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Trial History Detail on 2012-04-17

CUHK_CCT00155

2008-02-15

Prospective

Not applicable

N/A

Nil

Nil

Ms. Joyce Kung

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

27623134

joycekung@cuhk.edu.hk

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

Prof. Dennis SC Lam

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

27623134

email dennislam_cu_res@cuhk.edu.hk

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

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

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

Not applicable

Hong Kong

Yes

2007-11-10

phacoemulsification cystoid macular edema

Drug

Topical NSAID (ketorolac)

4 weeks after cataract surgery

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

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

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.

51

None set

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2009-12-01

200

Complete

1. Macular thickness and central foveal volume assessed by OCT

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

No

2012-04-17

ChiCTR-TRC-09000713

2010-05-04


Yes

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