The purpose of this study is to explore the clinical efficacy of intradermal acupuncture in the treatment of ocular surface diseases after Intractable Facial Paralysis, and to seek effective and convenient treatment for ocular surface diseases after intractable peripheral facial paralysis. The main question it aims to answer is ： Will the intradermal acupuncture intervention effectively reduce the OSDI score ? The researchers compared the intradermal acupuncture with the placebo-needle to observe whether the intradermal acupuncture could better improve the symptoms.
1.Male or female patients aged 18-65 years.
2.Meets diagnostic criteria for intractable peripheral facial paralysis, with disease duration from 1 month to 1 year. FNGS 2.0 ≥15 points; ENoG shows the ratio of CMAP amplitude≤ 20%.
3.At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision) and OSDI scores between 30 and 80.
4.Voluntarily provides written informed consent and can comply with treatment and follow-up.
1.Other ocular diseases (glaucoma, keratitis, retinopathy, acute inflammation of conjunctiva, sclera, cornea).
2. Intraocular surgery or laser therapy within the past 90 days.
3.Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks.
4.Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure.
Parallel
Intradermal acupuncture treatment
Other interventionThe IA group will receive basic background treatment. During the intervention phase, the group will receive IA treatment. After basic background treatment, IA treatment will adopt acupoints. Under strict aseptic conditions, a φ0.20\*1.2 mm IA(SEIRIN Co.,Japan) will puncture perpendicularly and retained in the skin.It will be retained for 72 hours and replaced twice weekly, with the entire intervention course lasting 4 weeks. During the IA treatment period, participants will perform standardized self-administered pressing by a dedicated WeChat mini program: 3 times daily, 3 minutes per session, 60 presses per minute, stimulating as much as tolerated.
Sham intradermal acupuncture
Other interventionThe SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.
ocular surface disease index
After 4 weeks of treatment, the proportion of patients with OSDI index score decreased by more than 12 points from baseline. According to previous studies, the minimal clinically important difference (MCID) for the Ocular Surface Disease Index (OSDI) was 10 points, and the MCID of the severe dry eye population was 7.3\~13.4 points. At the same time, based on the pre-test results of this study, 12 points corresponded to "significant improvement in patient perception" in this study. Therefore, the OSDI score decreased by ≥12 points from the baseline after 4 weeks of treatment, which was considered as "effective treatment".
tear meniscus height (TMH)
TMH：focuses on the tear meniscus at the lower eyelid margin via near-infrared mode, captures images below the pupil center, and calculates height through manual boundary calibration to assess baseline tear secretion.
Tear film break-up time (TBUT)
TBUT：uses non-invasive mode with near-infrared light and Prasy multi-disk projection; records the time from the last natural blink to the first corneal projection distortion (tear film break-up), with 3 repeated measurements averaged to evaluate tear film stability.
Meibomian Gland Imaging
The patient is seated with the head stabilized in the headrest of a slit-lamp or dedicated meibography device. The patient is instructed to gently rotate the eyeball to fully expose the eyelid margin. The physician gently everts the upper and lower eyelids, activates the infrared imaging mode to capture meibomian gland images. The system automatically analyzes the meibomian gland loss area and completes the assessment for both eyes (OD/OS). The entire procedure is non-invasive, rapid, and causes no significant discomfort.
The width of incomplete palpebral fissure closure
The width of incomplete palpebral fissure closure refers to the horizontal fissure distance left by the failure to fully fit the upper and lower eyelid margins when the eyelid is closed naturally or with maximum force. It is the core quantitative index for evaluating the eyelid closure function, usually in millimeters(mm).
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