Myopia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Hangzhou MSK Eye Hospital