External DCR Versus Canalicular SI With MMC in NLDO

Menoufia University

Status: Completed

Conditions: Primary Acquired Nasolacrimal Duct Obstruction

Treatments: Procedure: canalicular silicone intubation with MMC; Procedure: external dacryocystorhinostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03780868

Ebsar ophthalmic Center

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary acquired NLDO

Exclusion criteria

• All other secondary causes of NLDO

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

external DCR

Active Comparator group

Description:

A curvilinear incision of 10-15 mm length was made along the anterior lacrimal crest . The smaller end of the blunt dissector was used to fracture Lamina papyracea, the parchment like bone of the posterior half of the lacrimal fossa. the nasal mucosa was stripped from lacrimal bone with the help of Traquair's periosteal elevator, An osteotomy of approximately 12.5 x10mm was created with successive punching of bone by Cittelli's punch. Lacrimal sac and nasal mucosa were opened in a 'H' fashion with the no.11 Bard-Parker blade and Bowman's probe was in place, to form a large anterior and smaller posterior flap.

Treatment:

Procedure: canalicular silicone intubation with MMC

Procedure: external dacryocystorhinostomy

silicone intubation with MMC

Active Comparator group

Description:

Bowman's probe was gently inserted into the inferior canalicular system, until a hard stop was felt in the lacrimal sac, after which it was rotated into the NLD to reach below the inferior concha. The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus. After irrigation with normal saline to confirm duct patency, irrigation was performed by introducing 1 ml of MMC (0.5 mg/ml) into the duct with a syringe, the ocular surface then irrigatedby normal saline. Intubation was done by a silicone tube connected by each of its end to a malleable steel guide. A grooved director was placed under the inferior turbinate to guide the probe out of the nose, after which the steel guide was cut from the silicone tube

Treatment:

Procedure: canalicular silicone intubation with MMC

Procedure: external dacryocystorhinostomy