Efficacy and safety of the acupuncture combined with auricular acupressure for dry eye disease：study protocol for a multicenter randomized clinical trial

Abstract

Introduction: Dry eye disease (DED) is a chronic disorder of the ocular surface (OS) that is influenced by a variety of factors, resulting in ocular discomfort and visual impairment. Studies have also shown that dry eye syndrome detrimentally impacts patients' sleep quality (SQ), mental well-being, and overall mental health. This study aims to assess the efficacy and safety of the acupuncture combined with auricular acupressure in reducing ocular symptoms and enhancing sleep and mood among patients with DED. Methods In this multicenter, randomized controlled trial (RCT), 126 patients will be enrolled and randomly assigned in equal proportions to the intervention or control group. Participants in the intervention group will undergo three 30-minute sessions weekly over 8 weeks, whereas the control group will be treated with 0.1% sodium hyaluronate eye drop. Following the intervention, an eight-week follow-up will be conducted. Primary outcomes include the Ocular surface disease Index (OSDI), Breaking up time (BUT), Conjunctival Impression Cytology (CIC), and cornea fluorescein staining (CFS). Secondary outcomes are Tear meniscus height (TMH), Meibum quality score (MQS), Meibomian gland score (MGS), Meiboscore, Function of the meibomian gland, Pittsburgh Sleep Quality Index (PSQI), Self-rating depression Scale (SDS), and Self-rating anxiety scale (SAS). Evaluations will take place at weeks 0, 4, 8, 12, and 16. Discussion This research is intended to elucidate the advantages of acupuncture in mitigating symptoms of DED and in regulating disturbances in sleep and mood among patients. Trial registration: http://itmctr.ccebtcm.org.cn , ID: ITMCTR2024000673. Registered 7th November 2024.