Zhuoyi Li 1,†,#, Yika Mou 1,†,#, Shiyun Sun 1, Luyao Fu 1, Lingqian Chen 1, Qin Guo 2, Jing Liu 2,*, Ruijie Ma 1,2,*

1The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China

2Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China

*Correspondence: Jing Liu, liujing0113@126.com; Ruijie Ma, 20071028@zcmu.edu.cn

†These authors share first authorship

#Contributed equally.

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 SPIRIT- and STRICTA-compliant protocol describes a multicenter, single-blind randomized controlled trial designed to evaluate the efficacy and safety of acupuncture combined with auricular acupressure compared with 0.1% sodium hyaluronate eye drops in adults with DED.

Methods and analysis

A total of 126 patients with DED will be recruited and randomly assigned to one of two groups at a 1:1 ratio across three centers. Participants in the intervention group will receive acupuncture combined with auricular acupressure for 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 outcome is the Ocular surface disease Index (OSDI). Secondary outcomes are Breaking up time (BUT), Conjunctival Impression Cytology (CIC), cornea fluorescein staining (CFS), 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). The primary endpoint is the change in OSDI score from baseline to week 8, and the primary effect measure will be the adjusted between-group mean difference, estimated using a linear mixed-effects model. This study will assess whether acupuncture combined with auricular acupressure improves symptoms of dry eye and affects sleep and mood compared with sodium hyaluronate.

Clinical trial registration

https://itmctr.ccebtcm.org.cn, Identifier ITMCTR2024000673.

Keywords: acupuncture, auricular acupressure, dry eye disease, multicenter, randomized clinical trial, study protocol