Abstract
Purpose :
Safety and effectiveness of Ocular Magnetic Neurostimulation system (OMNS) treatment in the management of patients with moderate to severe dry eye disease (DED) as measured by changes from baseline in corneal epithelial defects, artificial tears usage and subjective symptom scores.
Methods :
Subjects with moderate to severe DED were enrolled into this prospective, interventional, open-label, single-arm, pilot study. Treated eyes received a single 11min OMNS treatment. Follow-ups were conducted at 1, 4, 8, and 12 weeks post treatment. Effectiveness on signs was assessed by change in corneal staining using NEI grading scale (0-15). Schirmer’s test and Tear Break Up Time (TBUT) were also recorded. Effectiveness on symptoms was assessed using a validated questionnaire, PRWL2A (Post-Lasik q62-69, scale 0-100) and eye lubricants consumption. Safety measurements included treatment related Adverse Events (AE), BCVA, IOP, Slit lamp dilated biomicroscopy and macular SD-OCT.
Results :
Twenty-nine moderate to severe DED mixed etiologies were included: Sjögren’s syndrome (n=13), Meibomian Gland Dysfunction (n=12), and Aqueous Tear Deficiency (n=5). Treatment was administered to one eye with the higher NEI score in the first 15 subjects, and to both eyes in the following 14 subjects, resulting in a cohort of 43 eyes for analysis. A statistically significant mean reduction in corneal staining was recorded: 1w (-1.37, p=0.002), 4w (-1.70, p<0.001), 8w (-2.28, p<0.001) and 12w (-1.73, p<0.001). Significant mean reduction in PRWL2A symptoms scores at 1w (-9.69, p=0.004), 4w (-13.15, p<0.001), 8w (-13.41, p<0.001), and at 12w (-15.27, p<0.001). Twenty-four subjects reported a statistically significant reduction in daily consumption at 4w (-2.46, p=0.057) at 8w (-2.88, p=0.026) and 12w (-3.82, p=0.005) post treatment. No AE related to the device or treatment were observed. BCVA and IOP measurements were relatively stable compared to baseline.
Conclusions :
A single session of Ocular Magnetic Neurostimulation treatment was safe, well-tolerated and induced substantial reduction of corneal epithelium defects, dry eye symptoms and eye lubricant usage in subjects with moderate to severe DED. This innovative treatment may serve as an effective adjunct in the management of dry eye disease warranting further clinical evaluation.
This is a 2020 ARVO Annual Meeting abstract.