A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy

作者：Maa April Y; Feuer William J; Davis C Quentin; Pillow Ensa K; Brown Tara D; Caywood Rachel M; Chasan Joel E; Fransen Stephen R^*

来源：Journal of Diabetes and Its Complications, 2016, 30(3): 524-532.

DOI：10.1016/j.jdiacomp.2015.12.005

• Diabetic retinopathy
• Diabetic macular edema
• Retinal diagnostic test
• ERG
• Pupillography
• Diabetic eye exam

Aims: To evaluate the performance of the RETeval device, a handheld instrument using flicker electroretinography (ERG) and pupillography on undilated subjects with diabetes, to detect vision threatening diabetic retinopathy (VTDR).
Methods: Performance was measured using a cross-sectional, single armed, non-interventional, multi-site study with Early Treatment Diabetic Retinopathy Study 7-standard field, stereo, color fundus photography as the gold standard. The 468 subjects were randomized to a calibration phase (80%), whose ERG and pupillary waveforms were used to formulate an equation correlating with the presence of VTDR, and a validation phase (20%), used to independently validate that equation. The primary outcome was the prevalence-corrected area under the receiver operating characteristic (ROC) curve for the detection of VTDR.
Results: The area under the ROC curve was 0.86 for VTDR. With a sensitivity of 83%, the specificity was 78% and the negative predictive value was 99%. The average testing time was 2.3 min.
Conclusions: With a VTDR prevalence similar to that in the US, the RETeval device will identify about 75% of the population as not having VTDR with 99% accuracy. The device is simple to use, does not require pupil dilation, and has a short testing time.

• 出版日期2016-4