NCT03382288

Clinical Trial ES 900 - 2016

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (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, 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.

Detailed description

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).

Conditions

• Optical Biometry of the Human Eye
• General Analysis of the Anterior Chamber of the Human Eye

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 experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.

Timeline

• Start date: 2017-06-09
• Primary completion: 2019-02-12
• Completion: 2019-02-12
• First posted: 2017-12-22
• Last updated: 2026-03-30

Locations

1 site across 1 country: Switzerland