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A Prospective Single-Center Comparative Study on the Effect of Three Optical Design Spectacle Lenses on Myopia Progression in Children and Adolescents

A Prospective Single-Center Comparative Study on the Effect of Three Optical Design Spectacle Lenses on Myopia Progression in Children and Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125787
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Myopia

Interventions

Group A:Spherical single-vision spectacle lenses
Group B:Aspherical single-vision spectacle lenses
Group C:Peripheral myopic defocus spectacle lenses (DIMS technology)

Sponsors

Hangzhou MSK Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8–13 years, male or female; 2. Diagnosed with simple myopia by cycloplegic refraction, spherical equivalent –0.50D to –6.00D, astigmatism <=1.50D; 3. Axial length 22.00 mm to 25.00 mm; 4. No prior use of any myopia control spectacle lenses, or use of conventional single-vision lenses for less than 3 months; 5. Uncorrected visual acuity <=0.8, best corrected visual acuity =1.0; 6. No organic ocular diseases (e.g., cataract, glaucoma, retinopathy, etc.), no strabismus or amblyopia; 7. No systemic diseases (e.g., diabetes, autoimmune diseases, etc.); 8. Guardians and subjects voluntarily participate in this study, sign the informed consent form, and are able to complete the entire follow-up.

Exclusion criteria

Exclusion criteria: 1. Failure to meet the inclusion criteria; 2. Poor compliance with spectacle wear, unable to ensure daily wearing time >=8 hours; 3. Need for other myopia control interventions during follow-up (e.g., orthokeratology, low-concentration atropine, etc.); 4. History of ocular surgery or ocular trauma; 5. Guardians or subjects unable to comply with the required examinations and follow-up; 6. Occurrence of serious adverse events during follow-up requiring study termination.

Design outcomes

Primary

MeasureTime frame
Equivalent spherical refractive error change (the change from baseline to 12 months, unit: diopters D);Change in axial length (the difference from the baseline to 12 months, unit: mm);

Secondary

MeasureTime frame
Wearing compliance (daily wear time: full =8h, partial 4-8h, non-compliance =4h);Adverse event rate (ocular discomfort, lens-related problems, etc.);Change in best corrected visual acuity from baseline to 12 months;

Countries

China

Contacts

Public ContactZhang Jun

Hangzhou MSK Eye Hospital

mskzj@sina.cn+86 571 8531 8888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026