Optical Biometry of the Human EyeNCT04112472

Clinical Trial ES 900 - 2019

A study testing EYESTAR 900 in people with Optical Biometry of the Human Eye and General Analysis of the Anterior Chamber of the Human Eye, run by Haag-Streit AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Optical Biometry of the Human Eye, General Analysis of the Anterior Chamber of the Human Eye
What is being tested?: EYESTAR 900
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteSwitzerland
Study dates: 11 Jul 2019to 1 Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

underage patients (younger than 18 years);
vulnerable patients;
inability to give informed consent;
inability to maintain stable fixation;
corneal lesions or scarring;
previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);

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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 locations and contacts

1 site in 1 country.

Switzerland1 site

University Hopital Basel
Basel, 4056

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed 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).

Conditions: Optical Biometry of the Human Eye, General Analysis of the Anterior Chamber of the Human Eye
Being tested: EYESTAR 900

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EYESTAR 900Device
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.

Study groups in NCT04112472
Study group	Role	What they receive
Examination of participants	Experimental	Examination of participants by means of the investigational device as well as the comparative devices. Receives: Device: EYESTAR 900

What is being measured

The primary outcome is the main question the study is designed to answer.

Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Kmean.
Measured: Through study completion, approximately 7 months.
Keratometry Measurand: AST (Anterior central corneal astigmatism) in [dpt]
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AST.
Measured: Through study completion, approximately 7 months.
Keratometry Measurand: Axis (Anterior steep meridian angle) in [°]
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].
Measured: Through study completion, approximately 7 months.
Axial Measurand: AL (Axial length) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Axial Measurand: CCT (Corneal thickness) in [μm]
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.
Measured: Through study completion, approximately 7 months.
Axial Measurand: ACD (Anterior chamber depth) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Axial Measurand: LT (Lens thickness) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Imaging Measurand: WTW (White-to-White) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Imaging Measurand: ICX / ICY (Iris barycenter in horizontal direction / in vertical direction) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Imaging Measurand: PD (Pupil diameter) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Imaging Measurand: PCX / PCY (Pupil barycenter in horizontal direction / in vertical direction) in [mm]
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.
Measured: Through study completion, approximately 7 months.
Anterior corneal topography: Elevation (Anterior torical elevation) in [µm] (2D-map)
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µ]; axial curvature in [dpt].
Measured: Through study completion, approximately 7 months.
Anterior corneal topography: Axial curvature (Anterior tangential curvature) in [dpt] (2D-map)
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).
Measured: Through study completion, approximately 7 months.
Posterior corneal topography: Elevation (Posterior torical elevation) in [µm] (2D-map)
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).
Measured: Through study completion, approximately 7 months.
Posterior corneal topography: Axial curvature (Posterior tangential curvature) in [dpt] (2D-map)
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).
Measured: Through study completion, approximately 7 months.
Corneal pachymetry: Corneal thickness map in [µm]
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).
Measured: Through study completion, approximately 7 months.
Simulated Keratometry: SimKmean (Mean simulated keratometry) in [dpt]
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimKmean.
Measured: Through study completion, approximately 7 months.
Simulated Keratometry: SimAST (Simulated astigmatism) in [dpt]
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimAST.
Measured: Through study completion, approximately 7 months.
Simulated Keratometry: SimAxis (Simulated keratometry anterior steep meridian angle) in [°]
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.
Measured: Through study completion, approximately 7 months.
Simulated Keratometry: Anterior corneal shape factor (E): Dimensionless quantity
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.
Measured: Through study completion, approximately 7 months.
Simulated Posterior Keratometry: SimPKmean (Mean simulated posterior keratometry) in [dpt]
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.
Measured: Through study completion, approximately 7 months.
Simulated Posterior Keratometry: SimPAST (Simulated keratometry posterior corneal astigmatism) in [dpt]
In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAST.
Measured: Through study completion, approximately 7 months.
Simulated Posterior Keratometry: SimPAxis (Simulated keratometry posterior steep meridian angle) in [°]
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.
Measured: Through study completion, approximately 7 months.
Simulated Posterior Keratometry: Posterior corneal shape factor (PE): Dimensionless quantity
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.
Measured: Through study completion, approximately 7 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 20191 Sep 2019

First posted2 Oct 2019
Study start11 Jul 2019
Primary completion1 Sep 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Optical Biometry of the Human EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04112472
Sponsor's protocol ID: 1023551
Status last verified: Mar 2026
First submitted: 20 Sep 2019
Last updated: 30 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial - ES 900 - 2019
ClinicalTrials.gov ID: NCT04112472
Acronym / sponsor ID: 1023551
Conditions: Optical Biometry of the Human Eye, General Analysis of the Anterior Chamber of the Human Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Haag-Streit AGIndustry (pharma, biotech, devices)
Collaborators: University Hospital, Basel, Switzerland
Study start: 11 Jul 2019 (actual)
Primary completion: 1 Sep 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 2 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Examination of participants	Experimental	Device: EYESTAR 900Examination of participants by means of the investigational device as well as the comparative devices.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (10 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EYESTAR 900EYESTAR 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.	Device	Examination of participants

Primary outcome

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.
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.
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].
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.
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.
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.
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.
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.
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.
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.
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.
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].
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Goldblum, Prof. Dr. principal investigator

University Hospital, Basel, Switzerland

Julian Kool van Langenberghe, ing. study director

Haag-Streit AG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EYESTAR 900 in people with Optical Biometry of the Human Eye and General Analysis of the Anterior Chamber of the Human Eye, run by Haag-Streit AG at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt] (time frame: Through study completion, approximately 7 months.). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04112472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.