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临床试验/NCT04077489
NCT04077489已完成不适用

To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery

yin ying zhao1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
macular thickness

研究概览

简要总结

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Month 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • congenital cataract

排除标准

  • incooperative to complete the preoperative and postoperative examinations.

研究组 & 干预措施

MT

Other

Macular thickness

干预措施: cataract surgery (Procedure)

结局指标

主要结局

macular thickness

时间窗: 6 months

macular thickness changes before and after cataract surgery

次要结局

未报告次要终点

研究者

发起方
yin ying zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yin ying zhao

Yin Ying Zhao

Wenzhou Medical University

研究点 (1)

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