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临床试验/NCT03968575
NCT03968575Unknown不适用

The Affiliated Eye Hospital of Wenzhou Medical University

The Eye Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Change in macular drusen volume

研究概览

简要总结

To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 50 years of age.
  • Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
  • clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
  • Able to give an informed consent.

排除标准

  • Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
  • unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
  • Ocular or periocular infections.

结局指标

主要结局

Change in macular drusen volume

时间窗: 6 and 12 months

Mean change in macular drusen volume on optical coherence tomograph(OCT)

Change in macular drusen area

时间窗: 6 and 12 months

Mean change in macular drusen area on OCT

次要结局

  • Change in visual acuity(6 and 12 months)

研究者

发起方
The Eye Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoling Liu

Clinical Professor

The Eye Hospital of Wenzhou Medical University

研究点 (1)

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