refractive error
Conditions
Interventions
ZEISS MOVE Myopia Control Spectacle Lenses Group:None
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Accompanied by parents or legal guardians who can read and understand Chinese, with written informed consent signed by guardians; 2. Aged from 6 to 16 years old (inclusive) at baseline enrollment; 3. Diagnosed with myopia, with cycloplegic spherical equivalent refraction ranging from -0.50 D to -9.00 D, and combined refractive power not exceeding -9.00 D in both eyes; 4. Absolute astigmatism = 0.8 in both eyes; 6. Both eyes are normal without other ocular abnormalities or diseases except refractive error.
Exclusion criteria
Exclusion criteria: 1. History of using any myopia control interventions within 3 months prior to study enrollment, including contact lenses, atropine, specially designed contact lenses/spectacles with claimed myopia control efficacy, light therapy devices for myopia control, etc.; 2. History of ocular trauma or eye surgery; or suffering from any ocular/systemic diseases that may affect myopia progression or refractive status, or receiving drug treatment that impairs vision; 3. Diagnosis of amblyopia; 4. Manifest strabismus; 5. Concurrent participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of myopia control with ZEISS MOVE lenses assessed by cycloplegic spherical equivalent change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all ocular and lens-wearing related adverse events within 12 months;Proportion of subjects with axial length elongation less than 0.2 mm during 12-month follow-up; | — |
Countries
China
Contacts
Public ContactXiao Yang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed