Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Lacrimal Duct Obstruction Clinical Trial

Official title:

Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960996
• Other study ID #: FNO-ENT-Dacryocystorinostomy
• Secondary ID: 22/RVO-FNOs/2019
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction

Intervention

Procedure:
• dacryocystorinostomy
Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of lacrimal duct obstruction at 6 months	The recurrence of lacrimal duct obstruction at 6 months after the procedure will be observed.	6 months
Primary	Recurrence of lacrimal duct obstruction at 12 months	The recurrence of lacrimal duct obstruction at 12 months after the procedure will be observed.	12 months
Primary	Recurrence of lacrimal duct obstruction at 24 months	The recurrence of lacrimal duct obstruction at 24 months after the procedure will be observed.	24 months
Primary	Recurrence of lacrimal duct obstruction at 36 months	The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed.	36 months