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Trial History Detail on 2013-01-14

CUHK_CCT00054

2005-09-23

Prospective

Not applicable

N/A

Nil

Nil

Miss Joyce Kung

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

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

dennislam_cu_res@cuhk.edu.hk

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

A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

Nil

Hong Kong

Yes

2005-08-05

Eye Diseases

Procedure

Grid laser photocoagulation

12 months

1. Posterior subtenon triamcinolone 40mg injection 2. Combined 40mg subtenon TA injection and grid laser

Inclusion criteria: 1. Documented CSME defined according to ETDRS guidelines. 2. Macular thickening ≥ 250µm in the foveal center measured on ocular coherent tomography (OCT). 3. Patients physically fit ot receive laser photocoagulation or intravitreal injection. 4. Age of at least 18 years. 5. Informed consent

Exclusion criteria:
1.Macular edema secondary to other causes, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularisation
2.≥ 1 disc diameter of capillary closure at the macula on fluorescein angiography
3.Signs of vitreomacular traction on either biomicroscopy or OCT examination
4.Proliferative diabetic retinopathy requiring immediate treatment
5.History of glaucoma or ocular hypertension
6.Chronic renal failure maintained on renal dialysis
7.Previous intraocular surgery (including previous vitrectomy or trabeculectomy) except uncomplicated cataract extraction and posterior intraocular lens insertion;
8.Any cataract extraction or laser procedure within 3 months
9.Media opacities (including significant cataract which requires cataract removal to improve visual acuity) which affect fundus examination or OCT measurements
10.Fellow eye of visual acuity ≥1.7 ETDRS logMAR units
11.Failure to comply with follow up schedule

18

None set

Both Male and Female

Interventional

Randomized

Active

Open label

Parallel

2005-10-01

90

Complete

Best-corrected visual acuity (ETDRS chart)

1. Macular eduma measured by optical coherent tomogram (OCT) - a non-contact and non-invasive investigation to assess the degree of macular edema. 2. Side effects including a) Intraocular pressure measured by non contact tonometer(NCT); b) Degree of cataract assessed clinically according to the Lens Opacity Classification System (LOCS) III.

No

2013-01-14

ChiCTR-TRC-09000666

2010-05-04


Yes

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