Source and clinical background
The clinical pilot evaluated the supportive potential of the SOMA.S device in patients under observation at the Eye Clinic of Jan Evangelista Purkyně University and Masaryk Hospital in Ústí nad Labem.
The protocol was conducted as a prospective, randomized, double-blind study evaluating retinal morphology in patients with wet age-related macular degeneration.
Study design and patient groups
Eighteen patients completed the one-month evaluation. Participants were randomized into two parallel double-blind cohorts: one receiving an active SOMA.S device and the other receiving an identical sham control device.
Both groups used their assigned devices at home under standardized placement instructions during a one-month observation window.
Clinical measurements
- Central retinal thickness (CRT) measured via high-resolution optical coherence tomography (OCT).
- Total macular volume (TMV) across the standard 6 × 6 mm macular zone.
- Best-corrected visual acuity evaluated using standard ETDRS eye charts.
- Circulating TNF-alpha inflammatory biomarker concentrations in serum.
- Statistical analysis conducted with Mann–Whitney and Wilcoxon signed-rank tests.
Documented outcomes
- Patients using the active SOMA.S device demonstrated stabilization in central retinal thickness (mean change −7.6 μm), compared to progressive thickening (+75.0 μm) in the sham control group.
- The difference in central retinal thickness trajectory between active and control groups was statistically significant (p = 0.022).
- Within the active group, visual acuity trends showed positive stabilization throughout the observation month.
Clinical perspective
The study authors observed that the active SOMA.S device was associated with favorable stabilization of retinal morphology during the evaluated period.
The findings support the complementary role of environmental harmonization alongside specialized ophthalmic management.