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临床试验/NCT07266597
NCT07266597尚未招募不适用

Micropulse Laser Photocoagulation Treatment of Diabetic Macular Edema ; 5 % Versus 15 % Duty Cycle

Sohag University0 个研究点目标入组 50 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
central macular thickness

研究概览

简要总结

To assess the safety and efficacy of 532 nm subthreshold micropulse laser 5 % duty cycle compared with 15 % duty cycle in treatment of diabetic macular edema .

详细描述

prospective interventional randomized comparative study that will be conducted on Patients with diabetic retinopathy who Are More than 18 years old with diabetic macular edema with a central retinal thickness < 400 um and best corrected visual acuity between 6/18 and 6/60 .

The participants will be divided randomly into two groups All Patients will receive single session of 532 nm subthreshold micropulse laser ,the following parameters will be used in all cases as follows,spot size : 200-µm ,exposure duration:200-ms ,power : 500-mW

While duty cycle will differ between 2 groups as follows :- Group A : will be treated using 5 % duty cycle . Group B : will be treated using 15 % duty cycle . follow up visits as follows 1 week ,4 weeks 12 weeks after laser therapy .

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diabetic retinopathy who:
  • Are More than 18 years old .
  • have diabetic macular edema with a central retinal thickness < 400 um .
  • have best corrected visual acuity between 6/18 and 6/60 .

排除标准

  • Previous lasered retina , Anti - VEGF injection or vitrectomy .
  • Extensive Macular ischemia on FFA .
  • Media opacity .
  • Associated ocular pathology as glaucoma, CNV (choroidal neovascularization ) , AMD (age related macular degenerations ), epiretinal membrane vitreomacular traction and retinal vein occlusion .

结局指标

主要结局

central macular thickness

时间窗: 3 months

assessment of change of central macular thickness before and after laser treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Younis Shabaan Aboelhassan

principle investigator

Sohag University

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