Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Success rate of visualizing the optic disc within 60 seconds
研究概览
简要总结
Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.
详细描述
Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit from 4 different clinical care settings for a total of 101 subjects. Success rate is defined as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of examination is determined by using a 10 point likert scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes
排除标准
- •Patients who were blind, younger than 1 year of age, or older than 4 years of age
研究组 & 干预措施
Study Arm A
Right eye examined first with video diversion then left eye examined without video diversion
干预措施: Video diversion (Other)
Study Arm B
Right eye examined first without video diversion then left eye examined with video diversion
干预措施: Video diversion (Other)
Study Arm C
Left eye examined first with video diversion then right eye examined without video diversion
干预措施: Video diversion (Other)
Study Arm D
Left eye examined first without video diversion then right eye examined with video diversion
干预措施: Video diversion (Other)
结局指标
主要结局
Success rate of visualizing the optic disc within 60 seconds
时间窗: 60 second
次要结局
- Time required to visualize the optic disc(60 seconds)
- Ease of performing fundoscopy(60 seconds)
研究者
Ash Singhal
principal investigator
University of British Columbia