General Analysis of the Anterior Chamber of the Human Eye Clinical Trial
Official title:
Clinical Trial - ES 900 - 2019
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.
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03382288 -
Clinical Trial ES 900 - 2016
|
N/A |