TY - JOUR
T1 - Transorbital Alternating Current Stimulation in a Double-Masked Randomized Clinical Trial
T2 - Visual Functional Effect and Quality of Life
AU - Ramos Cadena, Maria de los Angeles
AU - Sohn, Ashley
AU - Livengood, Heather
AU - Lee, Ting Fang
AU - Rubin, Batsheva
AU - Hu, Jiyuan
AU - Sabel, Bernhard A.
AU - Matayev, Rachel
AU - Panarelli, Joseph
AU - Wollstein, Gadi
AU - Schuman, Joel S.
N1 - Publisher Copyright:
© 2024 American Academy of Ophthalmology
PY - 2025/1/1
Y1 - 2025/1/1
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Glaucoma
KW - Neurostimulation
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U2 - 10.1016/j.xops.2024.100614
DO - 10.1016/j.xops.2024.100614
M3 - Article
AN - SCOPUS:85208230228
SN - 2666-9145
VL - 5
JO - Ophthalmology Science
JF - Ophthalmology Science
IS - 1
M1 - 100614
ER -