Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00043

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

CUHK Direct Grant

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 randomized controlled trial to compare cataract extraction alone by phacoemulsification versus combined phaco-trabeculectomy in the treatment of chronic angle-closure glaucoma (CACG) with coexisting cataract.

10 Public Title

A randomized controlled trial to compare cataract extraction alone by phacoemulsification versus combined phaco-trabeculectomy in the treatment of chronic angle-closure glaucoma (CACG) with coexisting cataract.

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

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?

2003-08-05

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

Cataract extraction by Phacoemulsification

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 to 45 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Combined Phaco-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. Eyes with CACG and coexisting cataract as defined above 2. Patient able and willing to give informed consent to phacoemulsification or phaco-TBx, prior to randomization

ii Exclusion Criteria

Exclusion criteria 1. Single functional eye 2. Eyes with very advanced glaucomatous damage, defined as visual field loss threatening fixation, or cup-to-disc ratio of 0.9 and above 3. Patients refusing either cataract extraction or trabeculectomy 4. Previous intraocular surgery, with the exception of laser peripheral iridotomy and argon laser peripheral iridoplasty (ALPI).

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

2003-08-05

21 Target Sample Size

150

22 Recruitment Status

Complete

23 Primary Outcome

IOP

24 Secondary Outcome

1. Number of IOP-lowering medications 2. Anesthetic method required, anesthetic complications, and subjective pain score by visual-analog scale 3. Peri-operative complications 4. Operative time, and Total operative time (including second-staged trabeculectomy performed for phaco-alone patients whose IOP is not sufficiently controlled, any other additional glaucoma procedures to further control IOP, and any procedures to handle complications of surgery) 5. Visual acuity (VA) 6. Angle status by indentation gonioscopy and ultrasound biomicroscopy (UBM) 7. Change in visual field by automated perimetry (Humphrey's) 8. Change in vertical cup-to-disc ratio of the optic nerve head 9. Rate of aqueous outflow by pneumatonometer measurements 10. Quality of Life (QOL) 11. Cost-effective analysis - including any additional procedures required to control IOP and cost of glaucoma drugs

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-04-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000642

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 2012-04-26