Abstract
Purpose: :
To report Reading Center reproducibility during grading of Optical Coherence Tomography images obtained during the Comparisons of Age-Related Macular Degeneration Treatments Trials (CATT).
Methods: :
CATT readers performed standardized grading on OCT images. A reading team, composed of two independent readers and a Senior Reader, evaluated each scan. Grading included the CATT OCT endpoints of total thickness at the foveal center point and presence of intraretinal fluid (IRF), subretinal fluid (SRF), and sub-retinal pigment epithelium (RPE) fluid (sub-RPE fluid). Independent reading teams reevaluated 270 OCT scans randomly sampled from the first 2 years of CATT enrollment to determine reproducibility of qualitative grading and measurements. To assess temporal drift, a cohort of 23 scans submitted during the initial portion of the CATT study underwent repeated reproducibility analysis over the duration of the trial.
Results: :
Reading Center teams reproducibly graded intraretinal fluid (percent agreement = 73%, kappa = 0.48, 95% CI 0.38 to 0.58), subretinal fluid (percent agreement = 90%, kappa = 0.80, 95% CI 0.73 to 0.87), and sub-RPE fluid (percent agreement 88%, kappa = 0.75, 95% CI 0.67 to 0.83). For independent Reading Center team measurements of total thickness at the foveal center point, the intraclass correlation was 0.99 (95% CI 0.99 to 0.99) and the absolute difference was 18.9 ± 17.9 micrometers. There was no qualitative or quantitative grading drift.
Conclusions: :
The standardized protocols used to evaluate OCT scans from the CATT study were reproducible. The methods used are suitable to monitor OCT imaging data from a large neovascular age related macular degeneration interventional multicenter study.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00593450
Keywords: age-related macular degeneration • vascular endothelial growth factor • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials