Myopia
Conditions
Interventions
Group 1:Defocus soft contact lens
Group 2:Single focus soft contact lens
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
7 Years to 11 Years
Inclusion criteria
Inclusion criteria: Subjects should read (or have someone read it for them), understand and sign the children's informed consent statement, and keep a copy of the fully signed informed consent form. Parents or legal guardians of the subjects should read, understand and sign the informed consent form, and keep a copy of the fully signed informed consent form. Subjects are willing to follow the instructions of this clinical research protocol. In line with the principle of fairness, respect and maximizing the benefits of subjects, we should be safe and healthy and avoid injuries as much as possible. 1. The age is over 7 years old and under 11 years old, and the written consent of the guardian is required, regardless of gender; 2. The spherical diopters of objective optometry under mydriasis of both eyes are between -1.00D (inclusive) and -5.00D (based on the average value of three repeated objective optometry examinations), and the best corrected visual acuity of subjective optometry of left and right eyes is not less than 1.0; 3. Cylindrical power, astigmatism is not less than 1.00 D; 4. Willing to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of corneal surgery or eye surgery within 1 year; 2. Eyelid abnormality or infection; 3. There are other active eye diseases; 4. Clinically meaningful findings of slit lamp inspection (see Annex III); 5. The results of corneal endothelial examination do not meet the requirements of the scheme in Appendix III; 6. The fundus examination do not meet the requirements of the scheme in Annex III; 7. Abnormal intraocular pressure (intraocular pressure less than 10mmHg, mare than 21mmHg or binocular intraocular pressure difference not less than 5mmhg); 8. The Breaking-up time of tears is not more than 5 seconds; 9. Suffering from certain eye diseases: including acute or chronic inflammation of the eye, catarrhal conjunctivitis in spring, glaucoma, and dry eye with drug intervention within 30 days; 10. Suffering from systemic diseases that may affect the eyes, incliuding sinusitis, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis or other diseases that researchers believe cannot wear soft hydrophilic contact lenses; 11 To use the therapeutic eye drops at the same time, including antibiotics, corticosteroids and compound eye drops with corticosteroids; 12. Use drugs that affect the eyes and wearing of corneal contact lenses; 13. Those who have participated in clinical trials of drugs within 3 months; 14. Those who have been allergic to contact lenses and/or care products; 15. Only one eye meets the selection criteria; 16. Those who cannot have regular eye examinations; 17. The candidate has participated in any clinical trial of myopia control, and has used or is currently using specially designed myopia control lenses such as orthokeratology lenses, multifocal contact lenses and progressive multifocal lenses, and atropine drugs. 18. The researcher evaluates that there are any treatments that conflict with contact lens wearing. 19. The researcher decided that the candidate could not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical equivalent refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| axial length;Choroidal thickness;Distant vision with glasses; | — |
Countries
China
Contacts
Public ContactWEI Ruihua
Tianjin Medical University Eye Hospital
Outcome results
None listed