Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Optos, PLC
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Qualitative B-Scan Assessment
研究概览
简要总结
The study evaluates the image quality between two OCT devices.
详细描述
The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- •Subjects who can follow the instructions by the clinical staff at the clinical site,
- •Subjects who agree to participate in the study;
- •Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;
排除标准
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- •Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
- •Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
- •Subjects with history of dementia or multiple sclerosis
结局指标
主要结局
Qualitative B-Scan Assessment
时间窗: 1 day (start: April 29, 2019 - completed: April 30, 2019)
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. 1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. 2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. 3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.
次要结局
- Number of Participants With Adverse Events(1 day)