DRKS00009985招募中4 期
Prospective, open, randomized, monocentric, two-armed, controlled clinical examination of phase 4 in cross-over-design for evaluation of the effect of tropicamide 0.5% eye drops vs. cyclopentolate 0.5% in cycloplegia for the objective refraction of the eye in 4- to 6 year old children - Tropicamide versus Cyclopentolate for cycloplegia
niversitätsklinikum Erlangenvertreten durch den Dekander Medizinischen Fakultät derFriedrich-Alexander-Universität Erlangen-Nürnberg0 个研究点目标入组 50 人开始时间: 2016年2月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 6 Years（—）
- 性别
- All
入选标准
- •1. Girl or boy aged =4 bis <7 years.
- •2. Indication for implementation of an objective retinoscopy.
- •3. Consent of the legal representative or representatives for participation of the minor in this clinical examination.
- •4. Consent of the minor to his/her participation in this clinical examination after age appropiate elucidation.
排除标准
- •1. Hypersensitivity for tropicamide, cyclopentolate or another ingredient of the investigational dissection in the history.
- •2. Application of a medicament in the seven days before the visit.
- •3. Organic alteration of the to be examined eye.
- •4. down syndrom.
- •5. Brain injury in the history.
- •6. Epilepsy in the history.
- •7. Heart rate in in rest >120 beats per minute.
- •8. Severe organic disease in the history.
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