跳至主要内容
临床试验/NCT03571659
NCT03571659已完成不适用

To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser

L.V. Prasad Eye Institute0 个研究点目标入组 32 人开始时间: 2014年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA

研究概览

简要总结

To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser

详细描述

Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.

Focal to Mas+ confluent burns to areas of diffuse leakage

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eyes with DME (center or non-center involving) with <350 microns central retinal thickness

排除标准

  • •Subfoveal exudates, history of VR surgery, history of macular laser

结局指标

主要结局

1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA

时间窗: 3 months

Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) laser.

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

Dr Jay Chhablani

Principal Investigator

L.V. Prasad Eye Institute

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