AcupunctureNCT06823388
Assessment of Acupuncture on Eye Fatigue
A study testing acupuncture and pseudo-acupuncture in people with Acupuncture and Eye Fatigue, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Eye Fatigue, Accomodation
- What is being tested?
- acupuncture and pseudo-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Acupuncture on Eye Fatigue : a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Acupuncture, Eye Fatigue, Accomodation
- Being tested
- acupuncture, pseudo-acupuncture
- Keywords
- eye fatigue, acupuncture
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
acupuncture
pseudo-acupunctureDevice
The pseudo-acupuncture device can simulate the sensation of acupuncture stimulation.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Active comparator | Not described Receives: Device: acupuncture |
| pseudo-acupuncture group | Placebo comparator | Not described Receives: Device: pseudo-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye accommodation ability
Value of eye accommodation ability difference before and after the intervention, measured by an autorefractor
Measured: From enrollment to the end of treatment in 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823388
- Sponsor's protocol ID
- CS1-24044
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: eye accomodation ability
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acupuncture on Eye Fatigue : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06823388
- Acronym / sponsor ID
- CS1-24044
- Conditions
- Acupuncture, Eye Fatigue, Accomodation
- Keywords
- eye fatigue, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Active comparator | Device: acupuncture |
| pseudo-acupuncture group | Placebo comparator | Device: pseudo-acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureacupuncture | Device | acupuncture group |
| pseudo-acupunctureThe pseudo-acupuncture device can simulate the sensation of acupuncture stimulation. | Device | pseudo-acupuncture group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. eye accomodation ability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and pseudo-acupuncture in people with Acupuncture and Eye Fatigue, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye accommodation ability (time frame: From enrollment to the end of treatment in 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.