NCT06823388

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

June 27, 2024

Last Update Submit

December 10, 2025

Conditions

Keywords

eye fatigueacupuncture

Outcome Measures

Primary Outcomes (1)

  • eye accommodation ability

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

    From enrollment to the end of treatment in 30 minutes

Study Arms (2)

acupuncture group

ACTIVE COMPARATOR
Device: acupuncture

pseudo-acupuncture group

PLACEBO COMPARATOR
Device: pseudo-acupuncture

Interventions

acupuncture

acupuncture group

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

pseudo-acupuncture group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 400, Taiwan

Location

MeSH Terms

Conditions

Asthenopia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

February 12, 2025

Study Start

August 1, 2024

Primary Completion

December 30, 2024

Study Completion

May 30, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

eye accomodation ability

Locations