Optos P200TE Agreement and Precision Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Optos, PLC
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
研究概览
简要总结
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Optical Coherence Tomography (OCT)
干预措施: Optos P200TE (Device)
Optical Coherence Tomography (OCT)
干预措施: Predicate Device (Device)
结局指标
主要结局
Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of full retinal thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of GCC thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm).
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm).
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the RNFL thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the full retinal thickness.
时间窗: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
次要结局
未报告次要终点