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Trial History Detail on 2011-03-02

CUHK_CCT00130

2007-06-01

Prospective

Not applicable

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

Nil

Nil

Miss Joyce Kung

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

27623134

email 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

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

Nil

Hong Kong

Yes

2007-05-04

Diabetic macular edema

Drug

Subtenon triamcinolone injection and macular photocoagulation

2 months

N/A

Inclusion criteria: 1. Aged 18 years or older 2. Clinically significant macular edema (CSME) defined according to the ETDRS 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomogram 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart) 5. Patients physically fit to receive treatment and comply with follow-up schedule 6. Informed consent

Exclusion criteria 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error. 2. Proliferative diabetic retinopathy 3. Media opacities which affect fundus examination or OCT measurements 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment 5. History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors. 6. History of fluorescein allergy 7. Fellow eye visual acuity worse than 20/400

18

None set

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2007-06-10

30

Complete

1. Best-corrected visual acuity 2. Central foveal thickness measured by optical coherent tomogram 3. Proportion of patients with a) moderate visual loss or b) stable/ gain in vision

1. Intraocular pressure 2. Changes in fluorescein angiography 3. Adverse events

No

2013-01-14

ChiCTR-TRC-09000743

2010-05-04


Yes

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