Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study

<b>Objective:</b> The aim of this study was to assess the safety and preliminary efficacy of repetitive magnetic stimulation (RMS) as a treatment intervention for dry eye disease (DED), focusing on symptom reduction. <b>Methodology:</b> This investigation involved 22 adult pa...

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Main Authors: Hadas Ben-Eli, Shimon Perelman, Denise Wajnsztajn, Abraham Solomon
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Biomedicines
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Online Access:https://www.mdpi.com/2227-9059/13/5/1064
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author Hadas Ben-Eli
Shimon Perelman
Denise Wajnsztajn
Abraham Solomon
author_facet Hadas Ben-Eli
Shimon Perelman
Denise Wajnsztajn
Abraham Solomon
author_sort Hadas Ben-Eli
collection DOAJ
description <b>Objective:</b> The aim of this study was to assess the safety and preliminary efficacy of repetitive magnetic stimulation (RMS) as a treatment intervention for dry eye disease (DED), focusing on symptom reduction. <b>Methodology:</b> This investigation involved 22 adult participants (85% females, aged between 22 and 79 years) diagnosed with moderate-to-severe DED. These individuals were subjected to RMS treatment targeting one or both eyes using the VIVEYE-Ocular Magnetic Neurostimulation System version 1.0 (Epitech-Mag LTD; National Institute of Health (NIH) clinical trials registry #NCT03012698). A placebo-controlled group was also included for comparative analysis, with all subjects being monitored over a three-month period. The evaluation of safety encompassed monitoring changes in best corrected visual acuity, ocular pathology, and the reporting of adverse events. Participant tolerance was gauged through questionnaires, measurements of intraocular pressure (IOP), Schirmer’s test, and vital signs. The efficacy of the treatment was assessed by comparing pre- and post-treatment scores for fluorescein staining (according to National Eye Institute (NEI) grading) and patient-reported outcomes. <b>Results:</b> No statistically significant changes were found in visual acuity, IOP, or Schirmer’s test results between the RMS-treated and control groups (<i>p</i> < 0.05), indicating that RMS does not negatively impact these ocular functions. However, RMS treatment was associated with improved tear film stability (<i>p</i> = 0.19 vs. <i>p</i> = 0.04) and corneal health (<i>p</i> = 0.52 vs. <i>p</i> = 0.004), with no improvements in the control group. Initial symptom improvement was observed in both RMS-treated and placebo groups (<i>p</i> = 0.007 vs. <i>p</i> = 0.008), suggesting a potential therapeutic benefit of RMS for ocular surface conditions beyond a placebo effect. <b>Conclusions:</b> This study presents RMS as a promising therapeutic approach for DED, highlighting its potential to promote corneal epithelial repair, enhance tear film stability, and improve patient-reported symptoms without negatively impacting IOP, visual acuity, or tear production. This confirms the safety and suggests the efficacy of RMS therapy for dry eye conditions.
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spelling doaj-art-8b4f96603b544d449eec2796922a42252025-08-20T02:33:43ZengMDPI AGBiomedicines2227-90592025-04-01135106410.3390/biomedicines13051064Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy StudyHadas Ben-Eli0Shimon Perelman1Denise Wajnsztajn2Abraham Solomon3Department of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, IsraelDepartment of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, IsraelDepartment of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, IsraelDepartment of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, Israel<b>Objective:</b> The aim of this study was to assess the safety and preliminary efficacy of repetitive magnetic stimulation (RMS) as a treatment intervention for dry eye disease (DED), focusing on symptom reduction. <b>Methodology:</b> This investigation involved 22 adult participants (85% females, aged between 22 and 79 years) diagnosed with moderate-to-severe DED. These individuals were subjected to RMS treatment targeting one or both eyes using the VIVEYE-Ocular Magnetic Neurostimulation System version 1.0 (Epitech-Mag LTD; National Institute of Health (NIH) clinical trials registry #NCT03012698). A placebo-controlled group was also included for comparative analysis, with all subjects being monitored over a three-month period. The evaluation of safety encompassed monitoring changes in best corrected visual acuity, ocular pathology, and the reporting of adverse events. Participant tolerance was gauged through questionnaires, measurements of intraocular pressure (IOP), Schirmer’s test, and vital signs. The efficacy of the treatment was assessed by comparing pre- and post-treatment scores for fluorescein staining (according to National Eye Institute (NEI) grading) and patient-reported outcomes. <b>Results:</b> No statistically significant changes were found in visual acuity, IOP, or Schirmer’s test results between the RMS-treated and control groups (<i>p</i> < 0.05), indicating that RMS does not negatively impact these ocular functions. However, RMS treatment was associated with improved tear film stability (<i>p</i> = 0.19 vs. <i>p</i> = 0.04) and corneal health (<i>p</i> = 0.52 vs. <i>p</i> = 0.004), with no improvements in the control group. Initial symptom improvement was observed in both RMS-treated and placebo groups (<i>p</i> = 0.007 vs. <i>p</i> = 0.008), suggesting a potential therapeutic benefit of RMS for ocular surface conditions beyond a placebo effect. <b>Conclusions:</b> This study presents RMS as a promising therapeutic approach for DED, highlighting its potential to promote corneal epithelial repair, enhance tear film stability, and improve patient-reported symptoms without negatively impacting IOP, visual acuity, or tear production. This confirms the safety and suggests the efficacy of RMS therapy for dry eye conditions.https://www.mdpi.com/2227-9059/13/5/1064dry eyemagnetic neurostimulationcorneatreatmentsafety and efficacy
spellingShingle Hadas Ben-Eli
Shimon Perelman
Denise Wajnsztajn
Abraham Solomon
Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
Biomedicines
dry eye
magnetic neurostimulation
cornea
treatment
safety and efficacy
title Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
title_full Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
title_fullStr Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
title_full_unstemmed Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
title_short Evaluating Magnetic Stimulation as an Innovative Approach for Treating Dry Eye Disease: An Initial Safety and Efficacy Study
title_sort evaluating magnetic stimulation as an innovative approach for treating dry eye disease an initial safety and efficacy study
topic dry eye
magnetic neurostimulation
cornea
treatment
safety and efficacy
url https://www.mdpi.com/2227-9059/13/5/1064
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