Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only

October 30, 2019 updated by: Sameh Hassan Abdelbaky, Cairo University
The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 31111
        • Recruiting
        • Abo El Resh Pedriatric Hospital Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children in the age group above 2 years old
  2. No history of previous probing.
  3. No history of previous intubation.
  4. Children with no any other association or congenital anomalies cause watery eye.
  5. children suffer from congenital nasolacrimal duct obstruction.

Exclusion Criteria:

  1. children less than 2 years old.
  2. previous probing.
  3. previous intubation.
  4. children with any other congenital anomalies as congenital ectropion , congenital entropion
  5. children suffer from any upper lacrimal anomalies as obstruction or stenosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: Endodiathermy Probe and Intubation Versus Intubation
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
Procedure: Endodiathermy Probe and Intubation Versus Intubation
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

  1. epiphora (overflow of tears onto the face)
  2. increase tear film meniscus ( more than 1mm in height)
  3. mucous discharge
  4. Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)
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

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: tamer gawdat, professor, professor of ophthalmology cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

October 27, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo118988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

after finishiny my research can share my data

IPD Sharing Time Frame

1 year untill 1 year and 6 months

IPD Sharing Access Criteria

after finish my study

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

No

Studies a U.S. FDA-regulated device product

No

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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