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Home-based microcurrent therapy for visual field defects in glaucoma - A controlled multicenter clinical trial
Dr. rer. nat. habil. Mirela Bîlc
The overall aim of the current project is to investigate the efficacy and safety of long-term treatment of glaucoma by transorbital alternating current stimulation with a home-stimulation device (SASm). We hypothesize that tACS home-stimulation significantly improves vision and associated biomarkers compared to sham-controls. Our secondary aim is exploratory, namely to investigate possible mechanisms of action. The current study will be a double blind, parallel group interventional study. Participants (N=30) will be randomized to one of two intervention arms: (1) arm 1 - intervention group receiving tACS; (2) arm 2 - placebo group receiving sham (no tACS, only phosphene threshold measured at study entry). The primary endpoint of this clinical investigation is a mixed endpoint as follows: (i) Improved detection accuracy in super-threshold high resolution perimetry (HRP) or improved near-threshold Humphrey Visual Field Index following active tACS stimulation compared to sham, as documented by relative change over baseline.

According to our goal of investigating the long-term tACS efficiency, participants will undergo 30 stimulation sessions. Endpoints will be assessed before, immediately after and 12 weeks after the intervention. To our knowledge, this would be the longest stimulation duration and follow-up period investigating the effect of tACS. It would allow us not only to collect information on long-term effects, but also to compare it with short-term interventions (i.e., 10 days). The study will be considered completed after the last follow-up measurement of the last patient.

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