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Completed

NCT Number: NCT06428266

Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institiuto de Oftalmología Fundación Conde de Valenciana

Mexico City, 06800, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Irrigation of tha lacrimal duct

    Time frame: three and four months after the procedure

    Irrigation of the lacrimal duct with saline solution to seek for permeability

  2. Epiphora

    Time frame: one, three and four months after surgery

    evidence of epiphora as told by the subject

Secondary outcomes

  1. Occurrence of epistaxis

    Time frame: one, three and four months after surgery

    postoperative bleeding throug the nose

  2. Presence of extrusion of bicanalicular intubation tubes

    Time frame: one, three and four months after surgery

    extruded or non-extruded

  3. How well is the positioning of the silicone tubes

    Time frame: one, three and four months after surgery

    how well positioned or poorly positioned the tubes are

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Acronym: DICvsBIcanal

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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