Clinical Trial ES 900 - 2016

Not Applicable

Completed

• Conditions: General Analysis of the Anterior Chamber of the Human Eye; Optical Biometry of the Human Eye
• Interventions: Device: EYESTAR 900

• Registration Number: NCT03382288
• Lead Sponsor: Haag-Streit AG

Brief 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).

Study Timeline

• Study Start: 2017-06-09
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Status Verified: 2019-02
• Primary Completion: 2019-02-12
• Study Completion: 2019-02-12
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 18 years or older;
• volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous;
• patients seeking cataract surgery;
• patients with pseudophakic eye;
• patients with oil-filled eye;
• patients with aphakic eye.

Exclusion Criteria

• underage patients (younger than 18 years);
• vulnerable patients;
• inability to give informed consent;
• inability to maintain stable fixation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Examination of participants	EYESTAR 900	Examination of participants by means of the investigational device, Eyestar 900 as well as the comparative devices.

Primary Outcome Measures

Name	Time	Method
Anterior corneal topography	Through study completion, approximately 9 months	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm \]; axial curvature in \[dpt\].
Posterior corneal keratometry	Through study completion, approximately 9 months	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in \[dpt\]; PAxis in \[°\].
Keratometry-Measurands	Through study completion, approximately 9 months.	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in \[dpt\]; Axis in \[°\].
Posterior corneal topography	Through study completion, approximately 9 months	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm\]; axial curvature in \[dpt\].
Corneal pachymetry	Through study completion, approximately 9 months	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in \[µm \].
Axial measurands	Through study completion, approximately 9 months	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 \[mm\].
Imaging	Through study completion, approximately 9 months	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 \[mm\].

Secondary Outcome Measures

Name	Time	Method
Aquisition of volumetric OCT Data of the eye.	Through study completion, approximately 9 months	Data is collected, but not processed within the scope of this clinical trial.
Aquisition of photographic images of the eye.	Through study completion, approximately 9 months	Data is collected, but not processed within the scope of this clinical trial.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland