Clinical Trial ES 900 - 2019

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

NCT04112472

1023551

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, the Limits of Agreement with respect to comparator devices are analyzed. The Limits of Agreement allow estimating the expected measurement deviation per measurand, which is compared to the "maximum acceptable measurement error", as defined by the Risk Analysis of the investigational device, to assess the risk involved in measurements of the investigational device. Furthermore, the in-vivo repeatability will be quantified for each measurand, as well as the confidence intervals for mean 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 improvement of existing algorithms, development of additional measurands and for retrospective analysis.

Full description

The EYESTAR900 (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: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

At least one eye of each subject needs to fulfill one of the following inclusion criteria:

• volunteers with normal phakic eye;
• patients seeking cataract surgery;
• patients with pseudophakic eye;
• patients with oil-filled eye;
• patients with aphakic eye.

Exclusion criteria

• Exclusion criteria per subject:

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

• Exclusion criteria per eye:

  • inability to maintain stable fixation;
  • corneal lesions or scarring;
  • previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
  • previous intraocular surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
  • active inflammation of the eye;
  • active infection of the eye;
  • tear film break up time of less than 5 sec.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Examination of participants

Experimental group

Description:

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

Treatment:

Device: EYESTAR 900