Optical Biometry of the Human EyeNCT03382288

Clinical Trial ES 900 - 2016

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: 116 participants
Where: 1 siteSwitzerland
Study dates: 9 Jun 2017to 12 Feb 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

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.

Who cannot join

underage patients (younger than 18 years);
vulnerable patients;
inability to give informed consent;
inability to maintain stable fixation.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Basel
Basel, 4056

Other trials in Switzerland

About this study

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.

Read the detailed 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).

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 experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.

Study groups in NCT03382288
Study group	Role	What they receive
Examination of participants	Experimental	Examination of participants by means of the investigational device, Eyestar 900 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-Measurands
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in [dpt]; Axis in [°].
Measured: Through study completion, approximately 9 months.
Axial measurands
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].
Measured: Through study completion, approximately 9 months
Imaging
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].
Measured: Through study completion, approximately 9 months
Anterior corneal topography
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm ]; axial curvature in [dpt].
Measured: Through study completion, approximately 9 months
Posterior corneal topography
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm]; axial curvature in [dpt].
Measured: Through study completion, approximately 9 months
Corneal pachymetry
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in [µm ].
Measured: Through study completion, approximately 9 months
Posterior corneal keratometry
In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in [dpt]; PAxis in [°].
Measured: Through study completion, approximately 9 months

Secondary outcomes (2)

Aquisition of volumetric OCT Data of the eye.
Data is collected, but not processed within the scope of this clinical trial.
Measured: Through study completion, approximately 9 months
Aquisition of photographic images of the eye.
Data is collected, but not processed within the scope of this clinical trial.
Measured: Through study completion, approximately 9 months

Timeline

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

9 Jun 201712 Feb 2019

First posted22 Dec 2017
Study start9 Jun 2017
Primary completion12 Feb 2019
Study completion12 Feb 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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382288
Sponsor's protocol ID: 1023191
Status last verified: Mar 2026
First submitted: 10 Nov 2017
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 - 2016
ClinicalTrials.gov ID: NCT03382288
Acronym / sponsor ID: 1023191
Conditions: Optical Biometry of the Human Eye, General Analysis of the Anterior Chamber of the Human Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Haag-Streit AGIndustry (pharma, biotech, devices)
Collaborators: University Hospital, Basel, Switzerland
Study start: 9 Jun 2017 (actual)
Primary completion: 12 Feb 2019 (actual)
Study completion: 12 Feb 2019 (actual)
First posted: 22 Dec 2017 (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.

Detailed 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).

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, Eyestar 900 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)

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;

Key exclusion criteria (4 listed)

underage patients (younger than 18 years);
vulnerable patients;
inability to give informed consent;
inability to maintain stable fixation.

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 experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.	Device	Examination of participants

Primary outcome

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 [°].
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].
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].
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].
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].
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 ].
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 [°].

2 secondary outcomes

Aquisition of volumetric OCT Data of the eye.
Time frame: Through study completion, approximately 9 months
Aquisition of photographic images of the eye.
Time frame: Through study completion, approximately 9 months

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

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 4 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-Measurands (time frame: Through study completion, approximately 9 months.). The study lists 7 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 NCT03382288.

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; AzTrials last refreshed its copy on 30 Oct 2026.