Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00046

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

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

iii Phone

2855 3788

iv Email

v Affiliation

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

2855 3788

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Argon laser peripheral iridoplasty (ALPI) versus systemic intraocular pressure lowering medications as the immediate management for acute phacomorphic angle-closure (phacomorphic 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?

2005-07-13

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

Argon laser peripheral iridoplasty

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

15 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Drugs

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 Age: >18 years, able to give informed consent + co-operate during laser procedure First acute attack of phacomorphic angle closure Intraocular pressure >40 mmHg

ii Exclusion Criteria

Exclusion criteria Treatment received prior to study Corneal opacity preventing laser treatment to peripheral iris Uncooperative patients Single-eyed patients

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

2005-07-13

21 Target Sample Size

30

22 Recruitment Status

Recruiting

23 Primary Outcome

IOP

24 Secondary Outcome

Return of corneal clarity Symptoms, particularly pain, nausea & vomiting, and visual acuity Corneal endothelial cell count by specular microscopy - serial Number and types of IOP lowering drugs required Evidence of optic nerve damage at presentation and follow-up Final visual outcome Final angle status by indentation gonioscopy Visual field loss Complications of treatment

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

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Trial History Detail on 2009-11-19