DRKS00020585已完成2 期
Safety and effects on visual function of 0.01% atropine eye drops for myopia Inhibition in children and adolescents - SAM IIT
niversitätsklinikum TübingenTübingen0 个研究点目标入组 28 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Years 至 17 Years（—）
- 性别
- All
入选标准
- •Children and adolescents in whom the decision to be treated with 0.01% atropine was made based on the individual situation (eye length, observed progression of myopia)
- •- Age 6-17 years
- •- Myopia progression at least 0.5 dpt in the past 12 months in at least one eye
- •- Myopia below 4.0 dpt
- •- Written consent of all parents and the proband
排除标准
- •- Anisometropia > 1.0 dpt.
- •- Astigmatism > 1.5 dpt.
- •- Best corrected visual acuity < 0.8
- •- diseases of the eye other than myopia, in particular changes in the conjunctiva, corneal scars and diseases of the anterior segment of the eye
- •- Known incompatibility of atropine or other components of the test product
- •- Primary and secondary open angle glaucoma, narrow angle glaucoma
- •- Tachycardia, heart failure, coronary stenosis
- •thyrotoxicosis, hyperthyroidism
- •- Mechanical closures of the gastrointestinal tract
- •- Paralytic ileus, megacolon
- •- Obstructive urinary tract diseases
- •- myasthenia gravis
- •- Acute pulmonary oedema
- •- Spastic paralysis
- •- rhinitis sicca
- •- Participation in another clinical trial within the last 30 days
- •- Breastfeeding, pregnant or childbearing study participants without highly effective contraceptive protection
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