- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240938
Adult Dacryocystocele Among Patients With Epiphora
January 23, 2020 updated by: Mohamed Farag Khalil Ibrahiem, Minia University
Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
Patients with lacrimal dacryocystocele were chosen for the study.
Dacryocystorhinostomy were done for them after their evaluation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minia
-
Minya, Minia, Egypt, 61111
- Faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Lacrimal sac mucocele
- Acquired type
Exclusion Criteria:
- No previous lacrimal sac surgery
- Suspected lacrimal sac malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lacrimal sac mucocele
Adult patients with lacrimal sac mucocele
|
Anastomosis between lacrimal sac and nasal cavity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patency of the lacrimal passage
Time Frame: 2 weeks
|
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
|
2 weeks
|
Disappearance of lacrimal sac swelling
Time Frame: 1 month
|
No evident swelling in the medial side of the eye
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
November 21, 2019
Study Completion (Actual)
December 30, 2019
Study Registration Dates
First Submitted
January 21, 2020
First Submitted That Met QC Criteria
January 23, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 23, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Minia2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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