Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of eyes with reduced macular thickness
研究概览
简要总结
Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the progression of non central CSME to central CSME in compare to glycemic control
详细描述
interventional randomised masked study will recruit patients have diabetes mellitus with non central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM laser with Glycemic control where BCVA will be recorded every month starting from baseline to 24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with central diabetic macular edema Best corrected visual acuity is 20/30 or more
- •Non central Macular thickness more than 250 microns
- •Patients who are able to come for all follow-up
排除标准
- •Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- •Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
- •Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
- •History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- •Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
研究组 & 干预措施
Subtherhold 532 nm laser
Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema
干预措施: Subthreshold 532nm laser (Device)
结局指标
主要结局
Number of eyes with reduced macular thickness
时间窗: 24 weeks
Measurements of retinal thickness in the area of edema
次要结局
- Number of patients achieved good glycemic control(24 weeks)
- Number of eyes with reduced vision(24 weeks)
- Number of eyes developing central macular edema(24 weeks)
研究者
Ameen Marashi
Principle investigator
Marashi Eye Clinic