2024-513091-17-00招募中3 期
Low-dose AtropIne for Myopia control in children
Medical Center - University Of Freiburg16 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年10月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- Change of cycloplegic refraction/year [D/year] after 1 year of treatment.
研究概览
简要总结
The primary objective is to demonstrate superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control in children of Caucasian origin, measured as change of cycloplegic refraction/year [diopter per year (D/year)] after one year of treatment.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- •Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- •Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- •Ability to understand the nature of the trial and the trial related procedures and to comply with them
排除标准
- •Asian or African origin
- •Any known systemic metabolic disease or chromosomal anomaly
- •Previous use of any kind of contact lenses
- •Previous use of atropine eye drops
- •Known hypersensitivity to the active substances or any of the excipients
- •Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
- •Caution and pediatric counselling shall be assured if any of the following conditions are present according to the Summary of Product Characteristics (SmPC): Cardiac insufficiency, arrhythmia, coronary stenosis, hyperthyroidism, stomach or bowel stenosis, bowel paralysis, megacolon, muscle weakness, lung edema, hypersensitivity to atropine, spastic paralysis
- •Parents or children with poor understanding of the German language
- •Abnormal binocularity
- •Person who is in a relationship of dependence/employment with the sponsor or the investigator
- •Astigmatism >1.5 D
- •Anisometropia >1.5 D
- •History of amblyopia
- •Corrected visual acuity in any eye <0.63
- •Any acquired or developmental organic eye disease
- •Premature birth
结局指标
主要结局
Change of cycloplegic refraction/year [D/year] after 1 year of treatment.
Change of cycloplegic refraction/year [D/year] after 1 year of treatment.
次要结局
- Axial eye length change/year [mm/year] after 1 year.
- Categorized rate of change in refraction and eye length after 1 year.
研究者
Coordinating Investigator
Scientific
Medical Center - University Of Freiburg
研究点 (16)
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