Myopia, Child Myopia ProgressionNCT07514039
Photolithography Microstructure Myopia Management Lenses in Preventing and Controlling Myopia in Children and Adolescents
A study testing Myopia management lens in people with Myopia, Child Myopia Progression, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Evaluate the effectiveness of different lithographic microstructured myopia management lenses in controlling the progression of myopia in children and adolescents, as well as the safety and comfort of wearing them. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Child Myopia Progression
- What is being tested?
- Myopia management lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 6 to 14 years old.
- After administering 1% Cyclopentolate Hydrochloride Eye Drops (Saifeijie) to induce ciliary muscle paralysis, both eyes showed refractive errors between -0.50D and -4.00D, with binocular lens differences ≤ 1.50D and anisometropia ≤ 1.50D. Best corrected visual acuity was 5.0 or better.
- Have not used over-focus glasses, corneal reshaping lenses, defocus flexible glasses, progressive lenses, atropine eye drops, red light therapy, acupuncture, moxibustion, or other myopia prevention methods within the past three months.
- The subject is willing to receive treatment, and their legal guardian has signed an informed consent form.
Who cannot join
- Diagnosed with persistent strabismus.
- Diagnosed with pathological myopia.
- Other congenital eye diseases.
- Other reasons the research doctor deems unsuitable for inclusion in the project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
Shanghai
About this study
Official title: A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing Myopia in Children and Adolescents
Evaluate the effectiveness of different lithographic microstructured myopia management lenses in controlling the progression of myopia in children and adolescents, as well as the safety and comfort of wearing them. Explore effective defocus microlens designs for myopia control and the feasibility of applying lithographic microstructured myopia management lenses in myopia prevention and control.
- Conditions
- Myopia, Child Myopia Progression
- Being tested
- Myopia management lens
- Keywords
- lithographic microstructured myopia management lenses, myopia progression, Chinese children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopia management lensDevice
Microstructure myopia management lens
| Study group | Role | What they receive |
|---|---|---|
| Photolithography microstructure myopia management lens (A) | Experimental | Not described Receives: Device: Myopia management lens |
| Photolithography microstructure myopia management lens (B) | Experimental | Not described Receives: Device: Myopia management lens |
| Photolithography microstructure myopia management lens (C) | Experimental | Not described Receives: Device: Myopia management lens |
| Myopia Management Lenses (highly aspherical lenslets) | Active comparator | Not described Receives: Device: Myopia management lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spherical equivalent (SE)
Changes in spherical equivalent (SE) of mydriatic refraction compared to baseline (D)
Measured: 12 months
Secondary outcomes (2)
Changes in axial length (AL)
Changes in axial length (AL) compared to baseline (mm)
Measured: 12 months
Changes in choroidal thickness (ChT)
Changes in choroidal thickness (ChT) compared to baseline (μm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Feb 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, Child Myopia ProgressionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514039
- Sponsor's protocol ID
- QX-2025-A-020
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing Myopia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT07514039
- Acronym / sponsor ID
- QX-2025-A-020
- Conditions
- Myopia, Child Myopia Progression
- Keywords
- lithographic microstructured myopia management lenses, myopia progression, Chinese children
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (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.
Evaluate the effectiveness of different lithographic microstructured myopia management lenses in controlling the progression of myopia in children and adolescents, as well as the safety and comfort of wearing them. Explore effective defocus microlens designs for myopia control and the feasibility of applying lithographic microstructured myopia management lenses in myopia prevention and control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Photolithography microstructure myopia management lens (A) | Experimental | Device: Myopia management lens |
| Photolithography microstructure myopia management lens (B) | Experimental | Device: Myopia management lens |
| Photolithography microstructure myopia management lens (C) | Experimental | Device: Myopia management lens |
| Myopia Management Lenses (highly aspherical lenslets) | Active comparator | Device: Myopia management lens |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6 to 14 years old.
- After administering 1% Cyclopentolate Hydrochloride Eye Drops (Saifeijie) to induce ciliary muscle paralysis, both eyes showed refractive errors between -0.50D and -4.00D, with binocular lens differences ≤ 1.50D and anisometropia ≤ 1.50D. Best corrected visual acuity was 5.0 or better.
- Have not used over-focus glasses, corneal reshaping lenses, defocus flexible glasses, progressive lenses, atropine eye drops, red light therapy, acupuncture, moxibustion, or other myopia prevention methods within the past three months.
- The subject is willing to receive treatment, and their legal guardian has signed an informed consent form.
Key exclusion criteria (4 listed)
- Diagnosed with persistent strabismus.
- Diagnosed with pathological myopia.
- Other congenital eye diseases.
- Other reasons the research doctor deems unsuitable for inclusion in the project.
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 |
|---|---|---|
| Myopia management lensMicrostructure myopia management lens | Device | Myopia Management Lenses (highly aspherical lenslets), Photolithography microstructure myopia management lens (A), Photolithography microstructure myopia management lens (B), Photolithography microstructure myopia management lens (C) |
Primary outcome
Changes in spherical equivalent (SE)
Time frame: 12 months
Changes in spherical equivalent (SE) of mydriatic refraction compared to baseline (D)
2 secondary outcomes
Changes in axial length (AL)
Time frame: 12 months
Changes in choroidal thickness (ChT)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myopia management lens in people with Myopia, Child Myopia Progression, 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 4 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: enrolling by invitation, as of the sponsor's last update on 7 Apr 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in spherical equivalent (SE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.