Actively Recruiting
The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
Led by The First Affiliated Hospital of Zhejiang Chinese Medical University · Updated on 2026-04-17
78
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of intradermal acupuncture for treating ocular surface diseases that occur after intractable peripheral facial paralysis, a condition often accompanied by eye problems like incomplete eyelid closure and irritation. This study aims to determine whether intradermal acupuncture can effectively reduce symptoms measured by the Ocular Surface Disease Index (OSDI) compared to a placebo needle. The trial is a single-center, randomized, single-blinded, placebo-controlled parallel study aiming to find a convenient and safe treatment option for these eye conditions. Participants will receive basic background treatment and are randomly assigned to either an intradermal acupuncture group or a sham acupuncture group. The intradermal acupuncture involves inserting a small needle at specific points under sterile conditions, retaining it for 72 hours, and replacing it twice a week during a 4-week treatment period. Participants in the acupuncture group will also perform standardized self-administered pressing guided by a WeChat mini program three times daily. The sham group receives the basic treatment plus sham acupuncture without needle insertion. During the 4-week treatment and a 6-week follow-up, participants will have regular assessments every two weeks to measure outcomes including the OSDI score, tear meniscus height, tear film break-up time, meibomian gland imaging, eyelid closure width, and facial nerve function grading. These evaluations help researchers monitor symptom changes and safety. The total participation time covers treatment and follow-up to observe the effects over 10 weeks.
CONDITIONS
Brief Title
The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-65 years
- Diagnosed with intractable peripheral facial paralysis, disease duration from 1 month to 1 year
- Facial Nerve Grading System 2.0 score of 15 points or higher; ENoG shows CMAP amplitude ratio 20% or less
- At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision)
- Ocular Surface Disease Index (OSDI) score between 30 and 80
- Voluntarily provide written informed consent and able to comply with treatment and follow-up
You will not qualify if you...
- Other ocular diseases such as glaucoma, keratitis, retinopathy, or acute inflammation of conjunctiva, sclera, or cornea
- Intraocular surgery or laser therapy within the past 90 days
- Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks
- Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure
- Coagulation disorders, open wounds, or local infection at intervention sites
- Allergy to press-needle materials like stainless steel or adhesive tape
- Pregnancy or lactation
- Severe cardiac, liver, kidney, psychiatric disorders, or malignant tumors
- Participation in another clinical trial within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive intradermal acupuncture or sham treatment along with basic background treatment for ocular surface diseases after facial paralysis.
Twice weekly visits for needle replacement and ongoing treatment
Duration - 6 weeks
Participants are monitored for 6 weeks after treatment to assess ocular surface disease and facial nerve function.
Assessments every 2 weeks during follow-up
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
B
Binyan Yu Binyan Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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