Refractive error
Conditions
Interventions
Experimental group:Wear rigid breathable contact lens for orthokeratology produced by Hangzhou Emei Mirror Medical Equipment Co., LTD. (Model: night wear type, specification: none)
Sponsors
Eye & ENT Hospital of Fudan 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. The degree of myopia is within -4.00D (inclusive), the cylindrical degree should be less than 1.75D, and the anti-standard astigmatism should be less than 1.00D; 3. Those who are expected to be able to complete all follow-up tasks and wear lenses as required; 4. Able to understand the purpose of the trial, voluntarily participate in this clinical trial, and sign the informed consent form, in which subjects under the age of 18 are required to sign the informed consent form by their legal guardians at the same time. 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, voluntarily participate in the clinical trial, and sign the informed consent, in which the subjects under 18 years old also require their legal guardians to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjective refraction, best corrected visual acuity 48.00D; 10. Those with unstable diopters; 11. Irregular corneal astigmatism; 12. Overt strabismus; 13. Abnormal intraocular pressure (intraocular pressure 21 mmHg, or intraocular pressure difference between the two eyes >=5mmHg); 14. The tear film break-up time test result <= 5s; 15. Those whose corneal endothelial pleomorphism changes were evaluated as grade 4; 16. Those who have worn rigid gas permeable contact lenses or rigid contact lenses for orthokeratology within 1 month before screening (including those who participated in clinical trials); 17. Those who have participated in drug clinical trials within 3 months or medical device clinical trials within 1 month before screening; 18. Those who have used contact lenses and/or care products for allergies; 19. Pregnant women, lactating women, or those who are planning to become pregnant; 20. Those who are unable to understand the limitations and reversibility of orthokeratology lenses in correcting myopia; 21. Those who have other contraindications to wearing orthokeratology lenses or are not suitable for wearing orthokeratology lenses due to the results of the examination; 22. Other situations where the investigator judges 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 Chen Zhi
Eye & ENT Hospital of Fudan University
Outcome results
None listed