Clinical Study - ES 900 - 2020-2

Summary

The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0.

This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.

Conditions

• Cataract
• Keratoconus

Interventions

DEVICE

Haag-Streit EYESTAR 900

The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices.

DEVICE

Tomey CASIA 2

The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography.

DEVICE

Oculus PENTACAM HR

The Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry.

DEVICE

Zeiss ATLAS 9000

ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography).

Sponsors & Collaborators

• Haag-Streit AG

  lead INDUSTRY

Principal Investigators

• David Goldblum, Prof. Dr. · University Hospital, Basel, Switzerland

• Julian Kool van Langenberghe, ing. · Haag-Streit AG

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2020-08-20

Completion

2020-12-10

Countries

• Switzerland

Study Locations