Electroacupuncture treatment for mild-to-moderate dry eye
Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye
This study is trying out electroacupuncture to see if it can help people with mild-to-moderate dry eye feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05552820 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of electroacupuncture as a treatment for mild-to-moderate dry eye compared to a sham treatment. It will involve 168 participants who will be randomly assigned to receive either verum electroacupuncture or a non-penetrating sham treatment three times a week for four weeks, followed by a 24-week follow-up. The primary outcome will be the change in Noninvasive Tear Breakup Time (NIBUT), with secondary outcomes including various assessments of ocular health and quality of life. The study will also explore potential links between treatment benefits and changes in corneal subbasal nerves.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with mild-to-moderate dry eye as defined by the TFOS DEWS II criteria.
Not a fit: Patients with severe dry eye or other significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for patients suffering from mild-to-moderate dry eye.
How similar studies have performed: While acupuncture has been explored in various contexts, the specific use of electroacupuncture for dry eye is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ * Ages 18-65 years, no gender limit Exclusion Criteria: * 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 * 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
Where this trial is running
Shanghai
- Guang Yang — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Guang Yang, MD
- Email: sunnyyang0415@163.com
- Phone: +8618817818512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.