Objective The objective of this study was to assess the safety and preliminary efficacy of repetitive magnetic stimulation (RMS) as an intervention for dry eye syndrome, focusing on symptom reduction. Methodology This investigation involved 22 adult participants diagnosed with moderate to severe dry eye syndrome. These individuals were subjected to RMS treatment targeting one or both eyes using the VIVEYE - Ocular Magnetic Neurostimulation System Ver 1.0 (Epitech-Mag LTD; 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 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 on fluorescein staining (according to the National Eye Institute (NEI) grading) and patient-reported outcomes. Results The study found no significant changes in visual acuity, IOP, or Schirmer's test results between the RMS-treated and control groups (p<0.05), indicating RMS does not adversely affect these ocular functions. However, RMS treatment was associated with improved tear film stability (p=0.198 vs. p=0.045) and corneal health (p=0.52 vs. p=0.004), with no improvements in the control group. Initial symptom improvement was observed in both RMS-treated and placebo groups (p=0.007 vs p=0.008), suggesting RMS's potential for treating ocular surface conditions. Conclusion The findings of this study introduce repetitive magnetic stimulation (RMS) as a promising therapeutic option for dry eye syndrome, demonstrating its capability to promote corneal epithelium repair, enhance tear film stability, and improve subjective symptom evaluations without adversely affecting intraocular pressure, visual acuity, or tear production. This confirms the safety and suggests the efficacy of RMS therapy for dry eye conditions.

The authors have declared no competing interest.

#ClinicalTrials.gov Identifier: NCT03012698

The author(s) received no specific funding for this work.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the national Ministry of Health (#20162621) and by the institutional Helsinki committees of Hadassah Medical Center ( #HMO-0630-16).

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The data set generated during the current study is available from the corresponding authors on reasonable request.