Cataract and IOL SurgeryCH-0203NCT07325162
Development of Optical Biometer
A study testing New Investigational Optical Biometer (Device), Comparator Device A (Cassini Ambient) and omparator Device B (Argos) in people with Cataract and IOL Surgery, run by Cassini Technologies at 1 site in United States.
Trial summary
The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract and IOL Surgery
- What is being tested?
- New Investigational Optical Biometer (Device), Comparator Device A (Cassini Ambient) and omparator Device B (Argos)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of cataract in at least one eye.
- Minimally 21 years of age.
- Provided written informed consent.
Who cannot join
- The inability to properly fixate on a fixation target for several seconds
- The inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bishop Eye Center
Hilton Head Island, South Carolina, 29926
Paul Bell Bell, MD, 843-689-3937, paulmbell@gmail.com
About this study
Official title: Development of a Next-Generation Optical Biometer for Eyes With Cataract
The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device.
While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.
- Conditions
- Cataract and IOL Surgery
- Being tested
- New Investigational Optical Biometer (Device), Comparator Device A (Cassini Ambient), omparator Device B (Argos)
- Keywords
- Optical Biometer, SS-OCT
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Investigational Optical Biometer (Device)Device
Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement.
Comparator Device A (Cassini Ambient)Device
FDA-cleared corneal topographer used as a reference standard comparator for keratometry.
omparator Device B (Argos)Device
FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.
| Study group | Role | What they receive |
|---|---|---|
| All enrolled subjects | Other | All eligible subjects will undergo ocular biometry using three devices:
1. the investigational optical biometer,
2. Comparator Device A, and
3. Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs. Receives: Device: New Investigational Optical Biometer (Device); Device: Comparator Device A (Cassini Ambient); Device: omparator Device B (Argos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular parameters of cataractous eyes measured with a novel biometer
Primary endpoint:
Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.
Measured: Overall study to complete up to 12 months
Secondary outcomes (1)
Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery
Ocular biometric values (axial length, anterior chamber depth, keratometry, limbal white to white, lens thickness, and central corneal thickness - measured in millimetres) measured by the Helioscope device will be compared against the same values captured by the Argos biometer and Ambient topographer devices (both FDA approved devices on label use) in 200 eyes.
Measured: Overall study to complete up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start7 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract and IOL SurgeryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cassini Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325162
- Sponsor's protocol ID
- 2025-0203
- Acronym
- CH-0203
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared because, although the data are randomized, they are being used to develop and validate proprietary software algorithms for the investigational device.
Publications
Hashemi H, Sardari S, Yekta A, Khabazkhoob M. The repeatability and agreement of biometric measurements by dual Scheimpflug device with integrated optical biometer. Sci Rep. 2022 May 11;12(1):7748. doi: 10.1038/s41598-022-11953-8.
PubMed 35546610
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Next-Generation Optical Biometer for Eyes With Cataract
- ClinicalTrials.gov ID
- NCT07325162
- Acronym / sponsor ID
- CH-0203 / 2025-0203
- Conditions
- Cataract and IOL Surgery
- Keywords
- Optical Biometer, SS-OCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cassini TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 8 Jan 2026 (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 Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device.
While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled subjects | Other | Device: New Investigational Optical Biometer (Device), Device: Comparator Device A (Cassini Ambient), Device: omparator Device B (Argos)All eligible subjects will undergo ocular biometry using three devices: 1. the investigational optical biometer, 2. Comparator Device A, and 3. Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of cataract in at least one eye.
- Minimally 21 years of age.
- Provided written informed consent.
Key exclusion criteria (2 listed)
- The inability to properly fixate on a fixation target for several seconds
- The inability to provide informed consent.
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 |
|---|---|---|
| New Investigational Optical Biometer (Device)Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement. | Device | All enrolled subjects |
| Comparator Device A (Cassini Ambient)FDA-cleared corneal topographer used as a reference standard comparator for keratometry. | Device | All enrolled subjects |
| omparator Device B (Argos)FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences. | Device | All enrolled subjects |
Primary outcome
Ocular parameters of cataractous eyes measured with a novel biometer
Time frame: Overall study to complete up to 12 months
Primary endpoint: Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.
1 secondary outcome
Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery
Time frame: Overall study to complete up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Results publication: PubMed 35546610Hashemi H, Sardari S, Yekta A, Khabazkhoob M. The repeatability and agreement of biometric measurements by dual Scheimpflug device with integrated optical biometer. Sci Rep. 2022 May 11;12(1):7748. doi: 10.1038/s41598-022-11953-8.
- Individual participant dataSharing planned: No. IPD will not be shared because, although the data are randomized, they are being used to develop and validate proprietary software algorithms for the investigational device.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Investigational Optical Biometer (Device), Comparator Device A (Cassini Ambient) and omparator Device B (Argos) in people with Cataract and IOL Surgery, run by Cassini Technologies at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 8 Jan 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Michael Petrik Petrik, OD (236-982-8672, m.petrik@cassini-technologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular parameters of cataractous eyes measured with a novel biometer (time frame: Overall study to complete up to 12 months). 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 NCT07325162, which also lists 1 linked publication.
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 8 Jan 2026.