Lacrimal Duct ObstructionDICvsBIcanalNCT06428266
Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction
A study testing Bicanalicular intubation and Closed dacryointubation in people with Lacrimal Duct Obstruction and Lacrimal Apparatus Diseases, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacrimal Duct Obstruction, Lacrimal Apparatus Diseases, Lacrimal Stenosis
- What is being tested?
- Bicanalicular intubation and Closed dacryointubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institiuto de Oftalmología Fundación Conde de Valenciana
Mexico City, 06800
About this study
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
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 .
Read the 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
- Lacrimal Duct Obstruction, Lacrimal Apparatus Diseases, Lacrimal Stenosis, Lacrimal Elimination
- Being tested
- Bicanalicular intubation, Closed dacryointubation
- Keywords
- upper lacrimal duct obstruction, bicanalicular intubation, closed dacriointubation
- Medical subject headings
- Lacrimal Duct Obstruction, Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicanalicular intubationDevice
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 dacryointubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed dacryointubation | Active comparator | Patients undergoing conventional closed dacryointubation with Crawford's tube Receives: Procedure: Closed dacryointubation |
| Bicanalicular Intubation | Experimental | Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI Receives: Device: Bicanalicular intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irrigation of tha lacrimal duct
Irrigation of the lacrimal duct with saline solution to seek for permeability
Measured: three and four months after the procedure
Epiphora
evidence of epiphora as told by the subject
Measured: one, three and four months after surgery
Secondary outcomes (3)
Occurrence of epistaxis
postoperative bleeding throug the nose
Measured: one, three and four months after surgery
Presence of extrusion of bicanalicular intubation tubes
extruded or non-extruded
Measured: one, three and four months after surgery
How well is the positioning of the silicone tubes
how well positioned or poorly positioned the tubes are
Measured: one, three and four months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lacrimal Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428266
- Sponsor's protocol ID
- CI 09 015 008
- Acronym
- DICvsBIcanal
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
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.
PubMed 9893595Pashby 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.
PubMed 454271Tabatabaie 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.
PubMed 22259230
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06428266
- Acronym / sponsor ID
- DICvsBIcanal / CI 09 015 008
- Conditions
- Lacrimal Duct Obstruction, Lacrimal Apparatus Diseases, Lacrimal Stenosis, Lacrimal Elimination
- Keywords
- upper lacrimal duct obstruction, bicanalicular intubation, closed dacriointubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Closed dacryointubation | Active comparator | Procedure: Closed dacryointubationPatients undergoing conventional closed dacryointubation with Crawford's tube |
| Bicanalicular Intubation | Experimental | Device: Bicanalicular intubationPatients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicanalicular intubationPlacement 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. | Device | Bicanalicular Intubation |
| Closed dacryointubationPlacement 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. | Procedure or surgery | Closed dacryointubation |
Primary outcome
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
Epiphora
Time frame: one, three and four months after surgery
evidence of epiphora as told by the subject
3 secondary outcomes
Occurrence of epistaxis
Time frame: one, three and four months after surgery
Presence of extrusion of bicanalicular intubation tubes
Time frame: one, three and four months after surgery
How well is the positioning of the silicone tubes
Time frame: one, three and four months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background1. 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.
- Background: PubMed 9893595Fulcher 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.
- Background: PubMed 454271Pashby 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.
- Background: PubMed 22259230Tabatabaie 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.
- characteristics of the Self-Stable Intubation Set II FCILink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicanalicular intubation and Closed dacryointubation in people with Lacrimal Duct Obstruction and Lacrimal Apparatus Diseases, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irrigation of tha lacrimal duct (time frame: three and four months after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428266, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.