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【ChiCTR-TRC-09000743】The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

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基本信息

登记号

ChiCTR-TRC-09000743

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2010-05-04

临床申请受理号

靶点

适应症

Diabetic macular edema

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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

试验分类

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试验类型

非随机对照试验

试验分期

其它

随机化

盲法

试验项目经费来源

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

试验范围

目标入组人数

实际入组人数

第一例入组时间

2007-06-10

试验终止时间

1990-01-01

是否属于一致性

入选标准

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 250um 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.；

排除标准

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.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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