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

ABSTRACT:

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 oper

SUBMITTER: Maa AY 

PROVIDER: S-EPMC4853922 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature