Evidence map›Paper›PMID 26803474›Full record

Trial reportJournal of diabetes and its complications2016

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

Open access · hybridAbstract readMulticenter StudyRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Journal of diabetes and its complications, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 70 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. The reproducibility of handheld ERGs recorded with skin electrode and natural pupils.Documenta ophthalmologica. Advances in ophthalmology · 2025
    Article
  9. Article
  10. Article
  11. Measuring differences in the ERG in myopia using the RETeval device with skin electrodes.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2025
    Article
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Article
  18. Double Hyperautofluorescence Rings as a Sign of CFAP410-related Retinopathy.Investigative ophthalmology & visual science · 2023
    Article
  19. Review
  20. Visual Evoked Potentials for the Detection of Diabetic Retinal Neuropathy.International journal of molecular sciences · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

April Y MaaAtlanta 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.
William J FeuerUniversity 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.
C Quentin DavisLKC Technologies, Inc., 2 Professional Drive, Suite 222, Gaithersburg, MD, 20879, USA. Electronic address: qdavis@lkc.com.
Ensa K PillowOklahoma 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.
Tara D BrownOklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: tara.brown2@va.gov.
Rachel M CaywoodOklahoma City VA Medical Center, Ophthalmology, 921 NE 13th Street, Oklahoma City, OK 73104, USA. Electronic address: rachel.caywood@va.gov.
Joel E ChasanEmory University School of Medicine, Emory Eye Center, Comprehensive Ophthalmology, 1365B Clifton Road NE, Atlanta, GA, 30322, USA. Electronic address: jchasan@emory.edu.
Stephen R FransenUniversity 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.
Oklahoma City VA Medical Center · USEmory University · USDean McGee Eye Institute · USLKC Technologies (United States) · USUniversity of Miami · US

Funding

Screening Device for Diabetic RetinopathyR44EY021121 · NEI · LKC TECHNOLOGIES, INC. · PI DAVIS, C QUENTIN · 2010 to 2012
$1.2M
NEI NIH HHS R44 EY021121NEI NIH HHS R44EY021121
6 · The paper itself

Abstract

aimsTo 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).

methodsPerformance 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.

resultsThe 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.

conclusionsWith 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.

Indexed as

AdultCross-Sectional StudiesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic RetinopathyDiagnostic Techniques, OphthalmologicalFemaleHumansMalePhotographyPredictive Value of TestsPrevalenceSensitivity and SpecificityVision DisordersDiabetic eye examDiabetic macular edemaDiabetic retinopathyERGPupillographyRetinal diagnostic test

Identifiers

PMID26803474
PMCPMC4853922
OpenAlexW2193769689

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.