Dry EyeNCT05552820
Electroacupuncture for Mild-to-moderate Dry Eye
A study testing Verum Electroacupuncture in people with Dry Eye, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Verum Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 20 Apr 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
- Ages 18-65 years, no gender limit
Who cannot join
- Diagnosed with severe dry eye
- Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
- With active eye diseases or a history of eye surgery within 3 months
- Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
- Previously experienced electroacupuncture intervention
- Pregnant or breastfeeding females
Show all 10Show fewer
- Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic system and psychiatric disorders
- With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis
- With damaged, ulcerated, infected, or scarred skin at the selected acupoints
- Allergic to metal or tape
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye
To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.
Read the detailed description
Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.
This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.
- Conditions
- Dry Eye
- Being tested
- Verum Electroacupuncture, Sham Electroacupuncture
- Keywords
- Dry eye, Electroacupuncture
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum ElectroacupunctureDevice
Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA.
Sham ElectroacupunctureDevice
Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.
| Study group | Role | What they receive |
|---|---|---|
| Verum Electroacupuncture | Experimental | Verum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min. Receives: Device: Verum Electroacupuncture |
| Sham Electroacupuncture | Sham comparator | Sham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min. Receives: Device: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)
The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Secondary outcomes (9)
Change From Baseline in Tear Meniscus Height (TMH)
The digital slit lamp (SL990N, CSO, Italy) is applied to take images of the tear meniscus at the lower lid margin in a dark room. The tear meniscus height directly below the central pupil is measured with the system's built-in caliper tool.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Ocular Surface Disease Index (OSDI)
The OSDI scale is used to assess subjective symptoms related to dry eye, including ocular symptoms, visual function and environmental triggers, with a total score ranging from 0 to 100. The higher the score, the more severe the subjective symptoms.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal Fluorescein Staining (CFS)
Sodium fluorescein ophthalmic strips (Tianjin Jingming New Technology Development Co., Ltd., China) are used to evaluate corneal epithelial damage. According to the Oxford grading scheme, the CFS score ranges from 0 (no damage) to 5 (severe damage).
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal Topography
The corneal topography system is used to take photographs. The subjects are asked to blink naturally 3 to 4 times, and after the last full blink, they look at the central light source of the Placido disk for 10 s. The researchers take photographs of the anterior corneal surface immediately after the blink and at 10 s of continuous gaze. The SRI and SAI are systematically analyzed and obtained at 10 s.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal and Conjunctival sensation
The Cochet-Bonnet perception meter (Luneau Chartres, France) will be used to evaluate the corneal perception (including central, superior, inferior, nasal, and temporal corneas, all 2 mm from the corneal rim) and conjunctival perception (including temporal and nasal bulbar conjunctivae, both 3 mm from the corneal rim; superior and inferior conjunctiva, at the center of the eyelid). The measured fiber length will be converted to g/mm2 according to the criteria provided by the supplier, with a higher threshold indicating a more insensitive perception.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Schirmer I test (SⅠT)
SⅠT will be performed using a tear detection filter strip (Tianjin Jingming New Technology Development Co., Ltd., China). Patients are requested to avoid eye movement. The strips will be removed after 5 min, and recorded the wetting length.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Numerical Rating Scale (NRS)
Subjects are asked to rate their current Iocular pain intensity in the right and left eye (0-10 numerical rating scale, NRS) followed by placement of 0.4% hydroxybuprocaine hydrochloride (Santen Pharmaceutical Co., LTD., Japan), and rerating of pain 30 seconds later.
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Chinese Dry Eye Related Quality of Life Scale (CDERQOL)
CDERQOL includes 5 domians containing 45 items rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree).
Measured: Baseline, Week 4, Week 8, Week 16, Week 28
Adverse events
Any adverse events will be recorded. EA-related adverse events include local bleeding, subcutaneous hematoma, pain, itch, infection, and generalized symptoms such as dizziness and palpitation during treatment.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start12 Dec 2023
- Primary completion18 Oct 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center, Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Xiaopeng Ma, MD, PhD, Study chair, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552820
- Sponsor's protocol ID
- ShanghaiIAMM20220918
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu YQ, Yang G, Li MY, Hong J, Yang YT, Wang XJ, Kong XH, Zhao Y, Ma Z, Huang XY, Zou YL, Zhou XT, Ma XP. Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial. BMJ Open. 2023 Dec 6;13(12):e069369. doi: 10.1136/bmjopen-2022-069369.
PubMed 38056935
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye
- ClinicalTrials.gov ID
- NCT05552820
- Acronym / sponsor ID
- ShanghaiIAMM20220918
- Conditions
- Dry Eye
- Keywords
- Dry eye, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center, Eye & ENT Hospital of Fudan University
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 23 Sep 2022 (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.
To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.
Detailed description
Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.
This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Electroacupuncture | Experimental | Device: Verum ElectroacupunctureVerum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min. |
| Sham Electroacupuncture | Sham comparator | Device: Sham ElectroacupunctureSham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
- Ages 18-65 years, no gender limit
Key exclusion criteria (10 listed)
- Diagnosed with severe dry eye
- Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
- With active eye diseases or a history of eye surgery within 3 months
- Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
- Previously experienced electroacupuncture intervention
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 |
|---|---|---|
| Verum ElectroacupunctureAcupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA. | Device | Verum Electroacupuncture |
| Sham ElectroacupunctureSham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one. | Device | Sham Electroacupuncture |
Primary outcome
Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.
9 secondary outcomes
Change From Baseline in Tear Meniscus Height (TMH)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Ocular Surface Disease Index (OSDI)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal Fluorescein Staining (CFS)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal Topography
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Corneal and Conjunctival sensation
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Schirmer I test (SⅠT)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Numerical Rating Scale (NRS)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Change From Baseline in Chinese Dry Eye Related Quality of Life Scale (CDERQOL)
Time frame: Baseline, Week 4, Week 8, Week 16, Week 28
Adverse events
Time frame: Week 4
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 5 May 2026.
- Derived from this study: PubMed 38056935Lu YQ, Yang G, Li MY, Hong J, Yang YT, Wang XJ, Kong XH, Zhao Y, Ma Z, Huang XY, Zou YL, Zhou XT, Ma XP. Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial. BMJ Open. 2023 Dec 6;13(12):e069369. doi: 10.1136/bmjopen-2022-069369.
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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.
Xiaopeng Ma, MD, PhD study chair
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum Electroacupuncture in people with Dry Eye, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
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 2 inclusion and 10 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 5 May 2026. 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 China. 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?
Change from Baseline in Noninvasive Tear Breakup Time (NIBUT) (time frame: Baseline, Week 4, Week 8, Week 16, Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552820, which also lists 1 linked publication.
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 5 May 2026.