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

doi:10.1016/j.jdiacomp.2015.12.005

Cited by 61 publications

(86 citation statements)

References 42 publications

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“…used the RET eval device to screen for DR, and reported that it detected vision-threatening DR, e.g., severe NPDR or PDR, with a high level of sensitivity (AUC, 0.86)24. Their findings and the value of the AUC are comparable to our results.…”

Section: Discussionsupporting

confidence: 84%

“…The details of the RET eval (LKC Technologies, Gaithersburg, MD) device, a small, hand-held, non-mydriatic full-field flicker ERG recording system, have been described in detail22232425. The full-field flash stimuli are presented with a small dome of 60 mm in diameter (Fig.…”

Section: Methodsmentioning

confidence: 99%

“…This device is equipped with a small Ganzfeld dome and a special skin electrode to pick up the ERGs22232425. The full-field ERGs can be recorded without mydriasis because this device delivers stimuli of constant retinal illuminance (Td-s) by adjusting the luminance (cd-s/m 2 ) to compensate for changes in the pupillary area (mm 2 ).…”

mentioning

confidence: 99%

“…Thus, the application of this new device for the mass-screening for DR has been suggested. However as best we know, there has been only one study24 that examined whether the RET eval system can be used to screen individuals for the presence of DR. Maa et al 24. studied the performance of RET eval device that uses a combination of flicker ERG and pupillography, and reported that the RET eval device can identify the patients with diabetes mellitus (DM) as not having vision-threatening diabetic retinopathy with 99% accuracy.…”

mentioning

confidence: 99%

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Screening for diabetic retinopathy using new mydriasis-free, full-field flicker ERG recording device

Fukuo

Kondo

Hirose

et al. 2016

Sci Rep

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Diabetic retinopathy (DR) is a leading cause of blindness among working-age adults. Therefore, it is important to detect DR accurately during mass screening. The purpose of this study was to determine whether a small, hand-held, mydriasis-free, full-field flicker electroretinographic (ERGs) device called RETeval can be used to screen for DR. To accomplish this, we recorded full-field flicker ERGs with this device from 48 normal eyes and 118 eyes with different severities of DR in patients with diabetes mellitus (DM). This system delivered a constant flash retinal luminance by adjusting the flash luminance that compensated for changes in the pupil size. Our results showed that there were significant correlations between the severity of DR and the implicit times (P < 0.001; r = 0.55) and the amplitudes (P = 0.001; r = −0.29). When the implicit time was used for the index, the area under the receiver operating characteristic curve was 0.84 for the detection of DR, and was 0.89 for the detection of DR requiring ophthalmic treatments. These results suggest that the implicit times of the flicker ERGs recorded by the small, mydryasis-free ERG system can be used as an adjunctive tool to screen for DR.

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Section: Discussionsupporting

confidence: 84%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Screening for diabetic retinopathy using new mydriasis-free, full-field flicker ERG recording device

Fukuo

Kondo

Hirose

et al. 2016

Sci Rep

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“…The RETeval™ (LKC Technologies, Inc., Gaithersburg, MD, USA) is a handheld device for recording the full-field electroretinogram (ERG), which aims to improve the ease of ERG recording in a general clinical or office environment [1–3]. Equipped with a small Ganzfeld dome, an infrared LED and camera system (for monitoring the subject’s eye) and skin electrodes, it is designed to record monocular ERGs.…”

Section: Introductionmentioning

confidence: 99%

Effect of varying skin surface electrode position on electroretinogram responses recorded using a handheld stimulating and recording system

et al. 2018

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PurposeA handheld device (the RETeval system, LKC Technologies) aims to increase the ease of electroretinogram (ERG) recording by using specially designed skin electrodes, rather than corneal electrodes. We explored effects of electrode position on response parameters recorded using this device.MethodsHealthy adult twins were recruited from the TwinsUK cohort and underwent recording of light-adapted flicker ERGs (corresponding to international standard stimuli). In Group 1, skin electrodes were placed in a “comfortable” position, which was up to 20 mm below the lid margin. For subsequent participants (Group 2), the electrode was positioned 2 mm from the lid margin as recommended by the manufacturer. Amplitudes and peak times (averaged from both eyes) were compared between groups after age-matching and inclusion of only one twin per pair. Light-adapted flicker and flash ERGs were recorded for an additional 10 healthy subjects in two consecutive recording sessions: in the test eye, electrode position was varied from 2 to 10–20 mm below the lid margin between sessions; in the fellow (control) eye, the electrode was 2 mm below the lid margin throughout. Amplitudes and peak times (test eye normalised to control eye) were compared for the two sessions.ResultsIncluding one twin per pair, and age-matching yielded 28 individuals per group. Flicker ERG amplitudes were significantly lower for Group 1 than Group 2 participants (p = 0.0024). However, mean peak times did not differ between groups (p = 0.54). For the subjects in whom electrode position was changed between recording sessions, flash and flicker amplitudes were significantly lower when positioned further from the lid margin (p < 0.005), but peak times were similar (p > 0.5).ConclusionsMoving the skin electrodes further from the lid margin significantly reduces response amplitudes, highlighting the importance of consistent electrode positioning. However, this does not significantly affect peak times. Thus, it may be feasible to adopt a more comfortable position in participants who cannot tolerate the recommended position if analysis is restricted to peak time parameters.

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Constant luminance (cd·s/m2) versus constant retinal illuminance (Td·s) stimulation in flicker ERGs

Davis

Kraszewska

Manning³

2017

Doc Ophthalmol

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PurposeTo compare the effect of variable pupil size on the flicker electroretinogram (ERG) between a stimulus having constant luminance and a stimulus having constant retinal illuminance (constant Troland) that compensates for pupil size.MethodsSubjects (n = 18) were tested with 12 pairs of the stimuli. The stimulus pair consisted of the ISCEV standard constant luminance stimulus (3 cd·s/m2 with a 30 cd/m2 background) and a constant retinal illuminance stimulus (32 Td·s with a 320 Td background) selected to provide the same stimulus and background when the pupil diameter is 3.7 mm. Half the subjects were artificially dilated, and their response was measured before and during the dilation. The natural pupil group was used to assess intra- and inter-subject variability. The artificially dilated group was used to measure the flicker ERG’s dependence on pupil size.ResultsWith natural pupils, intra-subject variability was lower with the constant Troland stimulus, while inter-subject variability was similar between stimuli. During pupil dilation, the constant Troland stimulus did not have a dependence on pupil size up to 6.3 mm and had slightly larger amplitudes with longer implicit times for fully dilated pupils. For the constant luminance stimulus, waveform amplitudes varied by 22% per mm change in pupil diameter, or by 48% over the 2.2 mm diameter range measured in dilated pupil size. There was no difference in inter-subject variability between constant Troland natural pupils and the same subjects with a constant luminance stimulus when dilated (i.e., the ISCEV standard condition).ConclusionsThese results suggest that a constant Troland flicker ERG test with natural pupils may be advantageous in clinical testing. Because of its insensitivity to pupil size, constant Troland stimuli should produce smaller reference ranges, which in turn should improve the sensitivity for detection of abnormalities and for monitoring changes. In addition, the test can be administered more efficiently as it does not require artificial dilation.Clinical Trial registration number This trial is registered at ClinicalTrials.gov (NCT02466607).

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

Cited by 61 publications

References 42 publications

Screening for diabetic retinopathy using new mydriasis-free, full-field flicker ERG recording device

Screening for diabetic retinopathy using new mydriasis-free, full-field flicker ERG recording device

Effect of varying skin surface electrode position on electroretinogram responses recorded using a handheld stimulating and recording system

Constant luminance (cd·s/m2) versus constant retinal illuminance (Td·s) stimulation in flicker ERGs

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