CataractNCT05304182
Clinical Study - ES 900 - 2020-1
A study testing EYESTAR 900 and LENSTAR LS 900 in people with Cataract, run by Haag-Streit AG at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- EYESTAR 900 and LENSTAR LS 900
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 28 Feb 2024
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary participation
- informed consent
- 35 years of age or older
Who cannot join
- ineligibility for cataract surgery for any reason, e.g., aphakia
- Disqualifying pathologies:
- keratoconus
- corneal astigmatism of more than 3.5 D
- history of recurrent inflammation or infection of the eye
- Disqualifying corneal conditions:
Show all 18Show fewer
- comorbidities,
- deformations,
- lesions, or
- scarring of the cornea
- acute inflammation or infection of the eye
- Disqualifying treatments:
- previous refractive surgeries, including PRK and LASIK
- previous corneal surgeries
- previous corneal transplants
- previous intraocular surgeries
- Disqualifying outcomes:
- failed IOL implantation into the capsular bag
Trial locations and contacts
1 site in 1 country.
India1 site
Aravind Eye Hospitals
Chennai, Tamil Nadu, 600077
Nivetha K, chennai.research@aravind.org
Haripriya Aravind, MD
About this study
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. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. The EYESTAR 900 is CE marked.
These measurement results of this device are used for the planning of the medical treatment of patients. Depending on the application, the benefits of this device may include improved visual acuity (after cataract surgery), reduced risk of complications (after refractive surgery or implant of a phakic intraocular lens), early identification of pathological deformations of the cornea (keratoconus detection).
Read more
The primary objective of this clinical trial is to assess the clinical performance of the investigational device in dense cataracts. To that end, for each measurand, the in-vivo repeatability will be quantified, as well as limits of agreement and 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 the improvement of existing algorithms, development of additional measurands and for retrospective analysis.
No diseases are studied.
Read the detailed description
The EYESTAR 900 is a non-contact device for measuring the human eye, consisting of a swept source OCT sub-unit (OCT: optical coherence tomography, a measurement method to acquire tomographic images by optical interferometry) and an imaging system sub-unit.
The OCT sub-unit performs a three-dimensional measurement of all refractive ocular structures in the anterior eye segment (curvatures and locations of the anterior corneal surface, posterior corneal surface, the anterior crystalline lens surface, posterior crystalline lens surface), as well as a one-dimensional measurement of axial eye length. It also generates cross-sectional images of the anterior eye section and the central retina. The measurement is implemented by scanning the eye with a low-power near-infrared laser beam and measuring the light which is back-reflected to the device.
The imaging system sub-unit is used to obtain photographic images of the eye. Based on these images, the keratometry (anterior corneal curvature of the steepest and flattest meridian), the white-to-white distance and the pupil diameter are measured. Additionally, these images can serve to document the locations of special landmarks on the eye, such as blood vessels. The imaging system sub-unit is based on conventional digital photography technology. Illumination for imaging is provided by infrared and white-light LEDs (light emitting diodes). Measurement of keratometry additionally requires measuring the distance to the eye using the OCT sub-unit.
The EYESTAR 900 is designed as standalone-device with integrated PC (personal computer) and display for device operation, measurement acquisition and processing, and presentation of the measurement results. After a patient is placed in front of the device and the chin rest is adjusted, the device can perform the remaining positioning procedures and acquire the measurements in a fully automated manner. Position information is derived from the OCT and digital camera system sub-units.
Both implemented measuring methods, optical coherence tomography (OCT), as well as digital photography are non-invasive, contactless methods. OCT uses a laser beam of λ=1060nm central wavelength and less than 2 mW optical power, which is focussed to a beam diameter of approximately 80µm at the anterior lens plane, and is continuously scanned in the lateral direction. Digital photography uses diffuse illumination of the eye by white-light LEDs (425nm ≤ λ ≤ 725nm) and infrared LEDs with central wavelength λ=850nm. All light sources emit levels that comply with ISO 15004-2 ("Ophthalmic Instruments - Fundamental requirements and test methods - Part 2: Light hazard protection"), under normal operating conditions as well as in case of a single fault condition.
The main application of this device is to acquire biometric measurements of cataractous eyes which are used to calculate suitable intraocular lens power and dimension.
The patient population must be capable of sitting up straight and keeping their head still and their eyes opened. They must be physically and mentally able to cooperate and mentally capable of following the examination. Patients must be at least 18 years old.
The target device user is an ophthalmologist or a trained specialist.
The investigational device EYESTAR 900 is developed and manufactured by HAAG-STREIT AG, Koeniz (Switzerland).
For the duration of the examination (approximately 1-2 minutes), the patient is in contact with the device at following applied parts:
- the chin rest shell (Edistir RK451 G naturally coated with HAERATEX Aqua 2K-structural coater BW89 10K RAL 9005);
- the forehead rest band (Saxamid 126-N001 uncoated PA6 white FK 6659 PA);
- (depending on the subject's requirements) the patient handles (aluminium EN AW-6060 (AlMgSi 0.5) colourless anodized class 20 with sealing chemically polished and sandblasted).
No other contact with body tissues or fluids takes place. No critical biocompatibility issues were identified.
- Conditions
- Cataract
- Being tested
- EYESTAR 900, LENSTAR LS 900
- Keywords
- Optical Biometry, Corneal Topography
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYESTAR 900Device
Also called Optical Biometer
The 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. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations.
LENSTAR LS 900Device
Also called Optical Biometer
The LENSTAR LS 900 is a non-contact device for measurement of biometrical parameters of the eye, aimed to assist the calculation of intraocular lenses (IOLs) prior to intraocular lens implantation. The most common application is in preparation of cataract surgery.
This device uses OLCR (optical low-coherence reflectometry), an interferometric method to measure intraocular axial distances. Furthermore, it uses digital photography of the anterior section of the eye to measure pupil size and location, as well as the white-to-white distance of the eye. The same photographic unit, in conjunction with a specific illumination pattern, is used to measure the corneal curvature - this measurement is known as 'keratometry', or, more specifically, 'automated keratometry'.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Op | Experimental | The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye. Receives: Device: EYESTAR 900; Device: LENSTAR LS 900 |
| Post-Op | Active comparator | The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye. Receives: Device: EYESTAR 900; Device: LENSTAR LS 900 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dense Cataract Performance
The primary outcome is the performance of the EYESTAR 900 in dense cataracts. Specifically, the highest grade of cataract at which complete measurements can reliably be performed and, consequently, the number of patients measured successfully.
Measured: 18 months
Secondary outcomes (12)
Keratometry
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Axial Length
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
White-to-White Imaging
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Anterior Corneal Elevation
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Anterior Corneal Axial Curvature
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Anterior Corneal Tangential Curvature
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Posterior Corneal Elevation
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Posterior Corneal Axial Curvature
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Posterior Corneal Tangential Curvature
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Corneal Pachymetry
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Simulated Anterior Keratometry
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Simulated Posterior Keratometry
The limits of agreement and the confidence interval of difference in comparison with the LENSTAR 900.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
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
- Crossover
- Model description
- There are two identical arms in this study: pre-operative and post-operative. Every participant starts in the pre-operative arm and crosses over to the post-operative arm. During both arms, each study subject undergoes the experimental intervention and the control intervention. The study objective is to assess the clinical performance of the investigational device. This assessment is performed by a statistical analysis of the measurement results from the experimental intervention and the control intervention. The surgery is not a study intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haag-Streit AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aravind Eye Hospitals, India
- Responsible party
- Sponsor
- Investigators
- Haripriya Aravind, MD, Principal investigator, Aravind Eye HospitalsThomas Beutler, Dipl. Ing., Study director, Haag-Streit AGJulian Kool van Langenberghe, ing., Study chair, Haag-Streit AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304182
- Sponsor's protocol ID
- 1023703
- Status last verified
- Jun 2022
- First submitted
- 22 Mar 2022
- Last updated
- 29 Jun 2022
- 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 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study - ES 900 - 2020-1
- ClinicalTrials.gov ID
- NCT05304182
- Acronym / sponsor ID
- 1023703
- Conditions
- Cataract
- Keywords
- Optical Biometry, Corneal Topography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haag-Streit AGIndustry (pharma, biotech, devices)
- Collaborators
- Aravind Eye Hospitals, India
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
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. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. The EYESTAR 900 is CE marked.
These measurement results of this device are used for the planning of the medical treatment of patients. Depending on the application, the benefits of this device may include improved visual acuity (after cataract surgery), reduced risk of complications (after refractive surgery or implant of a phakic intraocular lens), early identification of pathological deformations of the cornea (keratoconus detection).
The primary objective of this clinical trial is to assess the clinical performance of the investigational device in dense cataracts. To that end, for each measurand, the in-vivo repeatability will be quantified, as well as limits of agreement and 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 the improvement of existing algorithms, development of additional measurands and for retrospective analysis.
No diseases are studied.
Detailed description
The EYESTAR 900 is a non-contact device for measuring the human eye, consisting of a swept source OCT sub-unit (OCT: optical coherence tomography, a measurement method to acquire tomographic images by optical interferometry) and an imaging system sub-unit.
The OCT sub-unit performs a three-dimensional measurement of all refractive ocular structures in the anterior eye segment (curvatures and locations of the anterior corneal surface, posterior corneal surface, the anterior crystalline lens surface, posterior crystalline lens surface), as well as a one-dimensional measurement of axial eye length. It also generates cross-sectional images of the anterior eye section and the central retina. The measurement is implemented by scanning the eye with a low-power near-infrared laser beam and measuring the light which is back-reflected to the device.
The imaging system sub-unit is used to obtain photographic images of the eye. Based on these images, the keratometry (anterior corneal curvature of the steepest and flattest meridian), the white-to-white distance and the pupil diameter are measured. Additionally, these images can serve to document the locations of special landmarks on the eye, such as blood vessels. The imaging system sub-unit is based on conventional digital photography technology. Illumination for imaging is provided by infrared and white-light LEDs (light emitting diodes). Measurement of keratometry additionally requires measuring the distance to the eye using the OCT sub-unit.
The EYESTAR 900 is designed as standalone-device with integrated PC (personal computer) and display for device operation, measurement acquisition and processing, and presentation of the measurement results. After a patient is placed in front of the device and the chin rest is adjusted, the device can perform the remaining positioning procedures and acquire the measurements in a fully automated manner. Position information is derived from the OCT and digital camera system sub-units.
Both implemented measuring methods, optical coherence tomography (OCT), as well as digital photography are non-invasive, contactless methods. OCT uses a laser beam of λ=1060nm central wavelength and less than 2 mW optical power, which is focussed to a beam diameter of approximately 80µm at the anterior lens plane, and is continuously scanned in the lateral direction. Digital photography uses diffuse illumination of the eye by white-light LEDs (425nm ≤ λ ≤ 725nm) and infrared LEDs with central wavelength λ=850nm. All light sources emit levels that comply with ISO 15004-2 ("Ophthalmic Instruments - Fundamental requirements and test methods - Part 2: Light hazard protection"), under normal operating conditions as well as in case of a single fault condition.
The main application of this device is to acquire biometric measurements of cataractous eyes which are used to calculate suitable intraocular lens power and dimension.
The patient population must be capable of sitting up straight and keeping their head still and their eyes opened. They must be physically and mentally able to cooperate and mentally capable of following the examination. Patients must be at least 18 years old.
The target device user is an ophthalmologist or a trained specialist.
The investigational device EYESTAR 900 is developed and manufactured by HAAG-STREIT AG, Koeniz (Switzerland).
For the duration of the examination (approximately 1-2 minutes), the patient is in contact with the device at following applied parts:
- the chin rest shell (Edistir RK451 G naturally coated with HAERATEX Aqua 2K-structural coater BW89 10K RAL 9005);
- the forehead rest band (Saxamid 126-N001 uncoated PA6 white FK 6659 PA);
- (depending on the subject's requirements) the patient handles (aluminium EN AW-6060 (AlMgSi 0.5) colourless anodized class 20 with sealing chemically polished and sandblasted).
No other contact with body tissues or fluids takes place. No critical biocompatibility issues were identified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two identical arms in this study: pre-operative and post-operative. Every participant starts in the pre-operative arm and crosses over to the post-operative arm. During both arms, each study subject undergoes the experimental intervention and the control intervention. The study objective is to assess the clinical performance of the investigational device. This assessment is performed by a statistical analysis of the measurement results from the experimental intervention and the control intervention. The surgery is not a study intervention.
| Arm | Type | Receives |
|---|---|---|
| Pre-Op | Experimental | Device: EYESTAR 900, Device: LENSTAR LS 900The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye. |
| Post-Op | Active comparator | Device: EYESTAR 900, Device: LENSTAR LS 900The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- voluntary participation
- informed consent
- 35 years of age or older
Key exclusion criteria (18 listed)
- ineligibility for cataract surgery for any reason, e.g., aphakia
- Disqualifying pathologies:
- Disqualifying corneal conditions:
- Disqualifying treatments:
- Disqualifying outcomes:
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 900Also: Optical BiometerThe 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. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. | Device | Post-Op, Pre-Op |
| LENSTAR LS 900Also: Optical BiometerThe LENSTAR LS 900 is a non-contact device for measurement of biometrical parameters of the eye, aimed to assist the calculation of intraocular lenses (IOLs) prior to intraocular lens implantation. The most common application is in preparation of cataract surgery. This device uses OLCR (optical low-coherence reflectometry), an interferometric method to measure intraocular axial distances. Furthermore, it uses digital photography of the anterior section of the eye to measure pupil size and location, as well as the white-to-white distance of the eye. The same photographic unit, in conjunction with a specific illumination pattern, is used to measure the corneal curvature - this measurement is known as 'keratometry', or, more specifically, 'automated keratometry'. | Device | Post-Op, Pre-Op |
Primary outcome
Dense Cataract Performance
Time frame: 18 months
The primary outcome is the performance of the EYESTAR 900 in dense cataracts. Specifically, the highest grade of cataract at which complete measurements can reliably be performed and, consequently, the number of patients measured successfully.
12 secondary outcomes
Keratometry
Time frame: 18 months
Axial Length
Time frame: 18 months
White-to-White Imaging
Time frame: 18 months
Anterior Corneal Elevation
Time frame: 18 months
Anterior Corneal Axial Curvature
Time frame: 18 months
Anterior Corneal Tangential Curvature
Time frame: 18 months
Posterior Corneal Elevation
Time frame: 18 months
Posterior Corneal Axial Curvature
Time frame: 18 months
Posterior Corneal Tangential Curvature
Time frame: 18 months
Corneal Pachymetry
Time frame: 18 months
Simulated Anterior Keratometry
Time frame: 18 months
Simulated Posterior Keratometry
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- 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.
Haripriya Aravind, MD principal investigator
Aravind Eye Hospitals
Thomas Beutler, Dipl. Ing. study director
Haag-Streit AG
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 EYESTAR 900 and LENSTAR LS 900 in people with Cataract, run by Haag-Streit AG at 1 site in India.
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 3 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Jun 2022. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachit Bhandary (+91 40 24891250, rachit@biomedixdevices.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dense Cataract Performance (time frame: 18 months). 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 29 Jun 2022.