Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00350

2 Trial Registration Date

2013-01-08

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Hospital Authority Kowloon Central Cluster Research Grant 2012/13 [Ref.: KCC/RC/G/1213 - B03]

5 Primary Sponsor

Hong Kong Eye Hospital

6 Secondary Sponsor

Prince of Wales Hospital, The Chinese University of Hong Kong

Function

Please specify

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

i Name

Chow Hei Ting, Margaret

ii Address

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

iii Phone

27623175

iv Email

margaretchow@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Li Yuen Mei, Emmy

ii Address

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

iii Phone

27623000

iv Email

emmyli@gmail.com

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Endoscopic Dacryocystorhinostomy as Primary versus Secondary Treatment in Acute Dacryocystitis

10 Public Title

Endoscopic Dacryocystorhinostomy as Primary versus Secondary Treatment in Acute Dacryocystitis

i Public Title in Chinese 研究名稱

比較淚囊鼻腔造口術作為初期或早期治療急性淚囊炎之效果

11 Short Title (Optional)

EDCR for Acute Dacryocystitis

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-12-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Acute dacryocystitis

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Endoscopic dacryocystorhinostomy (EN-DCR)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

The surgery will last for 1-2 hours

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Control group: EN-DCR will be performed within 1 month after acute dacryocystitis subsides with initial percutaneous drainage, as a secondary treatment of the underlying nasolacrimal duct obstruction
Treatment group: EN-DCR will be offered as a primary treatment for acute dacryocystitis within 2 weeks after presentation and randomization.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Subjects with acute dacryocystitis, defined as painful lacrimal
sac distention with marked medial canthal inflammation of less
than 2 weeks
2. Age 18-90
3. Fit for operation under general anesthesia

ii Exclusion Criteria

1. History of DCR
2. History of trauma / neoplasm / congenital anomalies of
lacrimal drainage system
3. History maxillofacial surgery or trauma
4. Immunocompromized patients
5. Poor cooperation for operation or subsequent endoscopic examination
6. Fail or refuse to give consent

iii Age Minimum

18

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-02-14

21 Target Sample Size

64

22 Recruitment Status

Recruiting

23 Primary Outcome

Resolution of symptoms of acute dacryocystitis including pain, medial canthal swelling, epiphora, discharge, associated cellulitis and fever

24 Secondary Outcome

1. Efficacy of EN-DCR
-Anatomical success
-Functional success
2. Safety of EN-DCR – incidence of complications
3. Causative agents of acute dacryocystitis in Hong Kong

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TCS-13003191

28 Date of Registration in Primary Registry

2013-04-28

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-01-20