Transorbital Alternating Current Stimulation in a Double-Masked Randomized Clinical Trial: Visual Functional Effect and Quality of Life.

Purpose: To determine the efficacy and safety of repetitive transorbital alternating current stimulation (rtACS) treatment by assessing vision-related quality of life and visual function outcome in subjects treated with rtACS versus sham-control.
Study Design: Double masked, randomized, sham-controlled clinical trial (NCT03188042).
Subjects: Sixteen subjects with moderate-to-advanced glaucoma (visual field [VF] mean deviation [MD] ≤-6.00 decibels) randomized into sham (9 subjects) or rtACS intervention (7 subjects) groups.
Methods: Subjects underwent 10 rtACS sessions over 2 weeks. All subjects had comprehensive ocular examination at baseline, 1-week, and 4-weeks posttreatment.
Main Outcome Measures: Visual acuity (VA), contrast sensitivity (CS), VF MD, number of threshold sensitivity points that changed or were unchanged, and vision-related quality of life (VR-QoL) questionnaire scores.
Results: The rtACS group showed a significantly greater improvement from baseline to 4 weeks posttreatment compared with sham in VR-QoL domains including near activities ( P < 0.01), dependency ( P  = 0.03), social functioning ( P  = 0.03), mental health ( P < 0.01) and in the overall composite score ( P  = 0.04). No significant changes were detected with VA, CS, and VF analyses for either group. No serious adverse events were noted in either study group.
Conclusions: Repetitive transorbital alternating current stimulation therapy showed a significant beneficial effect on several domains of VR-QoL. Further studies will determine its utility in glaucoma.
Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
(© 2024 by the American Academy of Ophthalmology.)