LKC Technologies, a leader in functional testing using electroretinography (ERG), announces results of a longitudinal prospective study, which found that ERG / pupillometry outperforms structural imaging in identifying patients at highest risk of progressing to vision-threatening complications (VTC) over one year.
This posthoc analysis of 56 parameters from four testing modalities obtained in a multi-center U.S. trial (NCT03197870) 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,” notes Dina Dubey, CEO, LKC Technologies. “The prospective study included patients with moderate to severe NPDR and no centerinvolved 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.”
The DR Score of 26.9 demonstrated a relative risk (RR) of 5.6 for progression to VTC (p < 0.0001).
This surpassed the other predictors evaluated, including ultra-widefield fluorescein angiography (UWF-FA), optical coherence tomography angiography (OCTA), and fundus photography (FP).
While these structural imaging parameters also showed statistical significance, their predictive power was lower.
The best predictive parameters from UWF-FA, OCTA and FP are:
- UWF-FA total ischemia index ≥ 0.125: RR = 5.3 (p < 0.0001)
- OCTA foveal avascular zone (FAZ) area ≥ 0.295 mm²: RR = 3.6 (p < 0.05)
- Fundus photograph–based DRSS ≥ 47: RR = 2.1 (p < 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,” says 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
The full study is available online. For more information on how ERG is shaping the future of diabetic eye care, visit www.lkc.com. About LKC Technologies.
LKC Technologies is a 35-year veteran of visual electrophysiology (ERG). The RETeval ERG is the only handheld, FDA-cleared device for ERG testing on dilated and un-dilated patients.
It was designed to streamline clinic operations and simplify testing for staff and patients alike. It is supported by more than 250 peer-reviewed publications and is used in optometry, ophthalmology, and research settings.
References
Davis, C.Q., Waheed, N.K. and Brigell, M., 2025. Predicting Progression to Vision-Threatening Complications in Diabetic Retinopathy. Ophthalmology Science, p.100859.
McAnany JJ, Persidina OS, Park JC. Clinical electroretinography in diabetic retinopathy: a review. Surv Ophthalmol. 2022 May-Jun;67(3):712-722. doi: 10.1016/j.survophthal.2021.08.011. Epub 2021 Sep 4. PMID: 34487740; PMCID: PMC9158180.
Brigell M, Davis Q, Waheed N. Predictive Value of ERG, OCT-A, and UWF-FA in Patients with Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4038.
Ratra D, Nagarajan R, Dalan D, et al. Early structural and functional neurovascular changes in the retina in the prediabetic stage. Eye (Lond). 2021;35(3):858-867. doi:10.1038/s41433-020-0984-z 5. Lim JI, Kim SJ, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern. Ophthalmology. Published online February 7, 2025.