Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage of Ultra-Widefield Retinal Images: A Multi-Reader Multi-Case Randomized Reader Study (ALERT-UWF)
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xiuju Chen, md
- Numéro de téléphone: +8618060955810
- E-mail: joyychen@aliyun.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Licensed ophthalmologists
- Willing to participate as readers
- Completion of study training
Exclusion Criteria:
- Retinal specialists involved in establishing gold-standard labels
- Prior access to gold-standard labels
- Incomplete study participation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AI-Assisted Interpretation
Readers interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.
|
Readers interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.
|
|
Comparateur actif: Unassisted Interpretation
Readers interpret UWF retinal images without AI assistance.
|
Readers interpret UWF retinal images without AI assistance.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correct Lesion-Based Urgent Referral Triage Rate
Délai: Immediately after image interpretation.
|
Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.
|
Immediately after image interpretation.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity for Urgent Referral Findings
Délai: Immediately after image interpretation.
|
Sensitivity for Urgent Referral Findings
|
Immediately after image interpretation.
|
|
Specificity for Urgent Referral Findings
Délai: Immediately after image interpretation.
|
Specificity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
|
Immediately after image interpretation.
|
|
False-Negative Rate for Urgent Referral Findings
Délai: Immediately after image interpretation.
|
Proportion of urgent referral images incorrectly classified as non-urgent referral by readers.
|
Immediately after image interpretation.
|
|
False-Positive Rate for Urgent Referral Findings
Délai: Immediately after image interpretation.
|
Proportion of non-urgent referral images incorrectly classified as urgent referral by readers.
|
Immediately after image interpretation.
|
|
Reader Confidence Score
Délai: Immediately after image interpretation.
|
Reader-reported confidence level for referral decisions measured using a 5-point Likert scale, ranging from 1 (very uncertain) to 5 (very confident).
|
Immediately after image interpretation.
|
|
Change in Correct Urgent Referral Decisions After AI Assistance
Délai: Immediately after image interpretation.
|
Number and proportion of cases in which AI assistance changed an incorrect referral decision to a correct referral decision.
|
Immediately after image interpretation.
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- XMYKZX-KY-2026-011
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .