Lacrimal Duct Obstruction
Conditions
Keywords
lacrimal duct obstruction, bicanalicular intubation, dacryocystorinostomy, silicone stent
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.
Interventions
PROCEDUREdacryocystorinostomy
Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking will be used in the course of this study.
Intervention model description
The patients will be randomized into two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of lacrimal duct obstruction at 6 months | 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 | 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 | 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 | 36 months | The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed. |
Countries
Czechia
Outcome results
None listed