The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
Phase: NA
Conditions: Facial Paralysis, Peripheral, Bell's Palsy, Ocular Surface Disease
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Single-Center Randomized Controlled Clinical Trial of
Intradermal Acupuncture for Ocular Surface Disease
Secondary to Intractable Peripheral Facial Paralysis
Lead Research Site: Zhejiang Provincial Hospital of Traditional Chinese Medicine
Principal Investigator (PI):
In accordance with the Measures for the Administration of Clinical Research Projects
Conducted by Medical and Health Institutions (2014 Edition), the Principal Investigator shall be
the person in charge of the relevant professional department or a health professional with an
associate senior professional title or above. Generally, there is only one Principal Investigator for
each project, and the rest are co-investigators.
Statistical Analysis Unit:
Protocol Version Number: 3.0
Protocol Version Date: March 15, 2026
Confidentiality Statement
All information contained in this study protocol is the property of the investigators of this project
and is provided solely for review by the Ethics Committee and relevant authorities. Without the
written consent of the Principal Investigator (PI), it is strictly prohibited to disclose any
information to third parties unrelated to this study.

CATALOGUE
CATALOGUE...............................................................................................................1
Visit Schedule................................................................................................................3
1. Research Background................................................................................................4
2. Research Objectives...................................................................................................6
3. Research Hypothesis..................................................................................................6
4. Study Design..............................................................................................................7
5. Randomization and Blinding.....................................................................................8
6. Sample Size............................................................................................................... 9
7. Subject Recruitment...................................................................................................9
8. Study Subjects........................................................................................................... 9
9. Study Intervention................................................................................................... 10
10. Study Flow.............................................................................................................13
11. Subject Withdrawal or Study Treatment Termination...........................................14
12. Outcome Measures................................................................................................ 15
13. Emergency Management....................................................................................... 15
14. Study Supply Management....................................................................................16
15. Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions
(ARs)............................................................................................................................17
16. Data Management..................................................................................................19
17. Statistical Analysis.................................................................................................20
18. Quality Control and Quality Assurance.................................................................22
19. Ethical Considerations...........................................................................................23
20. Study Schedule...................................................................................................... 23

Visit Schedule
Screening
Period
Intervention Period (4 weeks)
Follow-up Period( 6 weeks )
Enroll
ment
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit Phase
V0
V1
V2
V3
V4
V5
V6
Visit Time
week-1
week0
week2
week4
week6
week8
week10
Informed Consent
Form
Δ
Demographic
Information A
Δ
Medical History B
Δ
FNGS 2.0 C
Δ
Δ
Δ
Δ
Δ
Δ
ENoG D
Δ
OSDIE
Δ
Δ
Δ
Δ
Δ
Δ
Ocular
Surface
Function Test F
Δ
Δ
Δ
The
Width
of
Palpebral Fissure
Incompleteness G
Δ
Δ
Δ
Δ
Δ
Δ
Adverse Events
Δ
Δ
Δ
Δ
Δ
Δ
Δ
Blinded
Assessment
Δ
Δ
Notes:
A. Demographic statistics include the patient's date of birth, gender, ethnicity, and other relevant
information.
B. Medical history includes past and present medical histories of facial paralysis and ocular
diseases secondary to facial paralysis.
C. Facial Nerve Grading System 2.0[1] : A standardized tool for quantitatively assessing the
severity of facial nerve dysfunction, optimized from the House-Brackmann (H-B) Facial Nerve
Grading Scale. It achieves objective evaluation of facial nerve function through precise itemized

scoring and is a commonly used quantitative scoring system for facial nerve function in clinical
practice and scientific research.
D. Electroneuronography (ENoG)[2]: The maximum compound muscle action potential (CMAP)
amplitudes of the facial nerve on the healthy and affected sides are detected via
electroneuronography, and the ratio of the amplitude on the affected side to that on the healthy
side is calculated. Essentially, the healthy side serves as an internal normal control to reflect the
severity of nerve injury on the affected side. A lower ratio indicates fewer nerve fibers with
effective signal conduction on the affected side and more severe nerve injury.
E. Ocular Surface Disease Index (OSDI)[3]: The OSDI questionnaire is a self-assessment
questionnaire for quantitatively evaluating the impact of OSD on patients' quality of life.
F. Ocular Surface Function Test: Includes tear meniscus height, tear break-up time (TBUT), and
meibomian gland analysis.
G. Width of palpebral fissure incompleteness refers to the horizontal fissure distance between the
upper and lower eyelid margins that fails to fully adhere when the eyelids are closed naturally or
with maximum force. It is a core quantitative indicator for evaluating eyelid closure function, with
the unit usually being millimeters (mm).
1. Research Background
Intractable facial paralysis(IFP) generally refers to PFP(PFP) that does not show
significant recovery after conventional treatment, clinically manifesting as unilateral
deviation of the mouth and eye, incomplete eyelid closure, unilateral facial muscle
synkinesia, malposition, etc. This condition is mostly caused by severe facial nerve
injury in PFP, or delayed, prolonged, or incorrect initial treatment[4]. PFP is a
common clinical disease caused by inflammation, acute edema, and compression of
the facial nerve within the stylomastoid foramen due to cold exposure, viral infection,
and other factors. Bell's Palsy (BP) is the most representative type, accounting for
approximately 95% of clinical PFP cases. One in 60 people will develop BP at some
stage of life, with an annual incidence of 11.5–53.3 cases per 100,000 people[5].
Studies have shown that approximately 60%–87% of patients with IFP fail to achieve

full recovery[6], developing sequelae or permanent paralysis. However, the definition
of IFP has not been clearly unified. Electroneuronography (ENoG) is a widely
recognized important reference indicator for the prognosis of PFP[7], which records
CMAP of facial muscles after electrical stimulation of the main facial nerve trunk via
surface electrodes. Studies indicate that patients with an affected/healthy CMAP
amplitude ratio <20% generally have a recovery period of no less than 4 months, and
most experience incomplete recovery[8]. Therefore, this study mainly enrolls PFP
patients with a CMAP amplitude ratio <20%.
Due to severe facial nerve injury and a long recovery cycle, IFP is often
accompanied by a variety of associated OSD(OSD), among which incomplete eyelid
closure, epiphora, and ocular motor dysfunction are the most common. These can lead
to exposure keratitis, conjunctivitis, and even vision loss[9][10], severely affecting
patients' daily work. In modern life, electronic products have become a necessity for
work, study, and social interaction, and patients cannot avoid using them, which
further exacerbates ocular injury[11]. Meanwhile, high-frequency use of electronic
products leaves no time for the damaged corneal epithelium to repair, and the
superimposed effects of electronic products transform ocular surface injury from
intermittent to persistent. Currently, there are no clearly recommended therapeutic
drugs for PFP PFP in recovery guidelines, and Sodium Hyaluronate Eye Drops and
other symptomatic supportive treatments are commonly recommended for associated
OSD[9][12]. However, long-term corneal exposure combined with electronic product
use in these patients renders the clinical efficacy of artificial tears unsatisfactory.
Therefore, exploring an "effective, safe, convenient, and sustained" treatment method
has important
clinical value and can solve the long-term ocular problems
accompanying IFP in these patients.
Acupuncture is a treasure of traditional Chinese medicine (TCM). Studies have
shown that electroacupuncture and other therapies can effectively improve clinical
symptoms in patients with dry eye syndrome[13]. But they have limitations such as
high requirements for operator skills, poor patient treatment adherence, and
short-lasting effects. As an important component of acupuncture therapy, intradermal

acupuncture(IA) achieve the regulation of meridian qi and blood and improvement of
visceral function through subtle, sustained acupoint stimulation, featuring good
efficacy, simple operation, minimal trauma, and high safety[14]. A literature review
reveals a lack of high-quality clinical studies on IAtherapy for OSD after IFP.
Preliminary pilot experiments by the research team indicate that IA can effectively
improve OSDI scores in patients with OSD after IFP. To further verify the efficacy
and safety of this treatment method, we will conduct a single-center, randomized,
single-blind, placebo-controlled parallel trial, aiming to provide a convenient, safe,
and easily promotable treatment for OSD after IFP. This treatment is simple and
feasible, suitable for application in primary medical institutions and home-based
rehabilitation of patients, helping to reduce the medical burden on medical institutions
and patients, with important practical application value and promotion prospects.
2. Research Objectives
(1) Primary Objective
To preliminarily evaluate the effective rate of IA intervention for OSD after IFP
through a single-center, randomized, single-blind, placebo-controlled parallel trial,
and to provide a new effective treatment for ocular diseases secondary to intractable
PFP.
(2) Secondary Objectives
To assess whether IA intervention exerts a synergistic promoting effect on
improving patients' ocular symptoms, restoring ocular surface function, and
facilitating facial nerve function recovery; to clarify the operational feasibility, safety,
and patient acceptance of IA intervention, and to provide an optimized clinical
treatment protocol.
3. Research Hypothesis

IA intervention can effectively improve the clinical symptoms of OSD after IFP,
promote the recovery of ocular surface function (ocular indicators such as tear
meniscus height and tear break-up time), and accelerate the recovery of ocular motor
function. Compared with conventional treatment methods, IA intervention can more
safely, effectively, and conveniently improve the clinical effective rate of treating
OSD after IFP.
4. Study Design
This study adopts a single-center, randomized, single-blind, placebo-controlled
parallel design, conducted at Zhejiang Provincial Hospital of Traditional Chinese
Medicine. Conventional acupuncture therapy in the recovery phase and supportive
treatment for OSD serve as the basic treatment regimen, with the innovative
introduction of IA intervention for OSD after IFP. Block randomization is performed
using
the
hospital's
central
randomization
system,
with
dynamic
balanced
randomization of enrolled patients stratified by age and disease course. Patients are
randomly assigned to the IA group and the sham intradermal acupuncture(SIA) group
at a 1:1 allocation ratio. The total expected duration of participation for each subject is
10 weeks (4 weeks of intervention and 6 weeks of follow-up period). During the
treatment phase, both groups receive consistent basic treatment; the IA group receives
regular IA compression stimulation, while the SIA group receives SIA treatment. The
SIA are produced by the same company as the IA needle with identical appearance,
but the needle body is replaced with a thin silicone pad. Acupoint selection and
operation are identical to those of the IA group. A WeChat mini-program named
"Facial Paralysis Ocular Comfort Smart Assistant" is used during treatment to assist
patients in performing independent IA compression. Single-blinding is implemented
throughout the study: subjects, outcome assessors, and statisticians are unaware of
group allocation. The preliminary efficacy and safety of IA intervention are verified
through a scientifically designed trial.

Study interventions are performed by operators with more than 5 years of
medical experience; the specific intervention protocol is detailed in the Study
Intervention section below.
5. Randomization and Blinding
(1) Randomization
This study adopts block randomization using the hospital's central randomization
system, with dynamic balanced randomization of enrolled patients stratified by age
and disease course. Patients are randomly assigned to the IA group and the SIA group
at a 1:1 allocation ratio. The randomization protocol is generated by the hospital's
Clinical Evaluation Center. When a subject meets the inclusion/exclusion criteria and
enters the study, the researcher performs randomization; this researcher is not
involved in the statistical analysis of this project. The randomization protocol and all
parameters set during its generation are collectively referred to as the blinding list,
which is sealed and signed by the randomization protocol generator and kept by a
dedicated staff member of the Clinical Evaluation Center who is not involved in this
project. The central randomization system has strict access permissions; no one except
the highest-level system administrator has the right to view the randomization
protocol in the system.
(2) Blinding
In line with the principle of blinding, single-blinding is adopted due to the
involvement of acupuncture operations. The clinical research coordinator is aware of
patients' group allocation and provides limited information to each researcher.
Researchers conducting assessments are unaware of group allocation and only ask
simple questions critical for completing case report forms. Each subject receives
treatment at different times to prevent information exchange. Treaters minimize
conversation with subjects. Data statisticians are unaware of allocation information
and independently complete statistical analysis, ensuring independent work of all
researchers.

6. Sample Size
This study aims to demonstrate that the efficacy of the IA group is superior to
that of the SIA group. Sample size calculation is based on the principle of superiority
testing and completed using PASS 2025 software (Version v2025). Based on the
research team's preliminary pilot results, the expected effective rate (P2) of the SIA
group is set at 30% (0.3), and the expected effective rate (P1) of the IA group is set at
75% (0.45).
A clinically recognized superiority margin of 0.1 is set; the significance level (α)
for the two-sided test is 0.0125 (adjusted from the original α=0.05 to control Type I
error in multiple comparisons), and the test power is 80%. The calculated required
sample size per group is 31 cases, with test power >0.8.
This study design includes two groups: the IA group and the SIA group. In
addition, a dropout rate of approximately 20% is considered based on the total sample
size. With a 1:1 group allocation, at least 39 patients are recruited per group, with a
total of at least 78 patients to be recruited.
7. Subject Recruitment
This study has been approved by the Ethics Committee of Zhejiang Provincial
Hospital of Traditional Chinese Medicine. All patients are recruited from the
outpatient and inpatient departments of Zhejiang Provincial Hospital of Traditional
Chinese Medicine from March 2026 to March 2027, with a total of 78 patients
meeting the inclusion and exclusion criteria. Patients are randomly divided into two
groups: the IA group and the SIA treatment, with 39 patients in each group.
8. Study Subjects
(1) Diagnostic Criteria
Diagnostic criteria for PFP[15]: Main manifestations include paralysis of facial
expression muscles, disappearance of forehead wrinkles on the affected side, paralysis
of the orbicularis oculi muscle, inability to close or incomplete closure of the

palpebral fissure, shallow nasolabial fold, drooping mouth angle, deviation of the
mouth angle to the healthy side when showing teeth, and food retention between the
teeth and cheek on the affected side during mastication.
(2) Inclusion Criteria
①Aged 18–65 years, regardless of gender; ②Meets the diagnostic criteria for
PFP[15], disease course ≥1 month and ≤1 year, FNGS 2.0 score ≥15 points[6][7], and
ENoG-derived maximum CMAP amplitude ratio of the zygomatic branch (ocular
branch) of the facial nerve between the affected and healthy sides ≤20%[8][16]; ③Has
at least one subjective ocular symptom (dryness, foreign body sensation, burning
sensation, fatigue, discomfort, red eye, fluctuating vision) and an OSDI score of
30–80 points[17]; ④Voluntarily signs the informed consent form and can cooperate
with the completion of treatment and follow-up.
(3) Exclusion Criteria
Patients meeting any of the following criteria will be excluded: ①Complicated
with other underlying ocular diseases (glaucoma, keratitis, retinopathy, etc.), or acute
inflammation or pathological conditions of the conjunctiva, sclera, eyelid, or cornea;
②Underwent intraocular surgery or laser therapy within 90 days; ③History of
systemic or topical antibiotic use or use of drugs affecting tear secretion within 3
weeks; history of dry eye medication use within 2 weeks; ④Patients with lacrimal
duct obstruction, lacrimal sac/nasolacrimal duct stenosis (positive Jones test), closed
lacrimal puncta, or inability to fully close the eye due to damage to the nerve reflex
arc; ⑤Coagulopathy (thrombocytopenia, coagulation factor deficiency, etc.) or skin
damage/infection at the intervention site; ⑥Allergy to IA materials (stainless steel,
medical adhesive tape); ⑦Pregnant or lactating women; ⑧Complicated with severe
cardiac, hepatic, renal diseases, mental illness, or malignant tumors; ⑨Participated in
other clinical studies within the past month.
9. Study Intervention
(1) Interventional Treatment
①IA Group
Acupoint Selection: bilateral GB14, BL2, GB1, 6 acupoints in total

Acupuncture Operation: After the patient completes conventional acupuncture
treatment for facial paralysis, the patient is instructed to sit or lie supine. The ocular
acupoint skin is disinfected with 75% alcohol, and intradermal acupuncture
(φ0.20*0.12mm, Seirin Press Needle, SEIRIN Corporation, Japan) are vertically
inserted and embedded into the skin, avoiding blood vessels.
Treatment Frequency and Course: Needles are retained for 72 hours after
insertion, followed by a 1-day rest. Needles are replaced after weekly acupuncture
treatment for 4 consecutive weeks (8 sessions in total), with 4 weeks of follow-up
after treatment completion.
Patient Operation Requirements: Patients log into the WeChat mini-program
"Facial Paralysis Ocular Comfort Smart Assistant" to learn the standardized IA
compression operation tutorial. The mini-program regularly reminds patients to
perform IA therapy 3 times daily using a facial paralysis acupoint compression device,
with an interval of approximately 4 hours between sessions. Patients can set their
daily compression time independently; the mini-program sends timed reminders and
indicates compression frequency. Each compression session lasts 3 minutes at a
frequency of 60 compressions per minute. Compression intensity is adjusted to the
patient's tolerance.
②SIA group
The SIA group receives intervention with SIA treatment. SIA and IA needles are
both produced by SEIRIN Corporation (Japan) with identical appearance, but the
needle body is replaced with a thin silicone pad. Acupoint selection, operation, and all
other procedures are identical to those of the IA group.
Patient Operation Requirements: The same mini-program as the IA group is used,
with identical treatment frequency, compression time, compression frequency, and
compression intensity.
All treatment operations and informed procedures are performed in separate
rooms for each patient to prevent communication and information exchange between
patients.
(2) Basic Treatment

Both groups receive conventional treatment for PFP as usual, including
conventional acupuncture therapy for PFP in the recovery phase and supportive
treatment for OSD, as detailed below:
①Conventional Acupuncture Therapy for PFP in the Recovery Phase (based on
previous clinical research results)
Acupoint Selection: Affected-side BL2, GB1, GB14, ST2, SI18, ST4, ST6, ST7,
TE17, EN-HN16, EX-HN5, bilateral LI4.
Acupuncture Operation: Before operation, the patient is placed in a comfortable
position accessible to the operator. The doctor thoroughly disinfects hands with hand
sanitizer, then disinfects acupoint skin with 75% ethanol cotton balls from the
acupoint center outward, ensuring a disinfection diameter of 2–3 cm. Acupuncture is
performed after ethanol volatilization completely. Disposable acupuncture needles
(specification: 0.25×40mm, Wujiang Jiachen Acupuncture Appliance Co., Ltd.,
Jiangsu Province) are used for routine acupuncture at all acupoints, with insertion
depth adjusted to achieve local Deqi (needle sensation).
Electroacupuncture Operation: After routine acupuncture, a dedicated operator
connects
electroacupuncture
devices
to
BL2-GB1
and
ST6-ST4,
applies
discontinuous waves at 40Hz, and adjusts intensity to the patient's tolerance, with a
timer set for 30 minutes.
Treatment Frequency and Course: Twice weekly, 30 minutes per session, for 10
consecutive weeks.
②Supportive Treatment Protocol for OSD
Sodium Hyaluronate Eye Drops (specification: 5mL:5mg (0.1%), Santen
Pharmaceutical Co., Ltd., China) are administered to both eyes. Ocular contamination
must be avoided during medication, and the drug must be used strictly in accordance
with medical advice.
Treatment Frequency and Course: 3 times daily, 1 drop per time, for 10
consecutive weeks.

10. Study Flow
(1) Screening Phase
During the screening visit, the following procedures are performed:
Informed Consent: The study is explained in detail to the subject, and questions
are answered before obtaining the patient's written and signed informed consent form.
Laboratory tests and imaging assessments performed for routine clinical care prior to
signing informed consent may be used if the data are within the specified window
period. (If the study involves emergency situations where the subject or legal guardian
cannot sign informed consent before the trial, this shall be clearly stated here.) All
subsequent procedures are performed only after informed consent is obtained.
Demographic Statistics: Gender, date of birth, ethnicity, height, weight, body
mass index (BMI);
Relevant Medical History: ①History of PFP with disease course ≥1 month and
≤1 year; ②History of OSD after IFP.
Auxiliary Examinations: ①Ocular Surface Disease Index (OSDI) score 30–80
points; ②Facial Nerve Grading System 2.0 score ≥15 points; ③ENoG-derived
maximum CMAP amplitude ratio of the zygomatic branch (ocular branch) of the
facial nerve between the affected and healthy sides ≤20%.
(2) Randomization Phase
This study adopts block randomization using the hospital's central randomization
system, with dynamic balanced randomization of enrolled patients stratified by age
and disease course. Patients are randomly assigned to the IA group and the SIA group
at a 1:1 allocation ratio.
(3) Treatment and Follow-up Phase
The treatment phase includes V₁, V₂, and V₃, totaling 4 weeks. The
following procedures are performed and indicators are collected during each treatment
visit:
V₂ and V₃: OSDI, FNGS 2.0, and width of palpebral fissure incompleteness
are assessed.

V₃: Additional ocular surface function examination, including TBUT and
meibomian gland analysis.
(4) Observation Follow-up Phase
The 6-week period after the last treatment for all subjects constitutes the
follow-up phase, with follow-up conducted every 2 weeks.
During each follow-up visit (V₄, V₅, V₆): OSDI, FNGS 2.0, and width of
palpebral fissure incompleteness are assessed.
V₆: Additional ocular surface function test, including TBUT and meibomian
gland analysis.
Adverse event assessments are conducted at all study visit phases.
11. Subject Withdrawal or Study Treatment Termination
(1) Subject Withdrawal Criteria
Subjects will be excluded under the following circumstances: ①Dropout:
Failure to complete observation for any reason. ②Non-compliance: Failure to
receive embedding therapy as planned or non-adherence to medical advice. ③
Concomitant Intervention: Receipt of other treatments outside the study design during
the treatment period. ④Accident: Occurrence of severe IA embedding-related
accidents.
If a subject withdraws midway, the reason for withdrawal shall be identified and
recorded. The data will still be included in statistical analysis.
(2) Study Treatment Termination Criteria
The study will be terminated if major issues prevent its continuation, such as
severe safety problems or severe funding shortages.
(3) Procedures for Subject Withdrawal or Study Treatment Termination
Efficacy and safety examinations shall be performed on the subject in
accordance with the protocol provisions for withdrawal and final observation
follow-up, and all adverse events (AEs) and outcomes shall be fully recorded. The
researcher may recommend or provide alternative treatment methods to the subject
based on their actual condition.

If the subject refuses further visit to the study center, follow-up of their survival
status shall continue unless the subject revokes informed consent. In such cases, no
further study assessments shall be conducted, and no additional data shall be
collected.
12. Outcome Measures
(1) Primary Outcome Measure
Proportion of patients with a ≥12-point reduction in OSDI score from baseline
after 4 weeks of treatment.
Note: According to previous related studies[17][18], the "Minimal Clinically
Important Difference (MCID)" of the OSDI score is 10 points, with an MCID of
7.3–13.4 points for severe dry eye populations. Based on the study's pilot results, a
12-point reduction corresponds to "perceptibly significant improvement" in this study.
Therefore, a ≥12-point reduction in OSDI score from baseline after 4 weeks of
treatment is defined as "treatment response".
(2) Secondary Outcome Measures
①Ocular surface function test: TMH, TBUT and meibomian gland analysis; ②
Width of palpebral fissure incompleteness; ③Facial nerve function score: FNGS 2.0
(3) Other Evaluation Indicators
Adverse reactions related to acupuncture (bleeding, hematoma, needle syncope,
pain at needle insertion site, infection, etc.) and adverse events caused by topical eye
drops (eyelid pruritus, ocular irritation, conjunctival hyperemia, etc.) are recorded at
any time.
13. Emergency Management
All acupuncture operations during the trial shall be performed under the
guidance of a specialist or by a senior physician. If a patient experiences disease
changes severely affecting daily work and life during treatment, an emergency
adjusted treatment plan may be adopted after evaluation and diagnosis by a specialist,
who will also assess whether to discontinue the study. Based on the characteristics of

PFP, an independent assessor unaware of group allocation evaluates the eligibility for
electroacupuncture in the basic acupuncture protocol of this study before each
acupuncture session using the Facial Nerve Grading System 2.0. If the grade is Grade
I (4 points, complete recovery), or if facial muscle spasm, synkinesia, or malposition
occurs, the assessor informs relevant staff to discontinue electroacupuncture in the
corresponding area. No drugs are recommended in guidelines for PFP in the recovery
phase, so no emergency medication is established. The date, time, and dosage of any
treatments outside the study's prescribed protocol during the study period must be
recorded promptly.
14. Study Supply Management
(1) Supply Receipt and Storage
Study supplies are uniformly procured by the sponsor, who shall provide
complete qualification documents including quality certificates, production batch
numbers, expiration dates, and instructions. After verification by researchers, supplies
are warehoused and registered. A dedicated storage area is established with classified
storage: intradermal acupuncture are placed in sealed, dry, light-proof special storage
boxes to avoid extrusion deformation or contamination; Sodium Hyaluronate Eye
Drops are refrigerated at 2–8°C, strictly prohibited from freezing and direct sunlight.
Dual electronic and paper ledgers are established for all supplies, with detailed
records
of
name,
specification,
quantity,
batch
number,
expiration
date,
inbound/outbound time, recipient, and corresponding subject number to ensure full
traceability.
(2) Supply Distribution and Retrieval
Supply collection follows the principle of "on-demand application and dedicated
responsibility".
Researchers
collect
corresponding
supplies
based
on
subject
enrollment progress and treatment cycles with medical orders, verifying supply
integrity and expiration date before collection, and signing confirmation after
confirming no damage or deterioration. As an invasive intervention device,
intradermal acupuncture must be used in an aseptic operating environment; unused

intradermal acupuncture are disposed of in accordance with medical waste regulations.
As a prescription drug, Sodium Hyaluronate Eye Drops are distributed strictly in
accordance with each subject's individualized treatment plan, with clear instructions
on administration frequency, dosage, and precautions, and records of distribution time
and subject signature.
(3) Drug Disposal Requirements
Regular supply inventory is conducted weekly to reconcile ledgers with actual
inventory and ensure account consistency. Near-expiry supplies are specially marked
and prioritized for use. Expired, damaged, or unqualified supplies are stored
separately and uniformly disposed of in accordance with medical waste management
regulations, with complete disposal records. The study strictly complies with GCP
guidelines and hospital supply management requirements to prevent abuse, waste, or
loss of supplies, ensuring the safety, efficacy, and traceability of clinical trial supplies
and providing foundational support for the scientific validity of study results.
15. Adverse Events (AEs), Serious Adverse Events (SAEs), and
Adverse Reactions (ARs)
(1) Definitions
Adverse Event
(AE): Any untoward medical occurrence
in a subject
administered a test product, which may present as symptoms, signs, diseases, or
laboratory abnormalities, but is not necessarily causally related to the test
intervention.
Serious Adverse Event (SAE): Any untoward medical occurrence in a subject
administered a test product that results in death, life-threatening risk, permanent or
severe disability/functional loss, hospitalization or prolongation of hospitalization,
congenital anomaly, or birth defect.
Adverse Reaction (AR): Any harmful or unintended reaction occurring in a
clinical trial that may be related to the test intervention.
(2) Recording of AEs/SAEs

All AEs and SAEs occurring during the trial, regardless of causal relationship
with the test intervention, shall be recorded in the original case records and case
report forms (CRFs).
AE/SAE records shall include: event name, duration, severity, causal relationship
judgment between the event and the test product, measures taken, and event outcome.
The researcher shall sign and date the record.
(3) Assessment of AEs and SAEs
①Severity Grading
Grade 1: Mild; asymptomatic or slight; only clinical/diagnostic findings; no treatment
required.
Grade 2: Moderate; requiring minor, local, or non-invasive treatment; limitation in
instrumental activities of daily living appropriate for age.
Grade 3: Severe or medically significant but not immediately life-threatening; results
in hospitalization or prolongation of hospitalization; disability; limitation in self-care
activities of daily living.
Grade 4: Life-threatening; requiring emergency treatment.
Grade 5: Death related to the AE.
②Causal Relationship Judgment
The researcher assesses the potential causal relationship between AEs and the
test product in accordance with the following classification criteria: a) reasonable
temporal sequence between intervention initiation and AE onset; b) consistency of the
suspected AE with known adverse reactions to the test drug/acupuncture; c)
explainability of the suspected AE by concomitant medications, the patient's clinical
status, or other therapies; d) resolution or alleviation of the AE after drug/acupuncture
discontinuation;
e)
recurrence
of
the
same
reaction
after
re-administration/re-intervention. Based on these principles, causal relationships are
classified
into
6
levels:
Definite,
Probable,
Possible,
Unlikely,
Unassessed,
Unassessable.
Definite: Reasonable temporal sequence between intervention and reaction;
reaction ceases or rapidly alleviates after discontinuation (some ADRs may persist for

days after discontinuation due to immune status); reaction recurs and worsens upon
re-administration (positive re-challenge test); supported by literature, with exclusion
of confounding factors such as underlying disease.
Probable: No re-administration, but otherwise consistent with "Definite"; or
concomitant medications are present but essentially excluded as the cause of the
reaction.
Possible: Close temporal relationship between intervention and reaction,
supported by literature; but multiple drugs may be implicated, or progression of
underlying disease cannot be ruled out.
Unlikely:
Poor
temporal
correlation
between
intervention
and
reaction;
inconsistent with known ADRs of the test product; similar manifestations may occur
with underlying disease progression.
Unassessed: Incomplete report data, pending supplementation for assessment; or
undetermined causal relationship due to lack of literature support.
Unassessable: Severe report omissions, undetermined causal relationship, and
unobtainable supplementary data.
(4) SAE Reporting
Researchers shall closely monitor the occurrence of SAEs during the clinical trial.
In the event of an SAE, the trial shall be terminated immediately, necessary measures
taken to ensure subject safety, and the Ethics Committee and other relevant authorities
notified within 24 hours.
16. Data Management
A clinical research coordinator, data manager/statistician, and clinical treating
physician are appointed, ensuring separation of data managers, study designers, and
clinical implementers.
Data Collection: Electronic Data Capture (EDC) system is used for data
collection.
Data Recording: Original medical records and CRFs shall be completed
truthfully and carefully as required; no content may be altered arbitrarily once entered.

If corrections are necessary for entry errors, the original record shall not be modified;
only supplementary narratives may be used, signed and dated by the responsible
treating physician.
Data Query and Correction: All observed results and abnormal findings in the
clinical trial shall be promptly verified and recorded to ensure data reliability.
All
instruments,
equipment,
reagents,
standards,
etc.,
used
for
various
examinations in the clinical trial shall have strict quality standards and be used in
normal working condition.
17. Statistical Analysis
After completion of the trial protocol and CRFs, a professional statistician
develops a statistical analysis plan. A statistical analysis report is provided upon
completion of data analysis.
(1) Statistical Analysis Software
Statistical analysis is performed using SAS 9.4 software.
(2) Basic Principles of Statistical Analysis
Statistical analysis includes descriptive statistics and inferential statistics.
Baseline data are first described systematically and between-group balance tested,
followed by intra-group and inter-group comparisons of outcome measures.
Corresponding statistical methods are adopted for different types of outcome
measures (binary, continuous, ordinal). Continuous indicators are described by mean,
standard deviation, median, minimum, maximum, and interquartile range. Categorical
indicators are described by case numbers and percentages. Ordinal categorical
indicators (ordinal indicators) are described using both continuous and categorical
variable methods.
(3) Missing Data Imputation
All missing data during the trial are handled using the Last Observation Carried
Forward (LOCF) method. No outcome measure data are excluded unless otherwise
specified.
(4) Baseline Data Analysis

Baseline demographic indicators (age, gender, ethnicity, BMI, etc.) and clinical
baseline indicators (disease course, baseline OSDI score, FNGS 2.0 score, TMH
TBUT, etc.) are statistically described:
Continuous data: "mean ± standard deviation" for normal distribution; median
(interquartile range) for non-normal distribution;
Binary/count data: frequency (constituent ratio, %);
Ordinal data: frequency (constituent ratio, %).
(5) Efficacy Analysis
①Primary Outcome Measure
In the Full Analysis Set (FAS) and Per-Protocol Set (PPS), the number of
responders, total enrolled subjects, and response rate of the IA group and SIA group
are described by frequency (constituent ratio, %). The distribution of "≥50% reduction
in OSDI score" and "<50% reduction in OSDI score" between the two groups is
presented in a contingency table.
Chi-square test is used for inferential statistics to compare between-group
differences in response rates and analyze the overall effect of IA.
Baseline Adjustment Analysis: If baseline OSDI scores are unbalanced between
groups (P≤0.10), binary logistic regression analysis is performed with baseline OSDI
score as a covariate to compare adjusted between-group response rates, calculating
Odds Ratios (OR) and 95% Confidence Intervals (CI).
②Secondary Outcome Measures
Statistical analysis is performed separately for continuous and ordinal indicators,
with all analyses conducted in both FAS and PPS.
Continuous indicators (TMH, TBUT, width of palpebral fissure incompleteness,
FNGS 2.0 score): Described by "mean ± standard deviation"; median (interquartile
range) for non-normal distribution, with minimum and maximum values reported.
Paired t-test (normal distribution)/Wilcoxon signed-rank test (non-normal distribution)
is used for intra-group pre- vs. post-treatment comparisons; independent samples
t-test/Wilcoxon rank-sum test for inter-group comparisons; repeated measures
ANOVA for multi-time point trends.

Ordinal
indicators
(meibomian
gland
analysis):
Described
by
frequency
(constituent ratio, %) for grade distribution and baseline improvement rate at each
visit in each group. Wilcoxon signed-rank test is used for intra-group pre- vs.
post-treatment comparisons; Kruskal-Wallis H test for inter-group comparisons;
ordinal logistic regression for confounding factor adjustment.
(6) Safety Analysis
The type, frequency, and causal relationship with the test drug of AEs are
described. Special notation is made for cases withdrawing from the study due to AEs
and those with severe or serious AEs.
18. Quality Control and Quality Assurance
(1) Development of Standard Operating Procedures (SOPs)
Prior to trial initiation, researchers and the Contract Research Organization
(CRO) jointly develop SOPs for the clinical trial to standardize operational methods,
judgment criteria, and recording formats, ensuring strict adherence to the protocol by
researchers.
(2) Investigator Training and Authorized Role Allocation
Prior to trial initiation, the principal investigator assembles a study-matched team
including physicians, nurses, coordinators, etc.
Before study start-up, the principal investigator trains all medical staff
participating in the trial on the clinical trial protocol, trial manual, SOPs, special
precautions, etc. If project procedures are modified during the trial, relevant
re-training is organized. True and complete training records are retained.
The principal investigator authorizes role allocation for relevant personnel, who
shall perform duties in accordance with the authorization roster. During the trial, the
principal investigator may add, remove, or adjust personnel and roles based on actual
conditions, with updated authorization rosters. All personnel receive adequate training
prior to performing operations.
(3) Document and Specimen Management

No biological specimens are collected in this study; only standardized
management of all study documents and retained samples of key consumables is
implemented. Study documents are stored in dual electronic and paper files: paper
files in dedicated locked filing cabinets, electronic files encrypted and backed up
regularly. All documents are completed standardly and traceably, with approval and
registration procedures for borrowing and transfer. Retained samples of study
consumables (intradermal acupuncture, acupuncture needles, etc.) are stored by batch
with ledgers and classified in accordance with storage requirements, managed by
dedicated personnel. Unused retained samples are disposed of in accordance with
medical waste regulations after study completion, with complete records for future
reference.
(4) Subject Compliance Management
Researchers will actively implement follow-up measures to control the case
dropout rate within 10%.
19. Ethical Considerations
This clinical trial must be conducted in compliance with the Declaration of
Helsinki and relevant Chinese clinical trial regulations. Prior to trial initiation, the
clinical trial protocol, informed consent form, and other documents shall be submitted
to the Ethics Committee for approval; the trial may be implemented only after
approval. Modifications to the clinical trial protocol, informed consent form, and
other documents during the study shall be approved by the Ethics Committee before
implementation. Researchers shall ensure the rights and safety of subjects and protect
their privacy.
20. Study Schedule
This is a single-center randomized controlled clinical trial of IA treatment for
OSD after IFP, with an expected total study duration of 20 months. The timeline for
each phase is closely integrated with the study flow, with specific scheduling detailed

below (all time points are based on the approval of the study protocol as the starting
baseline):
(1) Study Initiation
Within 1 month after Ethics Committee approval of the protocol at Zhejiang
Provincial Hospital of Traditional Chinese Medicine, all start-up work (study team
training, procurement and acceptance of study supplies, EDC system debugging,
blinding preparation, etc.) shall be completed, and the study officially initiated.
(2) Subject Enrollment Period
Subject recruitment commences immediately after study initiation, with a
12-month enrollment period. Recruitment and randomization of all subjects meeting
inclusion/exclusion criteria shall be completed, ensuring standardized enrollment and
complete baseline data.
(3) Completion of Intervention and Follow-up
Subjects receive 4 weeks of intervention treatment and 6 weeks of observation
follow-up per the protocol. Intervention, visit assessments, AE recording, and
follow-up data collection for all subjects shall be completed within 10 weeks after
enrollment of the last subject, and the EDC data collection portal shall be closed.
(4) Data Management and Locking
Within 1 month after follow-up completion, all study data verification, query
resolution, and missing data handling shall be completed. Data locking and
unblinding shall be performed jointly by the principal investigator and statisticians.
(5) Statistical Analysis
Within 1.5 months after data locking and unblinding, the statistical team
completes data analysis in accordance with the pre-specified statistical analysis plan
and provides a statistical analysis report.
(6) Study Summary and Manuscript Preparation
Within 1.5 months after completion of the statistical analysis report, the principal
investigator leads the study team in completing the study summary report, sorting out
study results, conclusions, and clinical significance, and initiating academic
manuscript preparation.

(7) Manuscript Submission and Publication
Within 2 months after completion of the manuscript draft, manuscript revision
and internal peer review shall be completed. The manuscript is submitted to core
journals in the fields of integrated traditional Chinese and Western medicine,
acupuncture, and ophthalmology based on the study's findings, with target completion
of external review, revision, and acceptance within 3 months after submission.
Reasonable buffer periods are reserved for overlapping phases of the study to
ensure full implementation of quality control. All scheduling may be adjusted slightly
based on actual study conditions after Ethics Committee approval, with timely
notification to all study personnel upon adjustment.

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【Single-Center Randomized Controlled Clinical Trial of
Intradermal Acupuncture Intervention for Ocular Surface
Disease Secondary to Intractable Facial Paralysis】Informed
Consent Form
Part I: Informed Consent Information Sheet
Dear Study Participant,
You are cordially invited to consider participating in a clinical research study
entitled “ Single-Center Randomized Controlled Clinical Trial of Intradermal
Acupuncture Intervention for Ocular Surface Disease Secondary to Intractable
Facial Paralysis” . This study will be conducted at the First Affiliated Hospital of
Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional
Chinese Medicine), under the supervision of Binyan Yu (Associate Chief Physician).
Before you decide whether to participate in this study, please read the following
content carefully. It will help you understand the purpose, procedures, potential
benefits, risks, and discomforts of this study. If you have any questions, please consult
the study doctor or research staff, who will provide you with detailed explanations.
You may also discuss this with your family and friends before making a decision.
1. Research Background and Objectives
Intractable facial paralysis generally refers to peripheral facial paralysis that
shows no significant recovery after conventional treatment. Clinical manifestations
often include deviation of the mouth and eye, incomplete eye closure, synkinesia of
facial muscles, and muscle contracture on the affected side. This condition usually
results from severe facial nerve injury, or delayed, prolonged, or inappropriate initial
treatment of peripheral facial paralysis. Peripheral facial paralysis, also known as
peripheral facial palsy, falls under the categories of "Kou Pi" (facial paralysis) and

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"Deviation of Mouth and Eye" in traditional Chinese medicine. It is commonly caused
by exposure to cold, viral infection, and other factors leading to inflammation, acute
edema, and compression of the facial nerve within the stylomastoid foramen. Bell’s
palsy is the most representative type, accounting for approximately 95% of clinical
peripheral facial paralysis cases. About 1 in 60 people will develop Bell’s palsy at
some stage in life, with an annual incidence of 11.5–53.3 cases per 100,000 people.
Studies show that 60%–87% of patients with intractable facial paralysis fail to recover
completely and develop sequelae or permanent paralysis.
Due to severe facial nerve damage and a long recovery period, intractable
peripheral facial paralysis is frequently accompanied by various ocular surface
diseases. Incomplete eyelid closure, epiphora, and ocular motility disorders are the
most common, which may lead to exposure keratitis, conjunctivitis, and even vision
loss, severely affecting patients’ daily work. Electronic devices have become essential
for work, study, and social life in modern society, and patients cannot avoid using
them, which further aggravates ocular injury. Meanwhile, frequent use of electronic
devices leaves no time for damaged corneal epithelium to repair, turning intermittent
ocular surface damage into persistent damage. Currently, there are no clearly
recommended medications for peripheral facial paralysis in recovery phase guidelines.
For related ocular surface diseases, symptomatic and supportive treatments such as
sodium hyaluronate eye drops are commonly recommended. However, long-term
corneal exposure combined with electronic device use limits the clinical efficacy of
artificial tears for these patients. Therefore, exploring an effective, safe, convenient,
and sustained treatment method is of great clinical value to resolve persistent ocular
problems during facial paralysis.
Acupuncture is a treasure of traditional Chinese therapy. Studies show that
electroacupuncture and other treatments effectively improve clinical symptoms in
patients with dry eye syndrome, but they require high operator skill, are difficult for
patients to adhere to, and have short-lasting effects. As an important part of
acupuncture therapy, intradermal acupuncture stimulates acupoints gently and

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continuously to regulate meridian Qi and blood and improve visceral functions. It
features good efficacy, simple operation, minimal trauma, and high safety. A
literature review reveals few high-quality clinical studies on intradermal acupuncture
for ocular surface disease secondary to intractable peripheral facial paralysis.
Preliminary pilot experiments by our research team indicate that intradermal
acupuncture effectively improves OSDI scores in such patients. To further verify the
efficacy and safety of this treatment, we will conduct a single-center, randomized,
single-blind, placebo-controlled parallel trial. We aim to provide a convenient, safe,
and widely applicable treatment for ocular surface disease secondary to intractable
peripheral facial paralysis. This method is easy to implement, suitable for primary
medical institutions and home rehabilitation, helps reduce medical burdens for both
institutions and patients, and has important practical value and promotion prospects.
Study Objectives:
To preliminarily evaluate the effective
rate
of intradermal
acupuncture
intervention for ocular surface disease secondary to intractable facial paralysis via a
single-center, randomized, single-blind, placebo-controlled parallel trial, and to
provide a new effective treatment for ocular diseases after intractable peripheral facial
paralysis.
To assess whether intradermal acupuncture synergistically improves ocular
symptoms, restores ocular surface function, and promotes facial nerve recovery, and
to clarify the feasibility, safety, and patient acceptance of intradermal acupuncture
intervention, providing an optimized clinical treatment protocol.
This study has been reviewed and approved by the Ethics Committee in
accordance with the principles of the Declaration of Helsinki and medical ethics.
2. Who Is Eligible to Participate?
(1) Diagnostic Criteria
Diagnostic Criteria for Peripheral Facial Paralysis: Main manifestations include
paralysis of facial expression muscles, disappearance of forehead wrinkles on the

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affected side, paralysis of the orbicularis oculi muscle, incomplete or unable eye
closure, flattened nasolabial fold, drooping mouth angle, deviation of the mouth to the
unaffected side when showing teeth, and food retention between the teeth and cheek
on the affected side during mastication.
(2) Inclusion Criteria
1. Aged 18–65 years, male or female.
2. Meet the diagnostic criteria for peripheral facial paralysis; disease duration ≥1
month and ≤1 year; Facial Nerve Grading System 2.0 score ≥15; ratio of maximum
CMAP amplitude of bilateral facial nerves (zygomatic branch/ocular branch) on
electroneurography ≤20%.
3. Have at least one subjective ocular symptom (dryness, foreign body sensation,
burning sensation, fatigue, discomfort, redness, fluctuating vision) AND Ocular
Surface Disease Index (OSDI) score 30–80.
4. Voluntarily sign the informed consent form and be able to comply with
treatment and follow-up.
(3) Exclusion Criteria
Patients meeting any of the following will be excluded:
1. Complicated with other underlying ocular diseases (glaucoma, keratitis,
retinopathy, etc.) or acute inflammation/pathological conditions of the conjunctiva,
sclera, eyelid, or cornea.
2. Underwent intraocular surgery or laser treatment within 90 days.
3. Systemic or topical use of antibiotics or drugs affecting tear secretion within 3
weeks; use of dry eye medications within 2 weeks.
4. Lacrimal passage obstruction, dacryocystitis/stenosis of nasolacrimal duct
(positive Jones test); occluded lacrimal punctum or inability to close the eye
completely due to damage to the nerve reflex arc.
5. Coagulopathy (thrombocytopenia, coagulation factor deficiency, etc.) or skin
damage/infection at the intervention site.

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6. Allergy to intradermal acupuncture materials (stainless steel, medical adhesive
tape).
7. Pregnant or lactating women.
8. Severe heart, liver, or kidney disease, mental illness, or malignant tumor.
9. Participation in another clinical study within 1 month.
3. What Will You Do If You Participate?
1. Study Flow:
If you
agree to
participate,
the entire study
will last
approximately
10
weeks
(4-week
intervention
period
+
6-week
observation/follow-up period).
2. Visits: You will have 6 study visits. During visits, you may undergo
examinations including electroneurography (ENoG), ocular surface function tests,
measurement of incomplete palpebral fissure closure width, and assessments using
the Facial Nerve Grading System 2.0 and Ocular Surface Disease Index (OSDI)
questionnaire.
3. Group
Assignment:
This
study
uses
a
randomized,
double-blind,
placebo-controlled design. You will be randomly assigned to one of two groups:
Experimental Group: Receive intradermal acupuncture intervention.
Control Group: Receive sham intradermal acupuncture intervention.
You will not know which group you are in. Unblinding can be performed rapidly
in case of emergency.
Required Cooperation: You must use medications as instructed by the study
doctor, truthfully record your feelings and any discomfort, attend all visits on time,
and inform us of any changes in your health during the study.
4. Potential Benefits of Participation
1.Personal Benefits: You may directly benefit from the study intervention, such
as significant improvement in uncomfortable symptoms of ocular surface disease
secondary to intractable peripheral facial paralysis (epiphora, ocular foreign body

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sensation, eye fatigue, etc.). You will also receive closer medical attention and
examinations.
2.Social Benefits: Your participation will help the medical community better
understand the efficacy and safety of intradermal acupuncture intervention for
ocular surface disease secondary to intractable peripheral facial paralysis, providing
potential treatment options for more patients in the future.
5. Potential Risks, Discomforts, and Adverse Reactions
1.Treatment-Related Risks: All treatments carry risks. Interventions such as
acupuncture and eye drops used in this study may cause bleeding, hematoma,
fainting, pain at the needle site, or mild infection at the puncture site. Although most
adverse reactions are mild and transient, rare but serious adverse reactions cannot be
completely ruled out. If any of the above occur, promptly inform your attending
physician, who will evaluate and provide appropriate medical care.
2.Study Procedure-Related Risks: Ocular surface function tests required for the
study may cause transient discomfort or mild pain.
3.Privacy Breach Risk: We will strictly protect your personal information and
medical records, but a minimal risk of privacy breach remains.
6. Compensation for Study-Related Injury
If your health is harmed as a direct result of participating in this study, the First
Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial
Hospital of Traditional Chinese Medicine) will bear corresponding medical expenses
and provide financial compensation in accordance with relevant national laws and
regulations. This will not affect your other legal rights. You are not required to waive
any legal rights to sign this informed consent form.
7. Study-Related Costs and Compensation
1. Costs: All study-related costs for disposable intradermal acupunctures,
disposable acupuncture needles, and study medications will be covered by the
research team (or study sponsor).

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2. Compensation: You will receive high-quality medical services during the
study, including priority registration and free consultations, to compensate for your
time and effort.
8. Voluntary Participation and Withdrawal
Participation is completely voluntary. You may refuse to participate or withdraw
from the study at any time for any reason after signing the informed consent form.
This will not affect your relationship with your doctor or your future medical care,
and you will not face discrimination or retaliation.
The study doctor may terminate your participation if: the study is terminated
early; you develop a condition unsuitable for continued participation; or you fail to
comply with the study protocol.
9. How Is Your Privacy Protected?
Your medical records (study charts, laboratory reports, etc.) will be stored at the
hospital as required. All information related to this study will be kept strictly
confidential. Your identity will not appear in any public reports or publications. Only
authorized personnel (researchers, Ethics Committee, drug regulatory authorities) may
access your data within the scope permitted by law.
10. Additional Information
You may consult your study doctor at any time during the study with any
questions.
If you have questions about your rights as a study participant or believe your
rights have been violated, you may contact the Ethics Committee Office, which
protects the rights and welfare of study participants.
Ethics Committee Office Contact: First Affiliated Hospital of Zhejiang Chinese
Medical University Ethics Office, Tel: 0571-87072953.

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Part II: Informed Consent Signature Page
Study Participant Statement
I have read the above information about this study. The study doctor has
provided a full explanation and answered all my questions. I understand the purpose,
procedures, potential benefits, risks, and discomforts of the study. I know
participation is voluntary and I have the right to withdraw at any time without
discrimination or retaliation.
I consent to the collection and use of my health information by researchers at the
First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial
Hospital of Traditional Chinese Medicine) for this study.
I voluntarily agree to participate in this study and will follow the instructions of
the study doctor to the best of my ability.
Study Participant Signature: ______________________
Phone Number: ________________________
Date:_________
Legal Representative Statement (If Applicable)
I have read the above information about this study. The study doctor has
provided a full explanation and answered all my questions. I understand the purpose,
procedures, potential benefits, risks, and discomforts of the study. I know
participation is voluntary and I have the right to withdraw the participant at any time
without discrimination or retaliation.

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I consent to the collection and use of the participant’s health information by
researchers at [Insert Institution Name] for this study. I approve the participant’s
enrollment in this study.
Legal Representative Signature: __________________
Relationship to Participant: ____________________
Phone Number: ________________________
Date: _________
Researcher Statement
I confirm that I have explained the details of this study, including participants’
rights, potential benefits, risks, and discomforts, to the participant and/or legal
representative, and answered all their questions.
Researcher Signature: ______________________
Phone Number: ________________________
Date: _________
Study Doctor Contact Information:
Name: ____________________________
Phone: ____________________________
Important Note: Both you and the researcher will keep one signed copy of this
informed consent form.

第1页共1页
Ethics Approval Document
(Scientific Research Project)）
Approval No.2026-KLS-167-01
Initial Review Date
2026-04-01
Re-review Date
/
Review Venue
Conference Room No. 2, Administrative Building
Project Number
/
Clinical Research
Project
A Single-Center Randomized Controlled Trial of Intradermal
Acupuncture Intervention for Ocular Surface Diseases After
Intractable Facial Paralysis
Project Source
Self-funded Project (No Grant Funding)
Review Documents
1.Initial Review Application (Scientific Research Project)
2.National Medical Registration System Application (2026.03.19,
V1.0)
3.Clinical Research Protocol (2026.03.15, V3.0)
4.Informed Consent Form (2026.03.20, V3.0)
5.Study Medical Records and/or Case Report Forms, Subject Diary
Cards and Other Questionnaires (2026.03.17, V3.0)
6.Professional Curriculum Vitae of the Principal Investigator
(2026.03.16, V1.0)
7.List of the Research Team and Their Professional Curriculum
Vitae (2026.03.16, V1.0)
8.Conflict of Interest Statement (2026.03.17, V1.0)
9.Research Qualification Certificate of the Principal Investigator
(2026.03.17, No.20261160)
10.Letter of Commitment that Samples Shall Be Used Exclusively
for This Project (2026.03.17, V1.0)
Lead Unit
The First Affiliated Hospital of Zhejiang Chinese Medical University
(Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Local Center
The First Affiliated Hospital of Zhejiang Chinese Medical University
(Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Principal Investigator
Binyan Yu
Ethics Review
Method
Review Comments
Review Result: ☑Approved
☐Disapproved
Upon review by the Ethics Committee, the research protocol
is scientifically and rationally designed, with adequate protection
for subjects, ensuring the security of personal information and the
confidentiality of privacy. The conduct of clinical research for this
project is hereby approved.
During the research process, in the event of serious adverse
events and unexpected events that affect the risk-benefit ratio of
the research, a written report must be submitted to the Ethics
☑Full Committee Review
☐Expedited Review

第1页共1页
Committee of our hospital within the specified time limit.
Validity Period of
Approval
12months
Frequency of
Continuing Review
12months
Signature of
Chairperson
Ethics Committee of The First Affiliated Hospital of Zhejiang Chinese Medical University
Date：2026-04-01
,