External DCR Versus Canalicular SI With MMC in NLDO

Not Applicable

Completed

• Conditions: Primary Acquired Nasolacrimal Duct Obstruction

• Registration Number: NCT03780868
• Lead Sponsor: Menoufia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2014-07-01
• Study Completion: 2014-07-31
• Status Verified: 2018-12
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-17
• Last Update Submitted: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• primary acquired NLDO

Exclusion Criteria

• All other secondary causes of NLDO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
external DCR	2 years	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).