跳至主要内容
临床试验/NCT04252989
NCT04252989招募中不适用

Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
cycloplegia with SKIACOL

研究概览

简要总结

Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with active myopia treated with ATROPINE 0.01% eye drops
  • patient affiliated with a social security organization
  • agreement of both parents

排除标准

  • non compliance with treatment

结局指标

主要结局

cycloplegia with SKIACOL

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

biometrics

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

refraction of parents

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

intra-ocular pression

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

objective refraction after "fog"

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

slit lamp

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

previous refractions

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

dilated eye exam

时间窗: every 6 months up to age 18 years

effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice

次要结局

  • undesirable events collection(every 6 months up to age 18 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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