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

April Y. Maa, William J. Feuer, C. Quentin Davis, Ensa K. Pillow, Tara D. Brown, Rachel M. Caywood, Joel E. Chasan, Stephen R. Fransen

Research output: Contribution to journalArticlepeer-review

38 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)524-532
Number of pages9
JournalJournal of Diabetes and Its Complications
Issue number3
StatePublished - Apr 1 2016


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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology


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