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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
116
EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.
University Hospital Basel
Basel, Switzerland
Keratometry-Measurands
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in \[dpt\]; Axis in \[°\].
Time frame: Through study completion, approximately 9 months.
Axial measurands
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 \[mm\].
Time frame: Through study completion, approximately 9 months
Imaging
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 \[mm\].
Time frame: Through study completion, approximately 9 months
Anterior corneal topography
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm \]; axial curvature in \[dpt\].
Time frame: Through study completion, approximately 9 months
Posterior corneal topography
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm\]; axial curvature in \[dpt\].
Time frame: Through study completion, approximately 9 months
Corneal pachymetry
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in \[µm \].
Time frame: Through study completion, approximately 9 months
Posterior corneal keratometry
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in \[dpt\]; PAxis in \[°\].
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Time frame: Through study completion, approximately 9 months
Aquisition of volumetric OCT Data of the eye.
Data is collected, but not processed within the scope of this clinical trial.
Time frame: Through study completion, approximately 9 months
Aquisition of photographic images of the eye.
Data is collected, but not processed within the scope of this clinical trial.
Time frame: Through study completion, approximately 9 months