Byers Eye Institute, Stanford University, Palo Alto, California.
Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
Ophthalmology. 2022 May;129(5):e43-e59. doi: 10.1016/j.ophtha.2022.01.002. Epub 2022 Jan 10.
Health care systems worldwide are challenged to provide adequate care for the 200 million individuals with age-related macular degeneration (AMD). Artificial intelligence (AI) has the potential to make a significant, positive impact on the diagnosis and management of patients with AMD; however, the development of effective AI devices for clinical care faces numerous considerations and challenges, a fact evidenced by a current absence of Food and Drug Administration (FDA)-approved AI devices for AMD.
To delineate the state of AI for AMD, including current data, standards, achievements, and challenges.
Members of the Collaborative Community on Ophthalmic Imaging Working Group for AI in AMD attended an inaugural meeting on September 7, 2020, to discuss the topic. Subsequently, they undertook a comprehensive review of the medical literature relevant to the topic. Members engaged in meetings and discussion through December 2021 to synthesize the information and arrive at a consensus.
Existing infrastructure for robust AI development for AMD includes several large, labeled data sets of color fundus photography and OCT images; however, image data often do not contain the metadata necessary for the development of reliable, valid, and generalizable models. Data sharing for AMD model development is made difficult by restrictions on data privacy and security, although potential solutions are under investigation. Computing resources may be adequate for current applications, but knowledge of machine learning development may be scarce in many clinical ophthalmology settings. Despite these challenges, researchers have produced promising AI models for AMD for screening, diagnosis, prediction, and monitoring. Future goals include defining benchmarks to facilitate regulatory authorization and subsequent clinical setting generalization.
Delivering an FDA-authorized, AI-based device for clinical care in AMD involves numerous considerations, including the identification of an appropriate clinical application; acquisition and development of a large, high-quality data set; development of the AI architecture; training and validation of the model; and functional interactions between the model output and clinical end user. The research efforts undertaken to date represent starting points for the medical devices that eventually will benefit providers, health care systems, and patients.
全球医疗保健系统面临着为 2 亿名与年龄相关的黄斑变性(AMD)患者提供足够护理的挑战。人工智能(AI)有可能对 AMD 患者的诊断和管理产生重大积极影响;然而,为临床护理开发有效的 AI 设备面临着众多考虑因素和挑战,这一事实从目前缺乏 FDA 批准的 AMD 人工智能设备就可以证明。
描述 AMD 的 AI 现状,包括当前的数据、标准、成就和挑战。
AMD 人工智能协作社区成像工作组的成员于 2020 年 9 月 7 日举行了首次会议,讨论该主题。随后,他们对与该主题相关的医学文献进行了全面审查。成员们通过 2021 年 12 月的会议和讨论来综合信息并达成共识。
现有的用于 AMD 的强大 AI 开发基础设施包括几个大型的、带有彩色眼底摄影和 OCT 图像标签的数据;然而,图像数据通常不包含开发可靠、有效和可推广模型所需的元数据。尽管正在研究潜在的解决方案,但由于对数据隐私和安全的限制,AMD 模型开发的数据共享变得困难。尽管存在这些挑战,研究人员还是为 AMD 的筛查、诊断、预测和监测开发了有前途的 AI 模型。未来的目标包括定义基准,以促进监管授权和随后在临床环境中的推广。
为 AMD 临床护理提供 FDA 授权的基于 AI 的设备涉及众多考虑因素,包括确定合适的临床应用;获取和开发大型、高质量数据集;开发 AI 架构;训练和验证模型;以及模型输出与临床最终用户之间的功能交互。迄今为止开展的研究工作代表了最终将使提供者、医疗保健系统和患者受益的医疗器械的起点。