The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction

March 5, 2014 updated by: Cathay General Hospital

Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction

The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.

Study Type

Observational

Enrollment (Actual)

800

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

      • Taipei, Taiwan, 106
        • Department of Ophthalmology, Cathay General Hospital

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

1 week to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
  • anatomical nasolacrimal duct obstruction

Exclusion Criteria:

  • previous probing
  • glaucoma
  • trauma
  • lid malpositions
  • craniofacial anomalies
  • congenital mucocele of the nasolacrimal sac

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Probing, topical anesthesia
Nasolacrimal duct obstruction (NLDO) is a quite common condition among the infants. An imperforate membrane at the distal end of the nasolacrimal duct is the main cause of occlusion. Children with the signs of NLDO presenting with epiphora and/or mucous discharge were included in this study. Intervention with probing under topical anesthesia was performed on the same surgeon. And success rate was evaluated.
A punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct. A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
probing success: both anatomical patency of the duct and functional free of symptoms
Time Frame: one week
one week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Chih Heng Hung, M.D., Department of Ophthalmology, Cathay General Hospital

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.

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

February 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CGH-P103002

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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