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

Instituto de Oftalmología Fundación Conde de Valenciana

Status

Completed

Conditions

Lacrimal Apparatus Diseases

Lacrimal Stenosis

Lacrimal Elimination

Lacrimal Duct Obstruction

Treatments

Device: Bicanalicular intubation

Procedure: Closed dacryointubation

Study type

Interventional

Funder types

Other

Identifiers

NCT06428266

CI 09 015 008

Details and patient eligibility

About

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 .

Full 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

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.