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.
Ultra-widefield retinal imaging is increasingly used for retinal disease screening and referral triage. Many vision-threatening retinal abnormalities require timely identification and referral to retinal specialists. The AI system evaluated in this study is designed as a lesion-based triage tool rather than a disease-diagnosis system. The model identifies predefined urgent referral retinal findings and generates referral recommendations based on lesion-level evidence. Urgent referral findings include: * Retinal detachment * Untreated retinal tear or retinal hole * Vitreous hemorrhage * Pre-retinal hemorrhage * Subretinal hemorrhage * Retinal neovascularization * Optic disc neovascularization * Tractional fibrovascular membrane Treated retinal tears associated with laser barricade scars are classified as non-urgent referral findings. A total of 600 UWF retinal images acquired using Zeiss and Optos imaging systems will be included. Participating ophthalmologists will independently evaluate images in randomized AI-assisted and unassisted settings. The primary objective is to determine whether AI assistance improves lesion-based urgent referral triage accuracy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
Readers interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.
Readers interpret UWF retinal images without AI assistance.
Correct Lesion-Based Urgent Referral Triage Rate
Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.
Time frame: Immediately after image interpretation.
Sensitivity for Urgent Referral Findings
Sensitivity for Urgent Referral Findings
Time frame: Immediately after image interpretation.
Specificity for Urgent Referral Findings
Specificity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
Time frame: Immediately after image interpretation.
False-Negative Rate for Urgent Referral Findings
Proportion of urgent referral images incorrectly classified as non-urgent referral by readers.
Time frame: Immediately after image interpretation.
False-Positive Rate for Urgent Referral Findings
Proportion of non-urgent referral images incorrectly classified as urgent referral by readers.
Time frame: Immediately after image interpretation.
Reader Confidence Score
Reader-reported confidence level for referral decisions measured using a 5-point Likert scale, ranging from 1 (very uncertain) to 5 (very confident).
Time frame: Immediately after image interpretation.
Change in Correct Urgent Referral Decisions After AI Assistance
Number and proportion of cases in which AI assistance changed an incorrect referral decision to a correct referral decision.
Time frame: Immediately after image interpretation.
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