NCT03960996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

May 21, 2019

Last Update Submit

December 6, 2022

Conditions

Lacrimal Duct Obstruction

Keywords

lacrimal duct obstructionbicanalicular intubationdacryocystorinostomysilicone stent

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Dacryocystorinostomy with bicanalicular intubation

EXPERIMENTAL

Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.

Procedure: dacryocystorinostomy

Dacryocystorinostomy without bicanalicular intubation

EXPERIMENTAL

Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.

Procedure: dacryocystorinostomy

Interventions

dacryocystorinostomyPROCEDURE

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

Dacryocystorinostomy with bicanalicular intubationDacryocystorinostomy without bicanalicular intubation

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with lacrimal duct obstruction
  • to 79 years of age
  • capable of general anesthesia
  • signing of the informed consent

You may not qualify if:

  • \- inability to undergo general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 28321534BACKGROUND

  • 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.

    PMID: 27573690BACKGROUND

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Pavel Komínek, prof.,MD,PhD,MBA

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the course of this study.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The patients will be randomized into two parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

The investigators do not plan to make individual participant data available to other researchers.

Locations

CZ(1)