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Precision Study of CLAiR AI Software

NCT07747233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-08-05

No results posted yet for this study

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. 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.

Conditions

  • Cardiovascular Risk

Interventions

DEVICE

CLAiR Artificial Intelligence Software

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.

Sponsors & Collaborators

  • Toku Eyes Ltd

    lead INDUSTRY

Principal Investigators

  • Michael Mcconnell, MD · Toku Eyes

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-01-09
Completion
2026-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747233 on ClinicalTrials.gov