Original articlePeripheral Lesions Identified by Mydriatic Ultrawide Field Imaging: Distribution and Potential Impact on Diabetic Retinopathy Severity
Section snippets
Methods
A single-site, prospective, clinic-based, comparative instrument validation study evaluated agreement among nonmydriatic 100/200–degree images (Optomap; Optos plc), mydriatic 200-degree images (DiSLO200), DFE, and stereoscopic ETDRS 7-field 35-mm color film slides in determining DR severity. The retinal distribution of DR lesions and the agreement of DiSLO200 for DR severity with ETDRS film photographs and DFE were determined. The study design was consistent with the tenets of the Declaration
Results
A total of 206 eyes of 103 patients with type 1 or 2 diabetes were enrolled in this study. Mydriatic ultrawide field imaging was performed and completed in 204 eyes (99%) (1 patient [2 eyes] refused imaging). Complete ETDRS film photographs were available in 200 eyes (97.1%) (1 patient [2 eyes] refused imaging with film, and in 4 eyes of 4 different patients the film did not advance in the camera or the 35-mm slides were not returned from the processing laboratory). Table 1 shows the subject
Discussion
Mydriatic ultrawide field imaging demonstrated substantial agreement with ETDRS film photographs and DFE in determining DR severity, with 94.5% of eyes within 1 step of agreement. Compared with nonmydriatic ultrawide field imaging, mydriasis reduced the ungradable rate from 4.5% to 0% with a statistically nonsignificant increase in agreement. When DiSLO200 images did not match ETDRS film photographs, DiSLO200 images were deemed more accurate in 57% of eyes after side-by-side image comparison.
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Financial Disclosure(s): The Joslin Diabetes Center received a temporary equipment loan and unrestricted research grant funding for the performance of initial validation studies on the Optos, plc, ultrawide field retinal imager from Optos, plc (Dunfermline, Fife, Scotland, UK). No additional outside funding was received for the performance of the research presented in this report.
Funding: The performance of the study published by Silva et al14 was supported in part by grant funding provided to the Joslin Diabetes Center by Optos, plc, (Dunfermline, Fife, Scotland, UK). Ultrawide field images taken during that study were acquired on an Optos P200MA that was provided by Optos, plc, to the Joslin Diabetes Center on temporary loan. Subsequent studies that reviewed images obtained from the original cohort of patients reported in this article received no external funding. Optos, plc, was the partial sponsor and funding organization of the initial study and had no oversight in the design, conduct, or reports of the past or current research.