Evaluation of the standard test methods for optical coherence tomograph for the posterior segment of the human eye

Abstract

Optical Coherence Tomography (OCT) has revolutionized retinal imaging by offering non-invasive high-resolution three-dimensional visualization capabilities. OCT has become the standard of care in routine ophthalmological practice, especially for the posterior segment. Given its widespread clinical applications, establishing standardized test devices and methods for key OCT parameters is imperative to ensure both optimal imaging performance and diagnostic accuracy and treatment effectiveness. As a widely applied standard, ISO 16971:2015 published by the International Organization for Standardization specifies the minimum requirements, test device, and methods for OCT for the posterior segment of the human eye. Notably, these standards lacked experimental validation. In the present study, we implement the test device according to ISO 16971:2015, and assess a commercially available ophthalmic OCT instrument with the suggested test device and methods. Results show that the test device and methods could facilitate a rudimentary evaluation of OCT key parameters. Nevertheless, refinements of the test device and methods are requisite to enhance measurement accuracy, reliability, traceability, and practicability, catering to the diverse needs of manufacturers, end-users, and regulatory entities.