title: A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy.
abstract: OBJECTIVE
  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 U.S., 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.
authors.affiliation: Atlanta VA Medical Center, Ophthalmology, 1670 Clairmont Road MC 112E, Decatur, GA, 30033, USA; Emory University School of Medicine, Emory Eye Center, Comprehensive Ophthalmology, 1365B Clifton Road NE, Atlanta, GA, 30322, USA. Electronic address: april.maa2@va.gov.
authors.forename: April Y
authors.initials: AY
authors.lastname: Maa
authors.affiliation: University of Miami Miller School of Medicine, Biostatistics, Dominion Tower, Box C210, 1400 NW 10th Avenue, Suite 506, Miami, FL, 33136, USA; Bascom Palmer Eye Institute, 900 NW 17th Street, Miami, FL, 33136, USA. Electronic address: wfeuer@med.miami.edu.
authors.forename: William J
authors.initials: WJ
authors.lastname: Feuer
authors.affiliation: LKC Technologies, Inc., 2 Professional Drive, Suite 222, Gaithersburg, MD, 20879, USA. Electronic address: qdavis@lkc.com.
authors.forename: C Quentin
authors.initials: CQ
authors.lastname: Davis
authors.affiliation: Oklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA; University of Oklahoma College of Medicine, Ophthalmology, 608 Stanton L. Young Blvd, Oklahoma City, OK, 73104, USA; Dean McGee Eye Institute, 608 Stanton L. Young Blvd, Oklahoma City, OK, 73104, USA. Electronic address: ensa.pillow@va.gov.
authors.forename: Ensa K
authors.initials: EK
authors.lastname: Pillow
authors.affiliation: Oklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: tara.brown2@va.gov.
authors.forename: Tara D
authors.initials: TD
authors.lastname: Brown
authors.affiliation: Oklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: rachel.caywood@va.gov.
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Caywood
authors.affiliation: Emory University School of Medicine, Emory Eye Center, Comprehensive Ophthalmology, 1365B Clifton Road NE, Atlanta, GA, 30322, USA. Electronic address: jchasan@emory.edu.
authors.forename: Joel E
authors.initials: JE
authors.lastname: Chasan
authors.affiliation: University of Oklahoma College of Medicine, Ophthalmology, 608 Stanton L. Young Blvd, Oklahoma City, OK, 73104, USA; Dean McGee Eye Institute, 608 Stanton L. Young Blvd, Oklahoma City, OK, 73104, USA; Inoveon Corporation, 800 Research Parkway, Suite 370, Oklahoma City, OK, 73104, USA. Electronic address: stephen-fransen@ouhsc.edu.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Fransen
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000453:epidemiology; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D003941:Diagnostic Techniques, Ophthalmological / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D010781:Photography / Q000295:instrumentation / Q000379:methods; D011237:Predictive Value of Tests; D015995:Prevalence; D012680:Sensitivity and Specificity; D014786:Vision Disorders / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology
keywords: Diabetic eye exam; Diabetic macular edema; Diabetic retinopathy; ERG; Pupillography; Retinal diagnostic test