Acupuncture with micro-needle for dry eye disease: A study protocol for a randomized, sham-controlled, clinical trial

Dry Eye Disease (DED) is a prevalent and significant condition that affects a large number of people. Artificial tears can alleviate the symptoms in patients with mild to moderate dry eyes, but they do not have a long-term effect. Micro-needle is a novel type of acupuncture, with needle tips arrayed on a silicon chip attached to medical plaster, without penetrating the skin. Its effectiveness and efficacy need to be proven clinically.

This is a single-center, randomized, sham-controlled trial. In total, 129 DED patients will be recruited and randomized into three groups: micro-needle, sham, and artificial tears. They will receive four weeks of treatment and undergo follow-up at six and ten weeks. The primary outcome is measured by the Objective Symptoms Scoring Sheet (OSSS). Secondary outcomes include the China Dry Eye Questionnaire (CDEQ), Ocular Surface Disease Index (OSDI), non-invasive tear film break-up time (NIBUT), Schirmer Test I (SIT), Tear Meniscus Height (TMH), and Corneal Fluorescein Staining (CFS). Questionnaires, including OSSS, CDEQ, and OSDI, will be administered at screening, at the end of week two, and at the conclusion of week four, when treatment is completed. They will also be conducted at follow-up in week six and week ten; OSSS will be taken additionally on day two of the treatment. Tests of Intraocular Pressure (IOP), Best Corrected Visual Acuity (BCVA), NIBUT, SIT 1, TMH, and CFS are conducted at screening and upon completion of treatment. At week two, NIBUT, SIT 1, TMH, and CFS tests are taken as intermittent measurements.

The trial protocol and informed consent document were reviewed and approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine (Approval Number: 2023SHL-KY-101-01). Prior to enrollment, each potential participant undergoes a structured informed consent process conducted by a trained research coordinator, which includes explaining the trial purpose, design, interventions, benefits, risks, and time commitments; providing sufficient time for participants to review the plain-language written informed consent document; addressing all questions to ensure comprehension; and obtaining signed written consent, with a copy provided to the participant and the original stored in the trial file. To safeguard participant confidentiality, all data are labeled with a unique study ID instead of personal identifiers; paper records are stored in locked cabinets in a restricted-access office, and electronic data are stored on password-protected, encrypted servers accessible only to authorized team members via unique logins; de-identified data are used solely for analysis and reporting, with personal identifiers accessible only to the trial coordinator for enrollment and follow-up and never shared with other parties; and study findings in publications and presentations will be aggregated to prevent individual identification. The findings of this investigation will be disseminated through peer-reviewed publications, and any protocol amendments will be submitted to the ethics committee for re-approval and updated in the trial registry.

ChiCTR2300078187 TRIAL REGISTRATION DATE: 2023.11.30 TRIAL REGISTRY: China Clinical Trial Registration Center https://www.chictr.org.cn.