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Mitomycin, Intubation vs No adjuvant In MUcosal-preserving Mechanical endonasal dacryocystorhinostomy for primary acquired nasolacrimal duct obstruction (MINIMUM endonasal DCR for PANLDO)

Mitomycin, Intubation vs No adjuvant In MUcosal-preserving Mechanical endonasal dacryocystorhinostomy for primary acquired nasolacrimal duct obstruction (MINIMUM endonasal DCR for PANLDO)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008616
Enrollment
Unknown
Registered
2016-06-08
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary acquired nasolacrimal duct obstruction

Interventions

Two groups:a piece of medical grade cotton material soaked with normal saline applied over ostium for 3 minutes versus a piece of medical grade cotton material soaked with topical mitomycin C applied

Sponsors

Research Grants Council
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult >=18 years old and there is no maximum age limit; Primary acquired nasolacrimal duct obstruction (PANLDO) diagnosed by lacrimal irrigation and probing, confirmed intraoperatively after incision of lacrimal sac; Informed consent for operation, randomization and recording; Compliance to follow-up and treatment.

Exclusion criteria

Exclusion criteria: Pregnancy, lactation (contraindication for topical mitomycin C); Known allergy to mitomycin, cocaine, adrenaline, steroid, silicone material; Contraindications of endonasal DCR or inability to undergo nasal endoscopy; Acute (<3 months) or non-bacterial dacryocystitis e.g. tuberculosis, fungal or parasitic; Ipsilateral canalicular disorder e.g. obstruction, canaliculitis, canaliculocele, diverticulum; Ipsilateral recurrent NLDO or any prior lacrimal intervention except punctoplasty; Ipsilateral facial paralysis despite apparent clinical recovery; Ipsilateral conditions affecting bony nasolacrimal outflow e.g. midfacial trauma/fracture42, osteoma, fibrous dysplasia and other skull-base disorders; Ipsilateral suspected or confirmed nasolacrimal or sinoorbital neoplasm 43; Ipsilateral severe ocular surface disorders e.g. ocular cicatrical pemphigoid, chemical burns, Steven Johnson Syndrome, Toxic Epidermal Necrolysis44; Conditions affecting mucosa of the nose or nasolacrimal system e.g. rhinosinusitis, Wegeners granulomatosis, sarcoidosis45, radioactive iodide46, head & neck radiotherapy47, ipsilateral maxillectomy48, systemic chemotherapy (5-fluorouracil, docetaxel49); Ipsilateral topical antiglaucomatous or chemotherapy drops (e.g. timolol50, mitomycin C); Intraoperative false passage of Bowman probe or metal part of silicone stent; Dacryolith or intrasaccal mass.

Design outcomes

Primary

MeasureTime frame
anatomical patency, functional patency, ostium morphologies, additional procedure(s) and trial-related complication(s);

Secondary

MeasureTime frame
To identify preoperative ( demographic ), intraoperative ( endonasal, lacrimal sac ) and postoperative ( ostial ) features associated with poor outcomes.;

Countries

China

Contacts

Public ContactJanice Wong

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

chongkamlung@cuhk.edu.hk+852 39435805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026