straight skin incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic DCR</intervention_name>
    <description>Endonasal endoscopic technique as described by Wormold et al.</description>
    <arm_group_label>Endoscopic DCR</arm_group_label>
    <arm_group_label>External DCR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>External DCR</intervention_name>
    <description>External DCR</description>
    <arm_group_label>Endoscopic DCR</arm_group_label>
    <arm_group_label>External DCR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;18 year.&#xD;
&#xD;
          2. Diagnosis of PANDO (primary acquired nasolacrimal duct obstruction) if each one of the&#xD;
             following exist:&#xD;
&#xD;
        1) Regurgitation of pus/mucous by pressure on lacrimal sac. 2) Return of pus/mucous fluid&#xD;
        by irrigation test through one lacrimal punctum. 3) Dacryocystography or lacrimal&#xD;
        scintigraphy compatible with nasolacrimal duct obstruction.&#xD;
&#xD;
        3. Absence of secondary causes of nasolacrimal duct obstruction (NLDO) such as nasal and&#xD;
        sinuses diseases, inflammatory and neoplastic lesions involving the lacrimal drainage&#xD;
        system, nasolacrimal trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Punctal/Canalicular obstruction.&#xD;
&#xD;
          2. Use of anti-coaggulation medications [aspirin, NSAIDS (non-steroidal anti-inflammatory&#xD;
             drugs), Warfarin] within 3-10 days before surgery.&#xD;
&#xD;
          3. Handicap/mental retardation.&#xD;
&#xD;
          4. Pregnant women.&#xD;
&#xD;
          5. Patients with Immunodeficient status (AIDS, use of immunosuppressive medications,&#xD;
             leukemia, lymphoma,..).&#xD;
&#xD;
          6. Nasal inflammatory disease (rhinitis, allergies).&#xD;
&#xD;
          7. Granulomatous diseases such as Wegeners, Sarcoidosis, etc.&#xD;
&#xD;
          8. History of past lacrimal surgery.&#xD;
&#xD;
          9. Traumatic NLDO.&#xD;
&#xD;
         10. Follow up less than 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Farzad Pakdel, M.D.</last_name>
    <phone>00989123701876</phone>
    <email>fapakdel@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Farabi Hospital, Tehran University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <zip>1336616351</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Farzad Pakdel, MD</last_name>
      <phone>00989123701876</phone>
      <email>fapakdel@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Elham Ashrafi, PhD</last_name>
      <phone>0098 09123257338</phone>
      <email>ashrafi_eli61@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>February 1, 2020</last_update_submitted>
  <last_update_submitted_qc>February 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02993770
org study id: IR.TUMS.REC.1394.853
nct id: NCT02993770
lead sponsor: 
All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in
      Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary
      nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic
      consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR
      and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive
      regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo
      comprehensive ophthalmology examinations including best corrected visual acuity (BCVA),
      relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated
      fundoscopy with 78 D lens. Past history and review os systems will be elicited for
      medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries,
      epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ
      transplant, immunosuppressive drugs and immunodeficiency disorders.

      All operations will be performed under general or local anesthesia, based on patient and
      surgeon preferences.

      Surgical Technique:

      All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in
      endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by
      Wormold.

      Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal
      sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing
      lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed through
      puncta into nasal cavity and stabilized and will be kept for 2 months. After operation
      patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop phenylephrine
      0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily
      for one week.

      External DCR will be performed in a conventional manner [2]via a nasal side straight skin
      incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be
      separated using blunt dissection to expose the periosteum overlying and medial to the
      anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm
      in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an "H"
      incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta into
      nasal cavity of stabilized by multiple square knots at the end. The small posterior flaps
      will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl
      sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl sutures.
      Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner. Nasal packing
      will not be placed. All Ext-DCR operations will be performed by one of the two expert
      ophthalmic plastic surgeons (F.P and A.K.).

      The amount of bleeding will be estimated and recorded by the subtracting the total suction
      reservoir from the amount of irrigated fluid through syringe during operation. Time of
      operation will be estimated and recorded from the time of anesthetics injection to removing
      the drape.

      One week after operation patients will be asked to report post-operative pain and discomfort
      by visual analogue score scale (0-10).

      27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is
      healed, and complications, if any, will be detected and recorded in the special data sheets.
      Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining and
      any complications will be detected and recorded. Dye disappearance test (DDT) will be checked
      and recorded. Epiphora will be recorded according to modified Munk epiphora staging scale.

      Two months after operation, ocular surface will be checked by fluorescein for staining of
      cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded
      according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye
      test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS) visual
      analogue scale will be checked in months 2, 6, 12, 18 and after operation. Satisfaction will
      be checked 2 mo and 18 mo after operation by VAS. Any grade of daily epiphora or return of
      fluid>20% through opposite punctum in irrigation test or negative FDDT (absence of fluid
      passage) will be regarded as functional or anatomic failure, respectively. Any complication
      will be recorded in the specific forms.

      All pre-operative and post-op examinations will be performed by a masked senior ophthalmology
      resident subjective data will be checked and recorded by a trained nurse
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Anatomic success rate of endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO
time frame: 12 months after operation.
description: anatomic patency of lacrimal drainage
measure: Functional success rate endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO
time frame: 12 months after operation.
description: absence of epiphora and discharge
measure: general success rate
time frame: 12 months after operation.
description: anatomic patency of lacrimal drainage+ Functional such (absence of epiphora and discharge )
measure: Complications of operation
time frame: 12 months after operation.
arm group label: Endoscopic DCR
arm group type: Experimental
description: Endoscopic DCR will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by Wormold.
arm group label: External DCR
arm group type: Active Comparator
description: External DCR will be performed in a conventional mannervia a nasal side straight skin incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest
intervention type: Procedure
intervention name: Endoscopic DCR
description: Endonasal endoscopic technique as described by Wormold et al.
arm group label: Endoscopic DCR
arm group label: External DCR
intervention type: Procedure
intervention name: External DCR
description: External DCR
arm group label: Endoscopic DCR
arm group label: External DCR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Farzad Pakdel, M.D.
phone: 00989123701876
email: fapakdel@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
sharing ipd: Undecided