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Clinical Trials/NCT03960996
NCT03960996CompletedNot Applicable

Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

University Hospital Ostrava2 sites in 1 country120 target enrollmentStarted: July 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
Recurrence of lacrimal duct obstruction at 6 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Masking Description

No masking will be used in the course of this study.

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Recurrence of lacrimal duct obstruction at 6 months

Time Frame: 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

Time Frame: 12 months

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

Recurrence of lacrimal duct obstruction at 36 months

Time Frame: 36 months

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

Recurrence of lacrimal duct obstruction at 24 months

Time Frame: 24 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Ostrava
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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