NCT04931186

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

June 11, 2021

Last Update Submit

June 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success rate of NLDO interventions

    1.1.2013 - 31.12.2017

Secondary Outcomes (1)

  • Success rate of different surgical approaches

    1.1.2013 - 31.12.2017

Study Arms (1)

all patients

Other: retrospective analyis

Interventions

retrospective analysis of data

all patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Eye DiseasesLacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical Professor

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

July 3, 2018

Primary Completion

February 6, 2020

Study Completion

June 11, 2020

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations