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Completed

NCT Number: NCT04112472

Clinical Trial ES 900 - 2019

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.

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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 Hopital Basel

Basel, 4056, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

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 intervention are optical, non-contact examinations with the investigational device EYESTAR 900 and comparative device(s). Results of the examinations serve to compare the performance data of the investigational device with those of the comparative devices.

Primary outcomes

  1. Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Kmean.

  2. Keratometry Measurand: AST (Anterior central corneal astigmatism) in [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AST.

  3. Keratometry Measurand: Axis (Anterior steep meridian angle) in [°]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Axis. Axis is the angle of the anterior central corneal astigmatism.

    The value of Axis is measured in [°], whereas the differences shall be expressed in [dpt].

  4. Axial Measurand: AL (Axial length) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AL. AL is measured from the corneal tear film to the inner limiting membrane.

  5. Axial Measurand: CCT (Corneal thickness) in [μm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for CCT. CCT is measured from the corneal tear film to the corneal endothelium.

  6. Axial Measurand: ACD (Anterior chamber depth) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for ACD. ACD is measured from the corneal tear film to the anterior surface of the lens.

  7. Axial Measurand: LT (Lens thickness) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for LT. LT is measured from the anterior to the posterior surface of the lens.

  8. Imaging Measurand: WTW (White-to-White) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for WTW. WTW distance is the horizontal diameter of a best fit circle to the iris border.

  9. Imaging Measurand: ICX / ICY (Iris barycenter in horizontal direction / in vertical direction) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability of investigational and comparator device for Iris barycenter. The iris barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.

  10. Imaging Measurand: PD (Pupil diameter) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability of investigational and comparator device for PD. PD is measured at the diameter of a best fit circle to the pupil border.

  11. Imaging Measurand: PCX / PCY (Pupil barycenter in horizontal direction / in vertical direction) in [mm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability of investigational and comparator device for Iris barycenter. The pupil barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.

  12. Anterior corneal topography: Elevation (Anterior torical elevation) in [µm] (2D-map)

    Time frame: Through study completion, approximately 7 months.

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

  13. Anterior corneal topography: Axial curvature (Anterior tangential curvature) in [dpt] (2D-map)

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability and confidence interval of difference between investigational and comparator devices for Anterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).

  14. Posterior corneal topography: Elevation (Posterior torical elevation) in [µm] (2D-map)

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability of investigational and comparator device for Posterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).

  15. Posterior corneal topography: Axial curvature (Posterior tangential curvature) in [dpt] (2D-map)

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability and confidence interval of differences of investigational and comparator devices for Posterior tangential curvature. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).

  16. Corneal pachymetry: Corneal thickness map in [µm]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability and confidence interval of differences of investigational and comparator device for Corneal thickness map. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).

  17. Simulated Keratometry: SimKmean (Mean simulated keratometry) in [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimKmean.

  18. Simulated Keratometry: SimAST (Simulated astigmatism) in [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimAST.

  19. Simulated Keratometry: SimAxis (Simulated keratometry anterior steep meridian angle) in [°]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimAxis. The value of Axis is measured in [°], whereas the differences shall be expressed in [dpt]. SimAxis is the angle of the larger simulated keratometry radius with respect to the horizontal axis X.

  20. Simulated Keratometry: Anterior corneal shape factor (E): Dimensionless quantity

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Anterior corneal shape factor (E), that characterizes the anterior corneal asphericity.

  21. Simulated Posterior Keratometry: SimPKmean (Mean simulated posterior keratometry) in [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPKmean. SimPKmean is the corresponding refractive power in diopters.

  22. Simulated Posterior Keratometry: SimPAST (Simulated keratometry posterior corneal astigmatism) in [dpt]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAST.

  23. Simulated Posterior Keratometry: SimPAxis (Simulated keratometry posterior steep meridian angle) in [°]

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAxis. SimPAxis represents the angle of the larger simulated keratometry radius of curvature with respect to the horizontal axis X.

  24. Simulated Posterior Keratometry: Posterior corneal shape factor (PE): Dimensionless quantity

    Time frame: Through study completion, approximately 7 months.

    In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Posterior corneal shape factor (PE), that characterizes the posterior corneal asphericity.

Other outcomes

  1. Acquisition of volumetric OCT Data of the eye.

    Time frame: Through study completion, approximately 7 months

    The data is collected to allow for: Improvement of existing algorithms, development of additional measurands and for retrospective analysis. The data will not be processed within the scope of this clinical trial.

  2. Acquisition of photographic images of the eye.

    Time frame: Through study completion, approximately 7 months

    The data is collected to allow for: Improvement of existing algorithms, development of additional measurands and for retrospective analysis. The data will not be processed within the scope of this clinical trial.

Sponsors and collaborators

Lead sponsor

Haag-Streit AG

Industry

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Official study title

Clinical Trial - ES 900 - 2019

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
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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