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Trial History Detail on 2016-06-08

CUHK_CCRB00516

2016-06-08

Prospective

2016.038-T

Research Grants Council

Research Grants Council

Not Applicable

Not Applicable

Dr. CHONG Kelvin Kam-lung

3/F, Hong Kong Eye Hospital,
147K Argyle Street, Mong Kok,
Kowloon, Hong Kong

+852-3943-5825

chongkamlung@gmail.com

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

Hong Kong, China

Janice Wong

3/F, Hong Kong Eye Hospital,
147K Argyle Street, Mong Kok,
Kowloon, Hong Kong

+852-3943-5805

chongkamlung@cuhk.edu.hk

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

Hong Kong, China

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)

比較絲裂黴素C合併支架植入術與單純黏膜瓣保留鼻內鏡下淚囊鼻腔吻合術對原發性鼻淚管阻塞 的手術療效

Hong Kong, China

Yes

2016-04-13

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.038-T

Primary Acquired Nasolacrimal Duct Obstruction

Procedure

Subjects randomized to receiving no adjuvant group will have a piece of medical grade cotton material soaked with normal saline applied over ostium for 3 minutes.

Not applicable

Not applicable

Not applicable

Not applicable

Subjects randomized to silicone intubation with topical mitomycin C group will have a piece of medical grade cotton material soaked with topical mitomycin C applied over ostium or 3 minutes followed by normal saline nasal irrigation and silicone intubation.

Not applicable

Not applicable

Not applicable

Not applicable

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

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, Wegener’s 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.

18

999

Both Male and Female

Interventional

Randomized

Not Applicable

Not Applicable

Single-blind

Trial subjects

Not Applicable

3

2016-11-01

340

Not Yet Recruiting

To compare between study arms 12-month anatomical patency and other outcomes including functional patency, ostium morphologies, additional procedure(s) and trial-related complication(s).

Syringing will be done through the inferior canaliculus after topical anesthesia

Not Applicable

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

Morphological, other subjective and safety outcomes will be obtained

No

2016-09-02

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