MyopiaPhase 4NCT05357326
Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model
A Phase 4 study testing Atropine Sulfate 0.01% Eye Drop, Orthokeratology and Atropine Sulfate 0.04% Eye Drop in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to… Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate 0.01% Eye Drop, Orthokeratology and Atropine Sulfate 0.04% Eye Drop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged from 8-15 years old;
- children with spherical degree ranged from -1.0D to -4.0D, cylindrical degree less than -1.50D, astigmatism with the rule less than -1.25D, astigmatism with other axial distribution less than -0.50, anisometropia less than -1.50D;
- children with BCVA less than 0.1 LogMAR for both eyes;
- children without other eye diseases except for ametropia
Who cannot join
- children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
- children with cycloplegia contradictions;
- children who have used atropine or orthokeratology;
- children who are severly allergic with atropine;
- children who are using other eye drops for treatment;
- children who have contraindications to orthokeratology or cannot cooperate with it;
- children with severe heart, lung, liver and kidney diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianfeng Zhu
Shanghai, Shanghai Municipality, 200040
Jianfeng Zhu, 13501822932 ext. 13501822932, jfzhu1974@Hotmail.com
About this study
Official title: Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
Read the detailed description
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate 0.01% Eye Drop, Orthokeratology, Atropine Sulfate 0.04% Eye Drop
- Keywords
- myopia progression, atropine, orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine Sulfate 0.01% Eye DropDrug
use one drop into subconjunctiva
OrthokeratologyDevice
wear orthokeratology at night while sleeping
Atropine Sulfate 0.04% Eye DropDrug
use one drop into subconjunctiva
| Study group | Role | What they receive |
|---|---|---|
| 0.01% atropine | Active comparator | use atropine sulfate 0.01% eye drop every night before sleep for two years Receives: Drug: Atropine Sulfate 0.01% Eye Drop |
| 0.04% atropine | Experimental | use atropine sulfate 0.04% eye drop every night before sleep for two years Receives: Drug: Atropine Sulfate 0.04% Eye Drop |
| orthokeratology | Experimental | wear orthokeratology lens every night for two years Receives: Device: Orthokeratology |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent progression in over two years
equals sphere +1/2 cylinder
Measured: 2 years
axial length change over two years
measured by IOL-Master
Measured: 2 years
Secondary outcomes (6)
lens power change over two years
calculated by Bennett-Rabetts formula
Measured: 2 years
choroidal thickness change over two years
measured by SS-OCT
Measured: 2 years
choroidal blood flow density change over two years
measured by OCTA
Measured: 2 years
anterior chamber depth change over two years
measured by IOL-Master
Measured: 2 years
intraocular pressure change over two years
measured by a non-contact tonometer
Measured: 2 years
corneal topography change over two years
measured by Pentacam
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
- Investigators
- Jianfeng Zhu, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357326
- Sponsor's protocol ID
- SHYB2021003
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu H, Chen M, Ye L, Shu Q, Peng Y, Liang X, Yu T, Ji Y, Li S, Shen Q, He J, Li L, Zhu J, Xu X. Orthokeratology, 0.04% Atropine, and 0.01% Atropine for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jul 24;143(9):731-8. doi: 10.1001/jamaophthalmol.2025.2321. Online ahead of print.
PubMed 40705323
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning
- ClinicalTrials.gov ID
- NCT05357326
- Acronym / sponsor ID
- SHYB2021003
- Conditions
- Myopia
- Keywords
- myopia progression, atropine, orthokeratology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
Detailed description
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
| Arm | Type | Receives |
|---|---|---|
| 0.01% atropine | Active comparator | Drug: Atropine Sulfate 0.01% Eye Dropuse atropine sulfate 0.01% eye drop every night before sleep for two years |
| 0.04% atropine | Experimental | Drug: Atropine Sulfate 0.04% Eye Dropuse atropine sulfate 0.04% eye drop every night before sleep for two years |
| orthokeratology | Experimental | Device: Orthokeratologywear orthokeratology lens every night for two years |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged from 8-15 years old;
- children with spherical degree ranged from -1.0D to -4.0D, cylindrical degree less than -1.50D, astigmatism with the rule less than -1.25D, astigmatism with other axial distribution less than -0.50, anisometropia less than -1.50D;
- children with BCVA less than 0.1 LogMAR for both eyes;
- children without other eye diseases except for ametropia
Key exclusion criteria (7 listed)
- children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
- children with cycloplegia contradictions;
- children who have used atropine or orthokeratology;
- children who are severly allergic with atropine;
- children who are using other eye drops for treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine Sulfate 0.01% Eye Dropuse one drop into subconjunctiva | Drug | 0.01% atropine |
| Orthokeratologywear orthokeratology at night while sleeping | Device | orthokeratology |
| Atropine Sulfate 0.04% Eye Dropuse one drop into subconjunctiva | Drug | 0.04% atropine |
Primary outcome
spherical equivalent progression in over two years
Time frame: 2 years
equals sphere +1/2 cylinder
axial length change over two years
Time frame: 2 years
measured by IOL-Master
6 secondary outcomes
lens power change over two years
Time frame: 2 years
choroidal thickness change over two years
Time frame: 2 years
choroidal blood flow density change over two years
Time frame: 2 years
anterior chamber depth change over two years
Time frame: 2 years
intraocular pressure change over two years
Time frame: 2 years
corneal topography change over two years
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 40705323Xu H, Chen M, Ye L, Shu Q, Peng Y, Liang X, Yu T, Ji Y, Li S, Shen Q, He J, Li L, Zhu J, Xu X. Orthokeratology, 0.04% Atropine, and 0.01% Atropine for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jul 24;143(9):731-8. doi: 10.1001/jamaophthalmol.2025.2321. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Zhu study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine Sulfate 0.01% Eye Drop, Orthokeratology and Atropine Sulfate 0.04% Eye Drop in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Zhu (13501822932 ext. 18101853556, jfzhu1974@Hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spherical equivalent progression in over two years (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.