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临床试验/NCT04976608
NCT04976608Unknown不适用

Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Macular thickness

研究概览

简要总结

To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.

详细描述

According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.

研究设计

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

入排标准

年龄范围
4 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age of 4-60 years
  • Congenital cataract surgery is planned
  • The operation was successful without any complications
  • Can cooperate well with OCT and MRI examinations

排除标准

  • Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases
  • Behavioral, cognitive impairment
  • Developmental delay

结局指标

主要结局

Macular thickness

时间窗: 2021.12.30

Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.

Subfoveal choroidal thickness

时间窗: 2021.12.30

Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.

Retinal nerve fiber layer thickness

时间窗: 2021.12.30

Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT.

The volume of the lateral geniculate body

时间窗: 2021.12.30

Measure the volume of the lateral geniculate body by T1 phase scan of MRI

The volume of the brodmann 17,18,19 area

时间窗: 2021.12.30

Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI

The FA of the white matter fiber bundle

时间窗: 2021.12.30

Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI

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

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

研究点 (1)

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