NCT01233596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

3.4 years

First QC Date

November 2, 2010

Last Update Submit

March 3, 2015

Conditions

Nasolacrimal Duct Obstruction

Keywords

congenital nasolacrimal duct obstructionmonocanalicular intubationbicanalicular intubationcomplications

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

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).

Device: Canalicular intubation

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).

Device: Canalicular intubation

Interventions

Canalicular intubationDEVICE

Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.

Also known as: silicone tube
Bicanalicular intubationMonocanalicular intubation

Eligibility Criteria

Age10 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • \- children younger than 10 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Czech Republic, 708 52, Czechia

Location

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Pavel Kominek, MD,PhD,MBA

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

CZ(1)