Considering high prevalence of myopia in Asian countries, social cost paid for myopia may gradually increase in Korea. However, studies for developing myopia treatment are deficient. The study was to evaluate whether the periocular acupressure with a medical massager is effective for suppressing myopia progression. Methods: This study was an investigator-sponsored, prospective, open-labeled, and superiority pre and post single-armed study. 14 myopia children aged 7-12 years wore a medical massager for 15 minutes to stimulate periocular acupoints. For 24 weeks, the participants used the device twice a day. Based on prior studies, the refraction change of naturally proceeded myopia was set as-0.38 D. The axial length change of naturally proceeded myopia was set as 0.228 mm. To assess the safety, we performed vital sign check, physical examination, visual acuity test, slit lamp examination, IOP measurement, and fundus examination. Results: The refraction and axial length of the participants increased. For 24 weeks, the change in refraction was-0.38 D at the right eye and-0.40 D at the left. The change in axial length was 0.21 mm at the right and 0.22 mm at the left. In the safety assessment, any adverse event did not occur. Conclusions: There was no significant difference between the control group and the intervention group. The effect of growth may have more contributed to our result than that of acupressure. Based on our result, a full-scale study will not be conducted.

Background: The prevalence of dry eye, which is a common lacrimal disease, is steadily increasing in modern society. However, fundamental treatment for it has not yet been established. This study aims to assess the efficacy and safety of a novel medical device, the biodegradable microneedle acupuncture (BMA), using a traditional intradermal acupuncture needle as the control acupuncture for dry eye. Method: This study will be an investigator-initiated, assessor-blinded, comparative, superiority pilot randomized controlled trial. A total of 30 patients with dry eye will be randomly assigned to the experimental or the control group in equal proportion. For the experimental group, the BMA will be applied to both sides of 5 acupoints including BL2, GB14, TE23, EX-HN5, and ST1. For the control group, conventional intradermal acupuncture will be applied to the same acupoints. The needles will be attached for 4 hours. Over 4 weeks, both the interventions will be performed 12 times in total. The primary outcome would be the ocular surface disease index. The secondary outcomes would be the visual analog scale for subjective symptoms, quality of life, Schirmer I test, and general assessment. Discussion: The findings of this study on the efficacy and safety of the BMA would be helpful for patients with dry eye in clinical practice. Further, these results would provide for the foundation of a large-scale BMA study.

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