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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. Identifier: NCT04240938
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
Mohamed Farag Khalil Ibrahiem, Minia University

Brief Summary:
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.

Condition or disease Intervention/treatment Phase
Lacrimal Passage Obstruction Procedure: Dacryocystorhinostomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Adult Dacryocystocele
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : December 30, 2019

Arm Intervention/treatment
Lacrimal sac mucocele
Adult patients with lacrimal sac mucocele
Procedure: Dacryocystorhinostomy
Anastomosis between lacrimal sac and nasal cavity

Primary Outcome Measures :
  1. 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. Disappearance of lacrimal sac swelling [ Time Frame: 1 month ]
    No evident swelling in the medial side of the eye

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Lacrimal sac mucocele
  • Acquired type

Exclusion Criteria:

  • No previous lacrimal sac surgery
  • Suspected lacrimal sac malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04240938

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Faculty of Medicine
Minya, Minia, Egypt, 61111
Sponsors and Collaborators
Minia University
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Principal Investigator: Mohamed F Ibrahiem, MD Minia University
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Responsible Party: Mohamed Farag Khalil Ibrahiem, Assistant Professor, Minia University Identifier: NCT04240938    
Other Study ID Numbers: Minia2020
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lacrimal Apparatus Diseases
Eye Diseases