Cardiovascular RiskNCT07747233
Precision Study of CLAiR AI Software
A study testing CLAiR Artificial Intelligence Software in people with Cardiovascular Risk, run by Toku Eyes Ltd at 2 sites in United States.
Trial summary
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus images. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- CLAiR Artificial Intelligence Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2025to 9 Jan 2026
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed.
- Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit.
Who cannot join
- Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting.
- Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity <20/400).
- Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio, 44718
Illinois Retina Associates
Homer Glen, Illinois, 60491
About this study
Official title: A Multi-Site Precision Study to Validate the Performance of CLAiR AI Software in Identifying Elevated Atherosclerotic Cardiovascular Disease Risk From Retinal Images.
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus images. Participants underwent protocol-defined retinal imaging using Topcon NW400 and NW500 cameras. The study assessed agreement and consistency of device outputs across operators and imaging conditions. No medical management decisions were made based on device results.
Read the detailed description
This prospective, multi-site precision study was designed to evaluate the analytical performance and reproducibility of the CLAiR AI software, a software as a medical device (SaMD) intended to identify individuals with elevated risk of atherosclerotic cardiovascular disease (ASCVD) using retinal fundus images.
Participants were enrolled at U.S. clinical sites and underwent protocol-defined retinal imaging procedures using Topcon NW400 and NW500 non-mydriatic fundus cameras. Imaging was performed under controlled conditions, including predefined operator sequencing and repeated image acquisition, to assess reproducibility across operators and devices.
The primary objective was to evaluate agreement of device outputs across repeated imaging sessions and camera models. Secondary objectives included assessment of intra- and inter-operator variability.
The device under investigation was not FDA cleared or approved at the time of the study and was evaluated under institutional review board (IRB) oversight as a non-significant risk (NSR) device study. No therapeutic interventions were administered, and no clinical management decisions were made based on device outputs.
- Conditions
- Cardiovascular Risk
- Being tested
- CLAiR Artificial Intelligence Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLAiR Artificial Intelligence SoftwareDevice
CLAiR is an investigational software as a medical device (SaMD) designed to analyze retinal fundus images and classify individuals as having elevated or not elevated risk of atherosclerotic cardiovascular disease. The software was evaluated for performance and reproducibility under protocol-defined imaging conditions.
| Study group | Role | What they receive |
|---|---|---|
| CLAiR Imaging Cohort | Experimental | Participants underwent protocol-defined retinal fundus imaging using Topcon NW400 and NW500 cameras. Images were analyzed using the investigational CLAiR artificial intelligence software to evaluate performance and reproducibility. No clinical management decisions were made based on device outputs. Receives: Device: CLAiR Artificial Intelligence Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall inter-operator reproducibility of the CLAiR ASCVD risk classification
Inter-operator reproducibility will be assessed as the overall percent agreement between paired binary CLAiR outputs (Elevated Risk, Not Elevated Risk, or No Result) generated from retinal images acquired by different operators. Agreement will be calculated across all paired comparisons according to the predefined statistical analysis plan.
Measured: Single study visit (approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Dec 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toku Eyes Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mcconnell, MD, Study director, Toku Eyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747233
- Sponsor's protocol ID
- CPS-En02
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Precision Study to Validate the Performance of CLAiR AI Software in Identifying Elevated Atherosclerotic Cardiovascular Disease Risk From Retinal Images.
- ClinicalTrials.gov ID
- NCT07747233
- Acronym / sponsor ID
- CPS-En02
- Conditions
- Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Toku Eyes LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 5 Aug 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.
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus images. Participants underwent protocol-defined retinal imaging using Topcon NW400 and NW500 cameras. The study assessed agreement and consistency of device outputs across operators and imaging conditions. No medical management decisions were made based on device results.
Detailed description
This prospective, multi-site precision study was designed to evaluate the analytical performance and reproducibility of the CLAiR AI software, a software as a medical device (SaMD) intended to identify individuals with elevated risk of atherosclerotic cardiovascular disease (ASCVD) using retinal fundus images.
Participants were enrolled at U.S. clinical sites and underwent protocol-defined retinal imaging procedures using Topcon NW400 and NW500 non-mydriatic fundus cameras. Imaging was performed under controlled conditions, including predefined operator sequencing and repeated image acquisition, to assess reproducibility across operators and devices.
The primary objective was to evaluate agreement of device outputs across repeated imaging sessions and camera models. Secondary objectives included assessment of intra- and inter-operator variability.
The device under investigation was not FDA cleared or approved at the time of the study and was evaluated under institutional review board (IRB) oversight as a non-significant risk (NSR) device study. No therapeutic interventions were administered, and no clinical management decisions were made based on device outputs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLAiR Imaging Cohort | Experimental | Device: CLAiR Artificial Intelligence SoftwareParticipants underwent protocol-defined retinal fundus imaging using Topcon NW400 and NW500 cameras. Images were analyzed using the investigational CLAiR artificial intelligence software to evaluate performance and reproducibility. No clinical management decisions were made based on device outputs. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed.
- Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit.
Key exclusion criteria (3 listed)
- Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting.
- Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity <20/400).
- Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one 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 |
|---|---|---|
| CLAiR Artificial Intelligence SoftwareCLAiR is an investigational software as a medical device (SaMD) designed to analyze retinal fundus images and classify individuals as having elevated or not elevated risk of atherosclerotic cardiovascular disease. The software was evaluated for performance and reproducibility under protocol-defined imaging conditions. | Device | CLAiR Imaging Cohort |
Primary outcome
Overall inter-operator reproducibility of the CLAiR ASCVD risk classification
Time frame: Single study visit (approximately 2 hours)
Inter-operator reproducibility will be assessed as the overall percent agreement between paired binary CLAiR outputs (Elevated Risk, Not Elevated Risk, or No Result) generated from retinal images acquired by different operators. Agreement will be calculated across all paired comparisons according to the predefined statistical analysis plan.
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 5 Aug 2026.
- 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.
Michael Mcconnell, MD study director
Toku Eyes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLAiR Artificial Intelligence Software in people with Cardiovascular Risk, run by Toku Eyes Ltd at 2 sites 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 2 inclusion and 3 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Overall inter-operator reproducibility of the CLAiR ASCVD risk classification (time frame: Single study visit (approximately 2 hours)). 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 5 Aug 2026.