Clinical Study - ES 900 - 2020-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- In-vivo Repeatability
研究概览
简要总结
The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0.
This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.
详细描述
Ocular biometry is the act of measuring the geometric properties of the eye, in particular distances between and thicknesses of the visual axis of the cornea, lens and retina, as well as curvature of the anterior cornea. These measurements are used mainly to determine implant type and dimensions for cataract surgery.
Corneal topography is the act of measuring the shape of the cornea, in particular of the anterior cornea, but, depending on the device and the application, also of the posterior cornea, as well as the distance between the anterior to the posterior of the cornea. These measurements can be used in the context of ocular biometry, but are also useful for many other applications where knowledge of the optical and structural properties of the cornea are of interest.
Optical coherence tomography (OCT) is a well-established imaging modality in ophthalmology. It uses interferometry to obtain a scattering profile of the eye along the direction of propagation of a laser beam which is directed onto the eye. In analogy to ultrasound imaging, this scattering profile is called A-Scan. By laterally translating the measurement beam, several A-scans can be combined to form a 2-dimensional image or 3-dimensional (3D) tomogram of the eye. The main use of OCT is the cross-sectional imaging of the retina or the cornea, primarily for diagnostic purposes[4]. Recently, anterior segment OCT has also been used for corneal topography[5], as well as for biometry and cross-sectional imaging along the entire length of the eye[6].
EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. CE approval for EYESTAR 900 with software version i9.4.0.0 is pending and expected before the start of this clinical trial.
The development of this device has been continued, and the following additions have been made in software version i9.5.1.0 used for this clinical study with respect to the software version i9.4.0.0:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •voluntary participation of subjects of legal age, irrespective of age, gender, ethnicity, of which:
- •participants with healthy eyes,
- •participants with corneal scarring,
- •participants with irregular astigmatism.
排除标准
- •Involuntary participation or inability to provide consent,
- •persons of vulnerable populations,
- •persons unable or unwilling to follow instructions,
- •persons unable to maintain fixation for the duration of the examinations,
- •persons with active inflammation or infections of the eye,
- •persons with a tear film break up time of less than 5 sec.
结局指标
主要结局
In-vivo Repeatability
时间窗: 3 months
The in-vivo repeatability is calculated as the square root of the residual variance of a mixed-effects ANOVA model (using subject as a random effect, and eye within subject as a fixed effect), which we multiply with a factor of square root of two (in order to make it commensurate with the standard deviation of the differences between two independent measurements of each eye in the study sample). For comparator devices, the in-vivo repeatability will be assessed as well, based on two independent measurements of the same eye.
Limits of Agreement
时间窗: 3 months
For each measurand, a comparator device was defined which represents the current clinical standard. For the comparator device, for each measured parameter the mean value per eye is obtained (this value serves as the "best guess" of the true value of this parameter for one particular eye). Then, for each examination of EYESTAR 900, the difference with respect to this comparator mean value is calculated. For the resulting differences per parameter, the interval spanning the mean difference ± 1.96 \* the first standard deviation of the differences is obtained. This interval quantifies the limits of agreement, spanning 95% of the expected measurement differences between EYESTAR 900 and the comparator device.
Confidence Interval of Differences
时间窗: 3 months
The mean deviation with respect to a comparator device ("equivalence") is determined as the confidence interval of a double-sided Wilcoxon test (α=0.05) of the mean measurement difference between the investigational device and the comparator device, computed over the study sample.
次要结局
- Raw Image Data(3 months)
- Raw OCT Data(3 months)