External DCR Versus Canalicular SI With MMC in NLDO

Primary Acquired Nasolacrimal Duct Obstruction Clinical Trial

Official title:

External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780868
• Other study ID #: Ebsar ophthalmic Center
• Status: Completed
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: July 31, 2014

Study information

• Verified date: December 2018
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While external DCR is the gold standard procedure for primary NLDO as well as complicated cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence should be considered as an alternative as a safe and minimally invasive procedure.

Description:

Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).

Methods: the study was carried out at the department of Ophthalmology, Menoufia university Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases underwent external DCR and twenty-six cases underwent silicone intubation with MMC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 31, 2014
• Est. primary completion date: July 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• primary acquired NLDO

Exclusion Criteria:

• All other secondary causes of NLDO

Related Conditions & MeSH terms

• Primary Acquired Nasolacrimal Duct Obstruction

Intervention

Procedure:
• external dacryocystorhinostomy
external DCR under general anesthesia with standard sterilization procedures.
• canalicular silicone intubation with MMC
canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	canalicular silicone intubation with MMC	patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).	2 years
Primary	external DCR	patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).	2 years