Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Macular thickness change
研究概览
简要总结
To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •Type 1 or type 2 diabetics
- •Proliferative diabetic retinopathy
排除标准
- •Previous treatment with PRP
- •Media opacities
- •Previous treatment for macular edema (LASER or intravitreal injections)
- •Recent (less than 6 months) ophthalmic surgery
- •Only eyes
- •Intra-retinal or sub-retinal fluid with foveal involvement
- •Chronic renal failure
- •History of liver or pancreatic transplant
研究组 & 干预措施
Low-fluence
Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy
干预措施: Low-fluence PRP with 532nm green LASER (Device)
Full-fluence
Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy
干预措施: Full-Fluence PRP with 532nm LASER (Device)
结局指标
主要结局
Macular thickness change
时间窗: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)
次要结局
- Adverse events(16 weeks)