An eyecare foundation model for clinical assistance: a randomized controlled trial.

EyeFM was pretrained on 14.5 million ocular images from five imaging modalities paired with clinical texts from global, multiethnic datasets.

EyeFM在来自五个成像模态的1450万张眼部图像上进行了预训练，这些图像与来自全球多民族数据集的临床文本配对。

Efficacy validation invited 44 ophthalmologists across North America, Europe, Asia and Africa in primary and specialty care settings, highlighting its utility as a clinical copilot.

有效性验证邀请了来自北美、欧洲、亚洲和非洲的44名眼科医生，在初级和专科护理环境中进行，突显了其作为临床辅助工具的实用性。

The RCT-a parallel, single-center, double-masked study-assessed EyeFM as a clinical copilot in retinal disease screening among a high-risk population in China.

这项随机对照试验（RCT）-一项平行的、单中心的、双盲研究-评估了EyeFM作为临床辅助工具在中国高风险人群中的视网膜疾病筛查中的应用。

A total of 668 participants (mean age 57.5 years, 79.5% male) were randomized to 16 ophthalmologists, equally allocated into intervention (with EyeFM copilot) and control (standard care) groups.

共有668名参与者（平均年龄57.5岁，79.5%为男性）被随机分配给16名眼科医生，干预组（使用EyeFM辅助工具）和对照组（标准护理）的分配人数相等。

The primary endpoint indicated that ophthalmologists with EyeFM copilot achieved higher correct diagnostic rate (92.2% versus 75.4%, P < 0.001) and referral rate (92.2% versus 80.5%, P < 0.001).

主要终点指标显示，使用EyeFM辅助工具的眼科医生达到了更高的正确诊断率（92.2%对比75.4%，P < 0.001）和转诊率（92.2%对比80.5%，P < 0.001）。

Secondary outcome indicated improved standardization score of clinical reports (median 33 versus 37, P < 0.001).

次要结果表明，临床报告的标准评分有所提高（中位数33对比37，P<0.001）。

Participant satisfaction with the screening was similar between groups, whereas the intervention group demonstrated higher compliance with self-management (70.1% versus 49.1%, P < 0.001) and referral suggestions (33.7% versus 20.2%, P < 0.001) at follow-up.

两组参与者对筛查的满意度相似，然而在随访时，干预组在自我管理（70.1%对比49.1%，P<0.001）和遵循转诊建议（33.7%对比20.2%，P<0.001）方面的依从性更高。

Post-deployment evaluations indicated strong user acceptance.

部署后的评估显示了用户的高度接受度。

Our study provided evidence that implementing EyeFM copilot can improve the performance of ophthalmologists and the outcome of patients.

我们的研究提供了证据，表明实施EyeFM辅助系统可以提高眼科医生的工作表现和患者的治疗结果。

Chinese Clinical Trial Registry registration: ChiCTR2500095518 .

中国临床试验注册中心注册号：ChiCTR2500095518 .