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 language | English (US) |
|---|---|
| Journal | Journal of Diabetes and its Complications |
| DOIs | |
| State | Accepted/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
A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy. / Maa, April Y.; Feuer, William J; Davis, C. Quentin; Pillow, Ensa K.; Brown, Tara D.; Caywood, Rachel M.; Chasan, Joel E.; Fransen, Stephen R.
In: Journal of Diabetes and its Complications, 24.09.2015.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy
AU - Maa, April Y.
AU - Feuer, William J
AU - Davis, C. Quentin
AU - Pillow, Ensa K.
AU - Brown, Tara D.
AU - Caywood, Rachel M.
AU - Chasan, Joel E.
AU - Fransen, Stephen R.
PY - 2015/9/24
Y1 - 2015/9/24
N2 - 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.
AB - 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.
KW - Diabetic eye exam
KW - Diabetic macular edema
KW - Diabetic retinopathy
KW - ERG
KW - Pupillography
KW - Retinal diagnostic test
UR - http://www.scopus.com/inward/record.url?scp=84955277064&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84955277064&partnerID=8YFLogxK
U2 - 10.1016/j.jdiacomp.2015.12.005
DO - 10.1016/j.jdiacomp.2015.12.005
M3 - Article
C2 - 26803474
AN - SCOPUS:84955277064
JO - Journal of Diabetes and its Complications
JF - Journal of Diabetes and its Complications
SN - 1056-8727
ER -