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

Abstract

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 Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.