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Completed

NCT Number: NCT03382288

Clinical Trial ES 900 - 2016

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4056, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EYESTAR 900

Device

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.

Primary outcomes

  1. Keratometry-Measurands

    Time frame: Through study completion, approximately 9 months.

    In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in [dpt]; Axis in [°].

  2. Axial measurands

    Time frame: Through study completion, approximately 9 months

    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].

  3. Imaging

    Time frame: Through study completion, approximately 9 months

    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].

  4. Anterior corneal topography

    Time frame: Through study completion, approximately 9 months

    In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm ]; axial curvature in [dpt].

  5. Posterior corneal topography

    Time frame: Through study completion, approximately 9 months

    In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm]; axial curvature in [dpt].

  6. Corneal pachymetry

    Time frame: Through study completion, approximately 9 months

    In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in [µm ].

  7. Posterior corneal keratometry

    Time frame: Through study completion, approximately 9 months

    In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in [dpt]; PAxis in [°].

Secondary outcomes

  1. Aquisition of volumetric OCT Data of the eye.

    Time frame: Through study completion, approximately 9 months

    Data is collected, but not processed within the scope of this clinical trial.

  2. Aquisition of photographic images of the eye.

    Time frame: Through study completion, approximately 9 months

    Data is collected, but not processed within the scope of this clinical trial.

Sponsors and collaborators

Lead sponsor

Haag-Streit AG

Industry

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2017
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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