Condition focus: Diabetic Macular Edema (DME) & Retinal Metabolic Stress:

From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (n = 69) or placebo (n = 66); median age was 62 years, 37% were women, and 82% were White. The median device compliance was 92% with PBM and 95% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes, with the mean difference (95% confidence interval [CI]) being −2 (−20 to 16) μm (P = 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90%) PBM eyes and 57 (86%) placebo eyes at 4 months (adjusted odds ratio [95% CI] = 1.30 (0.44–3.83); P = 0.63). VA decreased by a mean (SD) of −0.2 (5.5) letters and −0.6 (4.6) letters in the PBM and placebo groups, respectively (difference [95% CI] = 0.4 (−1.3 to 2.0) letters; P = 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious.

WaveFront Alignment: This study used 670 nm PBM in a metabolic retinal condition characterized by mitochondrial stress and inflammation—mechanisms directly relevant to the Spectral WaveFront’s 670 nm and 810 nm wavelengths. Although the protocol, dosing, and delivery method differ from WaveFront’s ocular-specific geometry, the study reinforces the safety of red-light PBM applied near the retina and supports continued investigation of wavelength-specific retinal metabolic modulation.