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

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. 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. No statistically significant changes were found in visual acuity, IOP, or Schirmer's test results between the RMS-treated and control groups ( < 0.05), indicating that RMS does not negatively impact these ocular functions. However, RMS treatment was associated with improved tear film stability ( = 0.19 vs. = 0.04) and corneal health ( = 0.52 vs. = 0.004), with no improvements in the control group. Initial symptom improvement was observed in both RMS-treated and placebo groups ( = 0.007 vs. = 0.008), suggesting a potential therapeutic benefit of RMS for ocular surface conditions beyond a placebo effect. 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.