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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Auricular acupuncture + Artificial Tears

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.

Group Type EXPERIMENTAL

Auricular acupuncture

Intervention Type OTHER

Auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Artificial Tears (AT)

Intervention Type OTHER

Artificial tear drops were applied 5-6 times per day over the 4-week period

Sham auricular acupuncture + Artificial Tears

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.

Group Type SHAM_COMPARATOR

Sham auricular acupuncture

Intervention Type OTHER

Sham auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, without a needle. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Artificial Tears (AT)

Intervention Type OTHER

Artificial tear drops were applied 5-6 times per day over the 4-week period

Interventions

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Auricular acupuncture

Auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Intervention Type OTHER

Sham auricular acupuncture

Sham auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, without a needle. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Intervention Type OTHER

Artificial Tears (AT)

Artificial tear drops were applied 5-6 times per day over the 4-week period

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes