Purpose: to determine the effectiveness of the Aurai water propelled, heating Eye Massager (AEM) in managing dry eye disease and its effects on the ocular adnexa.Methods: This was a prospective, randomised cross-over study that enrolled 15 participants (aged 25.8 ± 5.45 years, 5 male). Participants wore a smart watch 24 hours a day to track their sleeping cycle and heart rate for 4 weeks, using the AEM twice a day for 2 of those weeks. A cycle of 6 minutes of a controlled heat and vibration pattern in the morning and another cycle in the evening were applied with the AEM. Primary outcomes of symptomatology (Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE)), tear film homeostasis markers (osmolarity, noninvasive breakup time (NIKBUT), tear meniscus height (TMH), lipid layer thickness and ocular staining) and safety measures (ocular redness and intraocular pressure), were assessed at baseline, after 2 weeks of AEM use and after 2 weeks of no treatment (in random-sequence). Sleeping tracking (ST) and heart rate/blood oxygen detection over these periods was also assessed.Results: There was a significant change in OSDI score from 34.3±19.5 at baseline to 18.8±17.5 after treatment (p = 0.001) and also for the SANDE (5.7 ± 2.4 vs 3.7 ± 2.1; p = 0.001). Heart rate was not affected by treatment (p=0.956), nor sleep pattern (p=0.529), but this varied by day (p=0.001). Tear film homeostasis, the ocular adnexia and safety measures were not affected by treatment (p>0.05).
Conclusion:The Aurai water propelled Eye Massager may relieve symptoms of dry eye and its severity, but there were no detectable effects on tear stability from two weeks use.