Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Regression of neovascularization
研究概览
简要总结
A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots
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 (Participant, 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
- •All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November
排除标准
- •significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
- •any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
- •those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
- •clinically significant macular oedema on clinical examination.
研究组 & 干预措施
1,700
Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
干预措施: Pan-retinal photocoagulation using pattern scanning laser (Device)
2,500
Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
干预措施: Pan-retinal photocoagulation using pattern scanning laser (Device)
结局指标
主要结局
Regression of neovascularization
时间窗: 3 months
Fluorescein angiogram assessment by independent observer
次要结局
- Activity of neovascularization(3 months)
- Best corrected visual acuity(1 week, 1 month, 3 months, 6 months)
- Complications(1 week, 1 month, 3 months, 6 months)
- Central foveal thickness(1 week)
- Retreatment rate(6 months)
研究者
Chung-yee Chung
Associate Consultant
United Christian Hospital