Lacrimal Apparatus Diseases, Lacrimal Duct Obstruction, Lacrimal Elimination, Lacrimal Stenosis
Conditions
Keywords
upper lacrimal duct obstruction, bicanalicular intubation, closed dacriointubation
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 .
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
Interventions
DEVICEBicanalicular 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.
PROCEDUREClosed 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.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irrigation of tha lacrimal duct | three and four months after the procedure | Irrigation of the lacrimal duct with saline solution to seek for permeability |
| Epiphora | one, three and four months after surgery | evidence of epiphora as told by the subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of epistaxis | one, three and four months after surgery | postoperative bleeding throug the nose |
| Presence of extrusion of bicanalicular intubation tubes | one, three and four months after surgery | extruded or non-extruded |
| How well is the positioning of the silicone tubes | one, three and four months after surgery | how well positioned or poorly positioned the tubes are |
Countries
Mexico
Outcome results
None listed