April Y Maa1, William J Feuer2, C Quentin Davis3, Ensa K Pillow4, Tara D Brown5, Rachel M Caywood6, Joel E Chasan7, Stephen R Fransen8. 1. 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. 2. 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. 3. LKC Technologies, Inc., 2 Professional Drive, Suite 222, Gaithersburg, MD, 20879, USA. Electronic address: qdavis@lkc.com. 4. 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. 5. Oklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: tara.brown2@va.gov. 6. Oklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: rachel.caywood@va.gov. 7. Emory University School of Medicine, Emory Eye Center, Comprehensive Ophthalmology, 1365B Clifton Road NE, Atlanta, GA, 30322, USA. Electronic address: jchasan@emory.edu. 8. 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.
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 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.
RCT Entities:
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 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.
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