Optos plc (LSE: OPTS), a leading medical retinal imaging company, has announced the results of a clinical validation study comparing Optos ultra-widefield imaging to Early Treatment Diabetic Retinopathy Study (ETDRS) protocol fundus photography, the gold standard for assessing severity of diabetic retinopathy. The study, completed by the Joslin Diabetes Center, has been published in the American Journal of Ophthalmology.
ETDRS protocol seven standard field 30-degree color fundus photography (ETDRS photos) has long been the imaging benchmark for assessing diabetic retinopathy severity. This study reports that the Optos’ ultra-widefield non-dilated optomap images compared favorably with dilated ETDRS photos and dilated retinal examination in determining clinical severity of diabetic retinopathy and diabetic macular edema.
Researchers at Joslin’s Beetham Eye Institute, led by Lloyd Paul Aiello, MD, PhD, compared non-dilated ultra-widefield images and ETDRS photos in 103 patients with various severity levels of diabetic retinopathy. The two imaging modalities exactly matched for clinical level of diabetic retinopathy in 84% of patients and were within 1 level of agreement in 91%. Sensitivity and specificity of ultra-widefield images for detecting the presence or absence of diabetic retinopathy (DR) diagnosed on ETDRS photos were 99% and 100%.
The study also measured the length of time to capture images using both the Optos device and a traditional digital fundus camera and found that optomap imaging took less than half the time of dilated ETDRS photos not including the time needed to dilate the eyes. Thus, optomap can now allow more efficient imaging while still maintaining the current standards of diabetic retinopathy identification.
Dr Aiello said: “In this study, nonmydriatic ultra-widefield imaging compared favorably with dilated Early Treatment Diabetes Retinopathy Study protocol photography and dilated retinal examination in determining clinical severity of diabetic retinopathy and diabetic macular edema. The additional benefits of easier operation, no pupil dilation and more rapid image acquisition will be significant improvements if these results are confirmed across diverse sites and broader diabetic populations.”
Roy Davis, CEO of Optos, added: “We are extremely pleased with these results which clearly demonstrate that the ultra-widefield optomap technology compares favorably to current imaging standards in assessing diabetic retinopathy. We believe that this study, combined with the increasing body of clinical evidence, demonstrates the benefits of ultra-widefield imaging to clinicians.”