RECRUITINGINTERVENTIONAL

Electroacupuncture for Mild-to-moderate Dry Eye

Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ - Ages 18-65 years, no gender limit Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Verum Electroacupuncture

Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA.

DEVICE

Sham Electroacupuncture

Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.

Locations (1)

Guang Yang

Shanghai, China