Use of the Keratograph® 5M for the Diagnosis of Dry Eye Disease: A Scoping Review

Dry Eye Disease (DED) is a multifactorial disorder of the ocular surface characterized by tear film instability and associated ocular symptoms. Objective assessment of tear film parameters and meibomian gland function is essential for accurate diagnosis and subtype classification. In recent years, non-invasive imaging technologies have been increasingly incorporated into clinical practice to enhance diagnostic precision and reduce variability associated with traditional tests. The Keratograph® 5M (Oculus Optikgeräte GmbH, Germany) is a Placido-disc–based corneal topographer that integrates automated, non-contact measurements of tear film stability and ocular surface parameters. The device provides non-invasive break-up time (NIBUT), tear meniscus height (TMH), meibography, ocular redness quantification, and additional surface analyses. Although widely used in ophthalmology and optometry settings, the scope, consistency, and characteristics of the published evidence regarding its diagnostic application in DED have not been comprehensively mapped. The purpose of this scoping review is to systematically identify, describe, and synthesize the available scientific literature evaluating the use of the Keratograph® 5M in the diagnosis of Dry Eye Disease. Specifically, this review aims to: (1) map the clinical contexts in which the device has been studied; (2) describe the tear film and glandular parameters assessed; (3) summarize reported measurement properties (e.g., repeatability, reproducibility); and (4) identify research gaps related to diagnostic performance and clinical implementation. This review will follow established methodological guidance for scoping reviews and will include peer-reviewed primary studies evaluating the Keratograph® 5M in adult or mixed populations undergoing assessment for DED or related ocular surface conditions. Data extraction will focus on study design, population characteristics, diagnostic parameters evaluated, reference standards (when applicable), and key findings. No formal meta-analysis is planned, as the objective is evidence mapping rather than quantitative synthesis. Expected outcomes include a structured overview of the current evidence landscape, identification of methodological heterogeneity in diagnostic assessment, and clarification of how the Keratograph® 5M is positioned within the diagnostic pathway of DED. The findings may inform future diagnostic accuracy studies, health technology assessments, and clinical guideline development.