Intraoperative Mitomycin C in Lacrimal Sac Mucocele

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mohamed Farag Khalil Ibrahiem, Minia University

ClinicalTrials.gov Identifier:

NCT03176355

First received: May 28, 2017

Last updated: June 1, 2017

Last verified: June 2017

History of Changes

Purpose

30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.

Condition	Intervention
Lacrimal Mucocele	Procedure: Canaliculo- Dacryocystorhinostomy


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele

Resource links provided by NLM:

Drug Information available for: Mitomycin

U.S. FDA Resources

Further study details as provided by Mohamed Farag Khalil Ibrahiem, Minia University:

Primary Outcome Measures:

Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test [ Time Frame: 1 month ]
Patency of the lacrimal passage
Disappearance of lacrimal sac swelling [ Time Frame: 1 month ]
No evident swelling in the medial side of the eye


Enrollment:	30
Actual Study Start Date:	March 23, 2011
Study Completion Date:	January 7, 2013
Primary Completion Date:	January 7, 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Chronic dacryocystitis patients	Procedure: Canaliculo- Dacryocystorhinostomy Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa

Eligibility


Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Lacrimal sac mucocele

Exclusion Criteria:

Paediatric patients (less than 16 years old).
Previous lacrimal passage procedure.
Neoplasms as secondary causes of obstruction.

Contacts and Locations

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No Contacts or Locations Provided

More Information


Responsible Party:	Mohamed Farag Khalil Ibrahiem, Lecturer of ophthalmology, Minia University
ClinicalTrials.gov Identifier:	NCT03176355 History of Changes
Other Study ID Numbers:	Minia Hospital
Study First Received:	May 28, 2017
Last Updated:	June 1, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Mucocele Cysts Neoplasms Mitomycins Mitomycin Antibiotics, Antineoplastic	Antineoplastic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 14, 2017

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