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Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00312689
First received: April 7, 2006
Last updated: April 11, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition
Congenital Lacrimal Stenosis

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

Further study details as provided by University Hospital Muenster:

Estimated Enrollment: 120
Study Start Date: March 2006
Estimated Study Completion Date: April 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria: none

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312689

Locations
Germany
Augenklinik
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Annette Kolck, MD University Hospital Muenster
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312689     History of Changes
Other Study ID Numbers: Record 1
Study First Received: April 7, 2006
Last Updated: April 11, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
congenital
lacrimal
stenosis
bacteria
microbiological

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013