Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage of Ultra-Widefield Retinal Images

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiamen Ophthalmology Center Affiliated to Xiamen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Licensed ophthalmologists

Willing to participate as readers

Completion of study training

Disqualifiers

Retinal specialists involved in establishing gold-standard labels

Prior access to gold-standard labels

Incomplete study participation

Trial design

Design model

Factorial

Treatments tested in this trial

  • AI-Assisted UWF Lesion-Based Triage System

    Diagnostic test

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

  • Unassisted Interpretation

    Diagnostic test

    Readers interpret UWF retinal images without AI assistance.

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: AI-Assisted InterpretationExperimental treatment 1 intervention
Group B: Unassisted InterpretationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Correct Lesion-Based Urgent Referral Triage Rate

Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.

Time frame
Through study completion, up to 2 months

Secondary outcomes

1

Sensitivity for Urgent Referral Findings

Sensitivity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.

Time frame
Through study completion, up to 2 months
2

Specificity for Urgent Referral Findings

Specificity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.

Time frame
Through study completion, up to 2 months
3

False-Negative Rate for Urgent Referral Findings

Proportion of urgent referral images incorrectly classified as non-urgent referral by readers.

Time frame
Through study completion, up to 2 months
4

False-Positive Rate for Urgent Referral Findings

Proportion of non-urgent referral images incorrectly classified as urgent referral by readers.

Time frame
Through study completion, up to 2 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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