CataractNCT04392349
Clinical Study - ES 900 - 2020-2
A study testing Haag-Streit EYESTAR 900, Tomey CASIA 2 and Oculus PENTACAM HR in people with Cataract and Keratoconus, run by Haag-Streit AG at 1 site in Switzerland.
Trial summary
The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Keratoconus
- What is being tested?
- Haag-Streit EYESTAR 900, Tomey CASIA 2 and Oculus PENTACAM HR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 10 Dec 2020
- 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
- voluntary participation of subjects of legal age, irrespective of age, gender, ethnicity, of which:
- participants with healthy eyes,
- participants with corneal scarring,
- participants with irregular astigmatism.
Who cannot join
- Involuntary participation or inability to provide consent,
- persons of vulnerable populations,
- persons unable or unwilling to follow instructions,
- persons unable to maintain fixation for the duration of the examinations,
- persons with active inflammation or infections of the eye,
- persons with a tear film break up time of less than 5 sec.
Trial locations and contacts
1 site in 1 country.
About this study
The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0.
This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.
Read the detailed description
Ocular biometry is the act of measuring the geometric properties of the eye, in particular distances between and thicknesses of the visual axis of the cornea, lens and retina, as well as curvature of the anterior cornea. These measurements are used mainly to determine implant type and dimensions for cataract surgery.
Corneal topography is the act of measuring the shape of the cornea, in particular of the anterior cornea, but, depending on the device and the application, also of the posterior cornea, as well as the distance between the anterior to the posterior of the cornea. These measurements can be used in the context of ocular biometry, but are also useful for many other applications where knowledge of the optical and structural properties of the cornea are of interest.
Optical coherence tomography (OCT) is a well-established imaging modality in ophthalmology. It uses interferometry to obtain a scattering profile of the eye along the direction of propagation of a laser beam which is directed onto the eye. In analogy to ultrasound imaging, this scattering profile is called A-Scan. By laterally translating the measurement beam, several A-scans can be combined to form a 2-dimensional image or 3-dimensional (3D) tomogram of the eye. The main use of OCT is the cross-sectional imaging of the retina or the cornea, primarily for diagnostic purposes[4]. Recently, anterior segment OCT has also been used for corneal topography[5], as well as for biometry and cross-sectional imaging along the entire length of the eye[6].
EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. CE approval for EYESTAR 900 with software version i9.4.0.0 is pending and expected before the start of this clinical trial.
The development of this device has been continued, and the following additions have been made in software version i9.5.1.0 used for this clinical study with respect to the software version i9.4.0.0:
- Extended corneal topography: corneal topography can be evaluated over an extended area (diameter of trajectory d=13mm with respect to d=8.6mm in "standard corneal topography").
- Irregularity segmentation: segmentation methods (identification of corneal surfaces) used in corneal topography now incorporate an improved algorithm for segmentation of irregular corneal surfaces.
- Irregularity visualization: visualization of topography maps has been supplemented by an overlay of regions with irregular corneal surfaces.
- Zone-based keratometry: visualization of topography maps has been further supplemented by an overlay of local keratometry values (power and axes of flat and steep meridians in the centre, middle and outer corneal surface).
- Crystalline lens tilt: the tilt of the crystalline lens normal vector with respect to the visual axis can be visualized and quantified.
Both irregularity visualization and zone-based keratometry are applicable to corneal topography data acquired with the standard corneal topography protocol, as well as corneal topography acquired over the extended area (diameter 13mm, extended corneal topography).
The primary objective of this clinical trial is to assess the clinical performance of extended corneal topography using irregularity segmentation, standard corneal topography using irregularity segmentation and crystalline lens tilt. To that end, for each measurand, the in-vivo repeatability will be quantified. For "standard corneal topography" and "extended corneal topography", the limits of agreement and the mean measurement deviation, with respect to three comparators are analyzed.
As a secondary objective of the study, raw measurement data will be collected to allow for the improvement of existing algorithms, development of additional measurands and for retrospective analysis.
Examinations with EYESTAR 900 and the other study devices are non-contact examinations. No diseases are studied as part of this study.
- Conditions
- Cataract, Keratoconus
- Being tested
- Haag-Streit EYESTAR 900, Tomey CASIA 2, Oculus PENTACAM HR, Zeiss ATLAS 9000
- Keywords
- Optical Biometry, Corneal Topography
- Medical subject headings
- Cataract, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haag-Streit EYESTAR 900Device
The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices.
Tomey CASIA 2Device
The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography.
Oculus PENTACAM HRDevice
The Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry.
Zeiss ATLAS 9000Device
ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography).
| Study group | Role | What they receive |
|---|---|---|
| NORMAL | Other | Normal group includes eyes with healthy cornea. Receives: Device: Haag-Streit EYESTAR 900; Device: Tomey CASIA 2; Device: Oculus PENTACAM HR; Device: Zeiss ATLAS 9000 |
| IRREGULAR | Other | Irregular goup includes eyes with irregular astigmatism or corneal scarring. Receives: Device: Haag-Streit EYESTAR 900; Device: Tomey CASIA 2; Device: Oculus PENTACAM HR; Device: Zeiss ATLAS 9000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-vivo Repeatability
The in-vivo repeatability is calculated as the square root of the residual variance of a mixed-effects ANOVA model (using subject as a random effect, and eye within subject as a fixed effect), which we multiply with a factor of square root of two (in order to make it commensurate with the standard deviation of the differences between two independent measurements of each eye in the study sample).
For comparator devices, the in-vivo repeatability will be assessed as well, based on two independent measurements of the same eye.
Measured: 3 months
Limits of Agreement
For each measurand, a comparator device was defined which represents the current clinical standard. For the comparator device, for each measured parameter the mean value per eye is obtained (this value serves as the "best guess" of the true value of this parameter for one particular eye). Then, for each examination of EYESTAR 900, the difference with respect to this comparator mean value is calculated. For the resulting differences per parameter, the interval spanning the mean difference ± 1.96 * the first standard deviation of the differences is obtained. This interval quantifies the limits of agreement, spanning 95% of the expected measurement differences between EYESTAR 900 and the comparator device.
Measured: 3 months
Confidence Interval of Differences
The mean deviation with respect to a comparator device ("equivalence") is determined as the confidence interval of a double-sided Wilcoxon test (α=0.05) of the mean measurement difference between the investigational device and the comparator device, computed over the study sample.
Measured: 3 months
Secondary outcomes (2)
Raw OCT Data
Acquisition of volumetric OCT Data of the eye. This secondary study outcome allows for the improvement of existing algorithms, development of additional measurands and for retrospective analysis but will not be processed within the scope of this clinical trial.
Measured: 3 months
Raw Image Data
Acquisition of photographic images of the eye. This secondary study outcome allows for the improvement of existing algorithms, development of additional measurands and for retrospective analysis but will not be processed within the scope of this clinical trial.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jul 2020
- Primary completion20 Aug 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haag-Streit AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Goldblum, Prof. Dr., Principal investigator, University Hospital, Basel, SwitzerlandJulian Kool van Langenberghe, ing., Study chair, Haag-Streit AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392349
- Sponsor's protocol ID
- 1023707
- Status last verified
- Mar 2026
- First submitted
- 11 May 2020
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Study - ES 900 - 2020-2
- ClinicalTrials.gov ID
- NCT04392349
- Acronym / sponsor ID
- 1023707
- Conditions
- Cataract, Keratoconus
- Keywords
- Optical Biometry, Corneal Topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Haag-Streit AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 18 May 2020 (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.
The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0.
This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.
Detailed description
Ocular biometry is the act of measuring the geometric properties of the eye, in particular distances between and thicknesses of the visual axis of the cornea, lens and retina, as well as curvature of the anterior cornea. These measurements are used mainly to determine implant type and dimensions for cataract surgery.
Corneal topography is the act of measuring the shape of the cornea, in particular of the anterior cornea, but, depending on the device and the application, also of the posterior cornea, as well as the distance between the anterior to the posterior of the cornea. These measurements can be used in the context of ocular biometry, but are also useful for many other applications where knowledge of the optical and structural properties of the cornea are of interest.
Optical coherence tomography (OCT) is a well-established imaging modality in ophthalmology. It uses interferometry to obtain a scattering profile of the eye along the direction of propagation of a laser beam which is directed onto the eye. In analogy to ultrasound imaging, this scattering profile is called A-Scan. By laterally translating the measurement beam, several A-scans can be combined to form a 2-dimensional image or 3-dimensional (3D) tomogram of the eye. The main use of OCT is the cross-sectional imaging of the retina or the cornea, primarily for diagnostic purposes[4]. Recently, anterior segment OCT has also been used for corneal topography[5], as well as for biometry and cross-sectional imaging along the entire length of the eye[6].
EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. CE approval for EYESTAR 900 with software version i9.4.0.0 is pending and expected before the start of this clinical trial.
The development of this device has been continued, and the following additions have been made in software version i9.5.1.0 used for this clinical study with respect to the software version i9.4.0.0:
- Extended corneal topography: corneal topography can be evaluated over an extended area (diameter of trajectory d=13mm with respect to d=8.6mm in "standard corneal topography").
- Irregularity segmentation: segmentation methods (identification of corneal surfaces) used in corneal topography now incorporate an improved algorithm for segmentation of irregular corneal surfaces.
- Irregularity visualization: visualization of topography maps has been supplemented by an overlay of regions with irregular corneal surfaces.
- Zone-based keratometry: visualization of topography maps has been further supplemented by an overlay of local keratometry values (power and axes of flat and steep meridians in the centre, middle and outer corneal surface).
- Crystalline lens tilt: the tilt of the crystalline lens normal vector with respect to the visual axis can be visualized and quantified.
Both irregularity visualization and zone-based keratometry are applicable to corneal topography data acquired with the standard corneal topography protocol, as well as corneal topography acquired over the extended area (diameter 13mm, extended corneal topography).
The primary objective of this clinical trial is to assess the clinical performance of extended corneal topography using irregularity segmentation, standard corneal topography using irregularity segmentation and crystalline lens tilt. To that end, for each measurand, the in-vivo repeatability will be quantified. For "standard corneal topography" and "extended corneal topography", the limits of agreement and the mean measurement deviation, with respect to three comparators are analyzed.
As a secondary objective of the study, raw measurement data will be collected to allow for the improvement of existing algorithms, development of additional measurands and for retrospective analysis.
Examinations with EYESTAR 900 and the other study devices are non-contact examinations. No diseases are studied as part of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NORMAL | Other | Device: Haag-Streit EYESTAR 900, Device: Tomey CASIA 2, Device: Oculus PENTACAM HR, Device: Zeiss ATLAS 9000Normal group includes eyes with healthy cornea. |
| IRREGULAR | Other | Device: Haag-Streit EYESTAR 900, Device: Tomey CASIA 2, Device: Oculus PENTACAM HR, Device: Zeiss ATLAS 9000Irregular goup includes eyes with irregular astigmatism or corneal scarring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- voluntary participation of subjects of legal age, irrespective of age, gender, ethnicity, of which:
- participants with healthy eyes,
- participants with corneal scarring,
- participants with irregular astigmatism.
Key exclusion criteria (6 listed)
- Involuntary participation or inability to provide consent,
- persons of vulnerable populations,
- persons unable or unwilling to follow instructions,
- persons unable to maintain fixation for the duration of the examinations,
- persons with active inflammation or infections of the eye,
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 |
|---|---|---|
| Haag-Streit EYESTAR 900The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices. | Device | IRREGULAR, NORMAL |
| Tomey CASIA 2The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography. | Device | IRREGULAR, NORMAL |
| Oculus PENTACAM HRThe Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry. | Device | IRREGULAR, NORMAL |
| Zeiss ATLAS 9000ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography). | Device | IRREGULAR, NORMAL |
Primary outcome
In-vivo Repeatability
Time frame: 3 months
The in-vivo repeatability is calculated as the square root of the residual variance of a mixed-effects ANOVA model (using subject as a random effect, and eye within subject as a fixed effect), which we multiply with a factor of square root of two (in order to make it commensurate with the standard deviation of the differences between two independent measurements of each eye in the study sample). For comparator devices, the in-vivo repeatability will be assessed as well, based on two independent measurements of the same eye.
Limits of Agreement
Time frame: 3 months
For each measurand, a comparator device was defined which represents the current clinical standard. For the comparator device, for each measured parameter the mean value per eye is obtained (this value serves as the "best guess" of the true value of this parameter for one particular eye). Then, for each examination of EYESTAR 900, the difference with respect to this comparator mean value is calculated. For the resulting differences per parameter, the interval spanning the mean difference ± 1.96 * the first standard deviation of the differences is obtained. This interval quantifies the limits of agreement, spanning 95% of the expected measurement differences between EYESTAR 900 and the comparator device.
Confidence Interval of Differences
Time frame: 3 months
The mean deviation with respect to a comparator device ("equivalence") is determined as the confidence interval of a double-sided Wilcoxon test (α=0.05) of the mean measurement difference between the investigational device and the comparator device, computed over the study sample.
2 secondary outcomes
Raw OCT Data
Time frame: 3 months
Raw Image Data
Time frame: 3 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.
- Clinical Trial ES 900 - 2019Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 chair
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 Haag-Streit EYESTAR 900, Tomey CASIA 2 and Oculus PENTACAM HR in people with Cataract and Keratoconus, 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 4 inclusion and 6 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?
In-vivo Repeatability (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.