- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148170
Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted on children above 2 year and will be divided randomly into two groups:
Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: mohamed hafez ibrahim
- Phone Number: 00201224010523
- Email: monsieur84@yahoo.com
Study Contact Backup
- Name: karim elessawy
- Phone Number: 00201144008882
- Email: kemos1984@yahoo.com
Study Locations
-
-
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Cairo, Egypt, 31111
- Recruiting
- Abo El Resh Pedriatric Hospital Cairo University
-
Contact:
- karim bakr, lecture
- Phone Number: 00201144008882
- Email: kemos1984@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children in the age group above 2 years old
- No history of previous probing.
- No history of previous intubation.
- Children with no any other association or congenital anomalies cause watery eye.
- children suffer from congenital nasolacrimal duct obstruction.
Exclusion Criteria:
- children less than 2 years old.
- previous probing.
- previous intubation.
- children with any other congenital anomalies as congenital ectropion , congenital entropion
- children suffer from any upper lacrimal anomalies as obstruction or stenosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: classic intubation
children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
|
children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
|
Active Comparator: endodiathermy probe
children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
|
children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recanalization of nasolacrimal duct
Time Frame: 6 months
|
compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication
Time Frame: 6 months
|
Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: tamer gawdat, professor, professor of ophthalmology cairo university
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cairo118988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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