External DCR Versus Canalicular SI With MMC in NLDO

NCT ID: NCT03780868

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Primary Acquired Nasolacrimal Duct Obstruction

Keywords

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External DCR, canalicular silicone intubation, Mitomycin C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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external DCR

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.

Group Type ACTIVE_COMPARATOR

external dacryocystorhinostomy

Intervention Type PROCEDURE

external DCR under general anesthesia with standard sterilization procedures.

canalicular silicone intubation with MMC

Intervention Type PROCEDURE

canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.

silicone intubation with MMC

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

Group Type ACTIVE_COMPARATOR

external dacryocystorhinostomy

Intervention Type PROCEDURE

external DCR under general anesthesia with standard sterilization procedures.

canalicular silicone intubation with MMC

Intervention Type PROCEDURE

canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.

Interventions

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external dacryocystorhinostomy

external DCR under general anesthesia with standard sterilization procedures.

Intervention Type PROCEDURE

canalicular silicone intubation with MMC

canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary acquired NLDO

Exclusion Criteria

* All other secondary causes of NLDO
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Amin Faisal Ellakwa

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Ebsar ophthalmic Center

Identifier Type: -

Identifier Source: org_study_id