myopia
Conditions
Interventions
experimental group:Wear defocused frame glasses (HOYA Xin Le Xue lenses)+myopia treatment device
control group:Wear defocused frame glasses (HOYA Xin Le Xue lenses)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Age 6 to 12 years old at the time of enrolment, gender is not limited; 2. Those who were diagnosed with myopia according to the Guidelines for Prevention and Treatment of Myopia of the General Office of the National Health Commission (Medical Letter of the National Health Office [2024] No. 168); 3. -0.75D= 5.0 in both eyes; 7. No other organic lesions affecting vision in both eyes; 8. Subjects and guardians can understand the purpose of this trial and sign an informed consent form; subjects can cooperate with the treatment and related ophthalmological examinations, and do not take other myopia prevention and control measures other than the study protocol during the whole study period;
Exclusion criteria
Exclusion criteria: 1. Diagnosed as having overt strabismus; 2. Far range oblique deviation+1 prism degree, close range oblique deviation0 prism degree; 3. Congenital color vision impairment (color blindness); 4. Any eye disease, ophthalmic surgery (including strabismus surgery), systemic or other diseases that may be related to myopia or affect refractive development, such as Marfan syndrome, retinopathy of premature infants, diabetes; 5. Eye injuries or corneal, conjunctival, or eyelid diseases (including keratoconus and herpetic keratitis) that have been assessed by researchers to affect the research results, as well as fundus lesions; 6. Other myopia prevention and control measures have been taken within the past 3 months, except for optical monocular lenses; 1.Have undergone binocular vision training within 7.1 months; 2.Conducted flip shooting training within 2 weeks; 8. Fear of light or inability to open eyes normally; 9. Any physiological structure, skin or other condition that may affect the wearing of glasses; 10. Participated in other clinical trials 4 weeks before enrollment; 11. The subjects suffer from acute or chronic diseases (including other currently existing acute or chronic pain) or mental illnesses, which may increase the risks associated with participating in the study or using experimental products, or may affect the interpretation of the study results. Based on the judgment of the researchers or designated personnel with medical qualifications, these conditions make the subjects unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| spherical equivalent lens after pupil dilation;choroidal thickness;Best corrected visual acuity(BCVA);Fundus photography;The morphological structure of each layer of the retina;Equipment defect rate;Adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactJie Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed