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临床试验/EUCTR2018-001286-16-DK
EUCTR2018-001286-16-DK进行中(未招募)1 期

ow-dose Atropine for the Prevention of Childhood Myopia Progression in Danish Children (APP-study) - The APP-study

Rigshospitalet0 个研究点目标入组 150 人开始时间: 2018年5月30日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Children aged =6-<9 years: myopia =-1 (spherical equivalent) in at least one eye
  • Children aged =9-=12 years: myopia =-2 (spherical equivalent) in at least one eye
  • Cylinder less than 1.5 diopters
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 150
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Myopia related to retinal dystrophies
  • Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
  • Other ocular pathology (e.g., amblyopia, strabismus)
  • Previous eye surgery
  • Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
  • Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
  • Non-compliance to eye examinations
  • Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays

研究者

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