ChiCTR-TRC-09000743已完成Unknown
The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study
Department of Ophthalmology and Visual Sciences The Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年6月10日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Best-corrected visual acuity
研究概览
简要总结
The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Aged 18 years or older;
- •Clinically significant macular edema (CSME) defined according to the ETDRS;
- •Macular edema of at least 250um involving the fovea, as documented on optical coherent tomogram;
- •Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart);
- •Patients physically fit to receive treatment and comply with follow-up schedule;
- •Informed consent.
排除标准
- •Ocular diseases other than cataract, diabetic retinopathy and refractive error;
- •Proliferative diabetic retinopathy;
- •Media opacities which affect fundus examination or OCT measurements;
- •Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment;
- •History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors;
- •History of fluorescein allergy;
- •Fellow eye visual acuity worse than 20/400.
研究组 & 干预措施
Case series
Subtenon triamcinolone injection and macular photocoagulation for two months
结局指标
主要结局
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
次要结局
- 1. Intraocular pressure
- 2. Changes in fluorescein angiography
- 3. Adverse events
研究者
研究点 (1)
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