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Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

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ClinicalTrials.gov Identifier: NCT03960996
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Lacrimal Duct Obstruction Procedure: dacryocystorinostomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized into two parallel groups.
Masking: None (Open Label)
Masking Description: No masking will be used in the course of this study.
Primary Purpose: Diagnostic
Official Title: Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Dacryocystorinostomy with bicanalicular intubation
Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.
Procedure: dacryocystorinostomy
Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.

Experimental: Dacryocystorinostomy without bicanalicular intubation
Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.
Procedure: dacryocystorinostomy
Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960996


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,PhD 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
University Hospital Ostrava Not yet recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70852
Contact: Petr Vávra, Ass.Prof.,MD,PhD    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Pavel Komínek, prof.,MD,PhD,MBA         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Pavel Komínek, prof.,MD,PhD,MBA University Hospital Ostrava

Publications:
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03960996     History of Changes
Other Study ID Numbers: FNO-ENT-Dacryocystorinostomy
22/RVO-FNOs/2019 ( Other Grant/Funding Number: University Hospital Ostrava )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Ostrava:
lacrimal duct obstruction
bicanalicular intubation
dacryocystorinostomy
silicone stent

Additional relevant MeSH terms:
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Lacrimal Duct Obstruction
Lacrimal Apparatus Diseases
Eye Diseases