Nasolacrimal Duct ObstructionPhase 3MCI_vs_BCINCT01233596
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
A Phase 3 study testing Canalicular intubation in people with Nasolacrimal Duct Obstruction, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The aim of the study was to compare the success rate of monocanalicular intubation versus bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children aged between 10 and 36 months. Read more about this study
- Who is it for?
- Ages 10 to 36 months
- Conditions the study is for
- Nasolacrimal Duct Obstruction
- What is being tested?
- Canalicular intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2006to Dec 2009
- Phase
- Phase 3
- 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 10 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- congenital nasolacrimal duct obstruction (CNLDO)
- resistance to a conservative therapy and/or probing
Who cannot join
- children younger than 10 months of age
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to compare the success rate of monocanalicular intubation versus bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children aged between 10 and 36 months.
Read the detailed description
In a prospective, nonrandomized comparative study, the monocanalicular intubations (MCI; n=35 eyes) through the inferior canaliculus or bicanalicular intubations (BCI; n=35 eyes) were performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). The tubes were removed 3-4 months after the tube placement. Thereafter, the children were followed up for 6 months after the removal of tubes. The therapeutic success was defined as the fluorescein dye disappearance test grade 0-1 corresponding with a complete resolution of previous symptoms. The partial success was defined as improvement with some residual symptoms.
The complete and partial improvement was achieved in 31/35(88.57%) in group I with BCI and in 34/35 (97.14%) in group II with MCI, respectively, and it was not significantly higher (p=0,584).
Complications occurred in both groups. Dislodgement of the tube and premature removal was observed in four cases in group I (BCI), the loss of the tube was observed twice in group II with MCI.. Canalicular slitting was observed in 5 eyes in the group with BCI. Granuloma pyogenicum observed in 2 cases with MCI revealed in a few weeks after the tube removal. Corneal erosion in the inferior medial quadrant was observed in 1 eye with MCI and revealed in a few days after the local treatment without tube removal.
Conclusions: Both MCI and the BCI are effective methods how to treat CNLDO. The advantage of the MCI shows the lower incidence of the canalicular slit and easy placement.
- Conditions
- Nasolacrimal Duct Obstruction
- Being tested
- Canalicular intubation
- Keywords
- congenital nasolacrimal duct obstruction, monocanalicular intubation, bicanalicular intubation, complications
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canalicular intubationDevice
Also called silicone tube
Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.
| Study group | Role | What they receive |
|---|---|---|
| Monocanalicular intubation | Active comparator | Monocanalicular intubations (MCI; n=35 eyes) through the inferior canaliculus intubations performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). Receives: Device: Canalicular intubation |
| Bicanalicular intubation | Active comparator | Bicanalicular intubation (BCI; n=35 eyes) performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). Receives: Device: Canalicular intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate and complications of monocanalicular and bicanalicular intubation in children
35 consecutive cases of bicanalicular intubations (group I) followed by 35 consecutive cases of monocanalicular intubations (group II). Silicone tubes were removed 3 to 4 months after the surgery. The children were followed up for 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolacrimal 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Kominek, MD,PhD,MBA, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233596
- Sponsor's protocol ID
- ORL-FNO-2010
- Acronym
- MCI_vs_BCI
- Status last verified
- Mar 2015
- First submitted
- 2 Nov 2010
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT01233596
- Acronym / sponsor ID
- MCI_vs_BCI / ORL-FNO-2010
- Conditions
- Nasolacrimal Duct Obstruction
- Keywords
- congenital nasolacrimal duct obstruction, monocanalicular intubation, bicanalicular intubation, complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Nov 2010 (estimated)
- 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.
The aim of the study was to compare the success rate of monocanalicular intubation versus bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children aged between 10 and 36 months.
Detailed description
In a prospective, nonrandomized comparative study, the monocanalicular intubations (MCI; n=35 eyes) through the inferior canaliculus or bicanalicular intubations (BCI; n=35 eyes) were performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). The tubes were removed 3-4 months after the tube placement. Thereafter, the children were followed up for 6 months after the removal of tubes. The therapeutic success was defined as the fluorescein dye disappearance test grade 0-1 corresponding with a complete resolution of previous symptoms. The partial success was defined as improvement with some residual symptoms.
The complete and partial improvement was achieved in 31/35(88.57%) in group I with BCI and in 34/35 (97.14%) in group II with MCI, respectively, and it was not significantly higher (p=0,584).
Complications occurred in both groups. Dislodgement of the tube and premature removal was observed in four cases in group I (BCI), the loss of the tube was observed twice in group II with MCI.. Canalicular slitting was observed in 5 eyes in the group with BCI. Granuloma pyogenicum observed in 2 cases with MCI revealed in a few weeks after the tube removal. Corneal erosion in the inferior medial quadrant was observed in 1 eye with MCI and revealed in a few days after the local treatment without tube removal.
Conclusions: Both MCI and the BCI are effective methods how to treat CNLDO. The advantage of the MCI shows the lower incidence of the canalicular slit and easy placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monocanalicular intubation | Active comparator | Device: Canalicular intubationMonocanalicular intubations (MCI; n=35 eyes) through the inferior canaliculus intubations performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). |
| Bicanalicular intubation | Active comparator | Device: Canalicular intubationBicanalicular intubation (BCI; n=35 eyes) performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- congenital nasolacrimal duct obstruction (CNLDO)
- resistance to a conservative therapy and/or probing
Key exclusion criteria (1 listed)
- children younger than 10 months of age
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 |
|---|---|---|
| Canalicular intubationAlso: silicone tubeIntubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement. | Device | Bicanalicular intubation, Monocanalicular intubation |
Primary outcome
Success rate and complications of monocanalicular and bicanalicular intubation in children
Time frame: 6 months
35 consecutive cases of bicanalicular intubations (group I) followed by 35 consecutive cases of monocanalicular intubations (group II). Silicone tubes were removed 3 to 4 months after the surgery. The children were followed up for 6 months.
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 4 Mar 2015.
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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.
Pavel Kominek, MD,PhD,MBA principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canalicular intubation in people with Nasolacrimal Duct Obstruction, run by University Hospital Ostrava at 1 site in Czechia.
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 2 inclusion and 1 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 4 Mar 2015. 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 Czechia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success rate and complications of monocanalicular and bicanalicular intubation in children (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2015.