NCT04961398已完成不适用
Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Macular layer thicknesses
研究概览
简要总结
Evaluation of effect of various OCT scan speeds and filters on parameter measurements.
详细描述
The objectives of this study are to
- Directly compare parameter measurements generated on scans acquired at different speed modes with various levels of signal-to-noise ratio (SNR).
- Evaluate the effects of SNR, as determined by the device's Q score, on parameters derived from segmentation results, i.e., thickness of peripapillary retinal nerve fiber layer on circle scans (pRNFL), minimum rim width of optical nerve head (MRW), and macular layer thicknesses (Retina, GCL, IPL).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- •Both eyes with an age-appropriate normal appearing OCT as determined by an investigator
排除标准
- •Subjects unable to read or write
- •Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter)
- •Subjects who cannot tolerate the imaging procedures
结局指标
主要结局
Macular layer thicknesses
时间窗: during the intervention
ETDRS grid (9 sectors)
Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)
时间窗: during the intervention
Classification chart (6 sectors)
Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)
时间窗: during the intervention
Classification chart (6 sectors)
次要结局
- Adverse Events(through study completion, an average of one day)
研究者
研究点 (1)
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