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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04931186
Other study ID # NLDO 01309113
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2018
Est. completion date June 11, 2020

Study information

Verified date June 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 625
Est. completion date June 11, 2020
Est. primary completion date February 6, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
retrospective analyis
retrospective analysis of data

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of NLDO interventions 1.1.2013 - 31.12.2017
Secondary Success rate of different surgical approaches 1.1.2013 - 31.12.2017
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