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 journalArticle

22 Scopus citations

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 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)
JournalJournal of Diabetes and its Complications
DOIs
StateAccepted/In press - Sep 24 2015

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Keywords

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

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine

Cite this

Maa, A. Y., Feuer, W. J., Davis, C. Q., Pillow, E. K., Brown, T. D., Caywood, R. M., Chasan, J. E., & Fransen, S. R. (Accepted/In press). A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy. Journal of Diabetes and its Complications. https://doi.org/10.1016/j.jdiacomp.2015.12.005