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Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial

Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015831
Enrollment
Unknown
Registered
2018-04-23
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye disease

Interventions

Acupuncture group:acupuncture

Sponsors

South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. individuals aged more than 18 years old and less than 60 years old; 2. participants meeting the diagnostic criteria of DED. The criteria of moderate to severe DED is based on the following ophthalmologic tests: a Schirmer I test (with the application of cocaine, a local anesthetic) value = 3 mm/5 minutes and = 9mm/5 minutes, a tear break-up time (TBUT) = 9 seconds and CFS = 1. These ophthalmologic tests will be performed by the ophthalmologists who don't know the results of random allocation; 3. Only the single eye with more severe scores or symptoms is selected to observe the outcome; and 4. participants who can complete the study, treatment, and assessments.

Exclusion criteria

Exclusion criteria: 1. participants who have undergone surgery for DED within 3 months; 2. participants with other ocular diseases (e.g., lacrimal duct obstruction, other conjunctiva and keratopathy) or immune system diseases (e.g., Sjogren syndrome and rheumatoid arthritis); 3. participantswith immune system diseases such as Sjogren syndrome and rheumatoid arthritis 4. participants with cardiovascular, liver, kidney, or hematopoietic system diseases, mental health disorders, or cancer for whom acupuncture may be inappropriate or unsafe; 5. participants who have received acupuncture within the past week; 6. women who are pregnant or lactating; 7. participants who are participating in other clinical trials; and 8. participants with a pacemaker, metal allergy, or severe fear of needles.

Design outcomes

Primary

MeasureTime frame
the Schirmer-I test;

Countries

China

Contacts

Public ContactXue Zhang

South Area of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

zhangxueresume@aliyun.com+86 13260476371

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026