Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00047

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

n/a

6 Secondary Sponsor

n/a

Function

Please specify

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

i Name

Prof. Clement CY Tham

ii Address

Dept. of Ophthalmology & Visual Sciences, Hong Kong Eye Hospital

iii Phone

2762 3196

iv Email

clemtham@hkstar.com

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Clement CY Tham

ii Address

Dept. of Ophthalmology & Visual Sciences, Hong Kong Eye Hospital

iii Phone

2762 3196

iv Email

clemtham@hkstar.com

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomised controlled trial to compare the clinical outcomes of needle revision of trabeculectomy bleb vs repeat trabeculectomy in managing failed trabeculectomy.

10 Public Title

A randomised controlled trial to compare the clinical outcomes of needle revision of trabeculectomy bleb vs repeat trabeculectomy in managing failed trabeculectomy.

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

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?

2005-03-24

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

needle revision of trabeculectomy bleb

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

repeat trabeculectomy

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. Eye with failed bleb after one single trabeculectomy or after one single trabeculectomy with phacoemulsification. 2. Patients with follow up at least 3 months after the index surgery 3. Definition of failed trabeculectomy : a. IOP>22mmHg on maximum tolerable anti-glaucoma drugs b. Fibrotic or scarred bleb with IOP higher than the target pressure for the patient 4. Patients able and willing to give informed consent.

ii Exclusion Criteria

Exclusion criteria 1. Single functional eye 2. Patients with previous glaucoma operations, including more than one trabeculectomy, needling, glaucoma drainage device or cyclophotocoagulation procedures. 3. Patients refusing needling or trabeculectomy 4. Patients unable to attend regular follow-up.

iii Age Minimum

n / a

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

Active

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

2005-03-24

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

a. IOP reduction in intraocular pressure by 2 criteria (<22mmHg or >30% reduction) b. number of IOP-lowering medications

24 Secondary Outcome

a. complications of treatment b. progression of disc changes and/or visual field loss c. need of subsequent surgical intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-24

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000647

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 2011-02-08