Ametropia
Conditions
Interventions
Test group:Wear multipoint micro lens defocusing lens
Control group:Wear optical single focus lenses
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years and <= 13 years, with the written consent of the guardian, regardless of gender; 2. The equivalent spherical diopter of objective optometry under mydriasis of both eyes is between -0.75 D (inclusive) and -5.00D (inclusive), the astigmatism is less than or equal to 1.50D, and the anisometropia of both eyes after the equivalent spherical lens is <= 1.50D; 3. The best corrected visual acuity of binocular subjective optometry is greater than or equal to 1.0; 4. Volunteer to participate in this clinical trial and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Have a history of ocular trauma or intraocular surgery; 2. Clinically significant slit lamp findings (see Appendix 1); 3. Fundus examination results >= Grade 2 (see Appendix 1); 4. Abnormal intraocular pressure (intraocular pressure 21 mmHg or bilateral intraocular pressure difference >= 5 mmHg); 5. Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumor, eye trauma, and dominant strabismus; And any eye disease affecting visual function; 6. Patients with systemic diseases that cause low immunity (such as acute and chronic sinusitis, diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); 7. Those who have participated in drug clinical trials within three months, or/and have used any myopia control products, such as specially designed myopia control lenses such as corneal shaping lenses, multifocal contact lenses, progressive multifocal lenses, atropine drugs, etc; 8. Only one eye meets the inclusion criteria; 9. Those who cannot perform eye examination regularly; 10. Dominant strabismus; 11. Those who cannot be selected as determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of equivalent spherical diopter (SER) of objective optometry after cycloplegia for 12 months ± 30 days compared with the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| SER and eye axis length (AL) at different time points, SER and AL changes from baseline; | — |
Countries
China
Contacts
Public ContactYang Xiao
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed