Stratus OCT Quality Control in Two Multi-Centre Multiple Sclerosis Clinical Trials

Abstract

The University of California (UC) Davis Reading Center evaluated 19,961 scans from 981 subjects in two multiple sclerosis therapeutic trials with the aim of determining the influence of optical coherence tomography quality control procedures on error rates. There was no optical coherence tomography technician certification in Trial 1, and technicians had very limited monitoring and feedback during the trial in view of the fact that data were received retrospectively. However, technicians were certified in Trial 2 and submitted data in accordance with the protocol. Trial 2 scans had higher signal strengths, fewer errors, and more useable data than the scans in Trial 1. Thus, certified technicians and prompt transmission of data for ongoing quality control monitoring provided higher quality data in multiple sclerosis trials.

KEYWORDS:

• multiple sclerosis
• neuro-ophthalmology
• OCT
• quality control
• reading centre

ACKNOWLEDGEMENT

These studies are based on industry-supported trials and are supported by Research to Prevent Blindness (RPB).

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Note: Figures 1–4 of this article are available in colour online at www.informahealthcare.com/oph.