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Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Primary Purpose

Lacrimal Duct Obstruction

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
dacryocystorinostomy
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lacrimal Duct Obstruction focused on measuring lacrimal duct obstruction, bicanalicular intubation, dacryocystorinostomy, silicone stent

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with lacrimal duct obstruction
  • 18 to 79 years of age
  • capable of general anesthesia
  • signing of the informed consent

Exclusion Criteria:

- inability to undergo general anesthesia

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dacryocystorinostomy with bicanalicular intubation

Dacryocystorinostomy without bicanalicular intubation

Arm Description

Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.

Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.

Outcomes

Primary Outcome Measures

Recurrence of lacrimal duct obstruction at 6 months
The recurrence of lacrimal duct obstruction at 6 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 12 months
The recurrence of lacrimal duct obstruction at 12 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 24 months
The recurrence of lacrimal duct obstruction at 24 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 36 months
The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03960996
Brief Title
Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation
Official Title
Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The most common cause of unsuccessful surgery is intranasal stoma scarring. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.
Detailed Description
Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. Lacrimal duct obstruction can be caused by inflamation and trauma or might be the consequence of previous surgery in the lacrimal duct region. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The results of DCR are generally excellent and the success rate (regression of complaints) varies between 85-95% depending on the condition of the lacrimal pathways before surgery. Yet there is a constant effort to improve the results of operations. The most common cause of unsuccessful surgery is intranasal stoma scarring. It is caused by an inadequately formed bone window, an individual tendency to healing and scar formation, but a frequent cause is the insufficient opening of the tear bag or the formation of scars between the nasal septum and the lateral nasal wall. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. Silicone stent remains in the lacrimal system for 12 weeks and prevents scarring. Results of previous studies are not clear whether bicanalicular intubation is beneficial. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction
Keywords
lacrimal duct obstruction, bicanalicular intubation, dacryocystorinostomy, silicone stent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into two parallel groups.
Masking
None (Open Label)
Masking Description
No masking will be used in the course of this study.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dacryocystorinostomy with bicanalicular intubation
Arm Type
Experimental
Arm Description
Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.
Arm Title
Dacryocystorinostomy without bicanalicular intubation
Arm Type
Experimental
Arm Description
Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.
Intervention Type
Procedure
Intervention Name(s)
dacryocystorinostomy
Intervention Description
Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.
Primary Outcome Measure Information:
Title
Recurrence of lacrimal duct obstruction at 6 months
Description
The recurrence of lacrimal duct obstruction at 6 months after the procedure will be observed.
Time Frame
6 months
Title
Recurrence of lacrimal duct obstruction at 12 months
Description
The recurrence of lacrimal duct obstruction at 12 months after the procedure will be observed.
Time Frame
12 months
Title
Recurrence of lacrimal duct obstruction at 24 months
Description
The recurrence of lacrimal duct obstruction at 24 months after the procedure will be observed.
Time Frame
24 months
Title
Recurrence of lacrimal duct obstruction at 36 months
Description
The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with lacrimal duct obstruction 18 to 79 years of age capable of general anesthesia signing of the informed consent Exclusion Criteria: - inability to undergo general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Komínek, prof.,MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
28321534
Citation
Nomura K, Arakawa K, Sugawara M, Hidaka H, Suzuki J, Katori Y. Factors influencing endoscopic dacryocystorhinostomy outcome. Eur Arch Otorhinolaryngol. 2017 Jul;274(7):2773-2777. doi: 10.1007/s00405-017-4541-8. Epub 2017 Mar 20.
Results Reference
background
PubMed Identifier
27573690
Citation
Coumou AD, Genders SW, Smid TM, Saeed P. Endoscopic dacryocystorhinostomy: long-term experience and outcomes. Acta Ophthalmol. 2017 Feb;95(1):74-78. doi: 10.1111/aos.13217. Epub 2016 Aug 29.
Results Reference
background

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Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

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