DRKS00023337招募中3 期
ow-dose Atropine for Myopia control in children - AIM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 8 Years 至 12 Years（—）
- 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.
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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