Role of the OCT Reading Center

Abstract

Clinical studies are increasingly employing optical coherence tomography (OCT) as an outcome measure in order to quantify the effects of disease and/or treatment on retinal and neuronal structures. To ensure the most accurate data possible, it is essential that the OCT scans are of usable quality and that the values of interest are extracted in a precise, objective manner without regard to the study outcome or clinical status of the individual patients. As such, studies typically utilize many patients spread across different national or international sites, with data acquired by different examiners who may be aware of the status of individual participants. A reading center (RC) may be employed in order to minimize bias and error. In the following chapter, we discuss the role of the RC in clinical studies with regard to developing a scan protocol, interaction with sponsors and regulatory authorities, training and certification of operators at different study sites, data processing and storage, and objective analysis of OCT data. The importance of operator training, correct OCT scan labeling, patient confidentiality, and the blinding of raters to the clinical status of patients is emphasized. Only with strict attention to such factors can OCT be used as an accurate, precise, and objective outcome measure in clinical studies.