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Clinical Trials/NCT01233596
NCT01233596CompletedPhase 3

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

University Hospital Ostrava1 site in 1 country70 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Success rate and complications of monocanalicular and bicanalicular intubation in children

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Months to 36 Months (Child)
Sex
All
Accepts 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

Arms & Interventions

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).

Intervention: Canalicular intubation (Device)

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).

Intervention: Canalicular intubation (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Ostrava
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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