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

Autor: William J. Feuer, Rachel M. Caywood, Tara D. Brown, Stephen R. Fransen, Ensa K. Pillow, Joel E. Chasan, C. Quentin Davis, April Y. Maa
Rok vydání: 2016
Předmět:
Adult
Male
genetic structures
Endocrinology
Diabetes and Metabolism
Population
Vision Disorders
Diagnostic Techniques
Ophthalmological
Sensitivity and Specificity
Article
Retinal diagnostic test
03 medical and health sciences
0302 clinical medicine
Endocrinology
Diabetic macular edema
Predictive Value of Tests
Photography
Prevalence
Internal Medicine
medicine
Pupillary response
Humans
030212 general & internal medicine
education
education.field_of_study
Diabetic eye exam
Diabetic Retinopathy
Receiver operating characteristic
Pupillography
business.industry
Diabetic retinopathy
Gold standard (test)
medicine.disease
Cross-Sectional Studies
Diabetes Mellitus
Type 1
Flicker electroretinography
Diabetes Mellitus
Type 2
ERG
Predictive value of tests
030221 ophthalmology & optometry
Optometry
Female
business
Zdroj: Journal of Diabetes and its Complications. 30:524-532
ISSN: 1056-8727
Popis: 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.
Databáze: OpenAIRE
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