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

Neuro-ophthalmology
John L KeltnerJohn S Werner

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.

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Citations

Sep 21, 2013·Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society·Kimberly M WingesJohn L Keltner
Nov 18, 2011·Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society·Reiko E SakaiLaura J Balcer
Nov 8, 2017·Multiple Sclerosis : Clinical and Laboratory Research·Kimberly M WingesRebecca I Spain
Dec 1, 2014·Brain : a Journal of Neurology·Laura J BalcerJeffrey A Cohen

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