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

NCT07643129 | Not Yet Recruiting

• 1 other identifier: XMYKZX-KY-2026-011
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vision-Threatening Retinal Lesions; Urgent Referral Retinal Findings; Retinal Detachment; Pre-retinal Hemorrhage; Subretinal Hemorrhage; Retinal Neovascularization

Keywords

Artificial Intelligence; Urgent Referral; Lesion-Based Triage; Ultra-Widefield Imaging; Clinical Decision Support; Multi-Reader Multi-Case Study

Outcome Measures

Primary Outcomes (1)

• Correct Lesion-Based Urgent Referral Triage Rate

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

  Through study completion, up to 2 months

Secondary Outcomes (6)

• Sensitivity for Urgent Referral Findings

  Through study completion, up to 2 months

• Specificity for Urgent Referral Findings

  Through study completion, up to 2 months

• False-Negative Rate for Urgent Referral Findings

  Through study completion, up to 2 months

• False-Positive Rate for Urgent Referral Findings

  Through study completion, up to 2 months

• Reader Confidence Score

  Immediately after image interpretation.

Study Arms (2)

AI-Assisted Interpretation

EXPERIMENTAL

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

Diagnostic Test: AI-Assisted UWF Lesion-Based Triage System

Unassisted Interpretation

ACTIVE COMPARATOR

Readers interpret UWF retinal images without AI assistance.

Diagnostic Test: Unassisted Interpretation

Interventions

AI-Assisted UWF Lesion-Based Triage System DIAGNOSTIC_TEST

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

AI-Assisted Interpretation

Unassisted Interpretation DIAGNOSTIC_TEST

Readers interpret UWF retinal images without AI assistance.

Unassisted Interpretation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Licensed ophthalmologists
• Willing to participate as readers
• Completion of study training

You may not qualify if:

• Retinal specialists involved in establishing gold-standard labels
• Prior access to gold-standard labels
• Incomplete study participation

Sponsors & Collaborators

• Xiamen Ophthalmology Center Affiliated to Xiamen University: lead

MeSH Terms

Conditions

Retinal Detachment; Retinal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiuju Chen, md

CONTACT

+8618060955810; joyychen@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Each participating ophthalmologist will independently review a library of 600 UWF retinal images. For each reader, cases will be randomly assigned to either: * AI-assisted interpretation * Unassisted interpretation Readers will initially provide an interpretation without AI support. For AI-assigned cases, lesion-level AI findings and urgent referral recommendations will subsequently be displayed before final decision making.

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion: June 25, 2026
• Study Completion: June 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06