NCT01384487已完成不适用
Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.
Nidek Co. LTD.1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2011年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Total Retinal Thickness
研究概览
简要总结
The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
- •Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
- •Subjects who sign an informed consent form to participate in the clinical study.
- •Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.
排除标准
- •Diabetes mellitus (DM) and/or diabetic retinopathy
- •Hypertension (HT)
- •Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
- •Cardiac, hepatic, renal and hematologic diseases
- •Current systemic administration of steroid
- •History of anticancer agent etc.
- •Optically-stimulated epileptic seizure
- •Subjects who have other life threatening and debilitating systemic diseases
- •NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist
结局指标
主要结局
Total Retinal Thickness
时间窗: One Visit
Inner Retinal Thickness
时间窗: One Visit
Outer Retinal Thickness
时间窗: One Visit
RNFL Thickness
时间窗: One Visit
Optic Disc Analysis
时间窗: One Visit
G Chart
时间窗: One Visit
Anterior Chamber Angle Image
时间窗: One Visit
SLO Image
时间窗: One Visit
Pachymetry
时间窗: One Visit
次要结局
- Any adverse events(One Visit)
研究者
研究点 (1)
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