• Ji-Hoon Song and Soo-Yeon Park.
• Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean Medicine, Dongshin University, Naju-si, Republic of Korea.
• Medicine (Baltimore). 2022 Nov 25; 101 (47): e31468e31468.

BackgroundThe 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.MethodThis 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.DiscussionThe 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.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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