Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-31

Brief Summary

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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 .

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Detailed Description

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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

Conditions

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Lacrimal Duct Obstruction Lacrimal Apparatus Diseases Lacrimal Stenosis Lacrimal Elimination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed dacryointubation

Patients undergoing conventional closed dacryointubation with Crawford's tube

Group Type ACTIVE_COMPARATOR

Closed dacryointubation

Intervention Type 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.

Bicanalicular Intubation

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

Group Type EXPERIMENTAL

Bicanalicular intubation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No