Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00159

2 Trial Registration Date

2008-04-24

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Ms. Jacqueline Shum

ii Address

Block B 7/F Staff Quarter The Prince of Wales Hospital Hong Kong

iii Phone

2632-2878

iv Email

jacqshum@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Dr. Kelvin K.L.Chong

ii Address

Block B 7/F Staff Quarter The Prince of Wales Hospital Hong Kong

iii Phone

2632-2878

iv Email

email chongkamlung@gmail.com

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Prospective randomized study of silicone stent intubation in endoscopic dacryocysto-rhinostomy for acquired nasolacrimal duct obstruction - SEND study

10 Public Title

Prospective randomized study of silicone stent intubation in endoscopic dacryocysto-rhinostomy for acquired nasolacrimal duct obstruction - SEND study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

SEND study

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?

2006-04-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Acquired nasolacrimal duct obstruction

15 Intervention

i Types of intervention

Other

Please specify

Device + procedure

ii Description/ name of Intervention/article

endoscopic dacryocysto-rhinostomy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Stenting: 8 weeks or no stent at all Follow-up: 26 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Endoscopic dacryocystorhinostomy with or without eight weeks bicanalicular silicone intubation

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

Inclusion criteria 1. Adult patients (>18) with NLDO (on table finding) 2. Informed consent 3. Follow-up to 6 months 4. No previous lacrimal surgery 5. No concomitant canalicular disease 6. Agree for randomization

ii Exclusion Criteria

Exclusion criteria 1. Previous dacryocystorhinostomy 2. Canalicular obstruction requiring membranectomy after sac exposure for free passage of Bowman probe 3. Requiring concomitant punctoplasty procedure

iii Age Minimum

18

iv Age Maximum

n/a

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

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

2006-04-05

21 Target Sample Size

120

22 Recruitment Status

Recruiting

23 Primary Outcome

% of success achieved in each group at postoperative six months % with formation of granulation tissue at rhinostomy site, time course, response to local debridement and nasal steroid spray

24 Secondary Outcome

Risk factors analyses for surgical failure or persistence of symptom (age, gender, duration of symptom preoperatively, postoperative tube prolapse, presence of granulation tissue around internal ostium, difficulty intraoperative hemostasis, surgeon's immediate impression, level of surgical experience, endoscopist's assessment postoperatively) Mean time to failure postoperatively (weeks) Complications rate: orbital fat prolapse, epistaxis, infection, tube prolapse, canalicular laceration, synechiae, additional surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000721

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2011-02-08