Myopia
Conditions
Interventions
Group A:Group A used the test product for the first 6 months, eluted for 1 month, and then used the control product for 6 months. Clinical observation was carried out for a total of 13 months. The tes
Group B:Group B was treated with control product for the first 6 months, eluted for 1 month, and then treated with test product for 6 months. Clinical observation was carried out for a total of 13 mon
Sponsors
Affiliated Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6-12 years old, with the written consent of the guardian, regardless of gender; 2. The objective optometric equivalent spherical degree in both eyes with cycloplegia was between -0.50D (inclusive) and -6.00D (inclusive) (Based on the mean value of objective optometry for ciliary paralysis); 3. Absolute value of astigmatism in both eyes =1.50D (based on the mean value of objective optometry after ciliary paralysis); 4. Best corrected visual acuity >= 4.9 in both eyes; 5. Voluntarily participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of intraocular surgery; 2. Clinically abnormal slit-lamp examination findings; 3. Fundus examination results >= grade 2; 4. Abnormal intraocular pressure (intraocular pressure 21 mmHg or intraocular pressure difference > 5 mmHg); 5. Combined with other eye diseases, such as various inflammation such as uveitis, glaucoma, cataract, fundus disease, eye tumors, and any eye lesions affecting visual function; 6. Patients with systemic diseases that cause immunosuppression (such as diabetes, Down syndrome, rheumatoid arthritis, psychiatric patients or other diseases that researchers deem unsuitable for taking the product); 7. Patients with sucrose intolerance, fructose intolerance, glucose-galactose malabsorption syndrome or sucrose/isomaltoolase deficiency; 8. Only one eye meets the inclusion criteria; 9. Those who cannot have regular eye examination; 10. Have participated or are currently participating in any clinical trial for myopia control within three months; 11. Have used or are currently using hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, light feeding instruments, low concentration atropine drugs, etc. within three months; 12. Dominant strabismus; 13. The researchers determined that the candidates could not be selected.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change of equivalent diopter after ciliary muscle paralysis;corneal curvature; | — |
Primary
| Measure | Time frame |
|---|---|
| Elongation of axial length; | — |
Countries
China
Contacts
Public ContactWu Hao
Affiliated Eye Hospital of Wenzhou Medical University
Outcome results
None listed