Pilot Comparative Study of the Kowa OCT Bi-μ and the Optovue iVue 100
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Compare KOWA OCT Bi-μ and Optovue iVue 100
研究概览
简要总结
This study is a prospective comparative study to gather pilot agreement and precision data 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
- 18 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
Random Sequenced Interventions
Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments.
干预措施: KOWA OCT Bi-µ (Device)
Random Sequenced Interventions
Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments.
干预措施: Optovue iVue 100 (Device)
结局指标
主要结局
Compare KOWA OCT Bi-μ and Optovue iVue 100
时间窗: 1-2 days
1. Full retinal thickness \[Early Treatment Diabetic Retinopathy Study (ETDRS) Grid\] 2. Full retinal thickness (Manual Measurement) 3. Retinal nerve fiber layer thickness 4. Ganglion cell complex thickness 5. Full retinal thickness map
次要结局
- Safety: Evaluate any adverse events found during the clinical study(1-2 days)