NCT03852485已完成不适用
Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
Optovue2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2019年1月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Limits of agreement
研究概览
简要总结
Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate
详细描述
The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
- •Glaucoma - Have glaucoma and no history of other retinal pathology.
- •Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
- •Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.
排除标准
- •Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
- •Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
- •Retina - Unable to complete required exams.
- •Cornea - Unable to complete required exams.
结局指标
主要结局
Limits of agreement
时间窗: Day 1
estimation of the interval within which a proportion of the differences between measurements lie
次要结局
- Regression Analysis(Day 1)
研究者
研究点 (2)
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