## Protocol Section
### Identification Module
**NCT ID:** NCT06428266

**Acronym:** DICvsBIcanal

**Brief Title:** Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction

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

#### Organization Study ID Info
**ID:** CI 09 015 008
#### Organization
**Class:** OTHER
**Full Name:** Instituto de Oftalmología Fundación Conde de Valenciana
### Status Module
#### Completion Date
**Date:** 2022-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-07-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Instituto de Oftalmología Fundación Conde de Valenciana

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Lacrimal Duct Obstruction

- Lacrimal Apparatus Diseases

- Lacrimal Stenosis

- Lacrimal Elimination

**Keywords:**

- upper lacrimal duct obstruction

- bicanalicular intubation

- closed dacriointubation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergoing conventional closed dacryointubation with Crawford's tube

**Intervention Names:**

- Procedure: Closed dacryointubation

**Label:** Closed dacryointubation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Device: Bicanalicular intubation

**Label:** Bicanalicular Intubation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bicanalicular Intubation

**Description:** 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.

**Name:** Bicanalicular intubation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Closed dacryointubation

**Description:** 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.

**Name:** Closed dacryointubation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Irrigation of tha lacrimal duct

**Time Frame:** three and four months after the procedure

**Description:** evidence of epiphora as told by the subject

**Measure:** Epiphora

**Time Frame:** one, three and four months after surgery

#### Secondary Outcomes

**Description:** postoperative bleeding throug the nose

**Measure:** Occurrence of epistaxis

**Time Frame:** one, three and four months after surgery

**Description:** extruded or non-extruded

**Measure:** Presence of extrusion of bicanalicular intubation tubes

**Time Frame:** one, three and four months after surgery

**Description:** how well positioned or poorly positioned the tubes are

**Measure:** How well is the positioning of the silicone tubes

**Time Frame:** one, three and four months after surgery

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Institiuto de Oftalmología Fundación Conde de Valenciana

**Zip:** 06800

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**Citation:** 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

**Citation:** 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

**Citation:** 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

#### See Also Links

**Label:** characteristics of the Self-Stable Intubation Set II FCI

**URL:** http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130375.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M10787

- Name: Lacrimal Duct Obstruction

- Relevance: HIGH

- As Found: Lacrimal Duct Obstruction

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: HIGH

- As Found: Lacrimal Apparatus Diseases

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007767

- Term: Lacrimal Duct Obstruction

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

### Misc Info Module

- Version Holder: 2024-05-31
