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NCT06808334 · ClinicalTrials.gov registry record

CLAiR Pivotal Study

A clinical trial of No Condition, sponsored by Toku Eyes.

Recruiting
Registry status
942
Enrollment target
1
Study location

NCT06808334: Recruiting study of No Condition, sponsored by Toku Eyes.

NCT06808334 is a study of No Condition that is actively recruiting participants, run by Toku Eyes. The registered enrollment target is 942 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06808334, a study of No Condition, is actively recruiting participants, sponsored by Toku Eyes.

RECRUITING
Registry status
942 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%

Conditions Studied

Interventions

  • OTHER CLAIR

Study Locations (1)

Ohio

  • Diabetes and Endocrine Associates of Stark County - Canton

Trial Details

FieldValue
Enrollment Target 942 participants
Start Date 2025-02-27
Est. Completion 2025-10-01
Toku Eyes

1 total trials

What NCT06808334 shows while recruiting

NCT06808334 is an observational study that tracks outcomes without assigning an intervention. The registered 942 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with No Condition appearing as the primary indexed condition, and to 1 intervention - of which CLAIR is the first listed.

NCT06808334 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT06808334 about?

NCT06808334 is a clinical study titled "CLAiR Pivotal 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.

What is the current status of trial NCT06808334?

This trial is currently recruiting. The enrollment target is 942 participants. The study started on 2025-02-27. Estimated completion is 2025-10-01.

What conditions does trial NCT06808334 study?

This clinical trial studies the following conditions: No Condition.

What interventions are being tested in trial NCT06808334?

The interventions under investigation include: CLAIR (OTHER).

Who is sponsoring clinical trial NCT06808334?

This trial is sponsored by Toku Eyes, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06808334 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06808334, the US trial registry maintained by the National Library of Medicine. NCT06808334 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.