NCT06511440已完成不适用
Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database
Crystalvue Medical Coporation1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- The reference OCT data
研究概览
简要总结
The objective of this study is to establish the Reference database of Vision-700.
详细描述
The objective is to collect and establish the Reference database of Vision-700, which is expected to recruit subjects with normal vision to collect the optical coherent tomography measurement data.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 22 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 bilaterally
- •IOP ≤ 21 mmHg bilaterally
- •BCVA 20/40 or better bilaterally
排除标准
- •Subjects unable to tolerate ophthalmic imaging.
- •Subjects with ocular media not sufficiently clear to obtain acceptable OCT images.
- •HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%
- •Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits."
- •History of leukemia, dementia or multiple sclerosis.
- •History of hydroxychloroquine or chloroquine use.
- •Subjects with photosensitivity.
- •Subject having Photodynamic therapy (PDT) within 6 months.
- •Subjects taking photosensitivity drug currently.
结局指标
主要结局
The reference OCT data
时间窗: 2022/09/01
The study is to collect OCT measurement data on normal healthy eyes in order to establish the reference data range for OCT parameters, included full retinal thickness (μm), retinal nerve fiber layer (μm), ganglion cell complex thickness (μm) and optic nerve head (μm). The reference data range will provide it with the doctor to dignoisis.
次要结局
未报告次要终点
研究者
研究点 (1)
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