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A Randomized Controlled Study on the Efficacy and Safety of Non-Periodic Tessellated Microstructure Lenses for Slowing Myopia Progression in Children

A Randomized Controlled Study on the Efficacy and Safety of Non-Periodic Tessellated Microstructure Lenses for Slowing Myopia Progression in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123689
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

A group:Wear non-periodic tessellated microstructure (Guangyin Control) lenses for 12 months.
B group:Wear multi-zone positive optical defocus design lenses for 12 months.
C group:Wear aspheric single-vision lenses for 12 months.

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Able to understand and participate in the consent process, accompanied by a parent or guardian who can read and understand Chinese, and sign the informed consent/consent statement; 2. Age 8-12 years at enrollment, of any gender; 3. Diagnosed with myopia, with cycloplegic objective computerized refractive spherical equivalent between -0.75D and -4.00D (inclusive of -0.75D and -4.00D); 4. Absolute value of astigmatism <=2.00D; 5. Anisometropia (based on cycloplegic objective computerized refractive spherical equivalent) <=1.50D; 6. Corrected visual acuity in each eye equal to or better than decimal visual acuity 0.8 (LogMAR 0.1); 7. Willing to wear the trial lenses as required by the investigator (full-time wear, not less than 10 hours per day), and complete scheduled visits as planned.

Exclusion criteria

Exclusion criteria: 1. Any active ocular disease and systemic diseases affecting the eyes (such as diabetes, Graves' disease, ankylosing spondylitis, multiple sclerosis, Sjogren's syndrome, systemic lupus erythematosus, etc.); 2. Use of or currently using products that slow myopia progression within the past month, including specially designed frame glasses, specially designed RGP lenses, specially designed soft contact lenses, and progressive frame glasses; 3. Use of or currently using OK lenses or atropine drugs within the past three months; 4. Have used or currently using red light or other optical therapy devices; 5. Currently using or during the follow-up research need to use drugs that may cause dry eye or affect vision (such as penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, etc.); 6. Known allergy to components of cycloplegic eye drops (obucaine, proparacaine, or tropicamide); 7. Manifest strabismus or obvious binocular vision abnormalities; 8. Currently participating in other clinical trials; 9. Abnormalities in slit-lamp examination, fundus examination, or intraocular pressure examination with clinical significance; 10. Ocular and systemic abnormalities that may affect visual function or refractive development; 11. Other situations deemed by the researcher as unsuitable for participation in the clinical study.

Design outcomes

Primary

MeasureTime frame
Axial length;Cycloplegic refraction;

Secondary

MeasureTime frame
corrected visual acuity with spectacles;visual function;

Countries

China

Contacts

Public ContactKai Wang

Peking University People's Hospital

wang_kai@bjmu.edu.cn+86 138 1009 7881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026