NCT03780868|Completed
External DCR Versus Canalicular SI With MMC in NLDO
External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction
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External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction
Sponsor study identifier
interventional
56
0 countries
N/A
Study Start
June 1, 2012
Actual (reported)Primary Completion
July 1, 2014
Actual (reported)Study Completion
July 31, 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2012
Actual (reported)July 1, 2014
Actual (reported)July 31, 2014
Actual (reported)December 9, 2018
Actual (reported)December 19, 2018
Actual (reported)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
canalicular silicone intubation with MMC
2 years
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.
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
external DCR under general anesthesia with standard sterilization procedures.
canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.
56 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2018
First Posted
December 19, 2018
Study Start
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June 1, 2012
Primary Completion
July 1, 2014
Actual (reported)Study Completion
July 31, 2014
Actual (reported)Last Updated
December 19, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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