Electroacupuncture for Mild-to-moderate Dry Eye

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Enrolling

Conditions: Dry Eye

Treatments: Device: Verum Electroacupuncture; Device: Sham Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05552820

ShanghaiIAMM20220918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 month that 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, systemic lupus erythematosus, or ankylosing spondylitis
• With damaged, ulcerated, infected, or scarred skin at the selected acupoints
• Allergic to metal or tape

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

Verum Electroacupuncture

Experimental group

Description:

Verum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Treatment:

Device: Verum Electroacupuncture

Sham Electroacupuncture

Sham Comparator group

Description:

Sham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Treatment:

Device: Sham Electroacupuncture