SOMA.S in a Randomized Double-Blind Retinal Clinical Study

Participants and methods

Eighteen participants with newly diagnosed wet age-related macular degeneration completed the study: nine used SOMA.S and nine used an identical nonfunctioning device. This randomized, double-blind comparison took place over one month while participants waited for planned anti-VEGF treatment.

The Eye Clinic of Masaryk Hospital measured central retinal thickness (CRT), best-corrected visual acuity, total macular volume and the blood marker TNF-alpha before and after device use.

Results

• Mean CRT changed by −7.6 µm in the active group and +75 µm in the comparison group. The between-group difference in change was statistically significant (p = 0.022). The change within the active group itself was not statistically significant (p = 0.213).
• Visual acuity improved significantly within the active group, but the difference in visual-acuity change between groups was not statistically significant (p = 0.329). Between-group changes in total macular volume (p = 0.094) and TNF-alpha (p = 0.724) were also not statistically significant.

Study context

These findings concern SOMA.S in this specific patient group over one month. The groups started with different mean retinal thicknesses, and each contained nine participants. The report describes randomization and double blinding but does not detail allocation, attrition or adjustment for testing several outcomes.

Source: Eye Clinic of Masaryk Hospital clinical report (2024), commissioned by Somavedic Technologies. Journal peer review, trial registration and ethics-review details are not identified in the report. The tested product was SOMA.S; the findings are specific to that device and study protocol.