Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00044

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

2. A randomized controlled trial to compare lens extraction alone by phacoemulsification versus trabeculectomy alone in the treatment of medically-uncontrolled CACG without visually significant cataract.

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?

2005-03-18

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

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

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 as defined above 2. No significant cataract: VA better than 20/40, and not affecting activities of daily living 3. Patient able and willing to give informed consent to phacoemulsification or trabeculectomy, prior to randomization 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).

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

2005-03-18

21 Target Sample Size

30

22 Recruitment Status

Recruiting

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 ¡V 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

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