Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00188

2 Trial Registration Date

2009-07-27

i Registration Status

Prospective

3 Secondary IDs

NIL

4 Source(s) of Funding

Department Funding [Department of Ophthalmology & Visual Sciences, CUHK]

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

Miss Joyce Kung

ii Address

Department of Ophthalmology & Visual Sciences, CUHK, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

iii Phone

Tel: 2762 3134;

iv Email

joycekung@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

Dr. Leung Kai Shun Christopher

ii Address

Department of Ophthalmology & Visual Sciences, CUHK, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

iii Phone

Tel: 2762 3080;

iv Email

cksleung@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Evaluation of Selective Laser Trabeculoplasty for Intraocular Pressure Lowering in Chinese Eyes – A pilot study

10 Public Title

Evaluation of Selective Laser Trabeculoplasty for Intraocular Pressure Lowering in Chinese Eyes – A pilot study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Intraocular pressure lowering effect of selective laser trabeculoplasty

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?

2009-06-29

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Glaucoma and ocular hypertension

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

selective laser trabeculoplasty

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

procedure duration - 15 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

none

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
-A diagnosis of normal tension glaucoma, primary open angle glaucoma, primary angle closure glaucoma or steroid induced ocular hypertension / glaucoma
-Older than 18 years of age
-Able to give informed consent

ii Exclusion Criteria

Exclusion Criteria
- Significant cataract rendering visual field testing or optic disc imaging not technically possible
- Previous SLT or ALT
- Participation in another therapeutic drug study within the last 30 days
- Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer.

iii Age Minimum

18

iv Age Maximum

None set

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-07-31

21 Target Sample Size

200

22 Recruitment Status

Suspended

23 Primary Outcome

Intraocular pressure at 1 week, 1 month, 3 months, 6 months, 1 year

24 Secondary Outcome

Visual field progression and Retinal nerve fiber layer progression at 1 year

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-06-23

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000731

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2013-01-14