Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.
详细描述
navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Diagnosed as diabetic retinopathy with Mild macular edema
- •No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
排除标准
- •Blood glucose was not controlled steadily(HbA1cd≥10%)
- •Accompanied with severe hypertension（BP≥180/110mmHg）
- •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
Navigation laser
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
干预措施: Navigation laser (Device)
Traditional laser
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
干预措施: Traditional laser (Device)
结局指标
主要结局
Best corrected visual acuity
时间窗: 12 months
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
次要结局
- Central Retinal Thickness(12 months)
- 10°retinal sensitivity(12 months)
- treatment time(1 hour)
- Number of laser spots within macular fovea(1 month)
- Participants pain intensity(1 hour)
研究者
Jin Chen-jin
Professor，Dr
Sun Yat-sen University