TY - JOUR
T1 - The impact of utilizing different optical coherence tomography devices for clinical purposes and in multiple sclerosis trials
AU - Warner, Christina V.
AU - Syc, Stephanie B.
AU - Stankiewicz, Aleksandra M.
AU - Hiremath, Girish
AU - Farrell, Sheena K.
AU - Crainiceanu, Ciprian M.
AU - Conger, Amy
AU - Frohman, Teresa C.
AU - Bisker, Esther R.
AU - Balcer, Laura J.
AU - Frohman, Elliot M.
AU - Calabresi, Peter A.
AU - Saidha, Shiv
N1 - Funding Information:
Dr. Laura Balcer has served as a consultant to Biogen Idec for development of visual outcome measures for MS trials. She is also on the advisory board for an MS trial sponsored by Biogen Idec. Dr. Elliot Frohman has received speaker honoraria and consulting fees from Biogen Idec, TEVA, and Athena. He has also received consulting fees from Abbott Laboratories. Dr. Shiv Saidha has received consulting fees from MedicalLogix for the development of continuing medical education programs. Dr. Peter Calabresi has provided consultation services to Novartis, Teva, Biogen-IDEC, and has received grant support from EMD-Serono, Teva, Biogen-IDEC, Genentech, Bayer, Abbott, and Vertex. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.
PY - 2011
Y1 - 2011
N2 - Optical coherence tomography (OCT) derived retinal measures, particularly peri-papillary retinal nerve fiber layer (RNFL) thickness, have been proposed as outcome measures in remyelinating and neuroprotective trials in multiple sclerosis (MS). With increasing utilization of multiple centers to improve power, elucidation of the impact of different OCT technologies is crucial to the design and interpretation of such studies. In this study, we assessed relation and agreement between RNFL thickness and total macular volume (in MS and healthy controls) derived from three commonly used OCT devices: Stratus time-domain OCT, and Cirrus HD-OCT and Spectralis, two spectral-domain (SD) OCT devices. OCT was performed on both Cirrus HD-OCT and Stratus in 229 participants and on both Cirrus HD-OCT and Spectralis in a separate cohort of 102 participants. Pearson correlation and Bland-Altman analyses were used to assess correlation and agreement between devices. All OCT retinal measures correlated highly between devices. The mean RNFL thickness was 7.4 μm lower on Cirrus HD-OCT than Stratus, indicating overall poor agreement for this measurement between these machines. Further, the limits of agreement (LOA) between Cirrus HD-OCT and Stratus were wide (-4.1 to 18.9 μm), indicating poor agreement at an individual subject level. The mean RNFL thickness was 1.94 μm (LOA: -5.74 to 9.62 μm) higher on Spectralis compared to Cirrus HD-OCT, indicating excellent agreement for this measurement across this cohort. Although these data indicate that these three devices agree poorly at an individual subject level (evidenced by wide LOA in both study cohorts) precluding their co-utilization in everyday practice, the small difference for mean measurements between Cirrus HD-OCT and Spectralis indicate pooled results from these two SD-devices could be used as outcome measures in clinical trials, provided patients are scanned on the same machine throughout the trial, similar to the utilization of multiple different MRI platforms in MS clinical trials.
AB - Optical coherence tomography (OCT) derived retinal measures, particularly peri-papillary retinal nerve fiber layer (RNFL) thickness, have been proposed as outcome measures in remyelinating and neuroprotective trials in multiple sclerosis (MS). With increasing utilization of multiple centers to improve power, elucidation of the impact of different OCT technologies is crucial to the design and interpretation of such studies. In this study, we assessed relation and agreement between RNFL thickness and total macular volume (in MS and healthy controls) derived from three commonly used OCT devices: Stratus time-domain OCT, and Cirrus HD-OCT and Spectralis, two spectral-domain (SD) OCT devices. OCT was performed on both Cirrus HD-OCT and Stratus in 229 participants and on both Cirrus HD-OCT and Spectralis in a separate cohort of 102 participants. Pearson correlation and Bland-Altman analyses were used to assess correlation and agreement between devices. All OCT retinal measures correlated highly between devices. The mean RNFL thickness was 7.4 μm lower on Cirrus HD-OCT than Stratus, indicating overall poor agreement for this measurement between these machines. Further, the limits of agreement (LOA) between Cirrus HD-OCT and Stratus were wide (-4.1 to 18.9 μm), indicating poor agreement at an individual subject level. The mean RNFL thickness was 1.94 μm (LOA: -5.74 to 9.62 μm) higher on Spectralis compared to Cirrus HD-OCT, indicating excellent agreement for this measurement across this cohort. Although these data indicate that these three devices agree poorly at an individual subject level (evidenced by wide LOA in both study cohorts) precluding their co-utilization in everyday practice, the small difference for mean measurements between Cirrus HD-OCT and Spectralis indicate pooled results from these two SD-devices could be used as outcome measures in clinical trials, provided patients are scanned on the same machine throughout the trial, similar to the utilization of multiple different MRI platforms in MS clinical trials.
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U2 - 10.1371/journal.pone.0022947
DO - 10.1371/journal.pone.0022947
M3 - Article
C2 - 21853058
AN - SCOPUS:80051635035
SN - 1932-6203
VL - 6
JO - PloS one
JF - PloS one
IS - 8
M1 - e22947
ER -