External DCR Versus Canalicular SI With MMC in NLDO

NCT03780868 | Completed

• 1 other identifier: Ebsar ophthalmic Center
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Acquired Nasolacrimal Duct Obstruction

Keywords

External DCR, canalicular silicone intubation, Mitomycin C

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• canalicular silicone intubation with MMC

  2 years

Study Arms (2)

external DCR

ACTIVE COMPARATOR

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.

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

silicone intubation with MMC

ACTIVE COMPARATOR

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 The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus.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

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

Interventions

external dacryocystorhinostomy PROCEDURE

external DCR under general anesthesia with standard sterilization procedures.

external DCR; silicone intubation with MMC

canalicular silicone intubation with MMC PROCEDURE

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

external DCR; silicone intubation with MMC

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• primary acquired NLDO

You may not qualify if:

• All other secondary causes of NLDO

Sponsors & Collaborators

• Menoufia University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

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

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 19, 2018
• Study Start: June 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 31, 2014
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share