人工智能(AI)技术在医学领域的应用是当前的热点。眼科作为医学领域中的AI应用前沿专业之一，运用机器学习技术应用于诊断、干预和预测眼科疾病方面取得了显著的成果。基于眼科AI临床研究的需求，为契合眼科AI临床诊疗发展的实际情况，中国医药教育协会眼科影像与智能医疗分会和智能医学专业委员会组织专家结合近年来国内外AI临床研究的评价报告，经过多轮讨论和修改，形成了针对眼科AI临床研究的评价指南。该指南包括了眼科AI临床研究评价指南制定的背景和方法、AI临床研究评价的国际指南介绍、眼科AI临床研究评价方法等内容，详细介绍了眼科AI临床研究通用评价方法、眼科AI临床研究模型评价方法、常用眼科AI临床研究模型评价指标和计算公式，并详细阐述了眼科AI临床试验评价方法。该指南的制定旨在为眼科AI临床研究人员提供指导和规范，并推动眼科AI临床研究的评价向着规范化和标准化方向发展，进一步提高眼科AI临床研究评价的整体水平。

With the upsurge of artificial intelligence(AI)technology in the medical field, its application in ophthalmology has become a cutting-edge research field. Notably, machine learning techniques have shown remarkable achievements in diagnosing, intervening, and predicting ophthalmic diseases. To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI, the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Special Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification. The main content includes the background and method of developing this guideline, introduction to international guidelines on the clinical research evaluation of AI, and the evaluation methods of ophthalmic AI models. This guideline introduces general evaluation methods of clinical ophthalmic AI research, evaluation methods of clinical AI models, and common indices and formulae for clinical AI model evaluation in detail, and amply elaborates the evaluation method of clinical ophthalmic AI trials. This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI, promote the development of regularization and standardization, and further improve the overall level of clinical ophthalmic AI research evaluations.

国家自然科学基金资助项目(No.61906066); 深圳市医疗卫生三名工程项目(No.SZSM202011015); 深圳市科技计划项目(No.KCXFZ20211020163813019)