Endoscopy Assisted Probing Versus Simple Probing in Primary Congenital Nasolacrimal Duct Obstruction (Non)

October 9, 2019 updated by: Tehran University of Medical Sciences

Endoscopy Assisted Probing Versus Simple Probing in Patients With Primary Congenital Nasolacrimal Duct Obstruction: A Randomized Clinical Trial

The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with the standard simple probing in cases with congenital nasolacrimal duct obstruction . Furthermore, investigators will identify associated anatomical anomalies. Investigators believe results of this study can be valuable in better understanding of this disease and provide a high evidence level necessary to propose a classification and management algorithm.

Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction, no past surgical management, with one or more of the below criteria will be included:

  1. Non-resolving symptoms of epiphora and/or discharge.
  2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics.
  3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and patients will undergo lacrimal tests before and after operation in one week, one month and 3months based on a special record form. Patients will be randomly assigned to "simple probing" group or "endoscopy assisted probing" group.

All operations will be performed in operative theater and under general anesthesia. Pre- and post-operative examinations will be performed in plastic clinic in Farabi hospital.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Congenital nasolacrimal duct obstruction is the most common cause of epiphora in infancy that can occur in 5% of newborn infants. It may resolve spontaneously in 95% of patients during the first year of life.(1) After that time surgical intervention is justified. Epiphora after birth is most commonly secondary to a developmental anomaly of imperforated membrane (Hasner valve) in distal part of nasolacrimal duct. Patients with congenital nasolacrimal duct obstruction (CNLDO) may show epiphora, eye discharge, acute dacryocystitis and cellulitis and dacryocele. Currently the management of primary CNLDO includes conservative treatment including lacrimal sac massage and topical antibiotics until 12 months of age.

The standard intervention for non-complicated, unresolved cases is simple blind probing of nasolacrimal duct. The overall success rate of one time simple probing is 75%-95 %. Simple probing is performed through a blind passage of a malleable metallic probe through punctum to nasolacrimal duct and inferior meatal space in nasal cavity.Although effective, probing may be associated with traumatic nasal bleeding, nasal mucosal damage,punctal and canalicular injury and false passage. The trauma is further concerned during stent insertion.In the past decade improvement in endoscopic instruments and techniques enabled us to visualize and smoothly manipulate anomalies in the nasal cavity and especially in the inferior meatus. Endoscopic assisted probing has been proposed as a measure to increase accuracy, efficacy and safety of nasolacrimal probing. Furthermore, by this method intranasal pathologies associated with failure of probing could be accurately diagnosed and specifically treated. To the best of our knowledge literature addressing this issue is limited to few limited case series.

The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with the standard simple probing in cases with congenital nasolacrimal duct obstruction . Furthermore, investigators will identify associated anatomical anomalies. Investigators believe results of this study can be valuable in better understanding of this disease and provide a high evidence level necessary to propose a classification and management algorithm.

Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction, no past surgical management, with one or more of the below criteria will be included:

  1. Non-resolving symptoms of epiphora and/or discharge.
  2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics.
  3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and patients will undergo lacrimal tests before and after operation in one week, one month and 3months based on a special record form. Patients will be randomly assigned to "simple probing" group or "endoscopy assisted probing" group.

All operations will be performed in operative theater and under general anesthesia. Pre- and post-operative examinations will be performed in plastic clinic in Farabi hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 weeks to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age: 3 weeks<Age<6 years
  2. epiphora or discharge since birth or within 8 weeks after birth

Exclusion Criteria:

  1. Follow up less than 3 months
  2. Epiphora secondary to etiologies than congenital naso-lacrimal duct obstruction such as puncta/canalicular aplasia/dysgenesis;midfacial anomalies; congenital eyelid malposition;epiblepharon; trichiasis; congenital glaucoma, tumors; blepharitis; trauma Treatment success: defined success absence of epiphora/lacrimation and discharge 6 months after intervention.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endoscopy Assisted Probing
Procedure: Endoscopy Assisted Probing procedure
The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system
Active Comparator: Simple Probing
Procedure: Endoscopy Assisted Probing procedure
The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
success rate
Time Frame: 6 months
absence of epiphora and discharge and negative dye disappearance test
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 6 month
Incidence of complications related to the treatment including epistaxis, nasal stuffiness, injury to the nasolacrimal system or the eye, canalicular stenosis, keratopathy, nasal mucosa scar, synechia, tightening of inferior meatus (not reported at the time first intervention) to be described in those who need re-probing and nasal endoscopy.
6 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tehran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Farzad Pakdel, M.D., Farabi Hospital, Tehran University of Medical Sciences

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IR.TUMS.VCR.REC.1395.1200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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