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

Primary Purpose

Nasolacrimal Duct Obstruction

Status
Completed
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
Canalicular intubation
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasolacrimal Duct Obstruction focused on measuring congenital nasolacrimal duct obstruction, monocanalicular intubation, bicanalicular intubation, complications

Eligibility Criteria

10 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- children younger than 10 months of age

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monocanalicular intubation

Bicanalicular intubation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2010
Last Updated
March 3, 2015
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT01233596
Brief Title
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
Acronym
MCI_vs_BCI
Official Title
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasolacrimal Duct Obstruction
Keywords
congenital nasolacrimal duct obstruction, monocanalicular intubation, bicanalicular intubation, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monocanalicular intubation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Bicanalicular intubation
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Canalicular intubation
Other Intervention Name(s)
silicone tube
Intervention Description
Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.
Primary Outcome Measure Information:
Title
Success rate and complications of monocanalicular and bicanalicular intubation in children
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Kominek, MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

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