Myopia or amblyopia
Conditions
Interventions
Experimental group:Wear frame glasses with defocus lenses (Aola brand)
Control group:Wear frame glasses with defocus lenses (Aola brand)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. At the time of enrollment, the age is between 8 and 12 years old, regardless of gender; 2. Diagnosed as myopic according to the "Myopia Prevention and Treatment Guidelines" issued by the General Office of the National Health Commission (Guoweiban Yi Han [2018] No. 393); 3. Wear defocus frame glasses of the Aola brand; 4. After cycloplegia of both eyes, the optometry result shows that -0.75D = 5.0; 7. There are no other organic diseases in both eyes that affect vision; 8. The subject and the guardian can understand the purpose of this trial, sign the informed consent form, and the subject can cooperate with the treatment and relevant ophthalmic examinations.
Exclusion criteria
Exclusion criteria: 1. Strabismus and/or amblyopia; 2. Astigmatism > 2.50D; 3. Have undergone ophthalmic surgeries that affect binocular visual function; 4. Congenital color vision deficiency (color blindness); 5. Any ocular, systemic or other diseases that may be related to myopia or affect refractive development, such as Marfan syndrome, retinopathy of prematurity, diabetes; 6. Have any eye injuries or diseases of the cornea, conjunctiva or eyelid (including keratoconus and herpes keratitis), fundus lesions; 7. Have worn orthokeratology lenses or myopia control soft contact lenses within 1 month; Have received binocular visual function training within 1 month; Have received flip card training within 2 weeks; Have used low-concentration atropine eye drops within 3 months; 8. Photophobia or inability to open eyes normally; 9. Any physiological structure, skin or other conditions that may affect the wearing of glasses; 10. Have participated in other clinical trials within 4 weeks before enrollment; 11. The subject has acute or chronic diseases (including other current acute or chronic pain) or mental diseases, etc., which may increase the risk associated with participating in the study or using the experimental product, or may affect the interpretation of the study results. According to the judgment of the researcher or the designated person with medical qualifications, these conditions make the subject unfit for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in axial length (AL, in mm) at 12 months compared to the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in spherical equivalent (SE, in diopters, D) after mydriasis at 12 months.;The change in the accommodative response at 12 months compared to the baseline.;The change in choroidal thickness at 12 months relative to the baseline.;The defect rate of the instrument(s).;The changes in the positive relative accommodation and negative relative accommodation at 12 months compared to the baseline.;The incidence rate of adverse events.;The change in accommodative facility at 12 months compared to the baseline.;The changes in the exophoria amount for distant vision and near vision at 12 months compared to the baseline.;The change in the amplitude of accommodation at 12 months compared to the baseline.;The changes in the fusional range for distant vision and near vision at 12 months compared to the baseline.;The change in the AC/A value at 12 months compared to the baseline.;The change in the near point of convergence at 12 months compared to the baseline.; | — |
Countries
China
Contacts
Public ContactWang Kai
Peking University People's Hospital
Outcome results
None listed