Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00155

2 Trial Registration Date

2008-02-15

i Registration Status

Prospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

N/A

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms. Joyce Kung

ii Address

UEC, 3/F, Hong Kong Eye Hospital, 147K Argyle Street

iii Phone

27623134

iv Email

joycekung@cuhk.edu.hk

v Affiliation

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Dennis SC Lam

ii Address

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon.

iii Phone

27623134

iv Email

email dennislam_cu_res@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Post phacoemulsification cystoid macular edema: Incidence, risk factors and efficacy of non-steroidal anti-inflammatory drug in its prevention

10 Public Title

Post phacoemulsification cystoid macular edema: Incidence, risk factors and efficacy of non-steroidal anti-inflammatory drug in its prevention

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Not applicable

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?

2007-11-10

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

phacoemulsification cystoid macular edema

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Topical NSAID (ketorolac)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks after cataract surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Study group will receive ketorolac tromethamine 0.5% (Acular) eye drop Control group will receive placebo ie. 0.9%normal saline eye drop

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. Senile cataract in patients older than 50 years old 2. Adequate fundal view for OCT measurement before cataract surgery 3. pre-op OCT could be obtained with signal strength 6.0 4. fully informed consent

ii Exclusion Criteria

Exclusion criteria 1. pre-existing macular edema 2. any conditions known to cause macular edema, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularisation 3. significant ocular diseases such as glaucoma 4. pre-existing refractive error of >-6.00 diopters or +6.00 diopters 5. systemic medications that may affect retinal thickening such as steroid or diuretics 6. single eye patients 7. For diabetic patients, history of intravitreal or sub-Tenon¡¦s capsule injection or triamcinolone acetonide.

iii Age Minimum

51

iv Age Maximum

None set

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

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

2009-12-01

21 Target Sample Size

200

22 Recruitment Status

Complete

23 Primary Outcome

1. Macular thickness and central foveal volume assessed by OCT

24 Secondary Outcome

2. Best corrected visual acuity (ETDRS chart) 3. risk factors for development of CME ( e.g. phaco time, phaco energy etc.) 4. development of posterior vitreous detachment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-04-17

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000713

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 2011-03-02