ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233596
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Nasolacrimal Duct Obstruction Device: Canalicular intubation Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
Study Start Date : January 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01233596     History of Changes
Other Study ID Numbers: ORL-FNO-2010
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: March 2015

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