An interventional study of external dacryocystorhinostomy and canalicular silicone intubation with MMC in Primary Acquired Nasolacrimal Duct Obstruction, sponsored by Menoufia University. Completed. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
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.
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.
34 studies on the registry are indexed under Lacrimal Duct Obstruction; 6 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 24 interventional studies indexed under Lacrimal Duct Obstruction.
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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
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 The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus.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
external DCR under general anesthesia with standard sterilization procedures.
canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.
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).
Time frame: 2 years
canalicular silicone intubation with MMC
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).
Time frame: 2 years
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Plan to share: No
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Menoufia University