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.

Baseline OCT Measurements in the Idiopathic Intracranial Hypertension Treatment Trial, Part I: Quality Control, Comparisons, and Variability

“…21 The success of this study, which used 24 sites naïve to SD-OCT data collection, shows the utility of an OCTRC. [22][23][24][25][26][27] Interocular correlations for all SD-OCT parameters reflecting papilledema-related swelling in the ONH or peripapillary retina were highly significant. The OCT continuous variable measures showed that most IIH patients, with newly diagnosed disease and mild visual field loss (PMD range, À2.00 to À7.00 dB), have relatively symmetrical amounts of papilledema.…”

Baseline Retinal Nerve Fiber Layer Thickness and Macular Volume Quantified by OCT in the North American Phase 3 Fingolimod Trial for Relapsing–Remitting Multiple Sclerosis

“…The OCT Reading Center received 18,733 scans from 939 patients at 96 sites. From this database, 2,880 high-quality representative OCT scans determined by the above strict quality control criteria (24) were selected. Only patients with complete data of each eye’s macula and RNFL were used, representing 1,434 eyes in 717 patients.…”

“…As published previously, scans were excluded from the final database if they met any of the following criteria: signal strength less than 7 (except in the case of a few clearly visible fovea or optic nerve scans with correct centration), exported data missing, extra scans, decentered scans, wrong scans or scanner used, or they required redraw by the technician due to segmentation artifact (24). …”

Vision and vision-related outcome measures in multiple sclerosis

“…Longitudinal studies of OCT underscore the value of a central OCT reading centre for clinical trials ( Keltner et al , 2011 ). Analogous to a central MRI reading centre, which has become the standard approach in multiple sclerosis trials, a central OCT reading centre would be responsible for training sites in standardized image acquisition procedures, developing case report forms, and deploying computerized retinal segmentation software.…”