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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Correct Lesion-Based Urgent Referral Triage Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed ophthalmologists
- •Willing to participate as readers
- •Completion of study training
排除标准
- •Retinal specialists involved in establishing gold-standard labels
- •Prior access to gold-standard labels
- •Incomplete study participation
研究组 & 干预措施
AI-Assisted Interpretation
Readers interpret UWF retinal images with lesion-level AI findings and urgent referral recommendations.
干预措施: AI-Assisted UWF Lesion-Based Triage System (Diagnostic Test)
Unassisted Interpretation
Readers interpret UWF retinal images without AI assistance.
干预措施: Unassisted Interpretation (Diagnostic Test)
结局指标
主要结局
Correct Lesion-Based Urgent Referral Triage Rate
时间窗: Through study completion, up to 2 months
Proportion of reader referral decisions consistent with expert-adjudicated lesion-based urgent referral classifications.
次要结局
- 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)
- Change in Correct Urgent Referral Decisions After AI Assistance(Through study completion, up to 2 months)
- Reader Confidence Score(Immediately after image interpretation.)
研究者
XiujuChen
Investigator
Xiamen Ophthalmology Center Affiliated to Xiamen University