Electroacupuncture for Mild-to-moderate Dry Eye

Phase

N/A

Condition

Eyelid Inflammation

Dry Eye Disease

Sjogren's Syndrome

Treatment

Sham Electroacupuncture

Verum Electroacupuncture

Clinical Study ID

NCT05552820

ShanghaiIAMM20220918

Ages 18-65
All Genders

Study Summary

To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
Ages 18-65 years, no gender limit

Exclusion

Exclusion Criteria:

Diagnosed with severe dry eye
Combined with other eye diseases (e.g. severe blepharitis, blepharospasm,conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease,ocular trauma)
With active eye diseases or a history of eye surgery within 3 months
Received acupuncture treatment or other dry eye treatment measures within 1 monththat may influence the assessment of efficacy
Previously experienced electroacupuncture intervention
Pregnant or breastfeeding females
Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal,and hematopoietic system and psychiatric disorders
With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemiclupus erythematosus, or ankylosing spondylitis
With damaged, ulcerated, infected, or scarred skin at the selected acupoints
Allergic to metal or tape

Study Design

Sham Electroacupuncture

October 12, 2022

August 31, 2026

Study Description

Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.

This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.

Connect with a study center

Guang Yang
Shanghai, 20030
China
Active - Recruiting

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