Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Cycloplegic refraction: diopters of spherical equivalent
研究概览
简要总结
The purpose is to test the hypothesis that microdrop instillation of cyclopentolate 1% is non-inferior to standard of care, i.e., standard drop instillation of cyclopentolate 1%. Comparison, also, will be made to the subsequent adverse events.
详细描述
A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops will be instilled using the Nanodropper® device, while standard drops will be instilled directly through the commercially available plastic multidose mydriatic dropper bottle. For all participants, the eyedrop will be firstly instilled in the right eye and this will be the eye that will be used for the analyses. Written informed consent will be obtained from the parents/guardians for the children's enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-16 years old, who require cycloplegic refraction measurements in the context of regular ophthalmological examination as outpatients in the 2nd Department of Ophthalmology of AUTh at a tertiary center in Northern Greece.
排除标准
- •Inability for the child to cooperate with autorefractometer
- •Difficulties for the family to attend the follow-up visit
- •Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution
- •Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)
结局指标
主要结局
Cycloplegic refraction: diopters of spherical equivalent
时间窗: 40 minutes post-instillation
The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy)
次要结局
- Heart rate: bpm(40 minutes post-instillation)
- Flushing: absent, minor, major(40 minutes post-instillation)
- Behavioral changes: yes or no(40 minutes post-instillation)
- Sleepiness: yes or no(40 minutes post-instillation)
研究者
Asimina Mataftsi
Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
Aristotle University Of Thessaloniki