Clinical Trial ES 900 - 2016

Haag-Streit

Status: Completed

Conditions: Optical Biometry of the Human Eye; General Analysis of the Anterior Chamber of the Human Eye

Treatments: Device: EYESTAR 900

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03382288

1023191

Details and patient eligibility

About

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.

Full 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).

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Examination of participants

Experimental group

Description:

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

Treatment:

Device: EYESTAR 900