Optos P200TE US Reference Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Optos, PLC
- 入组人数
- 954
- 试验地点
- 16
- 主要终点
- Optic Nerve Head
研究概览
简要总结
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
详细描述
The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subjects 22 years of age or older on the date of informed consent
- •Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- •BCVA (best corrected visual acuity) 20/40 or better(each eye)
- •Subject is able to comply with the study procedures
排除标准
- •Subjects unable to tolerate ophthalmic imaging
- •Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Subject with ocular media not sufficiently clear toobtain acceptable OCT images
- •.History of leukemia, dementia or multiple sclerosis
研究组 & 干预措施
OCT
Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.
干预措施: P200TE (Device)
结局指标
主要结局
Optic Nerve Head
时间窗: 1 year
The ONH size
GCC Thickness
时间窗: 1 year
The GCC Thickness
RNFL Thickness
时间窗: 1 year
The RNFL thickness
Retinal Thickness
时间窗: 1 year
The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.
次要结局
- Adverse Events(1 year)