Myopia
Conditions
Interventions
control group:No intervention
experience group:Wear glasses with specially designed circular cylindrical lens modulation lenses around the central flat light
Sponsors
Wenzhou Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 9 Years
Inclusion criteria
Inclusion criteria: In line with the principle of fairness, respect and maximizing the benefits of the subjects, we should ensure safety, health and avoid injuries as much as possible. 1. Age >= 6 and = 5.0; 5. Voluntarily participate in this clinical trial and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Have a history of intraocular surgery; 2. Clinically abnormal slit lamp findings (see Appendix 1); 3. Fundus examination results >= Level 2 (see Appendix 1) 4. Abnormal intraocular pressure (intraocular pressure21 mmHg or binocular intraocular pressure difference>5 mmHg); 5. Concomitant with other eye diseases, such as uveitis and various inflammatory diseases, glaucoma, cataract, fundus disease, eye tumors, 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. Only one eye meets the inclusion criteria; 8. Those who cannot undergo regular eye examinations; "Within three months, I have participated in any clinical research trial on myopia control, and have previously used or are currently using rigid corneal contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses, and other specially designed myopia control lenses, light feeding devices, and low concentration atropine drugs;"; 10. Dominant strabismus; The amount of esophoria at a distance or near distance >= 20 degrees of prism; The investigator determined that the candidate could not be selected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ocular axis length from baseline at 12 months +/- 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| During the follow-up process, the changes in ocular axis length from baseline at other time points except for the main index follow-up points;During the follow-up period, after ciliary muscle paralysis, the change value of objective refraction equivalent spherical diopter from baseline;Changes in the equivalent spherical diopter of subjective refraction from baseline during follow-up;The incidence of myopia during follow-up. Myopia occurs when the objective refractive equivalent spherical diopter is equal to or exceeds -0.50D after cycloplegia; | — |
Countries
China
Contacts
Public ContactXinting Liu
Outcome results
None listed