No ConditionNCT06808334
CLAiR Pivotal Study
An observational study of No Condition, run by Toku Eyes Ltd at 1 site in United States.
Trial summary
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition
- What is being tested?
- CLAIR
- How many people
- 942 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 1 Oct 2025
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and Females between the ages of 40-75 years of age.
Who may be able to join
- Male or female, aged 40-75 years
- Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
- Current use of cholesterol-lowering medication, such as a statin
- Pregnancy
- A person who has (in at least one eye):
- Persistent vision impairment: legally blind when wearing current driving glasses or known VA<20/400
- Known pathological myopia
- Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)
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
Diabetes and Endocrine Associates of Stark County
Canton, Ohio, 44718
Brandi Kerr, brandik@go2endo.com
Arvind Krishna, MD
About this study
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.
Read the detailed description
This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (<7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.
The primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes/No elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.
- Conditions
- No Condition
- Being tested
- CLAIR
- Keywords
- retinal image, ASCVD, AI, cardiovascular risk, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLAIROther
Subject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start27 Feb 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 942 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toku Eyes Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Michael McConnell, MD, Study director, Toku Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808334
- Sponsor's protocol ID
- CPS-En01
- Status last verified
- Mar 2025
- First submitted
- 27 Jan 2025
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLAiR Pivotal Study
- ClinicalTrials.gov ID
- NCT06808334
- Acronym / sponsor ID
- CPS-En01
- Conditions
- No Condition
- Keywords
- retinal image, ASCVD, AI, cardiovascular risk, adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 942 participants (estimated)
- Lead sponsor
- Toku Eyes LtdIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Feb 2025 (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 is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.
Detailed description
This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (<7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.
The primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes/No elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and Females between the ages of 40-75 years of age.
Key inclusion criteria (3 listed)
- Male or female, aged 40-75 years
- Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
- Current use of cholesterol-lowering medication, such as a statin
- Pregnancy
- A person who has (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 |
|---|---|---|
| CLAIRSubject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention. | Other | – |
Primary outcome
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
Time frame: through study completion, an average of 6 months
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%
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 25 Mar 2025.
- 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.
Michael McConnell, MD study director
Toku Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Condition, run by Toku Eyes Ltd 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 8 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 25 Mar 2025. 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 Yariv Levinson ((240) 442 2479, yariv.levin@tokueyes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score. (time frame: through study completion, an average of 6 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 25 Mar 2025.