refractive error
Conditions
Interventions
Experimental group:Wearing regular astigmatism stimulation technology lenses
Control group:Wearing Haoya Xinle Xue multi-point myopia defocus lenses
Sponsors
Eye Hospital,WMU
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. If the age is = 8 years old and = 13 years old, written consent from the guardian is required, regardless of gender; 2. Under binocular astigmatism, the equivalent spherical diopter of objective refraction is between = -0.75 D and = -5.00 D, with astigmatism = 1.50D and refractive error of both eyes = 1.50D after the equivalent spherical diopter; 3. The best corrected visual acuity for binocular subjective optometry is = 5.0; 4. Voluntarily participate in this clinical trial and sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of eye trauma or intraocular surgery that affects the wearing of frame glasses; 2. Clinically significant findings from slit lamp examination (see Appendix 1 of the protocol); 3. Abnormal fundus examination results (see Appendix 1 of the plan); 4. Abnormal intraocular pressure (intraocular pressure21mmHg); 5. Patients with combined other eye diseases, such as uveitis and other inflammations, glaucoma, cataracts, fundus diseases, eye tumors, eye injuries, and overt strabismus; And any eye lesions that affect visual function; 6. Patients with systemic diseases that cause low immunity (such as 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 non ophthalmic drug clinical trials within three months and have previously participated in ophthalmic drug or device clinical trials; 8. Have used any myopia control products, such as corneal shaping lenses, multifocal contact lenses, progressive multifocal lenses, and other specially designed myopia control lenses; Used atropine drugs or other medications, but not including dilated pupil drugs used during refractive examinations; 9. Only those who meet the inclusion criteria in one eye; 10. Those who cannot undergo regular eye examinations; 11. The researcher determined that those who were unable to be selected due to other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in axial length (AL) from baseline within ± 30 days of December; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in objective refractive equivalent spherical power (SER) from baseline after ciliary muscle paralysis at ± 30 days in June;The change in objective refractive equivalent spherical power (SER) from baseline after ciliary muscle paralysis at ± 30 days in December;Changes in axial length (AL) from baseline within ± 30 days in June; | — |
Countries
China
Contacts
Public ContactXinjie Mao
Wenzhou Medical University Eye Hospital
Outcome results
None listed