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Adult Dacryocystocele Among Patients With Epiphora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240938
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Farag Khalil Ibrahiem, Minia University

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • 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
  • Disappearance of lacrimal sac swelling [ Time Frame: 1 month ]
    No evident swelling in the medial side of the eye
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adult Dacryocystocele Among Patients With Epiphora
Official Title  ICMJE Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Adult Dacryocystocele
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lacrimal Passage Obstruction
Intervention  ICMJE Procedure: Dacryocystorhinostomy
Anastomosis between lacrimal sac and nasal cavity
Study Arms  ICMJE Lacrimal sac mucocele
Adult patients with lacrimal sac mucocele
Intervention: Procedure: Dacryocystorhinostomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2020)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Lacrimal sac mucocele
  • Acquired type

Exclusion Criteria:

  • No previous lacrimal sac surgery
  • Suspected lacrimal sac malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04240938
Other Study ID Numbers  ICMJE Minia2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Farag Khalil Ibrahiem, Minia University
Study Sponsor  ICMJE Minia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed F Ibrahiem, MD Minia University
PRS Account Minia University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP