Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00048

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

Comparative study on contact diode laser transscleral cyclophotocoagulation and Ahmed glaucoma valve in the management of neovascular glaucoma.

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?

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

Cyclophotocoagulation with G-probe

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

20 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Ahmed Glaucoma Drainage Device

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 New vessels on iris and/or anterior chamber angle due to an ischemic etiology IOP > 21mmHg despite maximally tolerated medical treatment Exclusion criteria Eyes with no light perception New vessels on iris and/or anterior chamber angle due to neoplastic etiology History of previous glaucoma surgery or cyclodestruction

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

2003-08-05

21 Target Sample Size

70

22 Recruitment Status

Recruiting

23 Primary Outcome

IOP

24 Secondary Outcome

Number of antiglaucoma medications Best corrected visual acuity (BCVA) Optic nerve head morphology ¡V qualitative and quantitative (OCT III) 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