Clinical trial NCT06876077: Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students
Official title: Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Symptoms
Keywords: Auricular Acupuncture
Dry eye symptoms
University students
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of OSDI between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
timeFrame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
Secondary outcomes:
measure: Comparison of DEQ-5 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
timeFrame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
measure: Comparison of NEI VFQ-25 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
timeFrame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
Other outcomes:
measure: Adverse effects during auricular acupuncture
timeFrame: During procedure
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University of Medical Center HCMC - Branch no.3
Study officials:
References:
citation: Wrobel-Dudzinska D, Osial N, Stepien PW, Gorecka A, Zarnowski T. Prevalence of Dry Eye Symptoms and Associated Risk Factors among University Students in Poland. Int J Environ Res Public Health. 2023 Jan 11;20(2):1313. doi: 10.3390/ijerph20021313.
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citation: Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.
citation: Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.
citation: Huang Q, Zhan M, Hu Z. Auricular Acupressure for Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicina (Kaunas). 2023 Jan 16;59(1):177. doi: 10.3390/medicina59010177.
citation: Asiedu K, Kyei S, Boampong F, Ocansey S. Symptomatic Dry Eye and Its Associated Factors: A Study of University Undergraduate Students in Ghana. Eye Contact Lens. 2017 Jul;43(4):262-266. doi: 10.1097/ICL.0000000000000256.