NCT02921568Unknown不适用
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Optos, PLC
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- retinal thickness
研究概览
简要总结
This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
- •Subjects who have signed the informed consent;
- •Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- •Subjects who agree to participate in the study;
- •Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
- •Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.
排除标准
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- •Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
- •Subjects with history of leukemia, dementia or multiple sclerosis.
结局指标
主要结局
retinal thickness
时间窗: completion of the study, up to 5 years
Cup/Disc Ratio
时间窗: completion of the study, up to 5 years
Optic Nerve Head Topography
时间窗: completion of the study, up to 5 years
Retinal Nerve Fibre Layer Thickness
时间窗: completion of the study, up to 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
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