myopia
Conditions
Interventions
Single-vision spectacle lenses combined with placebo group:Wearing single-vision spectacle lenses combined with once-daily administration of placebo eye drops.
Single-vision spectacle lenses combined with 0.04% atropine eye drops group:Wearing single-vision spectacle lenses combined with once-daily administration of 0.04% atropine eye drops.
Diffusion optics technology (DOT) spectacle lenses combined with placebo group:Wearing diffusion optics spectacle lenses combined with once-daily administration of placebo eye drops.
Diffusion optics technology (DOT) spectacle lenses combined with 0.04% atropine eye drops group:Wearing diffusion optics spectacle lenses combined with once-daily administration of 0.04% atropine eye
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age: 6-12 years old; 2. Spherical equivalent refraction in both eyes (under cycloplegic refraction) ranging from -6.00 D to -0.50 D, with astigmatism = 5.0; 4. No prior use of any myopia control interventions within the past three months, including atropine, specialized spectacle lenses, etc.; 5. Intraocular pressure <= 21 mmHg, with an interocular difference between eyes <= 5 mmHg.
Exclusion criteria
Exclusion criteria: 1. Presence of ocular diseases such as glaucoma, cataract, fundus pathology, or active ocular inflammation; 2. Diagnosis of strabismus, amblyopia, or other significant visual disorders; 3. History of ocular trauma, ocular surgery, or severe ocular infections; 4. Presence of systemic connective tissue disorders or autoimmune diseases; 5. Inability to comply with regular follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of axial length (AL) for 12 months +/- 30 days compared with the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change value of equivalent spherical diopter (SER) of objective optometry after cycloplegia for 12 months +/- 30 days compared with the baseline.;SER and eye axis length (AL) at different time points, SER and AL changes from baseline; | — |
Countries
China
Contacts
Public ContactXinjie Mao
Eye Hospital of Wenzhou Medical University
Outcome results
None listed