Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy rate
研究概览
简要总结
This study is a multicenter randomized controlled trial evaluating the effectiveness and safety of EyeAgent, a multimodal artificial intelligence (AI) agent designed to assist ophthalmologists in clinical decision-making. Participants will be recruited from ophthalmology clinics and hospitals in Hong Kong and mainland China. The AI agent acts as a digital co-pilot, analyzing patient images and clinical history to provide diagnostic and management recommendations. The trial aims to determine whether the use of the AI agent improves diagnostic accuracy, treatment decision-making performance, report generation, workflow efficiency, and user satisfaction compared to standard clinical practice.
详细描述
This multicenter, randomized controlled trial aims to evaluate the integration of EyeAgent, a multimodal artificial intelligence (AI) agent, in real-world clinical settings. The AI system is designed to support clinicians by analyzing patient data, including ocular images and electronic health records, to aid in image interpretation, diagnosis, and treatment planning.
A total of 300 participants will be randomly assigned to either an AI-assisted care arm or a standard care arm. In the AI-assisted arm, clinicians review the comprehensive report generated by AI agent as a supportive tool before finalizing their independent decisions. The study comprehensively measures diagnostic accuracy, the rate of inappropriate treatment decisions, report generation, workflow efficiency, and user questionnaire.
By comparing these two groups, the trial aims to provide robust evidence on the effectiveness and practical utility of AI-driven clinical decision support in ophthalmology, with the goal of enhancing both the quality and efficiency of patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient participants aged 6 to 75 years.
- •Participants who undergo ophthalmic examinations for medical purposes during the study period.
- •Participants who can produce clear ophthalmic images in both eyes.
- •Agree to participate in this study with written informed consent:
- •Participants aged 18 years or older provide their own consent.
- •Participants aged 6-17 years require consent from a parent or legal guardian.
排除标准
- •Participants who are reluctant to participate in this study.
- •Participants presenting with acute or emergency ocular conditions requiring immediate intervention.
- •Participants with poor quality of ophthalmic images, including blurriness, artifacts, underexposure, or overexposure.
- •Other unsuitable reasons determined by the evaluators.
研究组 & 干预措施
AI-assisted care arm
Clinicians perform report generation, diagnosis, and treatment planning with support from the EyeAgent system.
干预措施: EyeAgent AI system (Device)
Standard care arm
Clinicians provide routine ophthalmic care without support from the EyeAgent system.
结局指标
主要结局
Diagnostic accuracy rate
时间窗: Immediately after the intervention.
Proportion of diagnoses consistent with a reference expert panel.
Rate of inappropriate treatment decisions
时间窗: Immediately after the intervention.
The frequency of treatment recommendations (e.g., injection, laser therapy, or observation) that deviate from clinical guidelines as determined by the senior expert panel gold standard. Expert adjudication is conducted post-hoc after the enrollment phase concludes.
次要结局
- Report quality(Within 1 month after enrollment.)
- Clinician confidence(Immediately after the intervention.)
- Workflow efficiency(During the index diagnostic session.)
- Satisfaction and usability(At the end of each clinician's participation period, approximately 2 months.)