Dry Eye Symptoms
Conditions
Keywords
Auricular Acupuncture, Dry eye symptoms, University students
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.
Interventions
OTHERAuricular 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.
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 tear drops were applied 5-6 times per day over the 4-week period
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26 | The Ocular Surface Disease Index (OSDI) OSDI is a 12-item questionnaire that assesses dry eye symptoms occurring during the last week. The questions are divided into three sections which examine, respectively: subjective ocular symptoms, limitations in performing daily activities due to eye problems, and the influence of environmental conditions on eye comfort. Responses to every question ranged from 0, which represents none of the time, to 4, which represents all of the time. The final score ranges from 0 to 100 (sum of the 12 questions multiplied by 25 and divided by 12, and then rounded to the next integer) with higher scores representing greater disability: normal (0-12), mild (13-22), moderate (23-32), severe (33-100). A subject is classified as symptomatic when the total OSDI score is equal to or over thirteen points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26 | The 5-Item Dry Eye Questionnaire (DEQ-5) is a short subset of the full Dry Eye Questionnaire (DEQ) items which contains five questions regarding the frequency and intensity of eye discomfort, eye dryness and watery eyes in the past month. Responses are collected with two types of scales of the answers ranging from 0 to 4 or 5, with 0 corresponding to never, and 4 with constantly in questions regarding the frequency of symptoms, or 0 with never have it and 5 with very intense in questions regarding the intensity of symptoms. The final score ranges from 0 to 22, a score \> 6 suggests dry eye |
| 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 | Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26 | The National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) is composed of 25 items designed to assess visual disability and health-related quality of life. It contains 12 subcategories: general health, general vision, ocular pain, near vision activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision and peripheral vision. The questionnaire has a total score ranging from 0 to 100 (a higher score indicates better vision-specific quality of life). |
Other
| Measure | Time frame |
|---|---|
| Adverse effects during auricular acupuncture | During procedure |
Countries
Vietnam
Outcome results
None listed