Randomised clinical trials (RCTs) are generally considered the gold-standard for providing scientific evidence for treatments' effectiveness and safety but their findings may not always be generalisable to the broader population treated in routine clinical practice. RCTs include highly selected patient populations that fit specific inclusion and exclusion criteria. Although they may have a lower level of certainty than RCTs on the evidence hierarchy, real-world data (RWD), such as observational studies, registries and databases, provide real-world evidence (RWE) that can complement RCTs. For example, RWE may help satisfy requirements for a new indication of an already approved drug and help us better understand long-term treatment effectiveness, safety and patterns of use in clinical practice. Many countries have set up registries, observational studies and databases containing information on patients with retinal diseases, such as diabetic macular oedema (DMO). These DMO RWD have produced significant clinical evidence in the past decade that has changed the management of DMO. RWD and medico-administrative databases are a useful resource to identify low frequency safety signals. They often have long-term follow-up with a large number of patients and minimal exclusion criteria. We will discuss improvements in healthcare information exchange technologies, such as blockchain technology and FHIR (Fast Healthcare Interoperability Resources), which will connect and extend databases already available. These registries can be linked with existing or emerging retinal imaging modalities using artificial intelligence to aid diagnosis, treatment decisions and provide prognostic information. The results of RCTs and RWE are combined to provide evidence-based guidelines.

随机临床试验 (RCT) 通常被认为是为治疗有效性和安全性提供科学证据的黄金标准，但其研究结果可能并不总是适用于常规临床实践中接受治疗的更广泛人群。随机对照试验包括精心挑选的符合特定纳入和排除标准的患者群体。尽管它们在证据层次上的确定性可能低于随机对照试验，但观察性研究、登记和数据库等真实世界数据 (RWD) 提供了可以补充随机对照试验的真实世界证据 (RWE)。例如，RWE 可能有助于满足已批准药物的新适应症的要求，并帮助我们更好地了解长期治疗效果、安全性和临床实践中的使用模式。许多国家已经建立了登记处、观察性研究和数据库，其中包含糖尿病性黄斑水肿（DMO）等视网膜疾病患者的信息。这些 DMO RWD 在过去十年中产生了重要的临床证据，改变了 DMO 的管理。RWD 和医疗管理数据库是识别低频安全信号的有用资源。他们通常对大量患者进行长期随访并采用最低限度的排除标准。我们将讨论医疗保健信息交换技术的改进，例如区块链技术和 FHIR（快速医疗保健互操作性资源），这些技术将连接和扩展现有的数据库。这些登记可以使用人工智能与现有或新兴的视网膜成像模式相联系，以帮助诊断、治疗决策并提供预后信息。RCT 和 RWE 的结果相结合，提供基于证据的指南。