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CompletedNCT03960996

Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
University Hospital Ostrava · Academic / Other
Sex
All
Age
18 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREdacryocystorinostomyDacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.

Timeline

Start date
2019-07-01
Primary completion
2022-06-30
Completion
2022-06-30
First posted
2019-05-23
Last updated
2022-12-07

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT03960996. Inclusion in this directory is not an endorsement.