NCT03374020已完成不适用
Retinal Imaging Using NOTAL-OCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
研究概览
简要总结
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Ability and agreement to give informed consent (IC)
- •Diagnosis of AMD or DR in SE by OCT
- •Ability to undergo OCT scans
- •VA of 20/160 or better in SE
排除标准
- •AMD and DR in the same SE
- •Evidence of macular disease other than AMD or DME in SE
结局指标
主要结局
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
时间窗: 1 year
OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared
次要结局
未报告次要终点
研究者
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