Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00045

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

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

iii Phone

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

iv Email

2855 3788

v Affiliation

vi Country

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

i Name

Prof. Clement CY Tham

ii Address

iii Phone

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

iv Email

2855 3788

v Affiliation

vi Country

9 Official Scientific Title of the Study

Phaco-trabeculectomy with intra-bleb injection of triamcinolone acetonide versus phaco-trabeculectomy with mitomycin C in patients with co-existing cataract and glaucoma ¡V a randomized controlled trial.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-05-11

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

Drug

Please specify

ii Description/ name of Intervention/article

intra-bleb injection of triamcinolone acetonide

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 minute

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

mitomycin C

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. Eyes with visually significant cataract and glaucoma indicated phaco-trabeculectomy 2. Risk factors for filtration failure present. These include: • Conjunctival hyperemia caused by prolonged use of glaucoma eye drops; • Age <= 50 • Secondary glaucomas, in particular: uveitic glaucoma • Surgery requiring uveal manipulation, such as posterior synechialysis or pupil stretching 3. Patient able and willing to give informed consent to participation in the study, and to phaco-trabeculectomy with MMC or IBTA. Exclusion criteria 1. Single functional eye 2. Previous intraocular surgery, with the exception of laser peripheral iridotomy and argon laser peripheral iridoplasty (ALPI).

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

2005-05-11

21 Target Sample Size

30

22 Recruitment Status

Recruiting

23 Primary Outcome

VA IOP

24 Secondary Outcome

1. Number of IOP-lowering medications 2. Change in visual field by automated perimetry (Humphrey¡¦s) 3. Change in cup-to-disc ratio of the optic nerve head 4. Rate of aqueous outflow by pneumatonometer measurements (in UCH-recruited patient) 5. Anterior segment inflammation 6. Bleb morphology 7. Complications

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-08