EUCTR2020-001575-33-DE进行中（未招募）1 期
ow-dose AtropIne for Myopia control in children - AIM
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •1.Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- •2.Myopia of -1 D to -6 D with reported or documented annual progression = 0.5 D of myopia
- •3.Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- •4.Ability to understand the nature of the trial and the trial related procedures and to comply with them
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
- •1.Asian or African origin
- •2.Abnormal binocularity
- •3.Strabismus
- •4.Astigmatism >1.5 D
- •5.Anisometropia >1.5 D
- •6.History of amblyopia
- •7.Corrected visual acuity in any eye <0.63
- •8.Any acquired or developmental organic eye disease
- •9.Premature birth
- •10.Any known systemic metabolic disease or chromosomal anomaly
- •11.Previous use of any kind of contact lenses
- •12. Previous use of atropine eye drops
- •13.Epilepsy
- •14.Known hypersensitivity to the active substances or any of the excipients
- •15.Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •16.Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
- •17.Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
- •18.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
- •19.Parents or children with poor understanding of the German language
- •20.Person who is in a relationship of dependence/employment with the sponsor or the investigator
研究者
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