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NCT Number: NCT03960996

Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

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.

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Key information

Conditions

Lacrimal Duct Obstruction Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacryocystorinostomy

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 23, 2019
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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