NCT00801450Unknown1 期
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- central subfield macular thickness
研究概览
简要总结
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory diffuse DME unresponsive to focal laser photocoagulation
- •Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm
排除标准
- •Previous ocular surgery
- •Glycosylated hemoglobin (Hb A1C) rate above 10%
- •History of glaucoma or ocular hypertension
- •Loss of vision as a result of other causes
- •Systemic corticoid therapy
- •Severe systemic disease
- •Any condition affecting follow-up or documentation
研究组 & 干预措施
Intravitreal (IVI)
Experimental
干预措施: Triamcinolone acetonide (Drug)
SubTenon´s (STI)
Experimental
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
central subfield macular thickness
时间窗: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
次要结局
- Best Corrected Visual Acuity(baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively)
- Intraocular pressure(baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively)
研究者
研究点 (1)
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