Back to resultsFunctional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
Primary Purpose
Functional Epiphora (Tearing Without Any Anatomical Block)
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
External Dacryocystorhinostomy
Endonasal Dacryocystorhinostomy
Transcanalicular Dacryocystorhinostomy
Sponsored by
About this trial
This is an interventional treatment trial for Functional Epiphora (Tearing Without Any Anatomical Block)
Eligibility Criteria
Inclusion Criteria:
- patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)
Exclusion Criteria:
- Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months
Sites / Locations
- McMaster University
- Beyoglu Eye Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
External DCR
Endonasal DCR
Transcanalicular DCR
Arm Description
Patients treated with External DCR for functional epiphora
Patients treated with Endonasal DCR for functional epiphora
Patients treated with Transcanalicular DCR for functional epiphora
Outcomes
Primary Outcome Measures
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.
Secondary Outcome Measures
Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04952454
Brief Title
Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
Official Title
Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Epiphora (Tearing Without Any Anatomical Block)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External DCR
Arm Type
Active Comparator
Arm Description
Patients treated with External DCR for functional epiphora
Arm Title
Endonasal DCR
Arm Type
Active Comparator
Arm Description
Patients treated with Endonasal DCR for functional epiphora
Arm Title
Transcanalicular DCR
Arm Type
Active Comparator
Arm Description
Patients treated with Transcanalicular DCR for functional epiphora
Intervention Type
Procedure
Intervention Name(s)
External Dacryocystorhinostomy
Intervention Description
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision.
Intervention Type
Procedure
Intervention Name(s)
Endonasal Dacryocystorhinostomy
Intervention Description
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route.
Intervention Type
Procedure
Intervention Name(s)
Transcanalicular Dacryocystorhinostomy
Intervention Description
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route.
Primary Outcome Measure Information:
Title
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.
Time Frame
Last follow-up time, approximately 6 months
Secondary Outcome Measure Information:
Title
Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.
Time Frame
Last follow-up time, approximately 6 months
10. Eligibility
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)
Exclusion Criteria:
Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Can Ozturker, MD
Organizational Affiliation
Istanbul University, Istanbul Facukty Of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
Facility Name
Beyoglu Eye Research Hospital
City
Istanbul
ZIP/Postal Code
34421
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
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