Bioelectronic Medicine | |
Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy | |
Short Report | |
Yoshihito Ozawa1  Yohei Kawasaki1  Yuki Shiko1  Tadami Fujiwara1  Hideki Hanaoka1  Gen Miura2  Tomoaki Tatsumi2  Shuichi Yamamoto2  Takayuki Baba2  Tomohiro Nizawa2  Makoto Nakamura3  Sotaro Mori3  Takuji Kurimoto3  | |
[1] Clinical Research Centre, Chiba University Hospital, Chiba, Japan;Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, Inohana 1-8-1, Chuo-Ku, 260-8670, Chiba, Japan;Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, 650-0017, Kobe, Japan; | |
关键词: Nonarteritic anterior ischemic optic neuropathy; NAION; Electrical stimulation; Skin electrode; TES; | |
DOI : 10.1186/s42234-023-00125-2 | |
received in 2023-06-13, accepted in 2023-09-12, 发布年份 2023 | |
来源: Springer | |
【 摘 要 】
BackgroundNo effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with NAION.MethodsFive patients with monocular NAION underwent TdES (10-ms biphasic pulses, 1.0 mA, 20 Hz, 30 min) of the affected eye six times at 2-week intervals. The primary endpoint was the logarithm of the mini-mum angle of resolution (logMAR) visual acuity at 12 weeks compared with 0 weeks. The secondary endpoints were changes in the best-corrected logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, and mean deviation (MD) of the Humphrey field analyzer (HFA) 10–2 and HFA Esterman test scores. Additionally, the safety of TdES was evaluated.ResultsLogMAR visual acuity improved by ≥ 0.1 in two eyes, and ETDRS visual acu-ity improved by ≥ 5 characters in one eye. The mean change in logMAR visual acuity from week 0 showed an increasing trend. The mean MD of HFA 10–2 showed no obvious change, while HFA Esterman score improved in four eyes. All patients completed the study according to the protocol, and no treatment-related adverse events were observed.ConclusionsTdES treatment may have improved visual acuity and visual field in some patients. Further sham-controlled study in larger cohort is needed on its effectiveness.Trial registrationUMIN, UMIN000036220. Registered 15 March, 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041261.
【 授权许可】
CC BY
© Feinstein Institute for Medical Research 2023
【 预 览 】
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RO202311106925538ZK.pdf | 1432KB | download | |
MediaObjects/13046_2023_2843_MOESM2_ESM.docx | 5319KB | Other | download |
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12951_2015_155_Article_IEq56.gif | 1KB | Image | download |
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