Nasolacrimal Duct Obstruction

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04931186
Collaborator
(none)
625
1
23.3
26.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: retrospective analyis

Study Design

Study Type:
Observational
Actual Enrollment :
625 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Data Analysis of Patients Undergoing Lacrimal Drainage System Interventions at The Department of Ophthalmology and Optometry During The Years 2013 - 2017
Actual Study Start Date :
Jul 3, 2018
Actual Primary Completion Date :
Feb 6, 2020
Actual Study Completion Date :
Jun 11, 2020

Arms and Interventions

Arm Intervention/Treatment
all patients

Other: retrospective analyis
retrospective analysis of data

Outcome Measures

Primary Outcome Measures

  1. Success rate of NLDO interventions [1.1.2013 - 31.12.2017]

Secondary Outcome Measures

  1. Success rate of different surgical approaches [1.1.2013 - 31.12.2017]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reinhard Told, clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04931186
Other Study ID Numbers:
  • NLDO 01309113
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021