Refractive error
Conditions
Interventions
Experimental group:Wear rigid breathable contact lenses for orthokeratology produced by Mingyue Lenses Co., LTD. (Model: MYNK, specification: None)
Sponsors
Eye & ENT Hospital of Fudan University/West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. 8 years old = age =40 years old, gender is not limited; 2. Myopia =4.00D, and normal astigmatism < 1.75D, inverse astigmatism, oblique axis astigmatism < 1.00D; 3. Those who are expected to complete all follow-up tasks and can wear lenses as required; 4. Be able to understand the purpose of the trial, be willing to participate in the clinical trial, and sign the informed consent, in which the subjects under the age of 18 also require their legal guardians to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Primary optometry, the best corrected visual acuity 48.00D; 10. Unstable diopter; 11. Irregular corneal astigmatism; 12. Dominant strabismus; 13. Abnormal IOP (IOP 21mmHg); 14. Tear film rupture time test results =5s; 15. The polymorphic changes of corneal endothelium were evaluated as grade 4; 16. Researchers believe that fundus abnormalities affecting contact lens wearing; 17. Patients who have worn rigid breathable contact lenses or rigid contact lenses for orthokeratology within 1 month before screening (including participants in clinical trials); 18. Participants who have participated in drug clinical trials within 3 months before screening; 19. Allergic patients who have used contact lenses and/or care products; 20. Women who are pregnant, breastfeeding or planning to become pregnant (pregnancy testing is required for women of childbearing age); 21. Unable to understand the limitations and reversibility of orthokeratology to correct myopia; 22. The examination results indicate that there are other contraindications to wear or are not suitable for wearing orthokeratology glasses; 23. Other circumstances in which the investigator determines that the subject is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product effectiveness at 30 days of wear; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;diopter;Important parameters related to corneal topography (flat K, steep K, ?K); | — |
Countries
China
Contacts
Public ContactZhou Xingtao/Liu Longqian
Eye & ENT Hospital of Fudan University/West China Hospital of Sichuan University
Outcome results
None listed