Precision Study of CLAiR AI Software

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.

NCT Number	NCT07747233
Lead Sponsor	Toku Eyes Ltd
Conditions	Cardiovascular Risk
Enrollment	56 participants
Start Date	2025-12-05
Primary Completion	2026-01-09 (estimated)
Study Completion	2026-01-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-05