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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

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.

Interventions

  • Device: Self-retaining bicanalicular intubation stent
    • 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

Arms, Groups and Cohorts

  • Other: Canalicular obstruction

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of SRSll and bicanalicular silicone tube in management of canalicular obstruction
    • Time Frame: Baseline
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Minia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zamzam Mohamed alham khalil, Doctor at opthalmology department – Minia University
  • Overall Official(s)
    • Ahmed M Elshafei, Study Director, Minia university, egypt
    • Raafat M Abdelrahman, Study Director, Minia university, egypt
    • Amr A Mohrmed, I, Study Director, Minia university, egypt
  • Overall Contact(s)
    • Alham M Zamzam, Doctor, +201016909014, www.zamzamalham@gmail.com

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