Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00516

2 Trial Registration Date

2016-06-08

i Registration Status

Prospective

3 Secondary IDs

2016.038-T

4 Source(s) of Funding

Research Grants Council

5 Primary Sponsor

Research Grants Council

6 Secondary Sponsor

Not Applicable

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. CHONG Kelvin Kam-lung

ii Address

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

iii Phone

+852-3943-5825

iv Email

chongkamlung@gmail.com

v Affiliation

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

vi Country

Hong Kong, China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Janice Wong

ii Address

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

iii Phone

+852-3943-5805

iv Email

chongkamlung@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-04-13

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.038-T

14 Medical Condition Being Studied

Primary Acquired Nasolacrimal Duct Obstruction

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Not applicable

vi Frequency of the intervention

Not applicable

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i 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

ii 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, 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.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Not Applicable

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Not Applicable

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-11-01

21 Target Sample Size

340

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

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).

ii The metric or method of measurement used

Syringing will be done through the inferior canaliculus after topical anesthesia

iii The timepoint(s) of primary interest

Not Applicable

24 Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

Morphological, other subjective and safety outcomes will be obtained

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-06-08