Abstract
Purpose :
The RETeval 30 Hz Flicker ERG Device (LKC Technologies) is a diagnostic tool that has the potential to play a critical role in the early detection of diabetic retinopathy (DR) due to its increased ability to detect retinal ischemic disease.
The aim of this study is to (1) evaluate the use of the new RETeval ERG device in diabetic patients with varying stages of retinopathy, by using the DR assessment protocol and by measuring ERG amplitude and implicit times, (2) to observe whether the RETeval ERG device identifies any abnormalities in the retina before structural changes become evident, and (3) to correlate the RETeval ERG results to other standard of care measures used to diagnose DR in order to assess its reliability and utility as a tool in the management of diabetic patients.
Methods :
Eighty eyes of 40 diabetic volunteer subjects were prospectively studied. Recordings were obtained by the use of a skin sensor strip electrode which is comprised of the active, reference and ground electrode. It measured the time delay and amplitude of the retinas electrical response, as detected on the skin below the eye. Based on normative data, patients with diabetic retinopathy have a diabetic retinopathy assessment score above 20. For data analysis, each score and waveform was quantitatively and qualitatively assessed. Analysis of variance was used to determine significance between each condition.
Results :
The primary parameters of interest were the amplitude and implicit time of the flicker ERG waveform, as well as the diabetic retinopathy assessment score and its correlation to clinical findings. We found that the implicit time significantly increased (p<0.0001) as the severity of diabetic retinopathy advanced. When comparing the diabetic retinopathy assessment score to OCT findings, the score was found to be significantly higher (p=0.0002) in patients with diabetic macular edema, than in patients without diabetic macular edema. Lastly, when comparing the diabetic retinopathy assessment score to the stage of diabetic retinopathy, the score increased as the stage of retinopathy progressed (p=0.0031).
Conclusions :
The RETeval ERG device can be used as a valuable screening device for diabetic retinopathy, enabling health care practitioners to know if they should refer at-risk diabetics to ophthalmologists to allow for earlier management and prevention of disease progression.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.