myopia
Conditions
Interventions
Two:Each subject's left and right eyes were randomly wore with bc 5mm or 6mm designed orthokeratology lenses
Sponsors
Tianjin Eye Hospital
Eligibility
Sex/Gender
All
Age
9 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Children and adolescents aged 9-12 years; 2. The bulboscopic degree of myopia in both eyes ranged from -1.00 to -4.00D (including -1.00D and -4.00D); 3. If astigmatism exists in both eyes, the normal astigmatism shall be less than or equal to 1.5D, and the inverse astigmatism shall be less than 1.00D; 4. The best corrected visual acuity of binocular subjective optometry is greater than or equal to 1.0; 5. Be able to understand the purpose of this clinical trial, voluntarily participate in and sign the informed consent form by their legal guardian, and be able to complete the follow-up on time.
Exclusion criteria
Exclusion criteria: 1. Suffering from systemic diseases that may affect the eyes, such as sinusitis, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis or other diseases that researchers believe cannot wear corneal plastic lenses; 2. There are some eye diseases: such as acute or chronic eye inflammation, catarrhal conjunctivitis in spring, glaucoma, dry eyes with drug intervention within 30 days; 3. Those who need to use therapeutic eye drops at the same time, including antibiotics, corticosteroids and compound eye drops containing corticosteroids; 4. Abnormal intraocular pressure (intraocular pressure 21mmHg or binocular intraocular pressure difference >= 5mmHg); 5. Those who wear corneal shaping glasses or hard contact lenses within 30 days (including those who participate in the clinical trial) or those who participate in the clinical trial of soft hydrophilic contact lenses within 10 days; 6. Those who have participated in drug clinical trials within 90 days; 7. Use drugs that affect the wearing of eyes and corneal contact lenses; 8. Corneal surgery within 1 year; 9. Eyelid abnormality or infection; 10. Clinically meaningful slit lamp findings (see Annex III for specific requirements); 11. Those who have used contact lenses and / or nursing products for allergy; 12. The examination results showed that subjects with contraindications or unsuitable for wearing corneal shaping glasses; 13. Those who are unable to carry out eye examination regularly (or the guardian of the minor is unable to accompany the minor regularly); 14. The corneal flat curvature was lower than 39.00d or higher than 48.00d; 15. Other active eye diseases; 16. Number of endothelial cells < 2500 cells/cm2; 17. Tear film rupture time is less than or equal to 5S; 18. The researcher believes that it is not suitable to participate in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Residual diopter (Expressed by equivalent sphericity); | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial length;Corneal topography;Corneal endothelial cell count;Contrast sensitivity;Corneal biomechanics;Visual quality questionnaire; | — |
Countries
China
Contacts
Public ContactChen Xiaoqin
Outcome results
None listed