Reading Center Characterization of Central Retinal Vein Occlusion Using Optical Coherence Tomography During the COPERNICUS Trial.

PURPOSE: To determine the impact of segmentation error correction and precision of standardized grading of time domain optical coherence tomography (OCT) scans obtained during an interventional study for macular edema secondary to central retinal vein occlusion (CRVO).

METHODS: A reading center team of two readers and a senior reader evaluated 1199 OCT scans. Manual segmentation error correction (SEC) was performed. The frequency of SEC, resulting change in central retinal thickness after SEC, and reproducibility of SEC were quantified. Optical coherence tomography characteristics associated with the need for SECs were determined. Reading center teams graded all scans, and the reproducibility of this evaluation for scan quality at the fovea and cystoid macular edema was determined on 97 scans.

RESULTS: Segmentation errors were observed in 360 (30.0%) scans, of which 312 were interpretable. On these 312 scans, the mean machine-generated central subfield thickness (CST) was 507.4 ± 208.5 μm compared to 583.0 ± 266.2 μm after SEC. Segmentation error correction resulted in a mean absolute CST correction of 81.3 ± 162.0 μm from baseline uncorrected CST. Segmentation error correction was highly reproducible (intraclass correlation coefficient [ICC] = 0.99-1.00). Epiretinal membrane (odds ratio [OR] = 2.3, P < 0.0001), subretinal fluid (OR = 2.1, P = 0.0005), and increasing CST (OR = 1.6 per 100-μm increase, P < 0.001) were associated with need for SEC. Reading center teams reproducibly graded scan quality at the fovea (87% agreement, kappa = 0.64, 95% confidence interval [CI] 0.45-0.82) and cystoid macular edema (92% agreement, kappa = 0.84, 95% CI 0.74-0.94).

CONCLUSIONS: Optical coherence tomography images obtained during an interventional CRVO treatment trial can be reproducibly graded. Segmentation errors can cause clinically meaningful deviation in central retinal thickness measurements; however, these errors can be corrected reproducibly in a reading center setting.

TRANSLATIONAL RELEVANCE: Segmentation errors are common on these images, can cause clinically meaningful errors in central retinal thickness measurement, and can be corrected reproducibly in a reading center setting.