Clinical Trial ES 900 - 2016

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Trial ES 900 - 2016

Conditions
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Optical Biometry of the Human Eye, General Analysis of the Anterior Chamber of the Human Eye

Intervention / Treatment
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* Device: EYESTAR 900


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Examination of participants<br>Examination of participants by means of the investigational device, Eyestar 900 as well as the comparative devices. | Device: EYESTAR 900<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 [°]. | 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]. | 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]. | 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]. | 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]. | 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 ]. | 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 [°]. | Through study completion, approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aquisition of volumetric OCT Data of the eye. | Data is collected, but not processed within the scope of this clinical trial. | 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. | Through study completion, approximately 9 months |