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Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction

Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01233596
Acronym
MCI_vs_BCI
Enrollment
70
Registered
2010-11-03
Start date
2006-01-31
Completion date
2009-12-31
Last updated
2015-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolacrimal Duct Obstruction

Keywords

congenital nasolacrimal duct obstruction, monocanalicular intubation, bicanalicular intubation, complications

Brief 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.

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.

Interventions

DEVICECanalicular intubation

Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Months to 36 Months
Healthy volunteers
No

Inclusion criteria

* congenital nasolacrimal duct obstruction (CNLDO) * resistance to a conservative therapy and/or probing

Exclusion criteria

\- children younger than 10 months of age

Design outcomes

Primary

MeasureTime frameDescription
Success rate and complications of monocanalicular and bicanalicular intubation in children6 months35 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026