MyopiaNCT07535658
Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control
A study testing wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property, wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) and wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Myopia
- What is being tested?
- wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property, wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) and wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
- The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
- Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
- Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
- Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);
- General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs;
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- Previous intervention: No use of any myopia control methods within the past 3 months, including but not limited to: multifocal glasses, atropine eye drops, red light therapy, acupuncture, etc.
- Compliance with spectacle wear: Parents ensure that the child wears glasses for ≥8 hours per day;
- Follow-up capability: Ability to attend scheduled follow-ups for 12 months (4 visits in total);
- Informed consent from guardian: Legal guardian signs the informed consent form; children also sign the assent form.
Who cannot join
- History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;
- Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;
- Used any myopia intervention drugs or devices in the past 3 months;
- Those who have participated in other similar clinical studies in the past 3 months;
- Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases;
- Those who are allergic to the lens material or products related to the study;
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- Allergy to mydriatic agents and related ophthalmic medications;
- Allergic to photochromic materials or related dyes; taking photosensitizing drugs; suffering from photo-induced skin or neurological disorders;
- Unable to understand the study content or unable to cooperate with the follow-up;
- Other reasons why the research doctor believes the patient is not suitable for the study.
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 Disease Prevention and treatment Center
Shanghai, 200336
About this study
Official title: Comparative Efficacy and Safety of Multi-Type Photolithography Flat Microstructure Spectacle Lenses Versus Spectacle Lenses With Aspherical Lenslets for Myopia Control in Chinese Children: A 12-Month Randomized Controlled Trial
The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:
Are photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.
Read more
Participants will:
Wear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.
Visit the clinic once every 3 months for checkups and tests.
- Conditions
- Myopia
- Being tested
- wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property, wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest), wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation, wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation, wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical propertyDevice
wearing photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property for more than 8 hours a day.
wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)Device
wearing plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) for more than 8 hours.
wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activationDevice
Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation for more than 8 hours.
wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activationDevice
Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation for more than 8 hours.
wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical propertyDevice
wearing Photolithography Plano Microstructure Lenses designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property for more than 8 hours
| Study group | Role | What they receive |
|---|---|---|
| PPML(multi-point defocus design, non-fading, Nuo Tong) | Experimental | The group wears photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property. Receives: Device: wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property |
| PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong) | Experimental | PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation. Receives: Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation |
| PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong) | Experimental | PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation. Receives: Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation |
| PPML (designed to reduce contrast, non-fading, Nuo Tong) | Experimental | PPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property Receives: Device: wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property |
| Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest) | Active comparator | Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) Receives: Device: wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months.
Computerized refractometer testing, The formula for calculating sphere equivalent power: sphere power + 0.5 * cylinder power
Measured: From enrollment to the end of treatment at 12 month
Secondary outcomes (1)
Difference in 12-month axial length (AL, mm) from baseline
Measure the length of the eye axis using the IOL Master 700 and compare the difference in eye axis length over 12 months.
Measured: From enrollment to the end of treatment at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Sep 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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 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
- NCT07535658
- Sponsor's protocol ID
- QX-2025-A-021
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Multi-Type Photolithography Flat Microstructure Spectacle Lenses Versus Spectacle Lenses With Aspherical Lenslets for Myopia Control in Chinese Children: A 12-Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07535658
- Acronym / sponsor ID
- QX-2025-A-021
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 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.
The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:
Are photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.
Participants will:
Wear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.
Visit the clinic once every 3 months for checkups and tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PPML(multi-point defocus design, non-fading, Nuo Tong) | Experimental | Device: wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical propertyThe group wears photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property. |
| PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong) | Experimental | Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activationPPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation. |
| PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong) | Experimental | Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activationPPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation. |
| PPML (designed to reduce contrast, non-fading, Nuo Tong) | Experimental | Device: wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical propertyPPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property |
| Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest) | Active comparator | Device: wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
- The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
- Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
- Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
- Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);
Key exclusion criteria (10 listed)
- History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;
- Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;
- Used any myopia intervention drugs or devices in the past 3 months;
- Those who have participated in other similar clinical studies in the past 3 months;
- Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases;
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 |
|---|---|---|
| wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical propertywearing photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property for more than 8 hours a day. | Device | PPML(multi-point defocus design, non-fading, Nuo Tong) |
| wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)wearing plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) for more than 8 hours. | Device | Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest) |
| wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activationWearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation for more than 8 hours. | Device | PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong) |
| wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activationWearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation for more than 8 hours. | Device | PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong) |
| wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical propertywearing Photolithography Plano Microstructure Lenses designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property for more than 8 hours | Device | PPML (designed to reduce contrast, non-fading, Nuo Tong) |
Primary outcome
Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months.
Time frame: From enrollment to the end of treatment at 12 month
Computerized refractometer testing, The formula for calculating sphere equivalent power: sphere power + 0.5 * cylinder power
1 secondary outcome
Difference in 12-month axial length (AL, mm) from baseline
Time frame: From enrollment to the end of treatment at 12 month
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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property, wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) and wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 17 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?
Contact Qiurong Lin (+8615216698330, LQRoph@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months. (time frame: From enrollment to the end of treatment at 12 month). 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 17 Apr 2026.