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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01233596
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 2, 2010
November 2, 2010
January 2006
June 2009   (final data collection date for primary outcome measure)
Success rate and complications of monocanalicular and bicanalicular intubation in children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
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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

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasolacrimal Duct Obstruction
Device: Canalicular intubation
Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.
Other Name: silicone tube
  • Active Comparator: Monocanalicular intubation
    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).
    Intervention: Device: Canalicular intubation
  • Active Comparator: Bicanalicular intubation
    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).
    Intervention: Device: Canalicular intubation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- children younger than 10 months of age

Both
10 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01233596
ORL-FNO-2010
Yes
Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava
University Hospital Ostrava
Not Provided
Principal Investigator: Pavel Kominek, MD,PhD,MBA University Hospital Ostrava
University Hospital Ostrava
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP