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

Wu Y 1 , Qian B 2 , Li T 2 , Qin Y 1 , Guan Z 2 , Chen T 3 Show all authors , Jia Y 4 , Zhang P 5 , Zeng D 1 , Moroi S 6 , Raman R 7 , Thinggaard BS 8 , Pedersen F 8 , Ñehe JAO 9 , Kamalden TA 10 , Zhou Y 11 , Jin Y 1 , Li H 2 , Ran AR 12 , Yang D 12 , Meng Z 2 , Peng Q 13 , Zheng YF 14 , Wang D 15 , Ji H 1 , Zang P 4 , Yin C 5 , Shen J 16 , Chen Y 17 , Yu W 17 , Dai R 18 , Zhang C 13 , Zhao X 17 , Wang X 19 , Chen Y 19 , Wu Q 19 , Xie H 20 , Szeto SKH 12 , Chan JYY 12 , Chan VTT 12 , Xie HT 21 , Wei R 22 , Li J 23 , Ma W 24 , Zhu L 25 , Wang H 25 , Fu H 26 , Wang W 27 , Lin S 28 , Xu Z 28 , Guan N 28 , Zhang X 29 , Grzybowski A 30 , Gołębiowska-Bogaj M 31 , Gawęcki M 31 , Smedowski A 32 , Szaraniec W 33 , Wu Y 34 , Wen Y 35 , Chen X 2 , Yao Y 2 , EyeFM Global Reader Study Team , Lim LL 36 , Cheung CY 13 , Tan GSW 37 , Grauslund J 38 , Ruamviboonsuk P 39 , Sivaprasad S 40 , Keane PA 40 , Wang YX 1 , Tham YC 13 , Cheng CY 13 , Wong TY 41 , Sheng B 42

Affiliations 

  • 1 Beijing Visual Science and Translational Eye Research Institute (BERI), Beijing Tsinghua Changgung Hospital Eye Center, Tsinghua Medicine, Tsinghua University, Beijing, China
  • 2 Shanghai Belt and Road International Joint Laboratory for Intelligent Prevention and Treatment of Metabolic Disorders, Department of Computer Science and Engineering, School of Electronic, Information, and Electrical Engineering, Institute for Proactive Healthcare, Shanghai Jiao Tong University, Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, China
  • 3 Department of Ophthalmology, Shanghai Health and Medical Centre, Wuxi, China
  • 4 Casey Eye Institute, Oregon Health and Science University, Portland, OR, USA
  • 5 Department of Computer Science and Engineering, The Ohio State University, Columbus, OH, USA
  • 6 Department of Ophthalmology & Visual Sciences, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH, USA
  • 7 Department of Ophthalmology, University of Florida College of Medicine, Jacksonville, FL, USA
  • 8 Department of Ophthalmology, Odense University Hospital, Odense, Denmark
  • 9 Department of Ophthalmology, Malabo Regional Hospital, Malabo, Equatorial Guinea
  • 10 Department of Ophthalmology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia
  • 11 NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK
  • 12 Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China
  • 13 Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore
  • 14 State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangzhou, China
  • 15 Department of Ophthalmology, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, China
  • 16 Medical Records and Statistics Office, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 17 Key Laboratory of Ocular Fundus Diseases, Chinese Academy of Medical Sciences, Beijing, China
  • 18 Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
  • 19 Department of Ophthalmology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 20 Shenzhen Eye Hospital, Shenzhen Eye Center, Southern Medical University, Shenzhen, China
  • 21 Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • 22 Department of Ophthalmology, The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital), Shanghai, China
  • 23 Department of Ophthalmology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 24 Institute for AI Industry Research, Tsinghua University, Beijing, China
  • 25 ROAS Thrust, Hong Kong University of Science and Technology (Guangzhou), Guangzhou, China
  • 26 Institute of High Performance Computing, Agency for Science, Technology and Research, Singapore, Singapore
  • 27 Key Laboratory of River Basic Digital Twinning of Ministry of Water Resources, Macau University of Science and Technology, Macao Special Administrative Region, Taipa, China
  • 28 Wuhan Bright Eye Hospital, Wuhan, China
  • 29 The People's Hospital of Sixian County, Anhui, China
  • 30 Institute for Research in Ophthalmology, Foundation for Ophthalmology Development, Poznan, Poland
  • 31 Department of Ophthalmology, Pomeranian Hospitals, Wejherowo, Poland
  • 32 Department of Pediatric Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland
  • 33 Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland
  • 34 School of Healthcare Management, Tsinghua Medicine, Tsinghua University, Beijing, China
  • 35 Guangdong Provincial Key Laboratory of Intelligent Information Processing, College of Electronics and Information Engineering, Shenzhen University, Shenzhen, China
  • 36 Department of Medicine, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia
  • 37 Centre for Innovation and Precision Eye Health and Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
  • 38 Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark
  • 39 Department of Ophthalmology, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand
  • 40 Institute of Ophthalmology, University College London, London, UK
  • 41 Beijing Visual Science and Translational Eye Research Institute (BERI), Beijing Tsinghua Changgung Hospital Eye Center, Tsinghua Medicine, Tsinghua University, Beijing, China. wongtienyin@tsinghua.edu.cn
  • 42 Shanghai Belt and Road International Joint Laboratory for Intelligent Prevention and Treatment of Metabolic Disorders, Department of Computer Science and Engineering, School of Electronic, Information, and Electrical Engineering, Institute for Proactive Healthcare, Shanghai Jiao Tong University, Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, China. shengbin@sjtu.edu.cn
Nat Med, 2025 Oct;31(10):3404-3413.
PMID: 40877476 DOI: 10.1038/s41591-025-03900-7

Abstract

In the context of an increasing need for clinical assessments of foundation models, we developed EyeFM, a multimodal vision-language eyecare copilot, and conducted a multifaceted evaluation, including retrospective validations, multicountry efficacy validation as a clinical copilot and a double-masked randomized controlled trial (RCT). EyeFM was pretrained on 14.5 million ocular images from five imaging modalities paired with clinical texts from global, multiethnic datasets. 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. 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. 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. The primary endpoint indicated that ophthalmologists with EyeFM copilot achieved higher correct diagnostic rate (92.2% versus 75.4%, P 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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