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Completed

NCT Number: NCT06823388

Assessment of Acupuncture on Eye Fatigue

The study is designed to assess the effiacy of acupuncutre on eye fatigue. The indicator of eye fatigue is eye accommodation ability. Patients will be randomly assigned to the experimental group and the control group. The experimental group will receive acupuncture treatment, while the control group will receive sham acupuncture stimulation. The eye accommodation ability of both groups will be easured before and after the intervention, and the differences in eye accommodation ability before and after treatment will be analyzed.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 400, Taiwan

About this study

A dual-arm, parallel, randomized single-blind, sham-controlled trial will be conducted. The aim of the study is to assess the effiacy of acupuncutre on eye fatigue. Patients will be recruited from outpatient clinics. Subjects will be assessed at a Traditional Chinese Medicine (TCM) outpatient clinic and then have their accommodation function tested in an optometry room . This will determine if they meet the inclusion criteria.

Those who meet the inclusion criteria will be randomly assigned to the experimental group or the control group. The experimental group will receive treatment at seven acupuncture points: Fengfu (GV16), bilateral Fengchi (GB20), Yumen (TH2), and Hegu (LI4), using Jiasun 42G 1-inch acupuncture needles. The needles will be inserted perpendicularly to achieve the "De Qi" sensation, with a depth of 0.5 inches, and retained for 25 minutes before removal. The control group will undergo sham acupuncture at the same points using specially designed acupuncture needles from the manufacturer, which give the sensation of needling but retract into the handle without penetrating the skin, thus providing no real stimulation. Both groups will be treated by TCM physician .

After needle removal, visual acuity will be tested again to compare the differences in values between the pre- and post-test measurements of both groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjective experience of eye fatigue after using electronic devices at least twice a week.
  • Age ≥ 18 years.
  • Agreement to sign the informed consent form for this study.

Exclusion criteria

  • Accommodation assessment: Interocular accommodation difference greater than 3 diopters (D).
  • History of metabolic diseases with accompanying retinal conditions (e.g., diabetic retinopathy, hypertensive/hyperlipidemic patients with macular edema, retinal hemorrhage, glaucoma, etc.).
  • Current treatment for ocular inflammation or infection (e.g., conjunctivitis, orbital cellulitis).
  • Underwent eye surgery within the last 3 months (including LASIK surgery).
  • Received acupuncture treatment for eye-related symptoms in the past month.
  • Diagnosed with severe ophthalmic conditions (e.g., optic atrophy) and deemed unsuitable for the trial by an ophthalmologist.
  • Diagnosed with anemia, hypotension, or chronic fatigue in the past three months, making them unsuitable for acupuncture due to a tendency to faint.
  • Pregnant women.
  • Major diseases such as renal insufficiency, cerebrovascular disease, or cancer, deemed unsuitable for clinical research participation by the principal investigator.

Treatment and study plan

acupuncture

Device

acupuncture

pseudo-acupuncture

Device

The pseudo-acupuncture device can simulate the sensation of acupuncture stimulation.

Primary outcomes

  1. eye accommodation ability

    Time frame: From enrollment to the end of treatment in 30 minutes

    Value of eye accommodation ability difference before and after the intervention, measured by an autorefractor

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Assessment of Acupuncture on Eye Fatigue : a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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