Imaging Biomarkers for Dry Eye Disease.

Abstract

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.