Back to resultsAdult Dacryocystocele Among Patients With Epiphora
Primary Purpose
Lacrimal Passage Obstruction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dacryocystorhinostomy
Sponsored by
About this trial
This is an interventional treatment trial for Lacrimal Passage Obstruction
Eligibility Criteria
Inclusion Criteria:
- Lacrimal sac mucocele
- Acquired type
Exclusion Criteria:
- No previous lacrimal sac surgery
- Suspected lacrimal sac malignancy
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lacrimal sac mucocele
Arm Description
Adult patients with lacrimal sac mucocele
Outcomes
Primary Outcome Measures
Patency of the lacrimal passage
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Disappearance of lacrimal sac swelling
No evident swelling in the medial side of the eye
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04240938
Brief Title
Adult Dacryocystocele Among Patients With Epiphora
Official Title
Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.
Detailed Description
Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Passage Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Adult Dacryocystocele
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacrimal sac mucocele
Arm Type
Other
Arm Description
Adult patients with lacrimal sac mucocele
Intervention Type
Procedure
Intervention Name(s)
Dacryocystorhinostomy
Intervention Description
Anastomosis between lacrimal sac and nasal cavity
Primary Outcome Measure Information:
Title
Patency of the lacrimal passage
Description
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Time Frame
2 weeks
Title
Disappearance of lacrimal sac swelling
Description
No evident swelling in the medial side of the eye
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lacrimal sac mucocele
Acquired type
Exclusion Criteria:
No previous lacrimal sac surgery
Suspected lacrimal sac malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Ibrahiem, MD
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adult Dacryocystocele Among Patients With Epiphora
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