NCT01304225Unknown3 期
Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies
Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of severe visual loss after 1 year
研究概览
简要总结
This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. The investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.
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
- Single (Participant)
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
- •proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2)
- •best corrected visual acuity of 20/50 or better
- •capability to read and follow instructions
- •capability to sign the consignment term
排除标准
- •best corrected visual acuity worse than 20/50
- •significant macular edema responsible for visual acuity lower than 20/50
- •media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage)
- •previous laser treatment (PRP, focal or macular grid)
- •glaucoma (confirmed or suspicious)
- •other diseases of the retina and optic nerve
- •previous ocular surgery in the last 6 months
- •impossibility to obtain good quality images of retinography, angiography or OCT
结局指标
主要结局
Incidence of severe visual loss after 1 year
时间窗: 1 year
Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)
次要结局
- Clinical involution of retinal new vessels(1 year)
- Nerve fiber layer thickness(1 year)
- Retinal sensitivity(1 year)
研究者
研究点 (2)
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