Clinical trial NCT05552820: Electroacupuncture for Mild-to-moderate Dry Eye
Official title: Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Electroacupuncture
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Shanghai Eye Disease Prevention and Treatment Center
name: Eye & ENT Hospital of Fudan University
First posted: 2022-09-23
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
Secondary outcomes:
measure: Change From Baseline in Tear Meniscus Height (TMH)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Corneal Fluorescein Staining (CFS)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Corneal Topography
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Corneal and Conjunctival sensation
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Schirmer I test (SⅠT)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Numerical Rating Scale (NRS)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Chinese Dry Eye Related Quality of Life Scale (CDERQOL)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Adverse events
timeFrame: Week 4
Other outcomes:
measure: Change From Baseline in Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change From Baseline in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Week 4, Week 8, Week 16, Week 28
measure: Change in morphological changes of the corneal basal nerve
timeFrame: Baseline, Week 4
measure: Change in neuroimmunomodulatory indicators in tears and conjunctival cells
timeFrame: Baseline, Week 4
Locations:
city: Shanghai
country: China
facility: Guang Yang
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Xiaopeng Ma, MD, PhD
role: STUDY_CHAIR
References: