A Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy of Dynamic Spatiotemporal Optical Film (S.T.O.P®KIT) in Retarding Axial Length Growth in Children With Low Hyperopia
Phase: NA
Conditions: Children, Hyperopia
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
A Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy of
Dynamic Spatiotemporal Optical Film (S.T.O.P®KIT) in Retarding Axial Length
Growth in Children with Low Hyperopia
Clinical Study Protocol
Protocol Version No. and Date: 1.1/2025.12.29
Clinical Trial Institution:
Shanghai General Hospital / Wang Xiaojuan
Leading Clinical Trial Institution / Coordinating Investigator:
Shanghai General Hospital / Wang Xiaojuan

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Clinical Research Protocol Initiated by
Investigators of Shanghai General Hospital
(Interventional Study)
Study Title
A Multicenter, Randomized Controlled
Clinical Study Evaluating the Efficacy of
Dynamic Spatiotemporal Optical Film
(S.T.O.P®KIT) in Retarding Axial Length
Growth in Children with Low Hyperopia
Protocol Version No.
V1.1
Version Date
December 29, 2025
Responsible Department
Department of Ophthalmology
Research Institution
Shanghai General Hospital
Participating Institutions
Research Center 1: Shanghai General Hospital;
Research Center 2: The First Affiliated Hospital
of Zhengzhou University;
Research Center 3: Yantai Yuhuangding
Hospital

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Signature Page of the Principal Investigator's Protocol
I agree to perform the relevant duties in accordance with Chinese laws, the Declaration of
Helsinki, Chinese GCP, and this research protocol, and to personally participate in or directly
supervise this clinical study.
I will provide this protocol to all researchers under my responsibility who participate in this
study and discuss the protocol and relevant materials with them to ensure they fully understand the
research treatment/product and how to conduct this study.
During the implementation of the study, I will strictly adhere to the requirements of this
protocol. If modifications to the protocol are necessary, they may only be implemented after
notifying and obtaining re-approval or filing consent from the Ethics Committee, unless measures
must be taken to protect the safety, rights, and interests of research participants. I will be
responsible for making clinically relevant medical decisions, ensuring that research participants
receive timely and appropriate treatment in the event of adverse events during the study, and
recording and reporting these adverse events in accordance with relevant national regulations.
I guarantee that data will be recorded truthfully, accurately, completely, and in a timely
manner, and commit to keeping the personal information and relevant matters of research
participants confidential.
Principal Investigator (printed name):
Signature: _______________
Institution: Shanghai General HospitalSignature
Date: September 2, 2025

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Contents
1.
Protocol Version History..........................................................................................................7
2.
Protocol Summary....................................................................................................................8
3.
Technical Roadmap................................................................................................................ 13
4.
Research Flow Chart..............................................................................................................14
5. Research Background................................................................................................................ 15
5.1. Current Status of Domestic and Foreign Research...........................................................15
5.2. International Research Trends...........................................................................................16
5.3. Research Value and Significance...................................................................................... 17
5.3.1 Scientific Innovation Value..................................................................................... 17
6. Research Objectives................................................................................................................... 18
6.1. Primary Research Objective..............................................................................................18
6.2. Secondary Research Objectives........................................................................................ 18
7. Study Design................................................................................................................................18
7.1 Study Flow Chart................................................................................................................18
7.2. Study Implementation (Methods, Content, Procedures, etc.)...........................................20
7.2.1 Signing of Written Informed Consent Form........................................................... 20
7.2.2 Follow-up Period.....................................................................................................20
7.2.3 Unscheduled Visits..................................................................................................21
8. Pre-assessment of Project Risks and Benefits..............................................................................21
8.1 Risks of Participating in This Study...................................................................................21
8.2 Benefits of Participating in the Study................................................................................ 21
9. Study Population.........................................................................................................................21
9.1. Inclusion Criteria...............................................................................................................21
9.2. Exclusion Criteria..............................................................................................................22
10. Intervention Protocol and Concomitant Treatment............................................................. 22
10.1. Study Intervention................................................................................................................... 22
10.2. Concomitant Treatment...................................................................................................23
11. Randomization, Blinding, and Allocation Concealment Methods.......................................23

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
11.1. Randomization Method: Simple Randomization............................................................23
11.1.1 Definition...............................................................................................................23
11.1.2 Purpose.................................................................................................................. 23
11.1.3 Detailed Operational Description..........................................................................23
12. Study Endpoints........................................................................................................................24
12.1. Primary Study Endpoint..................................................................................................24
12.2. Secondary Study Endpoints............................................................................................ 24
13.1. Study Subjects and Grouping..........................................................................................24
13.2. Intervention Measures for the Experimental Group....................................................... 24
13.2.1 Eyeglass Fitting and Optical Film Application.....................................................24
13.2.2 Follow-up Arrangements and Eyeglass Replacement.......................................... 24
13.3. Monitoring Indicators and Examination Items............................................................... 25
13.4. Control Group Handling Measures................................................................................. 25
14. Termination of Study Intervention and Withdrawal/Termination of Study Subjects...... 25
14.1. Termination of Study Intervention.................................................................................. 25
14.1.1 Voluntary Withdrawal by Subjects........................................................................26
14.1.2 Termination Determined by Investigators.............................................................26
14.2. Withdrawal/Termination of Study Participants...............................................................26
14.3. Voluntary Withdrawal of Study Participants from the Study..........................................26
14.4. Loss to Follow-up............................................................................................................27
14.5. Follow-up Handling After Withdrawal of Study Participants........................................ 27
15. Adverse Events..........................................................................................................................27
15.1. Classification and Severity of Adverse Events............................................................... 27
15.1.1 Early Adaptive Reactions (Mild/Self-limiting).....................................................27
15.2. Ocular Tissue Reactions (Requiring Close Monitoring).................................................28
15.2.1 Corneal Surface Abnormalities............................................................................. 28
15.2.2 Conjunctival Hyperemia and Papillary Hypertrophy........................................... 29
15.2.3 Decreased Tear Film Stability...............................................................................29
15.3. Functional Visual Impairments (Moderate to Severe)....................................................29
15.4. Follow-up and Recording of Adverse Events................................................................. 30

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
15.5. Reporting of Adverse Events...........................................................................................30
15.6. Reporting of Serious Adverse Events (SAEs).................................................................30
16. Statistical Analysis....................................................................................................................30
16.1. Basis for Sample Size Determination............................................................................. 30
16.2. Analysis Sets....................................................................................................................31
16.3. Statistical Analysis Methods........................................................................................... 32
17. Data Management.................................................................................................................... 32
18. Quality Control.........................................................................................................................34
18.1. Protocol Design Quality Control.....................................................................................34
18.2. Qualification Quality Control of Participating Personnel...............................................34
18.3. Management and Preservation of Test Data....................................................................35
18.4. Statistical Analysis Quality Control................................................................................35
18.5. Whole-Process Quality Control.......................................................................................35
19. Ethical Protection and Informed Consent in Clinical Research......................................... 36

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1. Protocol Version History
Version No.
Modification Date
Chapters and
Modification Content
Reason for
Modification

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IT-CRU-FAMB-001 (V1.1,December 29, 2025)
2. Protocol Summary
Study Title
A Multicenter, Randomized Controlled Clinical Study Evaluating the
Efficacy of Dynamic Spatiotemporal Optical Film (S.T.O.P®KIT) in
Retarding Axial Length Growth in Children with Low Hyperopia
Protocol
Version No.
V1.0
Version Date
September 2, 2025
Research
Objectives and
Endpoints
Research Objectives
Research Endpoints
Primary Research Objective:
Primary Study Endpoint:
To evaluate whether the
experimental group achieves
efficacy in preventing myopia
progression rate (measured by
axial length) compared with the
control group.
Difference in the change in
axial length from baseline to 12
months after eyeglass fitting
between the experimental
group and the control group.
Secondary Research
Objectives:
Secondary Study Endpoint:
To compare the difference in
the change in spherical
equivalent power measured by
autorefractometer under
cycloplegia between the
experimental group and the
control group.
Difference in the change in
spherical equivalent power
measured by autorefractometer
under cycloplegia from
baseline to 12 months after
eyeglass fitting between the
experimental group and the
control group.
Study Design
This study is designed as a multicenter, parallel-group, open-label,
randomized controlled, superiority trial. The randomization method is
simple randomization, with grouping performed using a
computer-generated random number generator.

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Study
Population
Children aged 6-10 years with low hyperopia
Inclusion
Criteria
1. Eligible study participants must meet all the following criteria: 1. Age:
6-10 years old;
2. +0.75D ≤Spherical equivalent power ≤+3.00D;
3. Anisometropia ≤1.50D;
4. Astigmatism ≤1.50D;
5. No participation in other myopia prevention and control studies or use of
other myopia prevention and control methods (including low-concentration
atropine eye drops, defocus eyeglasses, orthokeratology lenses, multifocal
soft contact lenses, etc.) within 3 months;
6. Best-corrected visual acuity (BCVA) in both eyes ≥0.8 using a standard
logarithmic visual acuity chart;
7. Ability to wear frame glasses during near work for at least 6 hours per
day;
8. Study participants or their legal representatives sign the informed
consent form.
Exclusion
Criteria
Study participants meeting any of the following criteria are ineligible for
inclusion: 1. Patients with strabismus;
2. Patients with abnormal stereopsis;
3. Comorbidity with other ophthalmic diseases, including developmental
abnormalities affecting visual function and refractive status;
4. Previous ocular surgery history;
5. Previous receipt of other myopia control treatments (including
orthokeratology lenses, multifocal design soft contact lenses or frame
glasses, drug therapy [atropine], visual training, etc.);
6. Current use of medications that may affect pupil size and ocular surface
function;
7. Comorbidity with other systemic diseases that may affect visual function

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IT-CRU-FAMB-001 (V1.1,December 29, 2025)
or refractive status;
8. Family history of hereditary ophthalmic diseases;
9. Other conditions deemed unsuitable for participation by investigators.
Sample Size
Experimental group: 90 cases;
Control group: 90 cases;
Total sample size: 180 cases
Study Grouping
and
Intervention
Methods
Experimental group:
1. First, two pairs of eyeglasses need to be fitted, with S.T.O.P optical films
of different phases attached regularly;
2. Follow-up visits are conducted every 3 months, and eyeglasses are
replaced at 6 months (with changes in S.T.O.P optical film design and
phase);
3. All lenses are plano-spherical and plano-cylindrical lenses (0D sphere,
0D cylinder);
4. Monitoring of axial length, visual acuity, and corresponding ophthalmic
examinations are performed.
Control group:
1. No active intervention measures are implemented;
2. Re-examinations are conducted every 3 months.
Study Plan
1. Change in axial length from baseline to each follow-up visit for
each of the experimental and control groups;
2. Difference in the change in spherical equivalent power
measured by autorefractometer under cycloplegia from baseline
to each follow-up visit between the experimental group and the
control group;
3. Difference in visual function between the experimental group
and the control group.
Procedures/Data
Baseline
3
Months
6
Months
9
Months
12
Months

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IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Ocular
history/Medical
history/Family
history/Living
environment
-
-
-
-
Compliance
assessment
√
√
√
√
Eyeglass fitting
√
-
√
-
-
Visual acuity
√
√
√
√
√
Slit-lamp
examination
(uncorrected):
Ocular
assessment
√
√
√
√
√
Intraocular
pressure (IOP)
√
√
√
√
√
Axial length
measurement
√
√
√
√
√
Cycloplegia
√
-
-
-
√
Autorefraction
(objective
refraction)
√
√
√
√
√
Subjective
refraction
-
†
†
†
†
Cover test at 3m
and 40cm
√
√
√
√
√
Adverse event
assessment
√
√
√
√
√
Ocular
-
-
-
-

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
history/Medical
history/Family
history/Living
environment
Compliance
assessment
√
√
√
√
Eyeglass fitting
√
-
√
-
-
Statistical
Analysis
Method
Analysis of Covariance (ANCOVA)
Estimated
Study Period
February 1, 2026 (initiation) -August 1, 2027 (completion)
Notes
1. Indicators such as children's growth and development and refractive
status fluctuate naturally over time. A single measurement may be
accidental. Four follow-up visits can provide a "dynamic baseline" to help
researchers more accurately distinguish between normal fluctuations and
true intervention effects. 2. Regular ophthalmic health follow-up and
examinations actually provide these children with additional systematic
health monitoring opportunities. 3. The process is simplified, with special
personnel guiding the examinations, which will not impose an additional
burden on parents and children.

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3. Technical Roadmap

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
4. Research Flow Chart
Procedures/Data
Baseline
3 Months
6 Months
9 Months
12 Months
Ocular history/Medical
history/Family
history/Living
environment
-
-
-
-
Compliance assessment
√
√
√
√
Eyeglass fitting
√
-
√
-
-
Visual acuity
√
√
√
√
√
Slit-lamp examination
(uncorrected): Ocular
assessment
√
√
√
√
√
Intraocular pressure
(IOP)
√
√
√
√
√
Axial length
measurement
√
√
√
√
√
Cycloplegia
√
-
-
-
√
Autorefraction
(objective refraction)
√
√
√
√
√
Subjective refraction
-
†
†
†
†
Cover test at 3m and
40cm
√
√
√
√
√
Adverse event
assessment
√
√
√
√
√
Ocular history/Medical
history/Family
history/Living
environment
-
-
-
-
Compliance assessment
√
√
√
√

Shanghai General Hospital Clinical Research Center
IT-CRU-FAMB-001 (V1.1,December 29, 2025)
Eyeglass fitting
√
-
√
-
-
5. Research Background
5.1. Current Status of Domestic and Foreign Research
As the focus of myopia management shifts from simply controlling myopia progression to
comprehensive management of long-term risks, delaying the age of myopia onset has gradually
become an important part of clinical practice in myopia prevention and control. Timely
identification of early signs of myopia and implementation of intervention measures are
particularly crucial, especially for children at risk of early onset and rapid progression once
myopia develops. This conceptual innovation has spawned a series of cutting-edge studies and
technological breakthroughs worldwide, advancing myopia management into an era of
"prevention before control."
As a country with a high incidence of myopia, China has made breakthrough progress in the field
of pre-myopia intervention. The 2025 "Myopia Management White Paper" for the first time
established "pre-myopia" (-0.50D < SE ≤+0.75D) as a key intervention window, proposing that
intervention measures should be initiated immediately when a child's annual myopia progression ≥
0.75D or annual axial length growth ≥0.20mm. This standard is based on data from national
multicenter studies, among which a real-world study conducted by Rao Jing's team confirmed that
the use of multifocal defocus lenses (such as DIMS and HLA) in approximately 20 million
6-12-year-old children in the myopia critical state can significantly delay refractive progression
and axial length growth, providing high-level evidence-based support for pre-myopia intervention.
The rate of myopia progression is fastest around puberty. Wearing defocus glasses at the initial
stage of myopia (usually within 100 degrees or just after diagnosis) is equivalent to setting an
effective "speed bump" on the "highway" of myopia progression. Early intervention can maximize
the inhibition of abnormal elongation of the axial length during the period of rapid growth, gaining
valuable time for the entire myopia prevention and control journey.
Numerous clinical studies have confirmed that compared with wearing ordinary single-vision
glasses, wearing defocus glasses can delay the annual increase in myopia degree by an average of
50%-60%. This means that a child who originally may have an annual increase of 100 degrees can
have the annual increase controlled at 40-50 degrees after persistently wearing defocus glasses.
The significance of this delaying effect is extremely important, as it can significantly reduce the

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child's future risk of developing high myopia (exceeding 600 degrees), thereby reducing the
probability of fundus lesions caused by high myopia (such as retinal detachment, macular
degeneration, glaucoma, etc.).
5.2. International Research Trends
Global myopia prevention and control strategies show a trend of diversified development, and the
combined application of optical intervention and drug therapy has become a frontier research
direction. The research on the mechanism of action of optical defocus technology has been further
deepened, and the peripheral retinal hyperopic defocus theory has been verified through primate
models, confirming that it can inhibit abnormal axial length growth by regulating the activity of
scleral fibroblasts. This discovery provides a solid theoretical basis for the design of defocus
lenses.
Evidence-based Basis for Peripheral Defocus in Myopia Prevention and Control:Traditional
theory holds that the occurrence and development of myopia are closely related to hyperopic
defocus in the peripheral retina.
Emmetropia or hyperopia: Peripheral retinal imaging is in front of the retina, forming myopic
defocus, which helps inhibit excessive axial length growth.
Myopia: Peripheral retinal imaging is behind the retina, forming hyperopic defocus, which
stimulates axial length elongation and accelerates myopia progression.
Therefore, through specially designed optical products (such as special frame glasses or contact
lenses), artificially creating myopic defocus signals in the peripheral retina can theoretically delay
axial length growth, thereby controlling myopia.
Experimental Verification: In 2005 and subsequent animal experiments (such as rhesus monkeys,
marmosets, etc.), Dr. Earl Smith's team actively manipulated peripheral retinal imaging through
optical methods. They found that if the peripheral image focus can be moved from behind the
retina to on or in front of the retina (i.e., eliminating or converting to myopic defocus), the axial
length growth of experimental animals can be significantly reduced.
Neurophysiological Basis: Studies have also pointed out that the peripheral retina may play a
dominant role in regulating eyeball growth, which may be related to factors such as the
distribution of its ganglion cells.
The U.S. FDA has accelerated the approval of a number of myopia prevention and control devices

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in recent years. Among them, aspheric microlens plano defocus glasses (such as MiYOSMART),
as a special optical intervention product for pre-myopia, have obtained EU CE certification. Japan
is promoting the research and development of personalized defocus soft contact lens systems,
whose patented design achieves precise matching for patients with different pupil sizes by
dynamically adjusting the proportion of defocus area (30%-50%) and defocus power
(+1.50D-+4.00D). It is worth noting that the synergistic effect of combined therapy has become a
research hotspot. A Singaporean clinical trial showed that the combined use of 0.01% atropine and
orthokeratology lenses can reduce the risk of myopia progression by an additional 43% compared
with single intervention, providing new ideas for the prevention and control of refractory myopia
in China.
Table: Comparison of Characteristics of Main Intervention Methods for Pre-myopia
Intervention
Type
Representative
Products/Protocols
Applicable Stage
Core Advantages
Clinical Efficacy
Optical
Intervention
Multifocal defocus
frame glasses
(DIMS/HLA)
Pre-myopia to
low myopia
Non-invasive,
worn during the
day
Delays myopia
progression by
45-60%
Optical
Intervention
Aspheric
microlens plano
glasses
Period of rapid
consumption of
hyperopic
reserve
No need for
correction of
refractive errors
Reduces myopia
incidence by
33%
Drug
Intervention
0.04% atropine eye
drops
Rapid
progression
stage
(>0.75D/year)
Minimal
systemic
absorption,
convenient to
use
Superior to
0.01% atropine
and
orthokeratology
lenses
5.3. Research Value and Significance
5.3.1 Scientific Innovation Value
This project focuses on the optimization of pre-myopia intervention strategies and has significant
scientific innovation and clinical transformation value. The study targets the blind spot of

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traditional myopia management—the period of rapid consumption of hyperopic reserve (i.e.,
clinical pre-myopia stage), exploring the control effect of dynamic optical signals in optical
intervention methods on preventing children with low hyperopia from rapidly developing into
myopia. This research direction fills a key evidence gap: most current studies focus on
intervention after myopia has occurred, while research on the prevention and control mechanisms
in children with low hyperopia is insufficient, especially the synergistic mechanism of different
intervention measures in delaying myopia onset has not been clarified.
6. Research Objectives
6.1. Primary Research Objective
To evaluate whether the experimental group achieves efficacy in preventing myopia progression
rate (measured by axial length) compared with the control group.
6.2. Secondary Research Objectives
To compare the difference in the change in spherical equivalent power measured by
autorefractometer under cycloplegia between the experimental group and the control group.
7. Study Design
This study is designed as a multicenter, parallel-group, open-label, randomized controlled,
superiority trial. The randomization method is simple randomization, with grouping performed
using a computer-generated random number generator.
7.1 Study Flow Chart

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(1) Subjects shall be patients who meet the inclusion and exclusion criteria of the protocol;
(2) Inform subjects of the clinical trial content, and have them understand and sign the Informed
Consent Form;
(3) Conduct ocular examinations and screen for eligibility, and randomly assign eligible subjects
to corresponding groups with random numbers;
(4) Issue experimental/control products;
(5) Investigators conduct follow-up examinations according to the follow-up schedule, record

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follow-up data, and monitor adverse events throughout the trial;
(6) Collate and analyze trial data, and form a clinical trial report.
7.2. Study Implementation (Methods, Content, Procedures, etc.)
After subjects meet the inclusion and exclusion criteria, they shall be followed up in accordance
with the clinical trial protocol. During the clinical period, adverse events shall be closely observed
and recorded.
The following relevant examinations and operations shall be performed throughout the study:The
trial steps are divided into: screening and enrollment, 3 months ± 7 days, 6 months ± 14 days, 9
months ± 14 days, 12 months - 28 days.
7.2.1 Signing of Written Informed Consent Form

Collect subject information:

Concurrent diseases, past medical history, myopia prevention and control intervention history,
surgical history, trauma history, etc.;

Concomitant medications, and determine whether there is concurrent ophthalmic drug
therapy, especially atropine of different concentrations;

Conduct ocular examinations:
a. Axial length;
b. Refractive error;
c. Visual acuity, intraocular pressure, fundus color photography, OCT, eye position examination,
and slit-lamp examination;
d. Cycloplegia shall be performed only at the baseline visit and at the end of the 12-month trial;

Verify inclusion/exclusion criteria, and randomly assign eligible subjects to corresponding
groups;

Customize and issue products to the experimental group and the control group.
7.2.2 Follow-up Period
Follow-up visits shall be conducted 30 days, 3 months, 6 months, 9 months, and 12 months after
intervention to complete the following assessments:

Inquire whether any adverse events have occurred since the last follow-up;

Inquire whether there have been any changes in concomitant medications or treatments since
the last follow-up;

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IT-CRU-FAMB-001 (V1.1,December 29, 2025)

Conduct ocular examinations:
a. Axial length;
b. Refractive error;
c. Visual acuity, compliance assessment, refraction, and slit-lamp examination;
d. Recording of experimental device defects and protocol deviations;
e. Schedule the next follow-up visit with the subject.
7.2.3 Unscheduled Visits
Between two follow-up visits, if the subject experiences any discomfort or special conditions
(such as any obvious discomfort, damage or loss of study products, etc.) and needs guidance or
support from investigators, the subject may return to the research center for an unscheduled
follow-up visit. During the unscheduled visit, the reason for the unscheduled visit and the
measures taken by the investigator (including examinations or treatments provided, supplementary
replacement and issuance of study products, etc.) shall be recorded.
8. Pre-assessment of Project Risks and Benefits
8.1 Risks of Participating in This Study
A very small number of children may experience symptoms such as dizziness, glare, and blurred
vision in the initial stage of wearing the glasses. Most children can adapt spontaneously within one
week after wearing. If adaptation is really difficult, please inform your research doctor in a timely
manner; there are no other known risks at present.
8.2 Benefits of Participating in the Study
Direct benefits: If you agree to participate in this study, you may be able to delay the axial length
growth of children through the S.T.O.P®KIT optical film, but we cannot make any promises in
this regard.Potential benefits: We hope that the information obtained from your participation in
this study can benefit you or other patients with the same condition in the future.In the control
group of this trial, subjects who can adhere to completing all follow-up visits as required will
receive a pair of dynamic optical films and customized glasses matching their diopter for free at
the end of the trial.
9. Study Population
9.1. Inclusion Criteria
1)
Patients must meet all the following inclusion criteria to be eligible for the study:

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2)
Age: 6-10 years old;
3)
+0.75D ≤Spherical equivalent power ≤+3.00D;
4)
Anisometropia ≤1.50D;
5)
Astigmatism ≤1.50D;
6)
No participation in other myopia prevention and control studies or use of other myopia
prevention and control methods (including low-concentration atropine eye drops, defocus
eyeglasses, orthokeratology lenses, multifocal soft contact lenses, etc.) within 3 months;
7)
Best-corrected visual acuity (BCVA) in both eyes ≥0.8 using a standard logarithmic visual
acuity chart;
8)
Ability to wear frame glasses during near work for at least 6 hours per day;
9)
Study participants or their legal representatives sign the informed consent form.
9.2. Exclusion Criteria
1)
Patients meeting any of the following criteria will not be included in the study:
2)
Patients with strabismus;
3)
Patients with abnormal stereopsis;
4)
Comorbidity with other ophthalmic diseases, including developmental abnormalities
affecting visual function and refractive status;
5)
Previous ocular surgery history;
6)
Previous receipt of other myopia control treatments (including orthokeratology lenses,
multifocal design soft contact lenses or frame glasses, drug therapy [atropine], visual training,
etc.);
7)
Current use of medications that may affect pupil size and ocular surface function;
8)
Comorbidity with other systemic diseases that may affect visual function or refractive status;
9)
Family history of hereditary ophthalmic diseases;
10) Other conditions deemed unsuitable for participation by investigators.
10. Intervention Protocol and Concomitant Treatment
10.1. Study Intervention
Intervention methods:
1)
First, two pairs of eyeglasses need to be fitted, with S.T.O.P optical films of different phases

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attached regularly;
2)
Follow-up visits are conducted every 3 months, and eyeglasses are replaced at 6 months
(with changes in S.T.O.P optical film design and phase);
3)
Monitoring of axial length, visual acuity, and corresponding ophthalmic examinations are
performed;
4)
All lenses are plano-spherical and plano-cylindrical lenses (0D sphere, 0D cylinder).
10.2. Concomitant Treatment
There is no concomitant treatment plan.
11. Randomization, Blinding, and Allocation Concealment Methods
11.1. Randomization Method: Simple Randomization
11.1.1 Definition
Simple randomization is the most basic and direct method of random assignment. It ensures that
each subject who meets the inclusion criteria has an equal and independent chance of being
assigned to any group in the trial (e.g., experimental group or control group).
11.1.2 Purpose
Balancing confounding factors: Theoretically, with a sufficiently large sample size, baseline
characteristics (such as age, gender, disease severity) that are known or unknown and may be
related to the outcome tend to be evenly distributed among the groups, making the groups
comparable.Avoiding selection bias: Preventing investigators or subjects from choosing to enter a
specific group based on their own wishes or judgments, thereby affecting the authenticity of the
results.Meeting statistical assumptions: Providing a basis for subsequent statistical analyses (such
as t-test, chi-square test).
11.1.3 Detailed Operational Description
Determine the allocation ratio: First, determine the expected allocation ratio of each group as 1:1,
i.e., the number of subjects in the experimental group and the control group is equal;Generate a
random sequence: Use a computer-generated random number sequence (using a true random

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number generator or a validated pseudo-random algorithm).
12. Study Endpoints
12.1. Primary Study Endpoint
Difference in the change in axial length from baseline to 12 months after eyeglass fitting between
the experimental group and the control group.
12.2. Secondary Study Endpoints
Difference in the change in spherical equivalent power measured by autorefractometer under
cycloplegia from baseline to 12 months after eyeglass fitting between the experimental group and
the control group.
13. Study Process
13.1. Study Subjects and Grouping
A total of 180 subjects will be included in this study, and evenly divided into the experimental
group and the control group according to the randomization principle, with 90 cases in each group.
Before enrollment, all subjects will undergo comprehensive ophthalmic examinations, including
but not limited to visual acuity test, intraocular pressure measurement, slit-lamp examination,
fundus examination, etc., to exclude severe ocular diseases or other factors that may affect the
study results. After screening, eligible subjects will be formally included in the study.
13.2. Intervention Measures for the Experimental Group
13.2.1 Eyeglass Fitting and Optical Film Application
Based on the individual ocular parameters of each subject, two pairs of special eyeglasses will be
customized for them. These eyeglasses all use plano-spherical and plano-cylindrical lenses (0D
sphere, 0D cylinder) to ensure the unity of the basic refractive status. On this basis, S.T.O.P optical
films of different phases will be accurately attached to the lenses. This optical film has a unique
design and function, which can affect the propagation path and energy distribution of light to a
certain extent, thereby potentially regulating the growth and development of the eye.
At the start of the trial, each subject will be provided with the first pair of eyeglasses with S.T.O.P
optical films of a specific phase, and instructed on their correct wearing and use.
13.2.2 Follow-up Arrangements and Eyeglass Replacement
A strict follow-up system will be established, and comprehensive follow-up examinations will be
conducted for subjects in the experimental group every 3 months. During each follow-up visit,

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researchers will conduct a detailed understanding of the subject's eyeglass wearing situation,
check for damage or deformation of the eyeglasses, and perform necessary adjustments and
maintenance.
When the follow-up period reaches 6 months, the second pair of eyeglasses will be replaced for
the subject. This replacement involves not only new lenses but also the redesign and adjustment of
the phase of the S.T.O.P optical film. The purpose of this step is to continuously stimulate ocular
tissues by changing the phase setting of the optical film, and observe its long-term impact on
changes in axial length and visual acuity.
13.3. Monitoring Indicators and Examination Items
Throughout the study, the changes in axial length and visual acuity of the subjects will be closely
monitored. As an important indicator reflecting the growth and development of the eyeball, the
trend of axial length change is of great significance for evaluating the effect of intervention
measures. Visual acuity examination will use a standard logarithmic visual acuity chart to record
uncorrected visual acuity and corrected visual acuity respectively.
In addition to the above core indicators, corresponding ophthalmic examinations will also be
performed, such as corneal topography, anterior chamber depth measurement, lens transparency
assessment, etc. These examinations help to fully understand the structural and functional status of
the subject's eyes, detect potential abnormalities in a timely manner, and provide rich data support
for subsequent analysis and discussion.
13.4. Control Group Handling Measures
The 90 subjects in the control group will not receive any active intervention measures. However,
to ensure the comparability of the study and the completeness of the data, regular re-examinations
will also be arranged every 3 months. During the re-examination, only routine ophthalmic
examinations will be performed, including basic items such as visual acuity test and intraocular
pressure measurement, without any additional treatment or intervention measures. After the
completion of the entire trial, subjects in the control group who adhere to completing all follow-up
visits as required will receive a pair of dynamic optical films and customized glasses matching
their diopter for free.
14. Termination of Study Intervention and Withdrawal/Termination of Study Subjects
14.1. Termination of Study Intervention

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14.1.1 Voluntary Withdrawal by Subjects
Definition: Subjects voluntarily request to withdraw from the study due to personal reasons (such
as inability to tolerate intervention measures, time conflicts, family factors, etc.).Handling
principles: Respect the subject's decision, immediately stop all study intervention measures for
them, and complete the final visit record (including vital signs, adverse reactions, and current
ocular status).Data retention: Collected data will be included in the Intention-to-Treat (ITT)
analysis, but subsequent follow-up will not be mandatory.
14.1.2 Termination Determined by Investigators
Applicable scenarios:
Severe adverse events: Occurrence of severe ocular or systemic adverse reactions related to the
study intervention (such as corneal injury, allergic reactions, persistent increase in intraocular
pressure);
Major protocol violations: Subjects fail to wear eyeglasses or undergo examinations as required by
the protocol, and still do not cooperate after repeated reminders;
Risk of disease progression: Monitoring reveals rapid axial length growth, sharp decline in visual
acuity, or other pathological changes requiring emergency medical intervention;
Other medical indications: Aggravation of comorbidities or new diseases affecting study safety.
Handling process: The termination will be decided after evaluation by the principal investigator
and the ophthalmology expert team, and reported to the Ethics Committee and the sponsor for
filing within 24 hours.
14.2. Withdrawal/Termination of Study Participants
Withdrawal decided by investigators refers to the situation where an enrolled study participant is
deemed unsuitable to continue the study during the research process, and the investigator decides
that the study participant withdraws from the study.
14.3. Voluntary Withdrawal of Study Participants from the Study
In accordance with the provisions of the Good Clinical Practice (GCP) for Drugs, the Declaration
of Helsinki, and the informed consent form, study participants have the right to withdraw from the
study midway. If a study participant does not explicitly propose to withdraw from the study but no
longer accepts study treatment/drugs or blood collection and is lost to follow-up, it is also
considered withdrawal/dropout. If a study participant decides to withdraw, every effort should be

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made to complete the withdrawal visit.
14.4. Loss to Follow-up
When a study participant cannot be contacted, research staff must make every effort to contact the
study participant to confirm whether the study participant has discontinued the drug/withdrawn
from the study and record the reason for withdrawal. To ensure follow-up of study participants, the
research center must obtain primary and secondary contact information (such as home, work, and
mobile phone numbers) as well as other contact information (such as WeChat) before
randomization. In addition, before randomization, the investigator must emphasize the importance
of follow-up information to the study participant, and the measures taken during follow-up must
be recorded.
14.5. Follow-up Handling After Withdrawal of Study Participants
Investigators must fill in the reason for terminating the study treatment/research drug treatment or
withdrawing from the study in the original medical record. They should contact the study
participant to complete the early withdrawal visit as much as possible (conduct the withdrawal
visit within 7 days of withdrawing from the study), fill in the last follow-up record form for
treatment, and record the time of the last receipt of the study treatment/drug as much as possible.
For those who withdraw due to adverse events (AEs) and are finally judged to be related to the
study treatment/drug after follow-up, it must be recorded in the case report form (CRF).
Regardless of the reason, for withdrawn cases, the records in their CRFs should be retained.
15. Adverse Events
15.1. Classification and Severity of Adverse Events
15.1.1 Early Adaptive Reactions (Mild/Self-limiting)
Symptom
Mechanism of
Occurrence
Incidence
Treatment
Recommendations
Blurred
vision/Dizziness
The brain needs to
adapt to the optical
differences in the
peripheral defocus
area
Approximately
30%-50%
Gradually extend the
daily wearing time
(starting from 2 hours
and increasing);
explain that it is a

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normal phenomenon
to eliminate anxiety
Decreased contrast
sensitivity
Increased higher-order
aberrations affect the
recognition of
light-dark boundaries
Approximately
20%-40%
Adjust the frame
position to ensure the
optical center is
aligned with the pupil;
regularly recheck
visual quality
Diminished spatial
localization sense
Peripheral visual field
distortion interferes
with depth perception
Approximately
15%-30%
Avoid fine operations
such as
driving/working at
heights initially; it is
recommended to turn
on ambient lighting
when wearing at night
Decreased contrast
sensitivity
Increased higher-order
aberrations affect the
recognition of
light-dark boundaries
Approximately
20%-40%
Adjust the frame
position to ensure the
optical center is
aligned with the pupil;
regularly recheck
visual quality
15.2. Ocular Tissue Reactions (Requiring Close Monitoring)
15.2.1 Corneal Surface Abnormalities

Manifestations: Corneal staining (positive fluorescein staining), epithelial microdefects;

Inducing factors: Lens edge friction, insufficient tear exchange;

High-risk groups: Patients with a history of dry eye, patients with narrow palpebral fissures;

Interventions:

Switch to high oxygen permeability lenses (silicone hydrogel material is preferred);

Combine with artificial tear therapy (preservative-free formulations are recommended);

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
Suspend wearing if necessary until complete recovery.
15.2.2 Conjunctival Hyperemia and Papillary Hypertrophy

Characteristics: Eyelid conjunctival vascular dilation in a reticular pattern, accompanied by
small papillary protrusions;

Differential diagnosis: Need to exclude giant papillary conjunctivitis (GPC);

Treatments:
1)
Strengthen the lens care process (daily protease removal cleaning);
2)
Short-term use of low-concentration steroid eye drops (under the guidance of a physician);
3)
Replace lenses of different brands to test tolerance.
15.2.3 Decreased Tear Film Stability

Detection indicator: Non-invasive tear meniscus height measurement < 0.2mm;

Warning signs: Recurrent foreign body sensation, burning sensation;

Solutions:
1)
Prefer lenses with wet-angle curing treatment;
2)
Use viscous artificial tears before bedtime;
3)
Consider using moisture chamber glasses.
15.3. Functional Visual Impairments (Moderate to Severe)
Symptom Cluster
Typical
Manifestations
Potential Risks
Treatment Plan
Exacerbated
accommodation lag
Difficulty in switching
from near work to
distance vision after
prolonged near work
May accelerate
myopia progression
Implement
accommodation
function training
combined with
low-concentration
atropine medication
Binocular visual
function disorders
Decreased
stereoscopic acuity,
narrowed fusion range
Affect career choices
(such as pilots)
Conduct binocular
visual function
rehabilitation training
Color perception
Mild decrease in
Restrictions on
Provide color

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deviation
blue-yellow color
discrimination ability
occupations such as
art design
correction auxiliary
tools
15.4. Follow-up and Recording of Adverse Events
All adverse medical events occurring from the first time the study participant receives the study
product until the end of the study/early withdrawal visit will be collected in this study. All adverse
events, regardless of severity and causal relationship with the study treatment/research drug, must
be recorded by the investigator in the corresponding adverse event page of the CRF.
15.5. Reporting of Adverse Events
From the signing of the informed consent form until the end of the study, all adverse events
(whether related to the study treatment/research drug or not) must be recorded in the CRF.
15.6. Reporting of Serious Adverse Events (SAEs)
Any SAEs occurring during the study should follow the SAE reporting procedures specified by
Chinese regulations or the Independent Ethics Committee. Investigators should take the following
measures:
1)
Immediately take appropriate medical measures if necessary;
2)
Record the SAE in the original documents, the adverse event form of the CRF, and other
applicable SAE report forms;
3)
The investigator should immediately (within 24 hours of learning of the event) submit the
signed and dated SAE report form to the Ethics Committee and copy it to the Clinical
Research Center (shiyicss@126.com) in accordance with the requirements of the research
center;
4)
Follow up and record the course of the event until it resolves, returns to the baseline level,
reaches a clinically stable outcome, or the study participant is lost to follow-up.
16. Statistical Analysis
16.1. Basis for Sample Size Determination
The sample size of this study is calculated using PASS software. This study is a randomized
controlled trial with two groups: the experimental group and the control group. The axial length of
the study subjects is the primary outcome indicator. Referring to the "Expert Consensus on the
Application of Axial Length in Myopia Prevention and Control Management (2023)", a yearly
axial length growth ≤0.20mm is defined as effective control. Based on literature review and

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previous clinical trials, the expected effective rate is 67% in the experimental group and 35% in
the control group. A two-sided α = 0.05 and a power of 90% are set. Calculations are performed
using PASS 15 software.
The total sample size for the two groups is N = 94 cases. Considering the possibility of loss to
follow-up and refusal to participate, a dropout rate of 20% is assumed for each group. Therefore,
the final total required sample size for the experimental group and the control group is 118 cases,
with at least 59 cases in each group.
16.2. Analysis Sets
The Full Analysis Set (FAS) refers to the ideal set of study participants that is as close as possible
to the intention-to-treat principle (the primary analysis should include all randomized study
participants). This dataset is derived from all randomized study participants with minimal and
reasonable exclusions, generally including all randomized study participants who have received at

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least one treatment.
16.3. Statistical Analysis Methods
Descriptive statistical methods will be used to summarize and present the baseline data of the
study subjects. Continuous variables will be expressed as mean (standard deviation), categorical
variables as frequency (constituent ratio), and skewed distributed variables as median
(interquartile range). Inter-group comparisons of quantitative indicators will use t-test or Wilcoxon
rank-sum test according to the data distribution, categorical indicators will use chi-square test or
exact probability method (if chi-square test is not applicable), and ordinal data will use Wilcoxon
rank-sum test or CMH test.
17. Data Management
This randomized controlled trial uses paper case report forms (CRFs) for data collection, and a
research database will be established through electronic entry subsequently. Data managers will
design standardized paper CRFs according to the requirements of the study protocol to ensure
clear logic and ease of filling. Special RCT-specific forms such as randomization record forms,
treatment allocation forms, compliance assessment forms, primary endpoint assessment forms,
and adverse event report forms will be designed, including standardized entry formats and coding
rules for all study variables.
The randomization procedure will adopt an independent central randomization system or
randomization envelopes to ensure the integrity of allocation concealment. Investigators or clinical
research coordinators will be responsible for promptly, truthfully, completely, and accurately
recording all relevant data of each study participant during the study in the paper CRFs, including
the screening and enrollment process, randomization information, treatment implementation,
efficacy evaluation, safety monitoring, compliance evaluation, and dropout/withdrawal, ensuring
legible handwriting and accurate information.
Data entry will adopt a double-independent entry mode, with data entry personnel trained in GCP
entering data according to the paper CRFs. Special attention will be paid to the accuracy of
randomization sequence numbers, consistency of treatment allocation, completeness of primary
endpoint data, and accurate classification of adverse events during entry. After the two
independent entries are completed, consistency checks will be performed, and inconsistent data
items will be verified and corrected to ensure the accuracy of key data.

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Data managers will establish a standardized quality control procedure for this study, and regularly
perform quality checks through database queries or statistical software scripts, focusing on
randomization balance checks, baseline characteristic comparability verification, primary endpoint
data completeness assessment, treatment compliance analysis, adverse event report completeness
checks, dropout pattern analysis, and missing data impact assessment. Quality control will pay
special attention to key data quality issues that may affect the interpretation of trial results.
When data issues are identified, data managers will generate standardized data query forms,
detailing the issues to be clarified, including key issues such as randomization procedure
execution, treatment allocation accuracy, primary endpoint event determination, adverse event
causal relationship assessment, treatment compliance evaluation, and dropout reason analysis.
After receiving the query form, the investigator will provide a written response and sign for
confirmation. For complex issues involving endpoint event determination, an independent
endpoint event assessment committee may make a ruling.
Data entry personnel will make corresponding data modifications and entries according to the
investigator's responses. A complete written record of the entire query handling process will be
established, including the query content, response process, clinical judgment basis, and final
handling results, to ensure the traceability and scientificity of data modifications. Special attention
will be paid to the handling of key data queries affecting primary efficacy analysis and safety
evaluation.
After all data queries are resolved, data managers will perform the final data cleaning, generate a
"clean" dataset and a data quality report. The quality report will include key clinical trial quality
indicators such as randomization execution, baseline characteristic balance, primary endpoint data
completeness rate, treatment compliance distribution, adverse event occurrence, and
dropout/withdrawal analysis. A data audit meeting will then be organized, with the participation of
the principal investigator, statistical analysts, data managers, clinical trial monitors, and quality
control personnel.
The data audit meeting will comprehensively review the randomization quality, treatment
implementation, primary endpoint data quality, safety data completeness, and the impact of
missing data on different analysis sets, and make decisions on the handling of outliers and missing
data. It will be confirmed that the data quality meets the requirements of ITT analysis,

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Per-Protocol Set (PPS) analysis, and safety analysis. Representatives of all parties will sign the
data audit resolution based on full discussions, specifically confirming the quality and
completeness of the data required for primary efficacy analysis and safety evaluation.
After the data audit is passed, data managers will execute the database locking procedure,
establish version control records for the final analysis dataset, generate the ITT analysis set, PPS
analysis set, and safety analysis set respectively, and submit the locked data to the statistical
analysis team. Paper CRFs will be properly kept as original data, and a complete trial document
management system will be established, including randomization records, treatment allocation
documents, data collection forms, query handling records, and endpoint event ruling records.
Any data changes required after the database is locked must have sufficient scientific basis and
clinical rationality, and can only be executed after the joint signature and approval of the principal
investigator, statistician, data manager, and monitor. The complete process of the change and its
potential impact on the analysis results will be detailed recorded. The study will establish strict
data security and confidentiality measures to maintain the blinding integrity of the blinded trial,
restrict data access rights, and de-identify data involving personal identification information to
ensure compliance with relevant requirements and regulations.
18. Quality Control
18.1. Protocol Design Quality Control
Before the implementation of the study protocol, investigators will organize experts in related
fields such as adolescent myopia prevention and control to demonstrate the study protocol to
ensure its scientificity and feasibility. During the study, if necessary, the research team may revise
the study protocol in accordance with specified procedures. All revisions must be approved by the
Ethics Committee and promptly notified to all study participants.
18.2. Qualification Quality Control of Participating Personnel
The designers of the study protocol must have optometry knowledge/background. The principal
investigator should have a medical qualification/background. Data managers should have clinical
trial data management experience. Statistical analysts must have a biostatistics background and be
familiar with clinical trial statistical analysis methods.
The research team will conduct unified training for all study participants, covering detailed
interpretation of the study protocol, standardized operating procedures for equipment, study

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participant recruitment and screening criteria, data collection and recording specifications, adverse
event identification and reporting procedures, and data management.
For other clinical operators, they must hold professional qualifications in relevant fields (such as
practicing nurse, technician qualification certificate, etc.) and have at least 3 years of relevant
operational experience. All clinical operators must be familiar with the operational procedures
involved in the study, receive unified training, and pass the assessment.
The research team will regularly evaluate the standardization of surgical and clinical operations,
and record the quality control of relevant operations to ensure the scientificity and consistency of
operations.
18.3. Management and Preservation of Test Data
The research team will completely preserve all original data related to the study, including original
readings of test equipment, image data, etc., and properly preserve original documents such as
participant questionnaires.
Data in the data collection forms will be derived from and consistent with the original documents.
All test results, participant-reported outcomes, and follow-up information will be filled into the
database in a timely, accurate, complete, standardized, and truthful manner. Researchers are not
allowed to modify data arbitrarily. If corrections are needed due to filling errors, any corrections
made will be traced in the data records, and the reason for the correction will be recorded.
Special data managers will be responsible for preserving all relevant materials involved in the
study, including original examination and test data, participant screening and enrollment materials,
statistical analysis data and reports, etc., for a period of not less than 2 years after the end of the
study.
18.4. Statistical Analysis Quality Control
The statistical analysis process and result expression of the study will adopt internationally
recognized statistical methods. The research team has formulated a detailed statistical analysis
plan in the study protocol, which will be confirmed and refined before the official statistical
analysis. Statistical analysts will be independent of the data collection process to ensure the
objectivity of the analysis. The statistical analysis report will include detailed methodological
descriptions and result interpretations.
18.5. Whole-Process Quality Control

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The research team will conduct systematic inspections of the relevant activities and documents of
the study, evaluate whether the study is conducted in accordance with the study protocol, standard
operating procedures, and relevant regulations, check whether the study data is recorded in a
timely, truthful, accurate, and complete manner, and verify whether the distribution, use, and
recovery of study drugs comply with the protocol requirements.
Audits will be conducted by independent personnel not directly involved in the study. The first
audit is planned to be conducted within 3 months after the study initiation, followed by regular
audits every 6 months. The audit content will include the informed consent process,
implementation of inclusion/exclusion criteria, standardization of clinical examination operations,
completeness of data records, etc.
When study participants fail to conduct the study in accordance with the approved protocol or
relevant regulations, the study director will promptly point out and require corrections. All
protocol deviations will be recorded, and major deviations will be promptly reported to the Ethics
Committee. The research team will establish deviation prevention and correction measures to
ensure the continuous improvement of study quality.
19. Ethical Protection and Informed Consent in Clinical Research
Clinical research will comply with the relevant provisions of the World Medical Association's
Declaration of Helsinki and the National Health and Family Planning Commission of the People's
Republic of China's Measures for the Ethical Review of Biomedical Research Involving Humans,
specifically implementing informed consent, protecting privacy, research free of charge and
compensation, risk control, protection of special study participants, and principles and
requirements for compensation for research-related damages. Before the start of the study, the
clinical research will be implemented only after the study protocol is approved by the Ethics
Review Committee. Before each study participant is enrolled in the study, the investigator is
responsible for fully and comprehensively introducing the purpose, procedures, and potential risks
of the study to the study participant and/or their legal representative, and having them sign a
written informed consent form. The study participant should be informed that their participation in
the clinical research is completely voluntary, and they can refuse to participate or withdraw from
the study at any stage of the trial without discrimination or retaliation, and their medical treatment
and rights will not be affected. The informed consent form should be retained for inspection as a

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clinical research document to effectively protect the personal privacy and data confidentiality of
study participants.