Congenital Lacrimal StenosisNCT00312689
Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis
An observational study of Congenital Lacrimal Stenosis, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Congenital Lacrimal Stenosis
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Congenital Lacrimal Stenosis
- Keywords
- congenital, lacrimal, stenosis, bacteria, microbiological
- Medical subject headings
- Constriction, Pathologic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startMar 2006
- Study completionApr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Lacrimal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Annette Kolck, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312689
- Sponsor's protocol ID
- Record 1
- Status last verified
- Apr 2007
- First submitted
- 7 Apr 2006
- Last updated
- 12 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis
- ClinicalTrials.gov ID
- NCT00312689
- Acronym / sponsor ID
- Record 1
- Conditions
- Congenital Lacrimal Stenosis
- Keywords
- congenital, lacrimal, stenosis, bacteria, microbiological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Apr 2007 (estimated)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Kolck, MD principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Lacrimal Stenosis, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2007; AzTrials last refreshed its copy on 8 Nov 2026.