NCT03783858已完成不适用
Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Optos, PLC
- 入组人数
- 356
- 试验地点
- 10
- 主要终点
- Retinal thickness
研究概览
简要总结
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject 22 years of age or older on the date of informed consent
- •Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •Subject presenting at the site with normal eyes* (Cataracts and LASIK and PRK are allowed)
- •BCVA 20/40 or better (each eye)
- •Subject is able to comply with the study procedures in the view of the investigator *Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator
排除标准
- •Subject unable to tolerate ophthalmic imaging
- •Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- •History of leukemia, dementia or multiple sclerosis
结局指标
主要结局
Retinal thickness
时间窗: 1 day
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters. The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.
次要结局
未报告次要终点
研究者
研究点 (10)
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