Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction (DICvsBIcanal)

Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients

In Mexico, upper lacrimal duct obstruction (ULDO) is a common pathology, and the standard surgical treatment is closed dracryointubation. Based on statistics from our headquarters, in 30% of cases there is a failure of the technique and recurrence of symptoms due to associated complications. Because of this, the application of a self-stable bicananlicular intubation set is proposed. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (FCI) and closed dacryointubation in patients with ULDO .

Study Overview

• Status: Completed
• Conditions: Lacrimal Apparatus Diseases; Lacrimal Duct Obstruction; Lacrimal Stenosis; Lacrimal Elimination
• Intervention / Treatment: Procedure: Closed dacryointubation; Device: Bicanalicular intubation

Detailed Description

Upper lacrimal duct obstruction (ULDO) or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point, in superior and inferior canaliculi, or in the common canaliculus. When the ULDO is at the level of the canaliculi (superior, inferior or common), the alternatives available for its management are closed dacryointubation with Crowford catheter, conjunctivadacryocystorhinostomy, and bicanalicular intubation.

Closed dacryointubation with Crowford tube is a technique effective in approximately 90% of children diagnosed with congenital occlusion of the lacrimal duct, however, in adults the reported surgical success rate is lower, approximately 70% according to different authors.

The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction.

The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set (FCI R), an FDA-approved silicone bicanalicular retention device, is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction.

The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (ICF) and closed dacryointubation in patients with ULDO

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • Institiuto de Oftalmología Fundación Conde de Valenciana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years of age
• Patients with stenosis and incomplete obstruction of the upper lacrimal duct with epiphora > 2 on the Munk scale who have not previously undergone surgery on the affected tear duct
• Patients who may undergo general anesthesia and sedation
• Patients who are able to present and continue follow-up for the duration of the study
• Acceptance to participate in the study by signing an informed consent

Exclusion Criteria:

• Patients with ocular surface involvement affecting the upper lacrimal duct, such as blepharitis with tear point epithelialization
• Patients with lacrimal point malposition and/or eyelid malposition due to entropion or ectropion
• Patients with congenital or acquired obstruction of the lower lacrimal duct
• Patients with a history of facial paralysis
• Patients with systemic inflammatory disease such as scarring pemphigoid or Steven Johnson
• Patients in whom tumour involvement of the lacrimal duct is suspected
• Patients with reflex tear hypersecretion due to ocular surface involvement or other causes.
• Pregnancy and breastfeeding
• Active infection, eye trauma, history of facial trauma with broken bones of the nose, or history of sinus surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Closed dacryointubation; Patients undergoing conventional closed dacryointubation with Crawford's tube	Procedure: Closed dacryointubation; Placement of dacryointubation tube through the canaliculus until it reaches the medial wall of the lacrimal sac and then passed the nasolacrimal duct until it empties out at the level of the inferior meatus.
Experimental: Bicanalicular Intubation; Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI	Device: Bicanalicular intubation; Placement of the bicanalicular intubation set at each lacrimal point and fixed by means of its flaps at the level of the opening of the lacrimal sac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irrigation of tha lacrimal duct	Irrigation of the lacrimal duct with saline solution to seek for permeability	three and four months after the procedure
Epiphora	evidence of epiphora as told by the subject	one, three and four months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of epistaxis	postoperative bleeding throug the nose	one, three and four months after surgery
Presence of extrusion of bicanalicular intubation tubes	extruded or non-extruded	one, three and four months after surgery
How well is the positioning of the silicone tubes	how well positioned or poorly positioned the tubes are	one, three and four months after surgery

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Publications and helpful links

General Publications

• Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014.
• 1. Schaefer DP. Acquired Etiologies of Lacrimal System Obstructions. In: Cohen AJ, Mercandetti M, Brazzo BG, editors. The Lacrimal System [Internet]. Springer New York; 2006 [cited 2020 Jan 15]. p. 43-65.
• Fulcher T, O'Connor M, Moriarty P. Nasolacrimal intubation in adults. Br J Ophthalmol. 1998 Sep;82(9):1039-41. doi: 10.1136/bjo.82.9.1039.
• Tabatabaie SZ, Rajabi MT, Rajabi MB, Eshraghi B. Randomized study comparing the efficacy of a self-retaining bicanaliculus intubation stent with Crawford intubation in patients with canalicular obstruction. Clin Ophthalmol. 2012;6:5-8. doi: 10.2147/OPTH.S25172. Epub 2011 Dec 20.

Helpful Links

• characteristics of the Self-Stable Intubation Set II FCI

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: bicanalicular intubation; upper lacrimal duct obstruction; closed dacriointubation
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Lacrimal Duct Obstruction
• Other Study ID Numbers: CI 09 015 008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes