Nasolacrimal Duct Obstruction

June 18, 2021 updated by: Reinhard Told, Medical University of Vienna

Retrospective Data Analysis of Patients Undergoing Lacrimal Drainage System Interventions at The Department of Ophthalmology and Optometry During The Years 2013 - 2017

1.1 Background Obstructions of the lacrimal drainage system can be differentiated based on anatomical location or severity. But also, differentiating between congenital and acquired nasolacrimal duct obstruction (NLDO) is possible. The incidence of congenital NLDO (CNLOD) has been shown to be approximately 20%. Most of the cases undergo spontaneous remission, as the ductus nasolacrimalis may open spontaneously. About 2-12% display a symptomatic course. 2. S: 290; 3; 4, 5 Acquired NLDO may occur during childhood and adulthood. The incidence of symptomatic acquired NLDO is around 30 cases per 100.000 people in an US-based cohort study. S: 293; 30 Two major anatomical closure sites have been described, which are on the one hand located at the between the punctum and canaliculus, and on the other hand located after the lacrimal sac. 1. S. ; 2. S: 293 1.2 Aim of this study The aim of this study is to assess the success rates for different types of primary tear duct surgery, performed from 2013 - 2017 at the department of Ophthalmology and Optometry, Medical University of Vienna.

Treatment success was defined as the absence of clinical signs of lacrimal drainage system obstruction (epiphora, increased tear leak, mucous discharge) and without the need for re-intervention.

It is further investigated whether the type of operation performed or whether the silicone tube used influence success rates.

1.3 Methods A retrospective chart analysis of all patients - independent of the underlying pathology - undergoing surgery of the lacrimal drainage system between 1st of January 2013 and 31st December 2017. Success rates and patient profiles will be analyzed not only for all patients, but also for subgroups based on the underlying pathology and operation performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

625

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Charts of all patients - independent of the underlying pathology - undergoing surgery of the lacrimal drainage system between 1st of January 2013 and 31st December 2017. We expect approximately 700 eyes of 500 patients.

Description

Inclusion criteria

  • All charts of patients treated during the above-indicated period of time will be considered for this analysis.

Exclusion criteria

  • incomplete medical records are considered an exclusion criterion.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all patients
Other: retrospective analyis
retrospective analysis of data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of NLDO interventions
Time Frame: 1.1.2013 - 31.12.2017
1.1.2013 - 31.12.2017

Secondary Outcome Measures

Outcome Measure
Time Frame
Success rate of different surgical approaches
Time Frame: 1.1.2013 - 31.12.2017
1.1.2013 - 31.12.2017

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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)

July 3, 2018

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

June 11, 2020

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLDO 01309113

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

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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