NCT02177539Unknown4 期
A New More Efficient Cycloplegia Scheme
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Spherical equivalent
研究概览
简要总结
The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 1 and 10 years
排除标准
- •Strabismus
- •Ocular surgery
- •Another ocular disease than ametropias (i.e uveitis, cataract)
- •Cardiovascular or neurologic disease.
- •Allergy to any of drugs used in the study
研究组 & 干预措施
Cyclopentolate
Active Comparator
干预措施: Cyclopentolate (Drug)
Cyclopentolate
Active Comparator
干预措施: Cyclopentolate+tropicamide+phenylephrine (Drug)
Cyclopentolate+tropicamide+phenylephrine
Experimental
干预措施: Cyclopentolate (Drug)
Cyclopentolate+tropicamide+phenylephrine
Experimental
干预措施: Cyclopentolate+tropicamide+phenylephrine (Drug)
结局指标
主要结局
Change in Spherical equivalent
时间窗: average 18 days
In the first and second visit the spherical equivalent will be measured with retinoscopy. Change in spherical equivalent refraction from first visit to day average 18 days (second visit). On both visits the patient will receive different cyclopegia schemes.
次要结局
- Change in spherical refraction(average 18 days)
- Change in cylindrical refraction(average 18 days)
- iris motility(average 18 days)
研究者
研究点 (1)
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