Myopia
Conditions
Interventions
Intervention Group:Wear the A.M.L. spectacles during all waking hours.
Sponsors
Shanghai Eye Disease Prevention and TreatmentCenter
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Accompanied by a parent or legal guardian capable of reading and understanding Chinese/English, who provides written informed consent/assent. 2.Capable of understanding and participating in the consent/assent procedure. 3.Aged 6 to 12 years (inclusive) at the time of enrollment. 4.Diagnosed with myopia, with a cycloplegic objective spherical equivalent refractive error between -0.50D and -5.00D. 5.Absolute value of astigmatism = 0.8 (Snellen equivalent) in each eye. 8.Normal ocular examination findings. 9.Willingness to comply with the investigator's instructions regarding the trial lenses and to attend all scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Known systemic or ocular diseases that may affect vision or refraction (including infections). 2. Systemic diseases affecting ocular health (e.g., diabetes mellitus, Graves' disease, ankylosing spondylitis, multiple sclerosis, Sjögren's syndrome, systemic lupus erythematosus). 3.Use of systemic or topical medications known to alter ocular status/affect ocular health during the study period. 4.History of ocular trauma. 5.Amblyopia. 6.Manifest strabismus. 7. Use of myopia control interventions (e.g., orthokeratology lenses, atropine) within 1 month prior to enrollment. 8.History of ocular surgery. 9.Known allergy to any component of cycloplegic eye drops. 10.Concurrent participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cycloplegic spherical equivalent refraction>= 0.75 D per year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial elongation >= 0.20 mm per year;vision;Subjective experience and compliance with spectacle wear; | — |
Countries
China
Contacts
Public ContactXiangui He
Shanghai Eye Disease Prevention and TreatmentCenter
Outcome results
None listed