Clinical Study - ES 900 - 2020-1

Summary

EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. The EYESTAR 900 is CE marked.

These measurement results of this device are used for the planning of the medical treatment of patients. Depending on the application, the benefits of this device may include improved visual acuity (after cataract surgery), reduced risk of complications (after refractive surgery or implant of a phakic intraocular lens), early identification of pathological deformations of the cornea (keratoconus detection).

The primary objective of this clinical trial is to assess the clinical performance of the investigational device in dense cataracts. To that end, for each measurand, the in-vivo repeatability will be quantified, as well as limits of agreement and 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 the improvement of existing algorithms, development of additional measurands and for retrospective analysis.

No diseases are studied.

Conditions

• Cataract

Interventions

DEVICE

EYESTAR 900

The EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations.

DEVICE

LENSTAR LS 900

The LENSTAR LS 900 is a non-contact device for measurement of biometrical parameters of the eye, aimed to assist the calculation of intraocular lenses (IOLs) prior to intraocular lens implantation. The most common application is in preparation of cataract surgery. This device uses OLCR (optical low-coherence reflectometry), an interferometric method to measure intraocular axial distances. Furthermore, it uses digital photography of the anterior section of the eye to measure pupil size and location, as well as the white-to-white distance of the eye. The same photographic unit, in conjunction with a specific illumination pattern, is used to measure the corneal curvature - this measurement is known as 'keratometry', or, more specifically, 'automated keratometry'.

Sponsors & Collaborators

• Aravind Eye Hospitals, India

  collaborator OTHER

• Haag-Streit AG

  lead INDUSTRY

Principal Investigators

• Haripriya Aravind, MD · Aravind Eye Hospitals

• Thomas Beutler, Dipl. Ing. · Haag-Streit AG

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2023-12-30

Completion

2024-02-28

Countries

• India

Study Locations