Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage of Ultra-Widefield Retinal Images (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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Xiuju Chen, md
- Telefoonnummer: +8618060955810
- E-mail: joyychen@aliyun.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: Unassisted Interpretation
Readers interpret UWF retinal images without AI assistance.
|
Readers interpret UWF retinal images without AI assistance.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correct Lesion-Based Urgent Referral Triage Rate
Tijdsspanne: Through study completion, up to 2 months
|
Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.
|
Through study completion, up to 2 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reader Confidence Score
Tijdsspanne: 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.
|
|
Sensitivity for Urgent Referral Findings
Tijdsspanne: Through study completion, up to 2 months
|
Sensitivity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
|
Through study completion, up to 2 months
|
|
Specificity for Urgent Referral Findings
Tijdsspanne: Through study completion, up to 2 months
|
Specificity for correctly classifying non-urgent referral images according to expert-adjudicated lesion-based triage labels.
|
Through study completion, up to 2 months
|
|
False-Negative Rate for Urgent Referral Findings
Tijdsspanne: Through study completion, up to 2 months
|
Proportion of urgent referral images incorrectly classified as non-urgent referral by readers.
|
Through study completion, up to 2 months
|
|
False-Positive Rate for Urgent Referral Findings
Tijdsspanne: Through study completion, up to 2 months
|
Proportion of non-urgent referral images incorrectly classified as urgent referral by readers.
|
Through study completion, up to 2 months
|
|
Change in Correct Urgent Referral Decisions After AI Assistance
Tijdsspanne: Through study completion, up to 2 months
|
Number and proportion of cases in which AI assistance changed an incorrect referral decision to a correct referral decision.
|
Through study completion, up to 2 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- XMYKZX-KY-2026-011
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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