Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction

NCT06428266 | Completed DMC FDA Device

• 1 other identifier: CI 09 015 008
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Lacrimal Duct Obstruction; Lacrimal Apparatus Diseases; Lacrimal Stenosis; Lacrimal Elimination

Keywords

upper lacrimal duct obstruction; bicanalicular intubation; closed dacriointubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Occurrence of epistaxis

  one, three and four months after surgery

• Presence of extrusion of bicanalicular intubation tubes

  one, three and four months after surgery

• How well is the positioning of the silicone tubes

  one, three and four months after surgery

Study Arms (2)

Closed dacryointubation

ACTIVE COMPARATOR

Patients undergoing conventional closed dacryointubation with Crawford's tube

Procedure: Closed dacryointubation

Bicanalicular Intubation

EXPERIMENTAL

Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI

Device: Bicanalicular intubation

Interventions

Bicanalicular intubation DEVICE

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.

Bicanalicular Intubation

Closed dacryointubation PROCEDURE

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.

Closed dacryointubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Institiuto de Oftalmología Fundación Conde de Valenciana

Mexico City, 06800, Mexico

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 9893595 BACKGROUND

• 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.

  PMID: 454271 BACKGROUND

• 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.

  PMID: 22259230 BACKGROUND

Related Links

• characteristics of the Self-Stable Intubation Set II FCI

MeSH Terms

Conditions

Lacrimal Duct Obstruction; Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients from the consultation of the Oculoplastics Department of the Institute of Ophthalmology "Conde de Valenciana I.A.P", between July 2021 and July 2022 who met the inclusion and exclusion criteria were enrolled

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)