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NOT YET RECRUITING
NCT07643129
NA

Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage of Ultra-Widefield Retinal Images: A Multi-Reader Multi-Case Randomized Reader Study

Sponsor: Xiamen Ophthalmology Center Affiliated to Xiamen University

View on ClinicalTrials.gov

Summary

his study evaluates the clinical utility of an artificial intelligence (AI)-assisted lesion-based urgent referral triage system for ultra-widefield (UWF) retinal images. Unlike disease-classification systems, the AI system identifies predefined vision-threatening retinal findings and generates lesion-level urgent referral recommendations. Participating ophthalmologists will evaluate UWF retinal images under randomized AI-assisted and unassisted conditions. The primary objective is to determine whether lesion-based AI assistance improves urgent referral triage performance compared with unaided image interpretation.

Official title: Clinical Utility of an Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage System for Ultra-Widefield Retinal Images: A Prospective Multi-Reader Multi-Case Randomized Reader Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-06-15

Completion Date

2026-06-30

Last Updated

2026-06-11

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

AI-Assisted UWF Lesion-Based Triage System

Readers interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.

DIAGNOSTIC_TEST

Unassisted Interpretation

Readers interpret UWF retinal images without AI assistance.