Nasolacrimal Duct Obstruction Clinical Trial
— MCI_vs_BCIOfficial title:
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
Verified date | March 2015 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Months to 36 Months |
Eligibility |
Inclusion Criteria: - congenital nasolacrimal duct obstruction (CNLDO) - resistance to a conservative therapy and/or probing Exclusion Criteria: - children younger than 10 months of age |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | University Hospital Ostrava | Ostrava |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czech Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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