Clinical Trial ES 900 - 2016
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Anterior corneal topography
研究概览
简要总结
The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, for each measure and the in-vivo repeatability will be quantified, as well as the mean measurement deviation with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected, to allow for improvements of existing algorithms, development of additional measure and and for retrospective analysis.
详细描述
EYESTAR 900 (the investigational device) is a new device by HAAG-STREIT AG, for measurement of optical biometry and advanced corneal topography by swept-source optical coherence tomography (OCT).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older;
- •volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous;
- •patients seeking cataract surgery;
- •patients with pseudophakic eye;
- •patients with oil-filled eye;
- •patients with aphakic eye.
排除标准
- •underage patients (younger than 18 years);
- •vulnerable patients;
- •inability to give informed consent;
- •inability to maintain stable fixation.
结局指标
主要结局
Anterior corneal topography
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm \]; axial curvature in \[dpt\].
Posterior corneal keratometry
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in \[dpt\]; PAxis in \[°\].
Keratometry-Measurands
时间窗: Through study completion, approximately 9 months.
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in \[dpt\]; Axis in \[°\].
Posterior corneal topography
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm\]; axial curvature in \[dpt\].
Corneal pachymetry
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in \[µm \].
Axial measurands
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CCT in \[µm\]; AD in \[mm\]; ACD in \[mm\]; LT in \[mm\]; AL in \[mm\].
Imaging
时间窗: Through study completion, approximately 9 months
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for WTW in \[mm\]; ICX, ICY in \[mm\]; PD in \[mm\]; PCX, PCY in \[mm\].
次要结局
- Aquisition of volumetric OCT Data of the eye.(Through study completion, approximately 9 months)
- Aquisition of photographic images of the eye.(Through study completion, approximately 9 months)