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
About this trial
This is an interventional treatment trial for Canalicular Obstruction
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.
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
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
We'll reach out to this number within 24 hrs