Photolithography Microstructure Myopia Management Lenses in Preventing and Controlling Myopia in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myopia management lens.
- Who it may be relevant to
- Registry conditions: Myopia, Child Myopia Progression. Basic parameters: 6 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing Myopia in Children and Adolescents
Overview
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.
Interventions
- Device Myopia management lens
Microstructure myopia management lens
Primary outcome measures
- Changes in spherical equivalent (SE) [Time frame: 12 months]
Secondary outcome measures (2)
- Changes in axial length (AL) [Time frame: 12 months]
- Changes in choroidal thickness (ChT) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Diagnosed with persistent strabismus.
- Diagnosed with pathological myopia.
- Other congenital eye diseases.
- Other reasons the research doctor deems unsuitable for inclusion in the project.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medic — Shanghai
Identifiers
NCT: NCT07514039 · QX-2025-A-020