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LKC Technologies: RETeval DR Score Superior in Predicting Diabetic Retinopathy Outcomes

08/07/2025

LKC Technologies, a provider of electroretinography (ERG)-based functional diagnostics, announced the publication of a study that found that ERG/pupillometry outperforms structural imaging in identifying patients at highest risk of progressing to vision-threatening complications over 1 year. The post-hoc analysis, which evaluated 56 parameters across four modalities: ERG/pupillometry, UWF-FA, OCTA, and fundus photography, was published in Ophthalmology Science.[1]

“This publication is a significant advancement in the quest to identify high-risk patients earlier and improve clinical outcomes,” said Dina Dubey, Chief Executive Officer of LKC Technologies. “The prospective study included patients with moderate to severe NPDR and no center-involved DME at baseline and it revealed that a single number—known as the DR Score—is the most powerful predictor of progression from non-proliferative diabetic retinopathy (NPDR) to vision-threatening complications, including proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), or treatment.”

ModalityPredictive ParameterRRp-value
ERG / PupillometryDR Score ≥ 26.95.6< 0.0001
UWF-FATotal ischemia index ≥ 0.1255.3< 0.0001
OCTAFoveal avascular zone (FAZ) area ≥ 0.295 mm²3.6< 0.05
Fundus PhotographyDR Severity Score (DRSS) ≥ 472.1

< 0.05

“This research suggests that the ERG provides value in defining how DR is staged and monitored, supporting mounting evidence that functional changes in the retina can precede observable vascular abnormalities,” said Mitchell Brigell, PhD.[2–4]. “The findings clearly show the value of integrating objective functional testing into the management of diabetic retinopathy. This is also reflected in the inclusion of ERG in the American Academy of Ophthalmology’s Preferred Practice Pattern Guidelines for Diabetic Retinopathy.” [5]

According to LKC Technologies, RETeval is the only FDA-cleared handheld ERG device suitable for both dilated and non-dilated patients.

References

  1. Davis, C.Q., Waheed, N.K., & Brigell, M. (2025). Predicting Progression to Vision-Threatening Complications in Diabetic Retinopathy. Ophthalmology Science, 100859. https://doi.org/10.1016/j.ophsci.2025.100859

  2. McAnany, J.J., Persidina, O.S., & Park, J.C. (2022). Clinical electroretinography in diabetic retinopathy: A review. Surv Ophthalmol, 67(3), 712–722. https://doi.org/10.1016/j.survophthal.2021.08.011

  3. Brigell, M., Davis, Q., & Waheed, N. (2020). Predictive value of ERG, OCT-A, and UWF-FA in patients with diabetic retinopathy. Invest. Ophthalmol. Vis. Sci., 61(7): 4038.

  4. Ratra, D., Nagarajan, R., Dalan, D., et al. (2021). Early structural and functional neurovascular changes in the retina in the prediabetic stage. Eye (Lond)., 35(3), 858–867. https://doi.org/10.1038/s41433-020-0984-z

  5. Lim, J.I., Kim, S.J., Bailey, S.T., et al. (2025). Diabetic Retinopathy Preferred Practice Pattern®. Ophthalmology, published online February 7, 2025.

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