NCT01986478已完成不适用
Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 5
- 主要终点
- Retinal Thickness
研究概览
简要总结
To collect data for a reference database.
详细描述
Collection of multiple subjects to create a reference database.
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
- 是
入选标准
- •Subjects 18 years of age or older on the date of informed consent
- •Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •Subjects presenting at the site with normal eyes (eyes without pathology)
- •IOP ≤ 21 mmHg bilaterally
- •BCVA 20/40 or better (each eye)
- •Both eyes must be free of eye disease
排除标准
- •Subjects unable to tolerate ophthalmic imaging
- •Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- •HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
- •HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 33% or false positives > 25%, or false negatives > 25%
- •Presence of any ocular pathology except for cataract
- •Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
- •Narrow angle
- •History of leukemia, dementia or multiple sclerosis
- •Concomitant use of hydroxychloroquine and chloroquine
结局指标
主要结局
Retinal Thickness
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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