Ametropia
Conditions
Interventions
Sponsors
Eys Hospital,WMU Zhejiang Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age =8 years old, gender is not limited; 2. The subject's binocular diopter should be within the applicable parameters of the study lens (myopia degree within -4D~-6D (excluding -4D, including -6D), astigmatism degree within -1.5D (including -1.5D)); 3. Be able to complete the 12-month follow-up, and be able to correctly operate and care for the lens as required during the wearing period (for minors, the guardian can provide corresponding help to complete the operation and care); 4. Be able to understand the purpose of the experiment, participate voluntarily and have the informed consent signed by the subject himself or his legal guardian.
Exclusion criteria
Exclusion criteria: 1. One eye meets the inclusion criteria; 2. Patients with systemic diseases that cause immunosuppression or have an impact on orthokeratology (such as acute and chronic sinusitis (within 2 years), diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.); 3. Patients with corneal abnormalities, who have previously undergone corneal surgery, or who have a history of corneal trauma, corneal hypoperception, or corneal epithelial defect; 4. There are the following eye conditions: • Acute, subacute, or chronic inflammation or infection of the anterior segment; • Any eye disease, injury or structural abnormality affecting the cornea, conjunctivitis or eyelid, such as dacryocystitis, acute conjunctivitis, abnormal eye pressure, blepharitis, uveitis and other inflammation, glaucoma and lacrimal organ disease; • Dry eye (tear film rupture time TBUT=5 seconds); • Bacterial, fungal, viral and other active corneal infections; • Pathological eye congestion or redness. 5. Any patient whose best corrected visual acuity at a glance is less than 5.0 (5 points of visual acuity); 6, the flat curvature of the cornea is not between 39.00D and 48.00D; 7. Patients with unstable diopter; 8. Patients with irregular corneal astigmatism; 9. Patients with strabismus; 10. Patients with abnormal IOP (normal IOP ranges from 10 to 21 mmHg, and the difference between the two eyes should be less than 5 mmHg); 11. Patients with corneal endothelial cell density less than 2000 /mm2; 12. Patients who have worn orthokeratology lenses within the past 30 days; 13. Patients with a history of allergy to contact lens or contact lens solution; 14. Patients who are using or need to use drugs (immunosuppressants, glucocorticoids, IOP, etc.) that may cause dry eyes or affect vision (except mydriatic drugs used before vision tests) and corneal curvature during the planned study; 15. Participants participating in other drug clinical trials within 3 months before screening, and participating in other medical device clinical trials within 30 days; 16. Pregnant women, breastfeeding women or those planning to become pregnant in the near future; 17, can not follow the instructions of the ophthalmologist operation or regular visits; 18, unable to understand the limitations and reversibility of orthokeratology to correct myopia; 19, the examination results suggest that there are other contraindications to wear (such as obvious fluorescent staining of corneal epithelium) or is not suitable for wearing orthokeratology lens patients; 20, unable to carry out their own health management, can not meet the health conditions required for the use of plastic glasses patients; 21, engaged in a long time to maintain normal vision of the occupation, and when the vision changes, it is difficult to rest occupation patients; 22, the environmental conditions, health conditions and working conditions can not meet the requirements of the wearing of test instruments; 23. Other conditions for which the investigator determined the patient was not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| uncorrected visual acuity and diopter change (subject level); | — |
Secondary
| Measure | Time frame |
|---|---|
| uncorrected visual acuity and diopter change (Eye count level);uncorrected visual acuity(UCVA);diopter;Important parameters of corneal topographic map; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eys Hospital,WMU Zhejiang Eye Hospital
Outcome results
None listed