NCT03600519已完成不适用
Retinal Imaging Using NOTAL-OCT V2.5
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid
研究概览
简要总结
Primary objectives:
To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.
Secondary objectives:
- To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula.
- To evaluate the repeatability of the NOTAL-OCT V2.5
详细描述
Study population:
- AMD population - intermediate and advanced AMD (with active and nonactive CNV)
- DR population. Patient with and without DME
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
- 否
入选标准
- •a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) 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
- •Patient with dilated eye(s)
结局指标
主要结局
The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid
时间窗: less than an hour
measurements of retinal thickness.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
NOTAL-OCT V.2.5 vs Commercial OCT in AMD PatientsAMD - Age-Related Macular DegenerationDiabetic Macular EdemaNCT03969303Notal Vision Ltd.287
已完成
不适用
Retinal Imaging Using NOTAL-OCTDiabetic RetinopathyAge-Related Macular DegenerationNCT03374020Notal Vision Ltd.33
已完成
不适用
Topcon 3D OCT-1000 Optical Coherence Tomography SystemRetinal DiseaseGlaucomaNCT00792259Topcon Medical Systems, Inc.48
已完成
不适用
Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)Macular EdemaCNVNCT00564291Sebastian Wolf700
Unknown
不适用
Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution OctMultiple SclerosisNeuromyelitis OpticaNCT01024985University of Sao Paulo40