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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
  Purpose

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.


Condition Intervention Phase
Nasolacrimal Duct Obstruction
 Device: Canalicular intubation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction

Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • 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.


Enrollment: 70
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 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: 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).
 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

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.

  Eligibility

Ages Eligible for Study:   10 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- children younger than 10 months of age

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233596

Locations
Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Investigators
Principal Investigator: Pavel Kominek, MD,PhD,MBA University Hospital Ostrava
  More Information

No publications provided

Responsible Party: Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01233596     History of Changes
Other Study ID Numbers: ORL-FNO-2010
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Ostrava:
congenital nasolacrimal duct obstruction
monocanalicular intubation
bicanalicular intubation
complications

ClinicalTrials.gov processed this record on June 18, 2013