Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

Congenital Lacrimal Stenosis Clinical Trial

Official title:

Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00312689
• Other study ID #: Record 1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2006
• Last updated: April 11, 2007
• Start date: March 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Children with congenital lacrimal stenosis are treated by probing and intubation of the lacrimal drainage system.

Hypothesis: Microbiological findings at the time of insertion and removal of the silicon intubation have an influence on the clinical outcome and success rate of the surgical treatment. Microbiological specimens are taken from conjunctiva and nasal mucosa during the two procedures under general anaesthesia and from the silicon tube after removal and examined for bacterial contamination.

Description:

Children (age 0-14 years) with congenital lacrimal stenosis in whom probing and intubation of the lacrimal drainage system is indicated are included the study after informed written consent by their parents. Microbiological specimens are taken bilaterally from conjunctiva and nasal mucosa during the two procedures under general anaesthesia (insertion and removal of the silicon intubation) and from the silicon tube after removal. Specimens are examined for bacterial contamination. Microbiological findings are correlated with clinical data about the further clinical course and especially the success of the surgical treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria: age 0-14 years, congenital lacrimal stenosis, informed consent by the parents -

Exclusion Criteria: none

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Congenital Lacrimal Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Germany	Augenklinik	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany,