Clinical Trial - ES 900 - 2019
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]
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, the Limits of Agreement with respect to comparator devices are analyzed. The Limits of Agreement allow estimating the expected measurement deviation per measurand, which is compared to the "maximum acceptable measurement error", as defined by the Risk Analysis of the investigational device, to assess the risk involved in measurements of the investigational device. Furthermore, the in-vivo repeatability will be quantified for each measurand, as well as the confidence intervals for mean 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 improvement of existing algorithms, development of additional measurands and for retrospective analysis.
详细描述
The EYESTAR900 (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
- •At least one eye of each subject needs to fulfill one of the following inclusion criteria:
- •volunteers with normal phakic eye;
- •patients seeking cataract surgery;
- •patients with pseudophakic eye;
- •patients with oil-filled eye;
- •patients with aphakic eye.
排除标准
- •Exclusion criteria per subject:
- •underage patients (younger than 18 years);
- •vulnerable patients;
- •inability to give informed consent;
- •Exclusion criteria per eye:
- •inability to maintain stable fixation;
- •corneal lesions or scarring;
- •previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
- •previous intraocular surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
- •active inflammation of the eye;
- •active infection of the eye;
- •tear film break up time of less than 5 sec.
结局指标
主要结局
Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Kmean.
Keratometry Measurand: AST (Anterior central corneal astigmatism) in [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AST.
Axial Measurand: AL (Axial length) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AL. AL is measured from the corneal tear film to the inner limiting membrane.
Axial Measurand: CCT (Corneal thickness) in [μm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for CCT. CCT is measured from the corneal tear film to the corneal endothelium.
Axial Measurand: LT (Lens thickness) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for LT. LT is measured from the anterior to the posterior surface of the lens.
Imaging Measurand: WTW (White-to-White) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for WTW. WTW distance is the horizontal diameter of a best fit circle to the iris border.
Imaging Measurand: ICX / ICY (Iris barycenter in horizontal direction / in vertical direction) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability of investigational and comparator device for Iris barycenter. The iris barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.
Imaging Measurand: PCX / PCY (Pupil barycenter in horizontal direction / in vertical direction) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability of investigational and comparator device for Iris barycenter. The pupil barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.
Anterior corneal topography: Elevation (Anterior torical elevation) in [µm] (2D-map)
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µ\]; axial curvature in \[dpt\].
Keratometry Measurand: Axis (Anterior steep meridian angle) in [°]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Axis. Axis is the angle of the anterior central corneal astigmatism. The value of Axis is measured in \[°\], whereas the differences shall be expressed in \[dpt\].
Axial Measurand: ACD (Anterior chamber depth) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for ACD. ACD is measured from the corneal tear film to the anterior surface of the lens.
Imaging Measurand: PD (Pupil diameter) in [mm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability of investigational and comparator device for PD. PD is measured at the diameter of a best fit circle to the pupil border.
Posterior corneal topography: Axial curvature (Posterior tangential curvature) in [dpt] (2D-map)
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability and confidence interval of differences of investigational and comparator devices for Posterior tangential curvature. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).
Corneal pachymetry: Corneal thickness map in [µm]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability and confidence interval of differences of investigational and comparator device for Corneal thickness map. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).
Simulated Keratometry: SimKmean (Mean simulated keratometry) in [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimKmean.
Simulated Posterior Keratometry: SimPAST (Simulated keratometry posterior corneal astigmatism) in [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAST.
Simulated Posterior Keratometry: Posterior corneal shape factor (PE): Dimensionless quantity
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Posterior corneal shape factor (PE), that characterizes the posterior corneal asphericity.
Anterior corneal topography: Axial curvature (Anterior tangential curvature) in [dpt] (2D-map)
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability and confidence interval of difference between investigational and comparator devices for Anterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).
Simulated Keratometry: SimAST (Simulated astigmatism) in [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimAST.
Simulated Keratometry: SimAxis (Simulated keratometry anterior steep meridian angle) in [°]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimAxis. The value of Axis is measured in \[°\], whereas the differences shall be expressed in \[dpt\]. SimAxis is the angle of the larger simulated keratometry radius with respect to the horizontal axis X.
Posterior corneal topography: Elevation (Posterior torical elevation) in [µm] (2D-map)
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability of investigational and comparator device for Posterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).
Simulated Posterior Keratometry: SimPAxis (Simulated keratometry posterior steep meridian angle) in [°]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAxis. SimPAxis represents the angle of the larger simulated keratometry radius of curvature with respect to the horizontal axis X.
Simulated Keratometry: Anterior corneal shape factor (E): Dimensionless quantity
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Anterior corneal shape factor (E), that characterizes the anterior corneal asphericity.
Simulated Posterior Keratometry: SimPKmean (Mean simulated posterior keratometry) in [dpt]
时间窗: Through study completion, approximately 7 months.
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPKmean. SimPKmean is the corresponding refractive power in diopters.
次要结局
未报告次要终点