Abstract
Purpose: :
OCT images obtained during AMD clinical trials are often submitted for analysis by graders at reading centers. However the ability of independent graders to evaluate scan quality and grade images has not been reported. Herein we determined the OCT Reading Center at Duke inter–grader agreement for images produced for an interventional neovascular AMD clinical trial.
Methods: :
OCT was performed on eyes of patients enrolled in a neovascular AMD clinical trial using the Stratus OCT Fast Macular Thickness Map scan mode (6 radial scans/visit) and a 7mm high resolution scan centered on the fovea. Experienced OCT graders, certified to grade OCT scans according to a standardized protocol, first independently determined whether or not a scan was gradable. If gradable, each of the 6 scans and the 7mm scan for each visit was graded for: macular edema (ME), cysts (number and size), subretinal fluid (SRF), vitreomacular interface changes (VMI), epiretinal membrane (ERM), RPE elevations (RPED,number and size), RPE atrophy (RPEA), and CNV (size and morphological characteristics). To determine the inter–grader agreement, three grader pairs were studied; each pair member graded the scans independently. The pre–adjudication assessment of scan gradability, as well as the scan grades for each of the parameters, was compared among the graders.
Results: :
The inter–grader agreement was high for scan gradability; for three grader pairs combined, the percent agreement of whether a scan was gradable for CNV was 99%, for cysts was 98%, for ERM was 97%, for ME was 99%, for RPED was 98%, for RPEA was 98%, for SRF was 97%, and for VMI was 98%. Of the gradable scans, the percent inter–grader agreement for CNV was 89%, for cysts was 91%, for ERM was 90%, for ME was 84%, for RPED was 88%, for RPEA was 95%, for SRF was 90%, and for VMI was 90.5%. The agreement was similar for each parameter evaluated, among three different grader pairs.
Conclusions: :
Well–trained OCT graders can independently grade with a high level of inter–grader agreement multiple morphological parameters of OCT scans obtained from eyes with neovascular AMD. These scan data can be used to support interventional clinical trials of neovascular AMD.
Keywords: imaging methods (CT, FA, ICG, MRI, OCT, RTA, SLO, ultrasound) • age-related macular degeneration • imaging/image analysis: clinical