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

Canalicular Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04706117
• Other study ID #: Bicanalicular intubation
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: Minia University
• Contact: Alham M Zamzam, Doctor
• Phone: +201016909014
• Email: www.zamzamalham[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Canalicular Obstruction
• Lacrimal Duct Obstruction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline