Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Not yet enrolling

Conditions: Dry Eye Symptoms

Treatments: Other: Artificial Tears (AT); Other: Auricular acupuncture; Other: Sham auricular acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06876077

2468/DHYD-HDDD

Details and patient eligibility

About

Dry eye symptoms can cause various discomforts in the eyes and/or visual disturbances. This condition not only limits daily personal activities and reduces quality of life and mental health but also has negative economic impacts on families and society. Currently, complementary and alternative methods have been employed, with acupuncture being a promising treatment for patients with dry eye disease. Among these, auricular acupuncture has been proven effective in managing eye diseases and improving dry eye symptoms.

Full description

Participants and Methods: A randomized controlled trial was conducted to evaluate the effectiveness of auricular acupuncture in improving dry eye symptoms by stimulating five acupoints: Auricular Shenmen (TF4), Eye 1 (TG2b), Eye 2 (AT1b), Liver (CO12), and Kidney (CO10), combined with the application of artificial tears 5-6 times per day for 4 weeks and the potential adverse effects of auricular acupuncture. A total of 50 participants were randomly assigned to 2 group (A and B) and the allocation ratio was 1:1. In group A: Participants received sham auricular acupuncture by sticking patches at specific points on one ear, combined with artificial tear drops. In group B: Participants underwent auricular acupuncture at the same points on one ear, combined with artificial tear drops. Stimulation was performed three times daily by pressing each needle or adhesive patch for approximately 10 seconds or until the ear turned red or became slightly painful. The total duration of the study was 4 weeks. Participants alternated auricular acupuncture or sham acupuncture between ears for five sessions, with each session lasting 5 days. Our study evaluate: (1) The improvement in dry eye symptoms acccording to the Ocular Surface Disease Index (OSDI) and the 5-item Dry Eye Questionnaire (DEQ-5); (2) The impact on quality of life was evaluated using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) and (3) Adverse effects during auricular acupuncture: Pain, allergy at the site of auricular acupuncture, acupuncture vertigo.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants must meet the following criteria:

• Be at least 18 years of age.
• Exhibit symptoms of dry eye, such as dryness, eye fatigue, eye itching, a foreign body sensation in the eye, burning or stinging sensations, blurry vision, light sensitivity, excessive tearing, or drooping eyelids.
• Have no refractive errors or related eye conditions.
• Visual acuity of both eyes ≥ 8/10 on the Snellen chart (normal vision).
• Show signs of dry eye with an OSDI score of ≥ 13 points
• Have never undergone auricular acupuncture before.
• Voluntarily agree to participate in the study.

Exclusion criteria

Participants must meet at least one of the following criteria:

• Have symptoms suggesting an acute infection or conditions affecting the conjunctiva, sclera, eyelids, cornea, or systemic diseases.
• Are using other methods to treat eye diseases.
• Have undergone eye-related surgery within the past 3 months.
• Have changed or worn contact lenses during the study period.
• Have inflamed or ulcerated skin in both ears.
• Are debilitated, exhausted, or have severe concomitant diseases.
• Are using medications affecting vision (diuretics, antihistamines, antihypertensives) or eye drops.
• Have a history of acupuncture vertigo.
• Are contraindicated with Sodium Hyaluronate.
• Are participating in other interventional studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Auricular acupuncture + Artificial Tears

Experimental group

Description:

Auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. Artificial tears were continuously administered over the four-week intervention period.

Treatment:

Other: Auricular acupuncture

Other: Artificial Tears (AT)

Sham auricular acupuncture + Artificial Tears

Sham Comparator group

Description:

Sham auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. The artificial tear is continuously administered over the four-week intervention period.

Treatment:

Other: Sham auricular acupuncture

Other: Artificial Tears (AT)