Trials / Completed
CompletedNCT04112472
Clinical Trial ES 900 - 2019
Clinical Trial - ES 900 - 2019
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Haag-Streit AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EYESTAR 900 | EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The intervention are optical, non-contact examinations with the investigational device EYESTAR 900 and comparative device(s). Results of the examinations serve to compare the performance data of the investigational device with those of the comparative devices. |
Timeline
- Start date
- 2019-07-11
- Primary completion
- 2019-09-01
- Completion
- 2019-09-01
- First posted
- 2019-10-02
- Last updated
- 2026-03-30
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04112472. Inclusion in this directory is not an endorsement.