Myopia
Conditions
Interventions
Group A (Sequence A):Multi-dimensional compound aberration microstructure lens
Ultra-learning lens
Group B (Sequence B):Ultra-learning lens
Multi-dimensional compound aberration microstructure lens
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6–13 years; cycloplegic spherical equivalent refraction (SER): -0.50 D (inclusive) to -5.00 D (exclusive); 2. Cylinder power = -0.50 D/year, or annual axial length progression > 0.27 mm/year; (2) For subjects without reliable historical data: age <= 9 years; cycloplegic SER ranging from -0.50 D to -1.50 D; baseline axial length above the 75th percentile of normal values for children of the same age and gender (6 years old: Male 23.16 mm, Female 22.69 mm; 7 years old: Male 23.36 mm, Female 22.87 mm; 8 years old: Male 23.54 mm, Female 23.03 mm; 9 years old: Male 23.70 mm, Female 23.18 mm); 5. Discontinuation of low-concentration atropine and myopia-control spectacle lenses for more than 1 month; orthokeratology (OK) lens wear suspended for at least 2 months; 6. Voluntary participation in this clinical trial with written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. History of myopia control with high-concentration atropine (>0.05%) or low-intensity red light therapy; 2. Shallow anterior chamber or intraocular pressure (IOP) > 21 mmHg; 3. Active ocular surface inflammation; presence of other ocular disorders including uveitis and other intraocular inflammations, glaucoma, cataract, fundus diseases, ocular tumors, ocular trauma, manifest strabismus, or any other lesions impairing visual function; 4. Systemic diseases causing immunodeficiency, such as diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric disorders, or other conditions deemed unsuitable for spectacle wear by investigators; 5. History of ocular trauma or intraocular surgery; 6. Inability to complete regular follow-up visits; 7. Any other medical conditions judged by investigators to render the subject ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cycloplegic Peripheral auto-refraction;Choroidal Thickness (OCT);Visual confort questionnaire;Cycloplegic autorefraction; | — |
Countries
China
Contacts
Public ContactBao Jinhua
Eye Hospital, Wenzhou Medical University
Outcome results
None listed