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 volunteersQualifiers
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
Factorial
Treatments tested in this trial
AI-Assisted UWF Lesion-Based Triage System
Diagnostic testReaders interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.
Unassisted Interpretation
Diagnostic testReaders interpret UWF retinal images without AI assistance.
Treatment groups
Trial outcomes
Primary outcomes
Correct Lesion-Based Urgent Referral Triage Rate
Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.
Secondary outcomes
Sensitivity for Urgent Referral Findings
Sensitivity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
Specificity for Urgent Referral Findings
Specificity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
False-Negative Rate for Urgent Referral Findings
Proportion of urgent referral images incorrectly classified as non-urgent referral by readers.
False-Positive Rate for Urgent Referral Findings
Proportion of non-urgent referral images incorrectly classified as urgent referral by readers.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: