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临床试验/NCT04255524
NCT04255524尚未招募不适用

OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Parapapillary choroidal microvasculature void (MvV) area

研究概览

简要总结

Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Spherical equivalent measurement can be included in above 4 groups
  • •Willing to be followed up in the future 10 years

排除标准

  • •Deny to sign the patient consent, or deny to be followed
  • •Evidence of cardiac, or diabetic, or CNS disease.
  • •Clinically diagnosed with retinal or choroidal disease
  • •Cataract or corneal disease that influence the quality of fundus OCTA image

研究组 & 干预措施

Group 1/Control

Experimental

Spherical equivalent: -2.00~+2.00 D

干预措施: Optic coherence tomography angiography (OCTA) (Device)

Group 1/Myopia

Experimental

Spherical equivalent: -3.00~-6.00 D

干预措施: Optic coherence tomography angiography (OCTA) (Device)

Group 3/High

Experimental

Spherical equivalent: -6.00~-10.00 D

干预措施: Optic coherence tomography angiography (OCTA) (Device)

Group 4/Super High

Experimental

Spherical equivalent: <-10.00

干预措施: Optic coherence tomography angiography (OCTA) (Device)

结局指标

主要结局

Parapapillary choroidal microvasculature void (MvV) area

时间窗: changes of MvV area at 5 years

area of parapapillary choroidal microvasculature void on OCTA images

Parapapillary choroidal microvasculature void (MvV) area

时间窗: changes of MvV area from at 10 years

area of parapapillary choroidal microvasculature void on OCTA images

Parapapillary choroidal microvasculature void (MvV) area

时间窗: difference of MvV area in each group at baseline

area of parapapillary choroidal microvasculature void on OCTA images

Parapapillary choroidal microvasculature void (MvV) area

时间窗: changes of MvV area at 1 years

area of parapapillary choroidal microvasculature void on OCTA images

Parapapillary choroidal microvasculature void (MvV) area

时间窗: changes of MvV area at 3 years

area of parapapillary choroidal microvasculature void on OCTA images

次要结局

  • Correlation coefficient between choroidal MvV and PPA area(baseline)
  • Correlation coefficient between choroidal MvV and refractive power(baseline)
  • MvV number(baseline)
  • Correlation coefficient between choroidal MvV and RNFL thickness(baseline)
  • Correlation coefficient between choroidal MvV and Axial length(baseline)
  • Correlation coefficient between choroidal MvV and retinal parapapillary perfusion(baseline)
  • Correlation coefficient between choroidal MvV and choroid thickness(baseline)
  • Correlation coefficient between choroidal MvV and Macular perfusion(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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