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Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

Sponsor
University Hospital Muenster (Other)
Overall Status
Unknown status
CT.gov ID
NCT00312689
Collaborator
(none)
120
Enrollment
1
Location
13
Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis
    Study Start Date :
    Mar 1, 2006
    Anticipated Study Completion Date :
    Apr 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 14 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

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

      Exclusion Criteria: none

      -

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Augenklinik Muenster Germany 48149

      Sponsors and Collaborators

      • University Hospital Muenster

      Investigators

      • Principal Investigator: Annette Kolck, MD, University Hospital Muenster

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00312689
      Other Study ID Numbers:
      • Record 1
      First Posted:
      Apr 10, 2006
      Last Update Posted:
      Apr 12, 2007
      Last Verified:
      Apr 1, 2007
      Keywords provided by , ,
      congenital
      lacrimal
      stenosis
      bacteria
      microbiological
      Additional relevant MeSH terms:
      Constriction, Pathologic

      Study Results

      No Results Posted as of Apr 12, 2007