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临床试验/NCT06457295
NCT06457295已完成不适用

Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography

Sohag University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月20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
200
试验地点
1
主要终点
DCP thickness

研究概览

简要总结

the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Type of DM: Type
  • Fundus examination: no macular edema or other signs of clinical retinopathy

排除标准

  • Ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical OCTA changes [13, 14].
  • Fundus examination: macular edema or any other signs of clinical retinopathy

结局指标

主要结局

DCP thickness

时间窗: baseline

foveal, average parafoveal \& average perifoveal

Deep Vessel Density

时间窗: baseline

foveal, average parafoveal, average perifoveal

Superficial Vessel Density

时间窗: baseline

foveal, average parafoveal \& average perifoveal

SCP thickness

时间窗: baseline

foveal, average parafoveal \& average perifoveal

FAZ metrics

时间窗: baseline

FAZ area, FAZ perimeter \& FAZ flow density

Sectoral superficial vessel density

时间窗: baseline

superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal

Sectoral deep vessel density

时间窗: baseline

superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal

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

Mohamed Abdou Saeed

principal investigator

Sohag University

研究点 (1)

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