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Self-retaining Bicanalicular Intubation Stent Versus Bicanalicular Silicone Tube for Management of Canalicular Obstruction

Primary Purpose

Canalicular Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-retaining bicanalicular intubation stent
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Canalicular Obstruction

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with epiphora due to distal canalicular obstruction.

Exclusion Criteria: patients with epiphora due to

  • Punctual stenosis
  • lid malposition
  • Intra-operative nasolacrimal duct obstruction
  • previous eyelid or lacrimal drainage surgery
  • untreated conjunctivitis, blepharitis. Dacrocystitis Proximal and mid canalicular obstruction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Canalicular obstruction

    Arm Description

    Outcomes

    Primary Outcome Measures

    Comparison of SRSll and bicanalicular silicone tube in management of canalicular obstruction
    compare improvement of epiphora according to Munk scale for epiphora grading Grade 0 No epiphora Grade 1 Epiphora requiring dabbing less than twice a day Grade 2 Epiphora requiring dabbing 2-4 times a day Grade 3 Epiphora requiring dabbing 5-10 times a day Grade 4 Epiphora requiring dabbing more than 10 times a day Grade 5 Constant epiphora And fluorescein dye disappearance test was graded according to Ozgur et al., scale according the time of dye clearance Grade 1 <3 minutes Grade 2 3-5 minutes Grade 3 >5 minutes

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2021
    Last Updated
    February 22, 2021
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04706117
    Brief Title
    Self-retaining Bicanalicular Intubation Stent Versus Bicanalicular Silicone Tube for Management of Canalicular Obstruction
    Official Title
    Self-retaining Bicanalicular Intubation Stent Versus Bicanalicular Silicone Tube for Management of Canalicular Obstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate outcomes of the use of self_retaining intubation set versus bicanalicular silicone tube in management of canalicular obstruction
    Detailed Description
    Epiphora is a condition due to obstruction of lacrimal passages either proximal or distal. Canalicular obstruction is a condition in which the lacrimal canaliculi are narrowed or occluded. Canalicular obstructions can be anatomically classified as proximal type in which the obstruction found at the initial 2-3 mm from the punctal opening while in mid canalicular type obstruction at 3-8 mm from the punctum and the distal type in which a membrane of the common canaliculs to the lacrimal sac. Canalicular obstruction can be acquired or congenital. Acquired canalicular obstruction may result from infectious and inflammatory eyelid disorders, ocular surface disease, systemic or topical medications, irradation, iatrogenic, intrinsic cannalicular tumors and trauma. The correct chioce of the techinque for given canalicular obstruction and therefore the long-term success depends on the site and degree of the obstruction, incomplete obstruction or stenosis can be treated with canalicular stenting. Proximal and mid canalicular obstructions need reconstruction by excising the focal canaliculus obstruction near the punctum and the cut ends of the canaliculus can be anastomosed over a stent. Dacryocystorhinostomy with retrograde intubation of the lacrimal system has shown some success may avoid the need for a Jones tube. Patients with symptomatic distal canalicular obstruction should undergo timely insertion of a bicanalicular silicon stent to prevent permanent and complete closure of the canaliculi. There are several modalities of canalicular intubation for the patients with distal canalicular obstruction. In patients with nasolacrimal duct and canalicular obstruction ,preferred procedures include dacryocystorhinstomy with bicanalicular or monocanalicular intubation .However,in patients with canalicular obstruction without nasolacrimal duct obstruction use bicanalicuar silicone intubation. In 2014 P.Bige' designed self-retaining bicanaliculs intubation setII(SRSII) which is the latest innovation in the field as these silicone stent segments traverse both canaliculi till the lacrimal sac. In which each end of this semicircular device has 2 stout angulated wings/flanges which pose no resistance while proceeding forward into the canaliculus, but once they get into open cavity (lacrimal sac), the flanges open up and give resistance to their removal against the common canalicular opening.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Canalicular Obstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Canalicular obstruction
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Self-retaining bicanalicular intubation stent
    Intervention Description
    self-retaining bicanaliculs intubation setII(SRSII) which is the latest innovation in the field as these silicone stent segments traverse both canaliculi till the lacrimal sac. In which each end of this semicircular device has 2 stout angulated wings/flanges which pose no resistance while proceeding forward into the canaliculus, but once they get into open cavity (lacrimal sac), the flanges open up and give resistance to their removal against the common canalicular opening
    Primary Outcome Measure Information:
    Title
    Comparison of SRSll and bicanalicular silicone tube in management of canalicular obstruction
    Description
    compare improvement of epiphora according to Munk scale for epiphora grading Grade 0 No epiphora Grade 1 Epiphora requiring dabbing less than twice a day Grade 2 Epiphora requiring dabbing 2-4 times a day Grade 3 Epiphora requiring dabbing 5-10 times a day Grade 4 Epiphora requiring dabbing more than 10 times a day Grade 5 Constant epiphora And fluorescein dye disappearance test was graded according to Ozgur et al., scale according the time of dye clearance Grade 1 <3 minutes Grade 2 3-5 minutes Grade 3 >5 minutes
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with epiphora due to distal canalicular obstruction. Exclusion Criteria: patients with epiphora due to Punctual stenosis lid malposition Intra-operative nasolacrimal duct obstruction previous eyelid or lacrimal drainage surgery untreated conjunctivitis, blepharitis. Dacrocystitis Proximal and mid canalicular obstruction.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alham M Zamzam, Doctor
    Phone
    +201016909014
    Email
    www.zamzamalham@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alham M Zamzam
    Phone
    +201016909014
    Email
    www.zamzamalham@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed M Elshafei
    Organizational Affiliation
    Minia University, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Raafat M Abdelrahman
    Organizational Affiliation
    Minia University, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Amr A Mohrmed, I
    Organizational Affiliation
    Minia University, Egypt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Self-retaining Bicanalicular Intubation Stent Versus Bicanalicular Silicone Tube for Management of Canalicular Obstruction

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