myopia
Conditions
Interventions
Test group :Defocus contrast dual-effect myopia management lenses (D.C.D.E)
Control group:Defocus Incorporated Multiple Segments (DIMS) lenses
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age >=6 years old and =-6.00 D, astigmatism = 5.0; 4.Accompanied by a parent or guardian who was able to read and understand the contents of the informed consent form and signed the informed consent form voluntarily together with the child himself or herself.
Exclusion criteria
Exclusion criteria: 1. Have a history of ocular trauma or intraocular surgery affecting the wearing of frame glasses 2. The fundus examination was abnormal 3. Abnormal intraocular pressure (IOP 21mmHg) 4. Patients with other ocular diseases, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, ocular tumors, ocular trauma, overt strabismus; And any eye disease affecting the visual function of the eye 5. Immunocompromised patients with systemic diseases (e.g., diabetes, Down's syndrome, rheumatoid arthritis, psychiatric patients, or other conditions considered by researchers to be inappropriate for glasses) 6. Those who had participated in non-ophthalmic drug clinical trials within three months or had participated in ophthalmological drug or device clinical trials in the past 7. used any myopia control products, such as orthokeratology lenses, multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses; The use of atropine drugs,used red light therapy equipment, etc., does not include mydriatic drugs used during refractive examination 8. Only those with one eye meeting the inclusion criteria 9. Those who cannot undergo regular eye examinations; 10. Persons who could not be enrolled otherwise according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in axial length changes between the two groups of subjects without cycloplegia at 12 months of lens wear ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Curvature of cornea ;Cycloplegic subjective refraction spherical equivalent ;Cycloplegia objective refraction ;Axial length of the eye without ciliary muscle paralysis ;Non-cycloplegic objective refraction spherical equivalent ;Choroidal thickness and blood flow;Anterior chamber depth;Spectacle wearing time; | — |
Countries
China
Contacts
Public ContactMao Xinjie
Eye Hospital of Wenzhou Medical University
Outcome results
None listed