Department of Clinical Science and Community Health, University of Milan. Eye Clinic, San Giuseppe Hospital, IRCCS Multimedica, Milan, Italy.
Eye Contact Lens. 2020 Mar;46 Suppl 2:S141-S145. doi: 10.1097/ICL.0000000000000650.
The clinical, scientific, economic, and regulatory impact of validated biomarkers and surrogate endpoints has the potential to revolutionize the approach to ocular surface diseases. At present, there is a growing interest in developing biomarkers for dry eye disease, and other ocular surface disorders and imaging are of the most promising approaches to this issue. Among the several and constantly evolving imaging technologies, some tools that are aimed to assess tear film stability and volume, meibomian gland morphology and function, and ocular surface microanatomy are now supported by a good body of evidence. To date, clinical trials on ocular surface diseases have slowly started incorporating imaging biomarkers for disease diagnosis and stratification and as surrogate endpoints. Major efforts are still needed, mainly aimed to improve automatic acquisition and quantitative analysis, standardization (standard operating procedures, normative databases etc.), and validation of imaging biomarkers.
验证后的生物标志物和替代终点在临床上、科学上、经济上和法规方面的影响有可能彻底改变眼表疾病的处理方式。目前，人们对于开发干眼症和其他眼表疾病的生物标志物越来越感兴趣，而影像学则是解决这个问题最有前途的方法之一。在不断发展的多种影像学技术中，有一些工具旨在评估泪膜稳定性和容量、睑板腺形态和功能以及眼表微观结构，目前已经有了大量的证据支持。迄今为止，眼表疾病的临床试验已经开始缓慢地将影像学生物标志物纳入疾病诊断和分层以及替代终点的范畴。仍然需要做出重大努力，主要是为了改善自动采集和定量分析、标准化（标准操作规程、规范数据库等）以及验证影像学生物标志物。
