Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study Comparing the Dose-Response Relationship of LED Red Light in Controlling Myopia Progression
Phase: NA
Conditions: Myopia, Myopia, Progressive
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Version No. and Date: 2.0 2025/10/01 
 
Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study 
Comparing the Dose-Response Relationship of LED Red Light in Controlling 
Myopia Progression 
 
Clinical Study Protocol 
(Protocol No.Airdoc202510) 
Test Medical Device Name: Yingtong Vision Rehabilitation Instrument 
Model and Specification: sky-n1201 
Protocol Version No. and Date: 2.0/2025.10.01 
Regulatory Classification of the Test Medical Device: Class Ⅱ 
 
Clinical Trial Institution: 
Shanghai General Hospital / Wang Xiaojuan 
 
 
 
 
 
 
Leading Clinical Trial Institution / Coordinating Investigator: 
Shanghai General Hospital / Wang Xiaojuan 
Sponsor: Beijing Airdoc Technology Co., Ltd. 
 
 

Version No. and Date: 2.0 2025/10/01 
 
Version History 
Version Date 
Version No. 
Revision Records 
2025.07.01 
1.0 
None 
2025.10.01 
2.0 
1. Added to Research Content: "Although LED-based red light 
at specific wavelengths and appropriate doses also relies on the 
core biological mechanism of PBM therapy, it differs from laser. 
Lasers have high collimation, small divergence angles, and high 
energy density, posing a greater risk of damage to the eyes, 
especially the retina, compared to LED light. In contrast, non-
laser PBM therapy using LED light emits incoherent, divergent 
light with high safety. This light source, specially designed by 
Airdoc, forms a unique annular light spot on the fundus retina 
while avoiding the fovea centralis, greatly reducing safety 
concerns. This study adopts non-laser LED red light to slow 
down or control myopia progression in children and adolescents. 
ISO 15004-2 is an international standard for optical radiation 
safety testing of ophthalmic instruments, meeting the compliance 
requirements of global medical device regulations. The standard 
sets a limit of 0.7W/cm² for retinal power density. The non-laser 
LED red light device used in this study is strictly designed in 
accordance with this standard, with test results showing a retinal 
power density nearly 1/77 of the standard limit. Compared to 
laser red light, which may exceed this standard and pose risks, 
the retinal power density of the device in this study provides a 
sufficient safety margin. According to the Arndt-Schultz law, the 
dose of red light is correlated with its effect within a certain 
range, and energy density is related to time and power density. 
Currently, there is no corresponding basis for the recommended 
3-minute use duration. The 'safe window dose' is set based on 

Version No. and Date: 2.0 2025/10/01 
 
energy density. Calculations show that the intervention dose of 
the extended intervention duration in the study groups is still 
much lower than the 3-minute intervention dose of laser red 
light, so the claim that increasing the intervention dose will 
generate additional safety risks is unfounded. Studies on LED 
red light by the research team have shown that its effect is 
relatively weaker than that of laser red light. Whether different 
intervention durations will affect the effectiveness and safety of 
non-laser PBM therapy has become a new research question." 
2. Updated and added "12.7. Adverse Event Correlation 
Judgment and Risk Management" content. 
3. Added "Multiple comparison α requires Bonferroni correction 
(α=0.016667)" to 6.1 Sample Size Calculation. 
 
 

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Contents 
1. Clinical Study Summary ............................................................................................................... 7 
2. Sponsor Information ..................................................................................................................... 9 
3. List of Research Centers ............................................................................................................... 9 
4. Background Information of the Clinical Trial ............................................................................... 9 
4.1. R&D Background .............................................................................................................. 9 
4.2. Basic Product Information ............................................................................................... 11 
4.3. Scope of Application and Relevant Information .............................................................. 12 
4.3.1. Target Population .................................................................................................. 12 
4.3.2. Reusability ............................................................................................................ 12 
4.3.3. Usage Methods and Precautions of the Test Product ............................................ 12 
4.3.4. Contraindications .................................................................................................. 13 
5. Trial Design ................................................................................................................................. 13 
5.1. Overall Design and Rationale .......................................................................................... 13 
5.1.1. Trial Objective ....................................................................................................... 14 
5.1.2. Selection of Trial Method and Rationale ............................................................... 14 
5.2. Subject Selection .............................................................................................................. 15 
5.2.1. Inclusion Criteria ........................................................................................................... 15 
5.2.2. Exclusion Criteria ......................................................................................................... 15 
5.2.3. Criteria and Procedures for Terminating the Trial/Withdrawing Subjects ............ 16 
5.3. Evaluation Methods ......................................................................................................... 17 
5.3.1. Efficacy Evaluation ............................................................................................... 17 
5.3.1.1. Primary Efficacy Endpoint and Other Efficacy Indicators ................................. 17 
5.3.1.2. Selection and Explanation of Efficacy Parameters ............................................ 18 
5.3.2. Safety Evaluation .................................................................................................. 18 
5.4. Test Medical Device and Control Medical Device........................................................... 19 
5.5. Trial Process ..................................................................................................................... 19 
5.5.1. Trial Flow Chart .................................................................................................... 19 
5.5.2. Trial Implementation (Methods, Content, Steps, etc.)........................................... 19 
5.5.3. Specifications for Device Use ............................................................................... 21 
5.5.4. Device Management .............................................................................................. 21 
5.6. Bias Control Measures ..................................................................................................... 22 
5.7. Expected Total Duration of the Clinical Trial and Rationale ........................................... 23 
5.7.1. Rationale for Determining Enrollment Time......................................................... 23 
5.7.2. Rationale for Determining Follow-up Time .......................................................... 23 
5.7.3. Expected Participation Time and Duration for Each Subject ................................ 23 
5.7.4. Number of Subjects Required for the Clinical Trial .............................................. 23 
6. Statistical Considerations ............................................................................................................ 23 
6.1. Sample Size Estimation.................................................................................................... 23 
6.1.1. Calculation Formula, Parameter Values (e.g., Significance Level, Power, Expected 
Dropout Rate, Threshold, etc.) and Rationale, Calculation Results ................................ 23 
6.1.2. Sample Size Allocation and Rationale (if applicable) ........................................... 24 
6.2. Analysis Datasets ............................................................................................................. 24 

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6.3. Subject Exclusion Criteria ................................................................................................ 24 
6.4. Statistical Methods ........................................................................................................... 24 
6.4.1. General Principles ................................................................................................. 24 
6.4.2. Completion Status and Demographic Analysis ..................................................... 25 
6.4.3. Efficacy Evaluation ............................................................................................... 25 
6.5. Handling of Missing Values and Outliers......................................................................... 26 
7. Monitoring Plan .......................................................................................................................... 26 
8. Data Management ....................................................................................................................... 28 
8.1. Completion and Submission of Case Report Forms (CRF) ............................................. 28 
8.2. Data Verification .............................................................................................................. 28 
8.3. Data Locking .................................................................................................................... 28 
9. Risk-Benefit Analysis ................................................................................................................. 28 
9.1. Known Potential Risks ..................................................................................................... 28 
9.2. Known Potential Benefits ................................................................................................ 28 
10. Quality Control of the Clinical Trial ......................................................................................... 28 
10.1. Investigator Training ...................................................................................................... 28 
10.2. Measures to Improve Subject Compliance ..................................................................... 29 
10.3. Monitoring of the Clinical Trial ..................................................................................... 29 
11. Ethical Issues and Informed Consent of the Clinical Trial ........................................................ 29 
11.1. Ethical Considerations .................................................................................................... 29 
11.2. Informed Consent Process .............................................................................................. 29 
11.2.1. Basic Principles ................................................................................................... 30 
11.2.2. Informed Consent Process ................................................................................... 30 
11.2.3. Signing of the Informed Consent Form ............................................................... 31 
11.2.4. Notes ................................................................................................................... 31 
12. Adverse Events, Device Defects, and Risk Response Plans ..................................................... 31 
12.1. Definition and Reporting Requirements of Adverse Events .......................................... 31 
12.2. Device Defects ............................................................................................................... 32 
12.3. Definition of Serious Adverse Events (SAE) ................................................................. 32 
12.4. Reporting Procedures and Contact Information ............................................................. 32 
12.5. Investigation and Documentation of Adverse Events .................................................... 33 
12.6. Severity Assessment of Adverse Events......................................................................... 34 
12.7. Adverse Event Correlation Judgment and Risk Management Plan ................................ 34 
13. Provisions for Protocol Deviations and Amendments ............................................................... 36 
14. Direct Access to Source Data and Documents .......................................................................... 36 
15. Content to be Covered in the Clinical Trial Report ................................................................... 36 
16. Confidentiality Principle ........................................................................................................... 37 
17. Responsibilities of All Parties ................................................................................................... 37 
18. Other Explanations .................................................................................................................... 37 
19. References ................................................................................................................................. 37 
Annex 1: Flow Chart of the Clinical Trial ...................................................................................... 41 
Annex 2: List of Research Centers.................................................................................................. 43 
 
 
 

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List of Abbreviations 
Abbreviation     Full Name 
AE             Adverse Event 
CI             Confidence Interval 
CRF             Case Report Form 
CMH 
        Cochran-Mantel-Haenszel Chi-square test 
EC  
        Ethics Committee 
FAS  
        Full Analysis Set 
GCP 
        Good Clinical Practice 
ICF  
        Informed Consent Form 
NMPA 
 
    National Medical Products Administration 
PPS  
        Per-Protocol Set 
IRB  
        Institutional Review Board 
SS  
        Safety Set 
SAE  
        Serious Adverse Event 
SAP  
        Statistical Analysis Plan 
 

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1. Clinical Study Summary 
Item 
Content 
Study Title 
Multicenter, 
Open-Label, 
Parallel-Group, 
Randomized 
Controlled Study Comparing the Dose-Response Relationship 
of LED Red Light in Controlling Myopia Progression 
Study Product 
Yingtong Vision Rehabilitation Instrument 
Study Population 
Potential study population with myopia of -6.00D or less 
Research Institution 
Shanghai General Hospital 
Sponsor 
Beijing Airdoc Technology Co., Ltd. 
Study Objective 
To verify the effectiveness and safety of the LED red light 
combined with defocus lens therapy of the study product 
(Yingtong Vision Rehabilitation Instrument) by comparing 
with the marketed Hoya DIMS defocus lens, and to evaluate 
the impact of different intervention durations on the 
effectiveness and safety of this combined therapy. 
Trial Duration 
The expected total duration of this clinical trial is 18 months. 
Efficacy Indicators 
1. Primary Efficacy Endpoint 
Change in axial length at 6 months (mm) 
2. Secondary Efficacy Endpoints 
(1) Change in axial length at 1 month (mm); 
(2) Change in axial length at 3 months (mm); 
(3) Change in axial length at 9 months (mm); 
(4) Change in axial length at 12 months (mm); 
(5) Change in spherical equivalent refraction (SER) at 12 
months. 
Safety Indicators 
1. Adverse event rate and serious adverse event rate; 
2. 12-month visual adverse event rate (BVCA decrease ≥0.2 
logMAR); 
3. Device defect rate. 

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Inclusion Criteria 
1. Aged 6 to 14 years old, regardless of gender; 
2. After cycloplegic autorefraction, monocular or binocular 
spherical equivalent refraction (SER) meets: -6.00D ≤ SER ≤ -
1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 
0.8 (logMAR 0.1; Snellen 20/25); 
3. Binocular anisometropia ≤ 1.50D; astigmatism ≤ 2.50D; 
4. Able to understand the purpose of the study, willing to 
participate in this clinical verification, sign the informed 
consent form personally or through their legal guardian, and 
cooperate with the entire trial process (12 months). 
Exclusion Criteria 
1. Photophobia or allergy to cycloplegic agents (e.g., 
tropicamide or cyclopentolate); 
2. Received any of the following myopia control measures 
within one month (including but not limited to): low-
concentration atropine eye drops, orthokeratology lenses, 
myopia control-related frame glasses, low-level red light 
therapy, defocus soft contact lenses, or defocus RGP lenses; 
3. Subjects with ocular diseases that may affect visual acuity or 
refractive error (e.g., lens disorders such as cataracts, 
glaucoma, macular degeneration, corneal diseases, uveitis, 
retinal detachment, severe vitreous opacity, etc.); 
4. Neurological diseases (previous convulsion history, 
epilepsy, tic disorders, central nervous system developmental 
abnormalities) or mental and psychological diseases; 
5. Systemic diseases: immune system diseases, central nervous 
system 
diseases, 
Down 
syndrome, 
asthma, 
severe 
cardiopulmonary function impairment, severe liver and kidney 
dysfunction, acute or chronic sinusitis, or diabetes mellitus; 
6. Binocular manifest strabismus or any other pathological 

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changes of the eyeball or acute inflammatory ocular diseases; 
7. Subjects deemed inappropriate by the investigator. 
Number of Research Centers 
7 
Sample Size 
364 
2. Sponsor Information 
Relevant information of the sponsor is shown in Table 1 below. 
Table 1: Sponsor Information 
Item 
Details 
Name 
Beijing Airdoc Technology Co., Ltd. 
Address 
2M-16, M Floor, Building 2, No. 36 Zhenxing 
Road, Changping Science and Technology 
Park, Beijing 
Postcode 
100000 
Contact Person 
Fang Chunxu 
Contact Information 
13354593387 
Note: Changes in contact information during the study will not be considered as revisions to the 
study protocol. 
3. List of Research Centers 
See Annex 2. 
4. Background Information of the Clinical Trial 
4.1. R&D Background 
Myopia is the most common refractive error, prevalent worldwide, especially in East Asia. China 
has one of the highest myopia prevalence rates among adolescents globally, with a prevalence of 
15-80% among urban adolescents ¹⁻², which is 1.5-5.6 times that of the corresponding population in 
Chile and 11.4-30.8 times that in Nepal. According to a survey by the World Health Organization 
(WHO), myopia has become one of the main causes of visual impairment globally. Annual costs for 
myopia correction through optical means or surgery are substantial, and drug treatment for 
pathological myopia and irreversible blindness can impose a heavy burden on society and families. 
Moreover, over the past 30 years, the prevalence of myopia has increased significantly worldwide, 

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especially in developed regions; it is estimated that by 2050, 50% of the global population will be 
myopic, including 10% with high myopia. High myopia is associated with an increased risk of 
blindness and blinding eye diseases due to fundus abnormalities. Therefore, controlling myopia 
progression to prevent high myopia and reduce the burden of blinding eye diseases on individuals 
and society is an urgent public health issue. 
To effectively strengthen the prevention and control of myopia among children and adolescents, on 
August 30, 2018, the Ministry of Education, together with seven other ministries including the 
National Health Commission, formulated the "Implementation Plan for the Comprehensive 
Prevention and Control of Myopia Among Children and Adolescents". This plan involves the 
government, schools, medical and health institutions, families, and students, aiming to reduce the 
overall myopia rate of children and adolescents in China by more than 0.5 percentage points 
annually on the basis of 2018 by 2023, and by more than 1 percentage point annually in provinces 
with a high myopia rate; by 2030, the myopia rate of 6-year-old children should be controlled at 
around 3%, the myopia rate of primary school students should drop below 38%, that of junior high 
school students below 60%, and that of senior high school students below 70%. 
Notably, the development of myopia is a dynamic process, and preventive and control measures 
need to be implemented as early as possible. Previous studies have shown that risk factors for pre-
myopic status include changes in axial length, decreased uncorrected distance visual acuity, changes 
in ocular biological parameters, parental myopia degree, parental education level, indoor/outdoor 
activity time, and genetic risk ⁵⁻⁹. The greater harm of myopia is mainly reflected in the fundus of 
high myopia or even pathological myopia; intervening in children and adolescents with myopia to 
control myopia progression or even partially reverse myopia has always been the direction of 
medical efforts. 
In clinical studies on laser red light for controlling myopia progression published in the past two 
years, it has been confirmed that low-level red light can not only control the elongation of myopic 
axial length but also induce myopic axial length regression in 48.61% of myopic children after a 1-
year complete follow-up. A large number of relevant clinical studies have not reported 
complications related to fundus damage. Currently, non-laser PBM therapy using LED light has 
been widely used in neurotrauma, stroke, etc., and also provides an innovative, non-invasive 
treatment approach for severe vision-threatening eye diseases such as age-related macular 

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degeneration, amblyopia, diabetic retinopathy, and Leber's hereditary optic neuropathy. 
Although LED-based red light at specific wavelengths and appropriate doses also relies on the core 
biological mechanism of PBM therapy, it differs from laser. Lasers have high collimation, small 
divergence angles, and high energy density, posing a greater risk of damage to the eyes, especially 
the retina, compared to LED light. In contrast, non-laser PBM therapy using LED light emits 
incoherent, divergent light with high safety. This light source, specially designed by Airdoc, forms 
a unique annular light spot on the fundus retina while avoiding the fovea centralis, greatly reducing 
safety concerns. This study adopts non-laser LED red light to slow down or control myopia 
progression in children and adolescents. 
ISO 15004-2 is an international standard for optical radiation safety testing of ophthalmic 
instruments, meeting the compliance requirements of global medical device regulations. The 
standard sets a limit of 0.7W/cm² for retinal power density. The non-laser LED red light device used 
in this study is strictly designed in accordance with this standard, with test results showing a retinal 
power density nearly 1/77 of the standard limit. Compared to laser red light, which may exceed this 
standard and pose risks, the retinal power density of the device in this study provides a sufficient 
safety margin. According to the Arndt-Schultz law, the dose of red light is correlated with its effect 
within a certain range, and energy density is related to time and power density. Currently, there is 
no corresponding basis for the recommended 3-minute use duration. The 'safe window dose' is set 
based on energy density. Calculations show that the intervention dose of the extended intervention 
duration in the study groups is still much lower than the 3-minute intervention dose of laser red light, 
so the claim that increasing the intervention dose will generate additional safety risks is unfounded. 
Studies on LED red light by the research team have shown that its effect is relatively weaker than 
that of laser red light. Whether different intervention durations will affect the effectiveness and 
safety of non-laser PBM therapy has become a new research question. To explore the effectiveness 
and safety of LED red light combined therapy with different intervention durations in controlling 
myopia progression in children and adolescents, the research team plans to conduct a prospective, 
multicenter, randomized controlled clinical study to provide scientific basis and practical guidance 
for the application of PBM phototherapy intervention technology. 
4.2. Basic Product Information 
Main technical performance indicators of Yingtong Vision Rehabilitation Instrument: 

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Input voltage: 6V (4 × 1.5V alkaline dry batteries). 
Red light wavelength: 650nm; light spot diameter: outer diameter 5.0mm, inner diameter 1.5mm. 
Light source output power: 1.6 mW (±0.1mW at 30mm from the observation window). 
After obtaining informed consent from children and their parents at the start of the study, the 
Yingtong Vision Rehabilitation Instrument should be used twice a day under the regular 
communication and supervision of hospital optometrists/coordinators (via phone, WeChat, etc.), 
with an interval of at least 4 hours. 
Specific operation steps of Yingtong Vision Rehabilitation Instrument: 
Place the instrument on a stable desktop, and connect accessories such as headphones after 
confirming the interface; 
Open the rear bracket, then open the battery cover, and insert 4 fully charged AA 1.5V batteries; 
Let the subject sit in a suitable position, adjust the foldable bracket on the back to the most 
comfortable angle, so that the eyes are relatively comfortable when leaning against the instrument, 
and hold the sides of the instrument with both hands to fix the distance; 
Press the on/off button on the front of the instrument, and the screen will display the battery level, 
target distance (select a distance within the range of 50-70mm where both eyes can fuse into a single 
image), and set time; headphones can be inserted in advance to listen to music; the music function 
can only be activated after turning on the instrument, and the volume can be adjusted or turned off 
by clicking the music button continuously; 
Click the on/off button, then let the eyes be close to the red light emitting part of the instrument; 
During use, adjust the target distance so that the light can illuminate the pupil area of both eyes 
simultaneously. The instrument will automatically remember the target distance used last time when 
turned on again. 
Turn off the instrument after use. 
4.3. Scope of Application and Relevant Information 
4.3.1. Target Population 
Children and adolescents with myopia. 
4.3.2. Reusability 
Can be used long-term as recommended by doctors. 
4.3.3. Usage Methods and Precautions of the Test Product 

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See the product manual for details. 
4.3.4. Contraindications 
Ocular disease patients: Those with a history of photosensitivity, macular diseases, moderate to 
severe dry eye, corneal diseases, cataracts, vitreoretinal diseases, infectious conjunctivitis, allergic 
conjunctivitis, uveitis, optic nerve damage, congenital optic nerve dysplasia, or other ocular diseases. 
Patients with autoimmune diseases and systemic diseases: Systemic lupus erythematosus, 
dermatomyositis, Sjögren's syndrome, hypertension, albinism, previous convulsion history, diabetes 
mellitus, tic disorders, immature central nervous system development, psoriasis, epilepsy, mental 
and psychological diseases, etc. 
Other contraindications:(1) Patients using low-concentration atropine simultaneously;(2) Children 
with relatively high intraocular pressure (IOP), whose cup-to-disc ratio should be closely examined. 
Prohibited conditions:(1) If the child has a cold or fever, the device should be discontinued;(2) If 
the patient is in a stage of ocular surface inflammation (e.g., allergic conjunctivitis, corneal staining, 
or damage), the device should be discontinued;(3) The device should be discontinued if the patient 
experiences abnormal afterimage duration, significant short-term visual loss, persistent halos in 
front of the eyes, scotomas, systemic inflammation, photophobia, mydriasis, or other issues;(4) 
During the use of Yingtong Vision Rehabilitation Instrument, a few myopic patients may experience 
reactions unrelated to the mechanism of the instrument due to changes in physical condition, 
environment, psychology, mood, etc., such as red eyes, swollen eyes, dry eyes, or lacrimation caused 
by inflammation. In such cases, the cause should be identified promptly to determine whether 
temporary discontinuation is necessary. 
5. Trial Design 
5.1. Overall Design and Rationale 
Referring to the "Guidance Principles for the Design of Medical Device Clinical Trials", this study 
adopts a multicenter, randomized, open-label, parallel-group, non-inferiority design. The parallel 
control product is Hoya DIMS multi-point myopia defocus lens. After signing the informed consent 
form, subjects will be screened according to unified inclusion and exclusion criteria. Eligible 
subjects will be randomly assigned to Test Group A, Test Group B, Test Group C, and Control Group 
D at a ratio of 1:1:1:1. 
Intervention measures for the four groups: 

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⚫ 
Test Group A: PBM therapy with single intervention duration of 2 minutes + wearing Hoya 
DIMS defocus lens; 
⚫ 
Test Group B: PBM therapy with single intervention duration of 3 minutes + wearing Hoya 
DIMS defocus lens; 
⚫ 
Test Group C: PBM therapy with single intervention duration of 4 minutes + wearing Hoya 
DIMS defocus lens; 
⚫ 
Control Group D: Wearing Hoya DIMS defocus lens only. 
Subjects in the four groups will be followed up at screening/enrollment, 30 days ±7 days, 3 months 
±7 days, 6 months ±14 days, 9 months ±14 days, and 12 months -28 days. The effectiveness, safety, 
and other aspects of the product will be evaluated during the follow-up visits. 
This study will be conducted in accordance with the requirements of the NMPA's "Good Clinical 
Practice for Medical Devices" to ensure that the clinical trial process is standardized, and the results 
are true, scientific, reliable, and traceable. 
Investigators will adhere to the ethical principles of the World Medical Association's Declaration of 
Helsinki to maximize benefits for subjects and minimize harm, so as to evaluate whether the test 
product has similar effectiveness and safety to the control product under normal use conditions. 
5.1.1. Trial Objective 
To verify the effectiveness and safety of the PBM therapy combined with defocus lens therapy of 
the study product (Yingtong Vision Rehabilitation Instrument) by comparing with the widely used 
marketed Hoya DIMS defocus lens (with and without combination). 
5.1.2. Selection of Trial Method and Rationale 
In this clinical trial, the three test groups and the control group will use Yingtong Vision 
Rehabilitation Instrument combined with Hoya DIMS defocus lens and Hoya DIMS defocus lens 
alone, respectively. In accordance with the principles of the "Good Clinical Practice for Medical 
Devices", a multicenter, randomized, open-label, parallel-group controlled trial design is adopted. 
The rationale for this method is as follows:(1) Multicenter: Multicenter clinical trials can collect a 
large number of subjects in a short period of time, shortening the time required to complete the 
clinical trial. In addition, multicenter clinical trials involve investigators and subjects from multiple 
centers, avoiding the limitations of a single research center, reducing bias, and enhancing the 
credibility of the results, making the conclusions more widely applicable. Therefore, to ensure the 

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progress of this clinical study and the credibility of the conclusions, a multicenter trial design is 
adopted;(2) Randomization: This clinical trial adopts a randomization method with a randomized 
block design to ensure that subjects are evenly assigned to the three test groups or the control 
group;(3) Open-label: Due to the obvious differences in the use of the products in this clinical trial, 
double-blind or single-blind design cannot be achieved, so an open-label clinical trial design is 
adopted;(4) Parallel control: The parallel control product is Hoya DIMS multi-point myopia defocus 
lens, whose safety and effectiveness have been proven through wide clinical application after 
marketing. Through comparison, the safety and effectiveness of the combined use of the test product 
and this product can be evaluated;(5) This trial adopts a multicenter, parallel trial design, with the 
clinical trial starting and ending simultaneously to reduce bias. 
Based on the above considerations, to evaluate the effectiveness and safety of the combined use of 
Yingtong Vision Rehabilitation Instrument and Hoya DIMS defocus lens, and adhering to the 
principle of scientific rationality, this trial adopts a multicenter, randomized, open-label, parallel-
group controlled trial method. 
5.2. Subject Selection 
Subjects who provide informed consent and meet the case selection criteria enrolled by clinical 
institutions during the trial period: 
5.2.1. Inclusion Criteria 
1) 
Adhering to the principles of fairness, respect, and maximizing benefits for subjects, ensuring 
safety and health, and minimizing harm as much as possible. 
2) 
Aged 6 to 14 years old, regardless of gender; 
3) 
After cycloplegic autorefraction, monocular or binocular spherical equivalent refraction (SER) 
meets: -6.00D ≤ SER ≤ -1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 0.8 
(logMAR 0.1; Snellen 20/25); 
4) 
Binocular anisometropia ≤ 1.50D; 
5) 
Able to understand the purpose of the study, willing to participate in this clinical verification, 
sign the informed consent form personally or through their legal guardian, and cooperate with 
the entire trial process (12 months). 
5.2.2. Exclusion Criteria 
1) 
Photophobia or allergy to cycloplegic agents (e.g., tropicamide or cyclopentolate); 

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2) 
Received any of the following myopia control measures within one month (including but not 
limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control-
related frame glasses, low-level red light therapy, defocus soft contact lenses, or defocus RGP 
lenses; 
3) 
Subjects with ocular diseases that may affect visual acuity or refractive error (e.g., lens 
disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal 
detachment, severe vitreous opacity, etc.); 
4) 
Neurological diseases (previous convulsion history, epilepsy, tic disorders, central nervous 
system developmental abnormalities) or mental and psychological diseases; 
5) 
Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, 
asthma, severe cardiopulmonary function impairment, severe liver and kidney dysfunction, 
acute or chronic sinusitis, or diabetes mellitus; 
6) 
Binocular manifest strabismus or any other pathological changes of the eyeball or acute 
inflammatory ocular diseases; 
7) 
Subjects deemed inappropriate by the investigator. 
5.2.3. Criteria and Procedures for Terminating the Trial/Withdrawing Subjects 
5.2.3.1. Criteria for Terminating the Trial/Trial Treatment 
(1) Subjects voluntarily withdraw from the trial for various reasons, such as revoking informed 
consent, death, or loss to follow-up;(2) Subjects fail to follow the trial visit schedule;(3) Due to 
adverse events, especially serious adverse events, the sponsor, ethics committee, clinical trial 
institution, national or local drug regulatory authority decides to terminate the trial from an ethical 
perspective, regardless of whether it is related to the research medical device;(4) The sponsor 
decides to terminate the trial;(5) Pregnancy occurs during the clinical trial;(6) The subject's health 
condition does not allow them to participate in this trial;(7) Other circumstances that require 
termination of the trial/trial treatment. 
5.2.3.2. Handling of Termination/Withdrawal 
(1) Complete the final examination, and record in detail the concurrent medications and adverse 
events of the terminated/withdrawn subjects;(2) For terminated/withdrawn subjects, clinically 
reasonable medical treatment should be provided to ensure their safety, and effectiveness and safety 
data should be obtained as much as possible. For subjects who do not voluntarily withdraw, follow-

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up should be conducted until the end of the study;(3) The reason and time for the subject's 
termination/withdrawal from the trial should be recorded in detail in the Case Report Form (CRF);(4) 
Patients who terminate the trial due to adverse events must be followed up until the adverse event 
is resolved or stabilized. 
5.2.3.3. Dropout Criteria 
All subjects who have signed the informed consent form, passed the screening, been randomized, 
and used the study product but failed to complete the 12-month follow-up for any reason are 
considered dropout cases. 
5.2.3.4. Exclusion Criteria 
The exclusion criteria are one of the key indicators for determining the endpoint dataset of the 
clinical trial observation, including various situations that seriously violate the trial protocol and/or 
affect the evaluation of the efficacy or safety of the case, including those for whom observation data 
cannot be obtained. Whether to include them in the analysis set should be jointly discussed and 
decided by the principal investigator, data manager, statistical analysis expert, and sponsor during 
data verification. 
5.3. Evaluation Methods 
5.3.1. Efficacy Evaluation 
5.3.1.1. Primary Efficacy Endpoint and Other Efficacy Indicators 
Referring to the "Expert Consensus on the Application of Axial Length in Myopia Prevention and 
Control Management (2023)", the primary efficacy endpoint and other efficacy indicators of this 
study are formulated as follows: 
Primary Efficacy EndpointChange in axial length at 6 months (mm). It is considered "effective" 
when the axial length meets the following clinical evaluation requirements:(1) Taking an annual 
axial length growth of ≤0.20 mm as the threshold for the safe growth range, an axial length growth 
of ≤0.1 mm at 6 months is considered "effective". 
Secondary Efficacy Endpoints: Evaluate the following items and compare the corresponding 
secondary evaluation indicators of the four groups after intervention. The examination time is shown 
in Annex 1, and statistical analysis results of the three test groups and the control group should be 
provided:(1) Axial length results at all follow-up visits except 6 months;(2) Refractive error results 
at the 12-month follow-up. 

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5.3.1.2. Selection and Explanation of Efficacy Parameters 
Primary Efficacy Endpoint: Change in axial length at 6 months (mm).The change in axial length at 
6 months after intervention is an important indicator for evaluating product efficacy. Based on the 
characteristics of the product, expert opinions, and referring to the "Expert Consensus on the 
Application of Axial Length in Myopia Prevention and Control Management (2023)", the change in 
axial length at 6 months (mm) is designated as the primary efficacy endpoint. 
Secondary Efficacy Endpoints: Evaluate the following items and compare the corresponding 
secondary evaluation indicators of the four groups after intervention. The examination time is shown 
in Annex 1, and statistical analysis results of the three test groups and the control group should be 
provided:(1) Change in axial length at 1 month (mm);(2) Change in axial length at 3 months (mm);(3) 
Change in axial length at 9 months (mm);(4) Change in axial length at 12 months (mm);(5) Change 
in spherical equivalent refraction (SER) at 12 months. 
5.3.2. Safety Evaluation 
5.3.2.1. Safety Indicators 
Confirm the following items, compare the safety indicators of the four groups after intervention. 
The follow-up time is shown in Annex 1, and statistical analysis results of the test groups and the 
control group should be provided: 
Adverse event rate and serious adverse event rate; 
12-month visual adverse event rate (BVCA decrease ≥0.2 logMAR); 
Device defect rate. 
5.3.2.2. Selection and Explanation of Safety Parameters 
The follow-up time is shown in Annex 1. 
Symptoms, signs, complications, adverse events, or serious adverse events: List the symptoms, signs, 
complications, adverse events, etc., of subjects at each follow-up visit after intervention (30 days, 3 
months, 6 months, 9 months, 12 months), and provide statistical analysis results of the test groups 
and the control group.Slit lamp examination: Perform slit lamp examination at each follow-up visit. 
OCT examination: Observe changes in choroidal thickness and interlayer structure of subjects at 30 
days, 3 months, 6 months, 9 months, and 12 months. 
Best-corrected visual acuity: Analyze the best-corrected visual acuity at 30 days, 3 months, 6 months, 
9 months, and 12 months follow-up visits and the initial best-corrected visual acuity, and compare 

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the proportion of subjects in the test groups and the control group with a decrease of 1 line, 2 lines, 
or more than 2 lines in best-corrected visual acuity compared with the initial best-corrected visual 
acuity. 
Intraocular pressure (IOP): Measure the IOP of subjects at 30 days, 3 months, 6 months, 9 months, 
and 12 months follow-up visits, and analyze the impact of the test groups and the control group on 
IOP. 
5.4. Test Medical Device and Control Medical Device 
The test product for this clinical trial is Yingtong Vision Rehabilitation Instrument, and the control 
product is Hoya DIMS multi-point myopia defocus lens. Both the test and control products are 
marketed and widely used clinically, meeting clinical needs. 
5.5. Trial Process 
5.5.1. Trial Flow Chart 
Kick-off Meeting → Recruit Subjects → Sign Informed Consent Form → Routine Ocular 
Examinations and Screening for Eligibility → Randomization (Screening Failure if Not Meeting 
Any Inclusion Criterion or Meeting Any Exclusion Criterion) → Customize and Distribute Test 
Products → Conduct Follow-up Examinations According to the Follow-up Schedule (see Annex 1) 
→ Perform Various Evaluation Indicator Examinations and Record → Monitor and Record Adverse 
Events/Device Defects Throughout the Trial. 
Note: Investigators should conduct self-inspections throughout the trial process;(1) Subjects should 
be patients who meet the inclusion and exclusion criteria of the protocol;(2) Inform subjects of the 
content of the clinical trial, and have them understand and sign the Informed Consent Form;(3) 
Conduct ocular examinations and screen for eligibility. Eligible subjects who meet the inclusion and 
exclusion criteria will be randomly assigned to the corresponding groups and given random 
numbers;(4) Distribute the test/control medical devices;(5) Investigators will conduct follow-up 
visits according to the follow-up schedule, record follow-up data, and monitor adverse events 
throughout the process;(6) Collate and analyze trial data, and form a clinical trial report. 
5.5.2. Trial Implementation (Methods, Content, Steps, etc.) 
After meeting the inclusion and exclusion criteria, subjects should be followed up in accordance 
with the requirements of the clinical trial protocol. See Annex 1 (Clinical Trial Follow-up Table) for 
details. During the clinical trial, closely observe and record adverse events. 

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The following relevant examinations and operations need to be performed throughout the study:The 
trial steps include: screening/enrollment, 30 days ±7 days, 3 months ±7 days, 6 months ±14 days, 9 
months ±14 days, and 12 months -28 days. 
5.5.2.1. Screening/Enrollment 
Sign the written informed consent form; 
Collect subject information: 
Concurrent diseases, past medical history, myopia control intervention history, surgical history, 
trauma history, etc.; 
Concurrent medications, and determine whether there is concurrent ophthalmic drug treatment; 
Conduct ocular examinations: 
a. Axial length; 
b. Refractive error; 
c. Visual acuity, IOP, fundus color photography, OCT, eye position examination, and slit lamp 
examination. 
Verify the inclusion/exclusion criteria one by one. Eligible subjects will be randomly enrolled and 
assigned to the corresponding groups; 
Customize and distribute defocus lenses: Customize lenses according to clinical prescriptions and 
mail them to subjects. 
5.5.2.2. Follow-up Period 
Follow-up visits will be conducted at 30 days, 3 months, 6 months, 9 months, and 12 months after 
intervention to complete the following evaluations: 
Inquire about the occurrence of adverse events since the last follow-up; 
Inquire about changes in concurrent medications or treatments since the last follow-up; 
Conduct ocular examinations: 
a. Axial length; 
b. Refractive error; 
c. Visual acuity, IOP, fundus color photography, OCT, eye position examination, and slit lamp 
examination; 
d. Record of test device defects and protocol deviation; 
e. Schedule the next follow-up visit with the subject. 

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5.5.2.3. Unscheduled Follow-up 
Between two follow-up visits, if the subject experiences any discomfort or special conditions (e.g., 
any obvious discomfort, damage or loss of the study product, etc.) and needs guidance or support 
from the investigator, the subject can return to the research center for an unscheduled follow-up. 
During the unscheduled follow-up, the reason for the unscheduled follow-up and the measures taken 
by the investigator (including examinations or treatments provided, supplementary replacement and 
distribution of study products, etc.) should be recorded. 
5.5.3. Specifications for Device Use 
In accordance with regulations such as the NMPA's "Good Clinical Practice for Medical Devices", 
the specifications for the use of test medical devices mainly include the following aspects:(1) Before 
the start of the medical device clinical trial, the sponsor will organize training related to the medical 
device clinical trial, such as the principle, scope of application, product performance, operation 
method, technical indicators, clinical trial protocol, standard operating procedures, and other 
relevant documents of the test medical device.(2) The test medical device should be produced in 
accordance with the relevant requirements of the Good Manufacturing Practice for Medical Devices 
and be of qualified quality;(3) Determine the transportation conditions, storage conditions, storage 
time, validity period, etc., of the test medical device;(4) The test medical device should be properly 
packaged and stored in accordance with the requirements of the clinical trial protocol;(5) After the 
medical device clinical study is approved by the ethics committee, the sponsor is responsible for 
transporting the test medical device to the hospital under specified conditions;(6) For the test 
medical device recovered by the hospital, the sponsor is responsible for keeping records of recovery 
and disposal.(7) Investigators are responsible for managing the test medical device and control 
medical device provided by the sponsor, storing and keeping them in accordance with requirements 
during the clinical study, and handling them in accordance with relevant laws and regulations and 
the contract with the sponsor after the completion or termination of the clinical study. The above 
process should be managed by a dedicated person and recorded. Investigators shall not transfer the 
test medical device to any non-clinical trial participant. 
5.5.4. Device Management 
5.5.4.1. Pre-Reception Management 
Before the arrival of the test medical device, the sponsor should notify the trial center to make 

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reception preparations. The trial center should have an independent storage space to store the test 
medical device to avoid confusion with other similar products. 
5.5.4.2. Reception and Storage of Test Medical Device 
After the study product arrives at the trial center, the trial center should designate a person 
responsible for the reception work and complete the corresponding reception records. If there are 
any problems with the study product upon arrival (e.g., missing quantity, damaged outer packaging, 
etc.), it should be reported to the sponsor. 
The trial center should designate a person responsible for the management of the study product after 
reception (e.g., quantity counting). 
5.5.4.3. Outbound and Use of Test Medical Device 
The test medical device should be stored independently with corresponding inbound and outbound 
records for verifying material balance and medical device information. Issuance and return should 
be recorded in writing. 
5.5.4.4. Return of Test Medical Device 
After the on-site work of the clinical trial is completed, the warehouse manager is responsible for 
counting the quantity of remaining products, filling in the corresponding records, and filing the 
records. Investigators are responsible for explaining any discrepancies in the remaining quantity. 
The remaining medical device shall be handled in accordance with the agreement between the 
sponsor and the investigator to ensure that the test medical device does not circulate externally. 
5.6. Bias Control Measures 
Due to the need for trial use of the product before formal use in this clinical trial, double-blind or 
single-blind design cannot be achieved, so an open-label clinical trial design is adopted. To reduce 
and avoid bias as much as possible, the following aspects will be taken to control bias in the design 
and implementation of the study:(1) Select objective efficacy and safety evaluation indicators as 
much as possible;(2) Formulate a unified standard operating procedure (SOP) for examinations. 
Before the start of the clinical trial, the monitor, together with the person in charge of each trial 
center, will train all investigators on the study protocol and operating procedures to ensure that 
investigators understand and are familiar with the product and master all operations during the 
clinical trial.(3) Before the start of the clinical trial, the sponsor will assist each trial center in 
preparing for the start of the clinical trial and conducting training, and promptly identify problems 

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and take corrective and preventive measures to ensure that all contents of the clinical trial protocol 
are strictly followed. The original data will be checked to ensure consistency with the content of the 
CRF.(4) Adopt randomization, and each research center will compete for enrollment.(5) After the 
completion of the clinical study, do a good job in data collation and preservation. When problems 
are found in the data, the data analyst will verify and confirm the data through data query forms to 
avoid recording errors. 
5.7. Expected Total Duration of the Clinical Trial and Rationale 
The expected total duration of this clinical trial is 18 months. The total duration specifically includes 
two parts: enrollment time and subject follow-up time. The expected enrollment time is 6 months, 
and the subject follow-up time is 12 months. 
5.7.1. Rationale for Determining Enrollment Time 
Considering the uneven source of subjects in each center and the different trial start times, the 
expected enrollment time is 6 months based on the number of daily outpatient cases in each center. 
5.7.2. Rationale for Determining Follow-up Time 
The follow-up time is determined based on the "Good Clinical Practice for Medical Devices" and 
experience such as the occurrence time of product performance. 
5.7.3. Expected Participation Time and Duration for Each Subject 
The expected participation duration of each subject in this trial is 12 months. 
5.7.4. Number of Subjects Required for the Clinical Trial 
The total sample size is 364 cases. 
6. Statistical Considerations 
6.1. Sample Size Estimation 
6.1.1. Calculation Formula, Parameter Values (e.g., Significance Level, Power, Expected Dropout 
Rate, Threshold, etc.) and Rationale, Calculation Results 
The sample size of this study is calculated using PASS software. This study is a randomized 
controlled trial with four groups: High-Intervention Group (Group A), Medium-Intervention Group 
(Group B), Low-Intervention Group (Group C), and Control Group (Control Group). The axial 
length of the subjects is the outcome indicator for observation. Referring to the "Expert Consensus 
on the Application of Axial Length in Myopia Prevention and Control Management (2023)", an 
annual axial length growth of ≤0.20 mm is set as effective control. Based on literature review and 

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previous clinical trials, the expected treatment rate is 90% in the High-Intervention Group, 80% in 
the Medium-Intervention Group, 70% in the Low-Intervention Group, and 45% in the Control 
Group. A two-sided α=0.05 is set, with multiple comparison α requiring Bonferroni correction 
(α=0.016667) and a power of 80%. Calculations are performed using PASS 15 software. 
The total sample size for the four groups is N=308 cases. Considering the possibility of loss to 
follow-up and refusal to participate, a dropout rate of 15% is assumed. Finally, a total of 364 subjects 
are required for the High-Intervention Group, Medium-Intervention Group, Low-Intervention 
Group, and Control Group, with at least 91 subjects in each intervention group and 91 subjects in 
the Control Group. 
6.1.2. Sample Size Allocation and Rationale (if applicable) 
This study strictly restricts the inclusion and exclusion criteria of the enrolled subjects, which can 
be considered as targeting a single indication, and no further stratification is required. 
6.2. Analysis Datasets 
(1) Full Analysis Set (FAS): In accordance with the Intention-to-Treat (ITT) principle, all randomly 
enrolled cases who received red light irradiation are included in the full analysis set.(2) Per-Protocol 
Set (PPS): The PPS population refers to all cases who were randomly enrolled in accordance with 
the study protocol, received the treatment specified in the protocol, and had observable data for the 
primary evaluation indicator.(3) Safety Set (SS): All randomly enrolled cases who received red light 
irradiation and have post-irradiation safety evaluation data constitute the safety analysis dataset of 
this trial. No imputation is allowed for missing values in the safety dataset. 
6.3. Subject Exclusion Criteria 
Before statistical analysis of the data, the principal investigator, sponsor, and statistical analyst will 
review the data and jointly determine whether individual cases need to be excluded from the 
statistical analysis. The three parties will comprehensively judge whether to exclude the subject 
from the statistical analysis set based on factors such as the subject's completion of the trial, 
collection of the primary efficacy evaluation indicator, and the existence of serious protocol 
violations and/or reasons for withdrawing from the trial, and provide relevant explanations. Finally, 
the dataset for statistical analysis will be formed. 
6.4. Statistical Methods 
6.4.1. General Principles 

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SAS 9.4 or higher version will be used for statistical analysis. 
All data will be statistically described, including demographic data, baseline data, all efficacy 
indicators, and all safety data. For quantitative data, the mean, standard deviation, minimum value, 
maximum value, median, 25th percentile, and 75th percentile will be provided; for categorical data, 
the frequency and corresponding percentage will be provided. For the comparison of general 
conditions among the four groups, analysis of variance or Wilcoxon rank-sum test will be used for 
inter-group comparison of quantitative indicators according to the data distribution, chi-square test 
or exact probability method (if chi-square test is not applicable) for categorical indicators, and 
Wilcoxon rank-sum test or CMH test for ordinal data. 
All statistical tests will adopt two-sided tests, and a P value less than 0.05 will be considered 
statistically significant (unless otherwise specified). 
6.4.2. Completion Status and Demographic Analysis 
Baseline analysis is based on the Full Analysis Set (FAS). 
Summarize the number of screened, enrolled, and completed trial subjects, the number of lost to 
follow-up/withdrawn/excluded subjects, and list the list of dropout cases. Compare the size of each 
dataset in each group, the distribution of cases in each center, the total dropout rate, and detail the 
reasons for non-completion. Describe the demographic data, medical history, etc., of the subjects. 
6.4.3. Efficacy Evaluation 
(1) Primary Efficacy Endpoint:The primary efficacy evaluation is based on the Full Analysis Set 
(FAS) and Per-Protocol Set (PPS).A non-inferiority test will be used for the primary efficacy 
endpoint. 
(2) Secondary Efficacy Endpoints:The secondary efficacy evaluation is based on the Full Analysis 
Set (FAS) and Per-Protocol Set (PPS). Statistical description and inference of data will select 
applicable descriptive indicators and hypothesis testing methods according to the characteristics of 
the data. 
All statistical analysis tests will adopt two-sided hypothesis testing, and the significance level of the 
hypothesis test will be α=0.05, i.e., a P value less than 0.05 will be considered statistically significant 
for the tested difference. 
(3) Safety Indicators:The safety evaluation is based on the Safety Set (SS). 
Describe the number and incidence of adverse events (or SAEs), and detail the specific 

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manifestations, severity, and relationship with the device of all adverse events occurring in the cases 
of each group. 
In addition to the above statistical methods, detailed and additional exploratory analyses may be 
required, which will be confirmed in the study report and Statistical Analysis Plan (SAP). 
6.5. Handling of Missing Values and Outliers 
Handling of missing data: Imputation of missing data is only for missing primary efficacy endpoints 
in the FAS dataset. The imputation strategy is Last Observation Carried Forward (LOCF). If LOCF 
is not applicable, a conservative strategy such as Worst-Case Imputation will be adopted. Other 
missing data will not be imputed. Sensitivity analysis may be performed if necessary. 
Handling of unreasonable data: During the data management process, logical checks will be 
performed on the data in the database. Unreasonable data found will be questioned by the 
investigator in the form of a Query, and the unreasonable data will be adjusted according to the 
investigator's written reply until all unreasonable data are resolved before the database can be locked. 
Handling of erroneous data: During the data management process, quality control will be performed 
on the data in the database. Erroneous data found will be questioned by the investigator in the form 
of a Query, and the erroneous data will be corrected according to the investigator's written reply 
until all erroneous data are corrected before the database can be locked. 
7. Monitoring Plan 
(1) The sponsor will entrust monitors to monitor this clinical trial. 
(2) Monitors should have relevant professional backgrounds such as clinical medicine, pharmacy, 
biomedical engineering, and statistics, receive necessary training, be familiar with the Good Clinical 
Practice for Medical Devices and relevant regulations, and be familiar with non-clinical and clinical 
information of similar products of the test medical device, the clinical trial protocol, and its related 
documents. 
(3) The frequency of monitoring will be appropriately increased according to the enrollment status. 
(4) Monitors should follow the principles of the "Good Clinical Practice for Medical Devices" and 
supervise the conduct of the clinical trial to ensure that the clinical trial is strictly implemented in 
accordance with the protocol. The trial data should be true, complete, and accurate. Specific 
responsibilities include: 
1) 
Confirm that the clinical trial institution has appropriate conditions before the trial, including 

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qualified personnel allocation and training, complete laboratory equipment in good working 
condition, an expected sufficient number of subjects, and participating researchers familiar 
with the trial requirements; 
2) 
Monitor whether the clinical trial institution and investigators follow relevant regulations, these 
specifications, and the clinical trial protocol before, during, and after the trial; 
3) 
Confirm that each subject signs the informed consent form before participating in the clinical 
trial, understand the enrollment status of the subject and the progress of the trial; clearly and 
truthfully record the investigator's failure to conduct follow-up visits, unperformed trials, 
unconducted examinations, and whether errors and omissions have been corrected; confirm 
that subjects who have not completed the clinical trial process and are affected re-sign the 
revised informed consent form; 
4) 
Confirm that all case report forms are filled out correctly and consistent with the original data; 
all errors or omissions have been corrected or noted, signed by the investigator, and dated; the 
disease type, total number of cases, and gender, age, treatment effect, etc., of the cases in each 
trial should be confirmed and recorded; 
5) 
Confirm that the situation of subjects withdrawing from the clinical trial or failing to comply 
with the requirements of the informed consent form is recorded, and discuss such situations 
with the investigator; 
6) 
Confirm that all adverse events, complications, and other device defects are recorded, and 
serious adverse events and device defects that may lead to serious adverse events are reported 
and recorded within the specified time; 
7) 
Monitor the supply, use, maintenance, transportation, reception, storage, distribution, handling, 
and recovery of the test medical device samples; 
8) 
Supervise the regular maintenance and calibration of relevant equipment during the clinical 
trial; 
9) 
Ensure that all clinical trial-related documents received by the investigator are the latest version; 
10) Submit a written report to the sponsor after each monitoring visit, which should include the 
monitor's name, monitoring date, monitoring time, monitoring location, monitoring content, 
investigator's name, project completion status, existing problems, conclusions, and corrections 
made to errors and omissions. 

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8. Data Management 
8.1. Completion and Submission of Case Report Forms (CRF) 
The case report form will be filled out by the investigator or their designated person, and a case 
report form must be completed for each enrolled case. The completed case report form will be 
reviewed by the clinical monitor, and the first copy will be submitted to the data manager for data 
entry and management. 
8.2. Data Verification 
After data entry and inspection are completed, verification will be conducted, and the final definition 
and judgment of the analysis population will be completed. 
8.3. Data Locking 
Data can be locked when the following conditions are met: 1) All data have been entered; 2) All 
queries have been resolved; 3) The analysis population has been defined and judged. 
9. Risk-Benefit Analysis 
9.1. Known Potential Risks 
Discomfort may be felt during the first PBM phototherapy irradiation. 
Common manifestations include dry eyes or halos around objects, etc. 
If the above risks occur, the investigator needs to inquire about and treat the subject, record truthfully, 
and consider withdrawing from the study if necessary. 
9.2. Known Potential Benefits 
The use of vision rehabilitation instrument combined with defocus lens therapy may effectively 
improve the quality of myopia prevention and control. There is no guarantee or commitment that 
subjects will obtain any health benefits from this clinical trial, but it will provide help for the 
treatment of myopic patients in the future. 
10. Quality Control of the Clinical Trial 
10.1. Investigator Training 
Investigators should be professional and qualified personnel and relatively stable. Before the start 
of the clinical trial, the trial institution or sponsor will conduct necessary training for the 
investigators. 
On the basis of routine medical practice, investigators should truthfully and detailedly record all 
contents required by the study protocol to ensure the authenticity and reliability of the content. 

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10.2. Measures to Improve Subject Compliance 
Investigators should earnestly implement the informed consent process, make subjects fully 
understand the significance, benefits, and risks of this trial, and encourage them to actively 
cooperate with treatment and observation in accordance with the requirements of the trial protocol. 
10.3. Monitoring of the Clinical Trial 
Monitors appointed by the sponsor will conduct regular on-site monitoring visits to the trial hospital 
to ensure that all contents of the study protocol are strictly followed, and check the CRF to ensure 
consistency with the content of the original medical records. 
Investigators/research centers should allow monitors direct access to original data/records. Original 
data/records are the data/records where original data are first recorded, which can be hospital/doctor 
records, diaries, laboratory test results, etc. All original data/records must be accurate, clear, durable, 
and subject to audit/inspection. 
Monitors will conduct 100% source data verification for all data except screening failure data. 
11. Ethical Issues and Informed Consent of the Clinical Trial 
11.1. Ethical Considerations 
The clinical trial must be conducted in accordance with the Declaration of Helsinki and relevant 
clinical trial research norms and regulations in China. Before the start of the trial, the trial protocol 
must be approved by the ethics committee of the leading clinical trial institution before the clinical 
trial can be carried out. 
Before each subject is enrolled in this study, the investigating physician is responsible for fully and 
comprehensively introducing the purpose, procedures, and possible risks of this study to the subject 
or their designated representative in writing. Subjects should be informed that they have the right to 
withdraw from this study at any time. Before enrollment, each subject must be provided with a 
written informed consent form. The investigating physician is responsible for ensuring that each 
subject obtains informed consent before entering the study. The informed consent form should be 
kept for future reference as part of the clinical trial documentation. 
11.2. Informed Consent Process 
This trial is conducted in accordance with the ethical principles set forth in the Declaration of 
Helsinki, Chinese GCP, and relevant laws and regulations. It will be implemented after obtaining 
the review and approval of the ethics committee of the medical institution undertaking this clinical 

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trial. 
Before the potential participants participate in the clinical trial, the investigator is responsible for 
fully and comprehensively introducing the purpose, procedures, and possible risks of this clinical 
trial to them or their designated representatives in the form of written notification and oral 
explanation, so that they can fully understand the purpose, nature, method, duration, possible 
benefits, and risks of this trial. After careful consideration, they can voluntarily choose to participate 
in this clinical trial and sign the Informed Consent Form before the trial. 
11.2.1. Basic Principles 
(1) Investigators are medical professionals who have received training on the informed consent form 
and the informed consent process and are authorized. They should carefully read and fully 
understand the informed consent form before the project starts; 
(2) The informed consent method can be various, such as one-on-one or other forms, and attention 
should be paid to choosing an appropriate discussion environment; 
(3) Investigators must fully understand the confidentiality regulations for subjects' privacy and fully 
respect the subjects; 
(4) Allow subjects to read and discuss, ensure sufficient time to read the informed consent form, and 
ask questions appropriately to help subjects/guardians understand the content, so as to control the 
time progress. 
11.2.2. Informed Consent Process 
(1) Provide the informed consent form and ask the subject/guardian to read it first; 
(2) Explain the significance of the informed consent form, and inform the subject/guardian of their 
right to ask questions and refuse to sign the informed consent form; 
(3) Introduce the research project and research institution, and explain the research purpose and 
research design; 
(4) Fully introduce the research procedures, including screening examinations, product introduction, 
adverse reaction observation, and sample collection operations, and inform the specific time 
arrangement of the research project; 
(5) Inform the subject of possible or expected risks and benefits in objective language; 
(6) Inform the subject of the protection and consultation provided by this research in objective 
language; 

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(7) Inform the subject of their rights, including the right to withdraw at any time, the right to full 
information, and the protection of withdrawn subjects; 
(8) Inform the subject of the criteria for terminating participation in the research; 
(9) Inform the subject of the confidentiality of their privacy; 
(10) Confirm that the subject/guardian fully understands the method and way to seek consultation 
or help; 
(11) Confirm that the subject/guardian has completely read the informed consent form and answer 
the questions raised by the subject. 
11.2.3. Signing of the Informed Consent Form 
(1) The subject/guardian should sign their full Chinese name and date on the informed consent form 
in regular script; 
(2) The investigator should sign their full Chinese name and date in the "Investigator's Signature" 
section. 
11.2.4. Notes 
(1) Before obtaining informed consent, the subject's/guardian's identity documents should be 
verified; if the subject is incompetent, the legal guardian should participate together. 
(2) When the subject/guardian signs, the handwriting should be clear and completely consistent with 
the name on the original medical records, ID card, and household registration book. Avoid using 
irregular simplified characters or wrong characters. Neither the signature nor the date can be written 
by the doctor on behalf of the subject/guardian. 
(3) Informed consent must be obtained before any research steps and any medical procedures. 
(4) After the completion of informed consent, attention should be paid to separating the original and 
duplicate copies of the informed consent form. The duplicate copy should be given to the 
subject/guardian, and the original copy should be stored at the clinical trial site. After the end of the 
daily work, it should be counted together with the screening form. 
(5) If required by the IRB/EC, when the latest version of the ICF is available during the study 
participation, the subject must re-sign. 
12. Adverse Events, Device Defects, and Risk Response Plans 
12.1. Definition and Reporting Requirements of Adverse Events 
An Adverse Event (AE) refers to any adverse medical event that occurs during the clinical trial of a 

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medical device, regardless of whether it is related to the test medical device. 
When an AE occurs during the clinical trial of a medical device, the investigator should provide 
sufficient and timely treatment and handling for the subject; when the subject develops a concurrent 
disease that requires treatment and handling, the investigator should inform the subject in a timely 
manner. Investigators should record all AEs that occur during the clinical trial of the medical device. 
12.2. Device Defects 
A device defect refers to an unreasonable risk that may endanger human health and safety when the 
medical device is used normally during the clinical trial, such as labeling errors, quality problems, 
malfunctions, etc. 
Investigators should record all device defects found during the clinical trial of the medical device. 
12.3. Definition of Serious Adverse Events (SAE) 
A Serious Adverse Event (SAE) refers to an event that occurs during the clinical trial of a medical 
device that results in death or a serious deterioration of health status, including fatal diseases or 
injuries, permanent defects in body structure or function, the need for hospitalization or extension 
of hospitalization time, the need for medical measures to avoid permanent defects in body structure 
or function, fetal distress, fetal death, or congenital abnormalities or defects, etc. 
12.4. Reporting Procedures and Contact Information 
(1) When an SAE occurs during the clinical trial of a medical device, the investigator should 
immediately take appropriate treatment measures for the subject; at the same time, the investigator 
should report to the sponsor, the management department of the medical device clinical trial 
institution, and the ethics committee within 24 hours of learning of the serious adverse event; and 
follow up the serious adverse event in accordance with the provisions of the clinical trial protocol 
and submit a follow-up report on the serious adverse event; 
(2) The sponsor should, within 7 days of learning of a death or life-threatening SAE related to the 
clinical trial medical device, and within 15 days of learning of a non-death or non-life-threatening 
SAE related to the clinical trial medical device and other serious safety risk information, report to 
other medical device clinical trial institutions participating in the clinical trial, the ethics committee, 
and the principal investigator, report to the drug regulatory authority of the province, autonomous 
region, or municipality directly under the Central Government where the sponsor is located, and 
report to the drug regulatory authority and health and health management department of the province, 

Version No. and Date: 2.0 2025/10/01 
 
autonomous region, or municipality directly under the Central Government where the medical 
device clinical trial institution is located, and take risk control measures; if information that may 
affect the safety of subjects, may affect the implementation of the medical device clinical trial, or 
may change the approval opinion of the ethics committee appears, the clinical trial protocol, 
informed consent form, and other information provided to subjects, as well as other relevant 
documents, should be revised in a timely manner and submitted to the ethics committee for review; 
(3) If a large number of SAEs related to the clinical trial medical device or other major safety issues 
occur, the sponsor should suspend or terminate the medical device clinical trial, and report to the 
management departments of all medical device clinical trial institutions, the ethics committee, and 
the principal investigator, report to the drug regulatory authority of the province, autonomous region, 
or municipality directly under the Central Government where the sponsor is located, and report to 
the drug regulatory authorities and health and health management departments of the provinces, 
autonomous regions, or municipalities directly under the Central Government where all medical 
device clinical trial institutions are located. 
12.5. Investigation and Documentation of Adverse Events 
(1) All researchers who learn of adverse events have the obligation and responsibility to record and 
report them correctly and promptly. 
(2) Regardless of whether the adverse event is causally related to the trial, the investigator should 
record it in the original records, sign it, and date it. 
(3) Documentation of adverse events and serious adverse events includes: 
1) 
Detailed description of the adverse event and serious adverse event; 
2) 
Occurrence time of the adverse event and serious adverse event, including occurrence time and 
termination time; it can be recorded in days or hours, and the start date should be indicated; 
3) 
Severity and frequency of the adverse event and serious adverse event; 
4) 
If the event requires drug treatment, record the route of administration, dosage, treatment time, 
and reason of the treatment drug, and record the treatment outcome; 
5) 
Analysis of the causal relationship between the adverse event and serious adverse event and 
the test product; 
6) 
Follow-up of the adverse event and serious adverse event; 
7) 
All clinical data related to the adverse event and serious adverse event, such as laboratory test 

Version No. and Date: 2.0 2025/10/01 
 
sheets, electrocardiograms, etc., should be recorded in the original documents. 
12.6. Severity Assessment of Adverse Events 
Mild: Does not affect daily activities, does not affect treatment, and no special treatment is 
required;Moderate: Affects daily activities, requires discontinuation of the study product or special 
treatment;Severe: Unable to perform normal daily activities, requires immediate discontinuation of 
the study product or emergency treatment. 
12.7. Adverse Event Correlation Judgment and Risk Management Plan 
The judgment of adverse events should be reflected in the adverse event report with explanations: 
(1) Unrelated: The adverse event is caused by other factors, such as the subject's clinical condition, 
other treatments, or concurrent medications. 
(2) Probably unrelated: The occurrence of the adverse event may be caused by other factors, such 
as the subject's clinical condition, other treatments, or concurrent medications, which is inconsistent 
with the known information of the test product. 
(3) Possibly related: The adverse event is consistent with the known information of the test medical 
device and has a causal relationship with the test medical device, but may also be related to other 
factors. 
(4) Probably related: The adverse event is consistent with the known information of the test medical 
device and has a causal relationship with the test medical device, which cannot be explained by 
other factors, such as the subject's clinical condition, other treatments, or concurrent medications. 
(5) Definitely related: The adverse event is consistent with the known information of the test medical 
device and has a causal relationship with the test medical device, and this relationship cannot be 
explained by other factors, such as the subject's clinical condition, other treatments, or concurrent 
medications. In addition, the adverse event recurs when the subject uses the test medical device 
again. 
Risk Management Plan: 
General Principles: 
1) 
Subject safety first: The handling of any AE should prioritize ensuring the safety and health of 
the subject. 
2) 
Timely assessment and intervention: Once an AE is found, the investigator should immediately 
conduct an assessment, judge the severity and possible cause, and take appropriate measures. 

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3) 
Individualized handling: Develop a handling plan according to the nature, severity of the AE, 
and the specific situation of the subject. 
4) 
Suspension or termination of irradiation: When a serious ocular AE occurs or the investigator 
judges that the AE may threaten vision (regardless of severity), the trial intervention must be 
suspended immediately. Whether to terminate it should be comprehensively evaluated by the 
principal investigator based on the nature, severity, reversibility of the event, and the causal 
relationship with irradiation. 
5) 
Documentation and communication: Detailedly record all handling measures and effects, and 
fully communicate with the subject/guardian. 
Specific Handling Measures (Examples): 
(1) Mild ocular discomfort (dryness, foreign body sensation, photophobia):Assessment: Examine 
the cornea and conjunctiva.Handling: Recommend the use of preservative-free artificial tears for 
lubrication; guide correct operation (e.g., keeping the eyelids open, aligning with the light spot); 
observe for relief.Irradiation decision: Irradiation can usually be continued with close observation. 
If it persists or worsens, consider suspending for 1-2 times for observation. 
(2) Conjunctival hyperemia:Assessment: Rule out infection or allergy.Handling: Cold compress; 
artificial tears; if no improvement or worsening, consider suspending irradiation and using anti-
inflammatory eye drops as appropriate (the necessity should be carefully evaluated).Irradiation 
decision: Mild cases can be observed; moderate to severe or persistent cases should have irradiation 
suspended. 
(3) Visual function complaints (blurred vision, dyschromatopsia, decreased contrast 
sensitivity):Assessment: Immediately conduct detailed ophthalmic examinations, including best-
corrected visual acuity, refraction, slit lamp, fundus examination (with mydriasis), OCT (especially 
the macular area), microperimetry, color vision examination (e.g., D-15 or FM100), contrast 
sensitivity examination, visual field (if necessary), compared with baseline.Handling: Immediately 
suspend irradiation. Identify the cause. Most reported cases are transient; close follow-up is required. 
If symptoms persist or abnormalities are found in examinations, a consultation with a retinal 
specialist should be requested for further assessment and treatment. Termination of trial intervention 
may be necessary.Irradiation decision: Irradiation must be suspended until symptoms completely 
disappear and examinations show no abnormalities, and the principal investigator and/or 

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independent Data and Safety Monitoring Board (DSMB) confirms safety before considering 
whether to resume (resumption is usually not recommended unless it is clearly unrelated and 
completely reversible). 
13. Provisions for Protocol Deviations and Amendments 
The clinical trial must follow the "Good Clinical Practice for Medical Devices" and comply with 
the trial protocol approved by the ethics committee; any intentional or unintentional deviation or 
violation of the "Good Clinical Practice for Medical Devices" and the trial protocol is called a 
protocol deviation or violation. 
According to the responsible subject, it can be divided into: protocol deviations caused by non-
compliance of investigators/research institutions, protocol deviations caused by non-compliance of 
subjects, and protocol deviations caused by non-compliance of the sponsor; according to the severity, 
it can be divided into: minor protocol deviations and major protocol deviations. 
Minor protocol deviations are generally reported to the ethics committee regularly, and the sponsor 
and/or investigator explain the cause, impact, and handling measures of the event. When a major 
protocol deviation occurs, it should be reported immediately. 
After each protocol deviation occurs, there should be handling or improvement measures to make 
up for the error or avoid the recurrence of similar protocol deviation behaviors. 
After this protocol is approved by the ethics committee, any revision must be accompanied by a 
"Protocol Revision Explanation", signed by the principal investigator, and re-approved by the ethics 
committee before implementation. 
After the protocol is revised, it must be recognized and signed by the sponsor. 
14. Direct Access to Source Data and Documents 
The clinical trial institution and investigators should allow monitoring, audit, ethics committee 
review, and regulatory authority inspection related to the trial to have direct access to source 
data/documents. 
15. Content to be Covered in the Clinical Trial Report 
The content of the clinical trial report should comply with the requirements of the "Good Clinical 
Practice for Medical Devices" (No. 28 of 2022). 
This report should be signed and dated by the principal investigator, reviewed and sealed by the 
medical device clinical trial institution, and then submitted to the sponsor. The multicenter clinical 

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trial report should be signed and dated by the coordinating investigator, reviewed and sealed by the 
medical device clinical trial institution of the leading unit, and then submitted to the sponsor. 
16. Confidentiality Principle 
This trial protocol is confidential information, provided to medical experts related to the trial, 
investigators participating in the trial, and other trial-related staff, as well as relevant business 
entrusting institutions such as the medical institution undertaking the trial, the ethics committee, and 
the contract research organization. Except for explaining to the subjects, no content of this trial 
protocol may be disclosed or leaked to a third party without the prior written consent of the sponsor. 
In addition, the partial or full results of this clinical trial must obtain the written consent of the 
sponsor before being published externally in academic societies, journals, etc. 
17. Responsibilities of All Parties 
The sponsor, investigators, leading research unit, and participating research units must earnestly 
assume corresponding responsibilities in accordance with the "Good Clinical Practice for Medical 
Devices" and the provisions of this protocol. 
18. Other Explanations 
None. 
19. References 
1. 
He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment 
in urban children in southern china. Invest Ophthalmol Vis Sci 2004;45:793-799. 
2. Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: 
results from Shunyi District, China. American journal of ophthalmology 2000;129:427-435. 
3. 
Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: 
results from La Florida, Chile. American journal of ophthalmology 2000;129:445-454. 
4. 
Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results 
from Mechi Zone, Nepal. American journal of ophthalmology 2000;129:436–444. 
5. 
Mutti DO, Hayes JR, Mitchell GL, et al. Refractive error, axial length, and relative peripheral 
refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci 2007;48:2510-2519. 
6. 
Zadnik K, Sinnott LT, Cotter SA, et al. Prediction of Juvenile-Onset Myopia. JAMA 
Ophthalmol 2015;133:683-689. 
7. 
Zhang M, Gazzard G, Fu Z, et al. Validating the accuracy of a model to predict the onset of 

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myopia in children. Invest Ophthalmol Vis Sci 2011;52:5836-5841. 
8. 
Jones-Jordan LA, Sinnott LT, Manny RE, et al. Early childhood refractive error and parental 
history of myopia as predictors of myopia. Invest Ophthalmol Vis Sci 2010;51:115-121. 
9. 
Tedja MS, Wojciechowski R, Hysi PG, et al. Genome-wide association meta-analysis 
highlights light-induced signaling as a driver for refractive error. Nat Genet 2018;50:834-848. 
10.  American Academy of Ophthalmology. Pathologic myopia with tilted disc and 
peripapillaryatrophyofRPEandchoroid. https://www.aao.org/image/pathologic-myopia-with-tilted-
disc-peripapillary-a-2 Accessed May 19, 2020. 
11. Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Chen Y, Xiong R, Bulloch G, Zeng J, Morgan IG, 
He M.   
Clinically Significant Axial Shortening in Myopic Children After Repeated Low-Level Red Light 
Therapy: A Retrospective Multicenter Analysis. Ophthalmol Ther. 2023 Jan 7. doi: 10.1007/s40123-
022-00644-2.  
12. Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, et al. LIGHTSITE III:13-month 
efficacy and safety evaluation of multiwavelength photobiomodulation innonexudative (Dry) age-
related macular degeneration using the lumiThera valeda lightdelivery system. Retina. (2023) 
44(3):487–97. doi: 10.1097/IAE.0000000000003980. 
13. Ivandic BT, Ivandic T. Low-level laser therapy improves visual acuity inadolescent and adult 
patients with amblyopia. Photomed Laser Surg. (2012) 30:167–71. doi: 10.1089/pho.2011.3089. 
14.Kaymak H, Munk MR, Tedford SE, Croissant CL, Tedford CE, Ruckert R, et al.Non-invasive 
treatment of early diabetic macular edema by multiwavelengthphotobiomodulation with the valeda 
light delivery system. Clin Ophthalmol. (2023)17:3549–59. doi: 10.2147/OPTH.S415883 
15. Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation 
therapy. Photomed Laser Surg. 2015;33(4):183-184. doi:10.1089/pho.2015.9848 
16. Linnik LA, Usov NI, Chechin PP, Pelepchuk OS. Perspektivy ispol'zovaniia stimuliruiushcheĭ 
lazernoĭ terapii v oftal'mologii [Prospects for using stimulating laser therapy in ophthalmology]. 
Oftalmol Zh. 1982;37(4):193-7. Russian. PMID: 7145299. 
17. Linnik LA. Lazernaia terapiia v oftal'mologii [Laser therapy in ophthalmology]. Oftalmol Zh. 
1985;(8):451-5. Russian. PMID: 4088581. 
18. Posten W, Wrone DA, Dover JS, Arndt KA, Silapunt S, Alam M. Low-level laser therapy for 

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wound healing: mechanism and efficacy. Dermatol Surg 2005;31:334-340. 
19. Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-
level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-
0454-7. Epub 2011 Nov 2. PMID: 22045511; PMCID: PMC3288797. 
 

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Investigator's Statement 
I agree to: 
1. 
Conduct this clinical trial strictly in accordance with the Declaration of Helsinki, applicable 
Chinese laws and regulations, and the requirements of the trial protocol. 
2. 
Accurately record all required data in the Case Report Forms (CRF) and cooperate in 
completing the clinical trial report. 
3. 
Use the test medical device solely for this clinical trial, and completely and accurately record 
the receipt and usage of the test medical device during the clinical trial while retaining the 
records. 
4. 
Allow monitors, auditors authorized or dispatched by the sponsor, and regulatory authorities 
to conduct monitoring, auditing, and inspection of this clinical trial. 
5. 
Strictly fulfill the terms of the clinical trial contract/agreement signed by all parties. 
I have fully read the clinical trial protocol, including the above statements, and I agree to all the 
contents herein. 
Principal Investigator 
 
                      Signature 
                  Date  
 
Medical Device Clinical Trial Institution 
 
                           Seal and Signature 
                Date 
 
 

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Annex 1: Flow Chart of the Clinical Trial 
Assessment Items 
Screening 
/Enrollment 
Follow-up 
1: 
30 Days ±7 
Days* 
Follow-up 2: 3 
Months 
±7 
Days* 
Follow-up 3: 6 
Months 
±14 
Days* 
Follow-up 4: 9 
Months 
±14 
Days* 
Follow-up 
5: 
12 Months-28 
Days*/Withdra
wal Visit 
Sign 
Informed 
Consent Form (ICF) 
√ 
- 
- 
- 
- 
- 
Demographic Data 
√ 
- 
- 
- 
- 
- 
Past 
Medical 
History/Concurrent 
Diseases 
√ 
- 
- 
- 
- 
- 
Myopia 
Control 
Treatment History 
√ 
- 
- 
- 
- 
- 
Concurrent 
Medications 
√ 
√ 
√ 
√ 
√ 
√ 
Visual Acuity 
√ 
√ 
√ 
√ 
√ 
√ 
Refractive Error 
√ 
√ 
√ 
√ 
√ 
√ 
Slit 
Lamp 
Examination 
√ 
√ 
√ 
√ 
√ 
√ 
Eye 
Position 
Examination 
√ 
√ 
√ 
√ 
√ 
√ 
Intraocular Pressure 
(IOP) 
√ 
√ 
√ 
√ 
√ 
√ 
Fundus 
Color 
Photography 
√ 
√ 
√ 
√ 
√ 
√ 
Axial Length 
√ 
√ 
√ 
√ 
√ 
√ 
OCT 
(Optical 
Coherence 
Tomography) 
√ 
√ 
√ 
√ 
√ 
√ 

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AE/SAE/Device 
Defects 
- 
√ 
√ 
√ 
√ 
√ 
Withdrawal 
Time/Reason 
- 
√ 
√ 
√ 
√ 
√ 
Trial Summary 
- 
- 
- 
- 
- 
√ 
*A follow-up visit beyond this range is considered a window violation. 
Notes: 
1. 
Follow-up includes pre-trial screening and regular follow-up after enrollment. Before 
enrollment, the signing of the Informed Consent Form and pre-trial screening should be 
completed, baseline assessment of ocular symptoms and signs should be conducted, and then 
lenses should be customized. 
2. 
Fundus Color Photography: Fundus examination requires photography. 
3. 
If a subject withdraws midway, a withdrawal visit will be conducted, and the content of the 
withdrawal visit is the same as that of the final observation visit. 
 

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Annex 2: List of Research Centers 
Clinical Trial 
Institution 
Code 
Name of Clinical Trial Institution 
Investigator 
Professional Title 
01 
Shanghai General Hospital 
Wang Xiaojuan 
Chief Physician 
02 
Tongji Hospital Affiliated to Tongji Medical College of 
Huazhong University of Science and Technology 
 
 
03 
The First Affiliated Hospital of Chongqing Medical 
University 
 
 
 
04 
The First Affiliated Hospital of Guangxi Medical University 
 
 
05 
The Fourth People's Hospital of Shenyang City 
 
 
06 
The First Affiliated Hospital of Xi'an Jiaotong University 
 
 
07 
The Second People's Hospital of Foshan City 
 
 
08 
The First Affiliated Hospital of Zhengzhou University