NCT02406157已完成不适用
Pure Yellow (577nm) Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change of Best Corrected Visual Acuity(BCVA)
研究概览
简要总结
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema compared with 532 subthreshold laser photocoagulation.
详细描述
- To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal treatment for diabetic macular edema.
- To investigate influence of 577nm micropulse laser photocoagulation on structure and function of macula compared with 532nm subthreshold laser photocoagulation.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years
- •Patients with diabetes mellitus type 2
- •Diagnosed as diabetic retinopathy with Clinical Significant Macular Edema
- •Central retinal thickness(CRT) of more than 250μm as measured by optical coherence tomography (OCT)
- •ETDRS visual acuity >19 letters (Snellen equivalent of 20/400 or better)
- •No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
- •Blood glucose was controlled steadily(HbA1c≤10%)
排除标准
- •Taking part in other clinical trial within 3 months
- •Planning panretinal photocoagulation(PRP) within 3 months
- •Performed cataract surgery in the last 3 months
- •Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
- •Accompanied with severe opacity of refractive media that maybe impact therapy and observation
- •Accompanied with nystagmus
- •Accompanied with some history that maybe interfere with result or increase the risk of patients
研究组 & 干预措施
577-MPL
Experimental
577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern
干预措施: 577-MPL (Device)
532-SLP
Active Comparator
532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern
干预措施: 532-SLP (Device)
结局指标
主要结局
Change of Best Corrected Visual Acuity(BCVA)
时间窗: 1 year
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
次要结局
- Change of fundus autofluorescence(1 year)
- Change in 10°retinal sensitivity(1 year)
- Change of Central Retinal Thickness(CRT)(1 year)
研究者
Jin Chen-jin
Dr
Sun Yat-sen University
研究点 (1)
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