Clinical Trial to Evaluate Safety and Efficacy of Transdermal Electrical Stimulation on Visual Functions of Patients with Retinitis Pigmentosa

Gen Miura,Hideki Hanaoka,Yohei Kawasaki,Takeshi Sugawara,Tomohiro Nizawa,Shuichi Yamamoto,Tomoaki Tatsumi,Takayuki Baba

doi:10.1038/s41598-019-48158-5

Gen Miura, Hideki Hanaoka + Show 6 more

Open Access

https://doi.org/10.1038/s41598-019-48158-5

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Journal: Scientific Reports	Publication Date: Aug 12, 2019
Citations: 16	License type: open-access

Affiliation: Chiba University, Chiba University Hospital

Abstract

To evaluate the safety and efficacy of transdermal electrical stimulation (TdES) with skin electrodes on improving the visual functions of patients with retinitis pigmentosa (RP), twenty eyes of 10 patients with RP underwent TdES (10-ms biphasic pulses, 20 Hz, 30 min) 6 times at 2 week intervals. All patients were stimulated bilaterally with 1.0 mA pulses. The primary endpoint was safety, and the secondary endpoints were the changes in the best-corrected visual acuity (BCVA), visual fields determined by the Humphrey field analyzer (HFA) 10-2 and Goldmann perimetry, and answers to the Visual Function Questionnaire-25. All of the 10 enrolled patients completed the study according to the protocol. No adverse events related to the treatments were reported during the follow-up examinations. The mean BCVA and Early Treatment Diabetic Retinopathy Study visual acuity were significantly improved after the TdES (P = 0.0078 and P = 0.001, respectively). The mean deviation of the HFA 10-2 was also significantly improved (P = 0.0076). We conclude that TdES with skin electrode is a safe therapeutic option and should be considered as a treatment option for patients with RP.

Highlights

Parameters Number of patients/eyes Age (y/o) Male/Female AD/AR/Sporadic logarithm of the minimum angle of resolution (logMAR) VA Early Treatment of Diabetic Retinopathy Study chart (ETDRS) VA MD value of HFA10-2 Central 4 points of HFA10-2 Area of visual field with target I/4 of Goldmann perimetry (GP) National Eye Institute (NEI) visual function questionnaire-25 (VFQ-25) Compo 9
It has been reported that TES using corneal electrodes improved the visual function of eyes with traumatic and ischemic optic neuropathy[10], retinal artery occlusion[11], and retinitis pigmentosa (RP)
The electrical stimulation therapy was completed according to the protocol in all 10 patients

Summary

Introduction

Parameters Number of patients/eyes Age (y/o) Male/Female AD/AR/Sporadic logMAR VA ETDRS VA (letters) MD value of HFA10-2 (dB) Central 4 points of HFA10-2 (dB) Area of visual field with target I/4 of GP NEI VFQ-25 Compo 9. The purpose of this clinical trial was to verify the safety and efficacy of TdES using skin electrodes for patients with retinitis pigmentosa and evaluate the visual functions before and after the TdES. A significant improvement was observed at 12 weeks (95% CI: 0.184–1.147, P = 0.0076) compared to the value at the baseline.

Results

Conclusion