June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
The functional effect of repetitive transorbital alternating current stimulation (rtACS) in a double-masked randomized clinical trial
Author Affiliations & Notes
  • Allison Toyos
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
  • Maria de los Angeles Ramos Cadena
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
  • Heather Livengood
    Division of Occupational Therapy, West Virginia University School of Medicine, Morgantown, West Virginia, United States
  • TingFang Lee
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
    Department of Population Health, NYU Langone Health, New York, New York, United States
  • Jiyuan Hu
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
    Department of Population Health, NYU Langone Health, New York, New York, United States
  • Bernhard Sabel
    Institute of Medical Psychology, Otto von Guericke Universitat Magdeburg, Magdeburg, Sachsen-Anhalt, Germany
  • Rachel Matayev
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
  • Gadi Wollstein
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
    Department of Biomedical Engineering, New York University Tandon School of Engineering, Brooklyn, New York, United States
  • Joel S Schuman
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
    Department of Biomedical Engineering and Electrical & Computer Engineering, New York University Tandon School of Engineering, Brooklyn, New York, United States
  • Footnotes
    Commercial Relationships   Allison Toyos None; Maria de los Angeles Ramos Cadena None; Heather Livengood None; TingFang Lee None; Jiyuan Hu None; Bernhard Sabel None; Rachel Matayev None; Gadi Wollstein None; Joel Schuman Zeiss, Code P (Patent)
  • Footnotes
    Support  NIH R01-EY013178; P30EY013079; Unrestricted Grant from Research to Prevent Blindness
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2590. doi:
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    • Get Citation

      Allison Toyos, Maria de los Angeles Ramos Cadena, Heather Livengood, TingFang Lee, Jiyuan Hu, Bernhard Sabel, Rachel Matayev, Gadi Wollstein, Joel S Schuman; The functional effect of repetitive transorbital alternating current stimulation (rtACS) in a double-masked randomized clinical trial. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2590.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Electrical stimulation therapy (EST) is reported to be effective in a range of clinical ophthalmic conditions to treat functional deficits. rtACS is a non-invasive EST procedure that is reported to improve contrast sensitivity, visual function, and quality of life. The purpose of this double-masked, randomized, sham-controlled clinical trial is to determine if there is a functional difference between the rtACS treated versus sham control subjects.

Methods : Subjects with moderate to advanced glaucoma (VF mean deviation (MD) ≤-6.00 dB) in at least one eye were randomized into sham (control) or rtACS intervention groups. Treatment (and sham) were delivered in 10 interventions (limited to 1 per day) within 2 consecutive weeks. All subjects had baseline, postintervention (PI; 1 week) and follow-up (FU; 4 weeks) visits with 24-2 VF testing (Humphrey Field Analyzer; Zeiss, Dublin, CA). The effect of treatment was assessed by comparing the average change from baseline to PI and FU respectively between the rtACS and sham groups for the following: 1) MD; 2) number of threshold sensitivity points which improved, worsened, or remained unchanged; 3) number of threshold sensitivity points which improved, worsened, or remained unchanged in vulnerable locations (edges of scotoma) that were defined at baseline. Baseline characteristics were also compared between eyes which showed improvement in MD and those which worsened.

Results : No significant difference was detected in age and disease severity between the 14 rtACS treated eyes and 18 sham group eyes (16 subjects; Table 1). A common finding across analysis methods 1-3 was a stable or slightly improved VF in the rtACS group between baseline to PI and baseline to FU, while in the same period, a deterioration was noted for the sham group (Table 2). Neither the trends for these changes nor the difference between the groups was statistically significant. No statistically significant difference was detected in baseline age or MD between improved and worsened eyes.

Conclusions : While none of the sham versus rtACS results reached statistical significance, there was a trend toward functional improvement in the rtACS group. Larger cohorts and longer follow-up are warranted to further evaluate the effects of rtACS in glaucoma.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

 

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