Evaluation Procedures and Reproducibility of the Evaluation Procedures for Optical Coherence Tomography Images in the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study

Abstract

Purpose: : To report the evaluation procedures and reproducibility of the evaluation procedures for optical coherence tomography (OCT) images of participants in the Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study.

Methods: : The SCORE Study consists of 2 multicenter randomized trials investigating the safety and efficacy of standard of care versus intravitreal triamcinolone to treat macular edema secondary to central and branch retinal vein occlusion (RVO). OCT-measured change in central retinal thickness is a secondary outcome of the study. Retinal thickness is recorded from paper prints of Stratus OCT scans by certified ocular disease evaluators (ODEs) at a central reading center using a standardized procedure. Center point thickness is manually measured if necessary (e.g. if SD is >10%). Qualitative aspects of retinal morphology are also evaluated. Morphological assessment includes cystoid spaces, serous retinal detachment (SRD), and vitreoretinal interface abnormalities (VRIA). Quality control exercises include annual re-grading of images to assess reproducibility among ODEs.

Results: : A randomly selected set of 106 images was identified for annual regrades. Intergrader agreements for categories of overall quality are 91% and 89% at 1 and 2 years, respectively. The intraclass correlation coefficient for manually measured center point thickness was 0.99 each year. Reproducibility for the presence and location of cystoid spaces was 83% and 76%, respectively. Reproducibility of SRD and VRIA could not be assessed due to their limited presence in the sample.

Keywords: imaging methods (CT, FA, ICG, MRI, OCT, RTA, SLO, ultrasound) • vascular occlusion/vascular occlusive disease • clinical research methodology