myopia
Conditions
Interventions
trial group:wearing the trigid gas permeable contact Lenses for orthokeratology (model: KTOL)
control group:wearing the trigid gas permeable contact Lenses for orthokeratology (model: NOR)
Sponsors
Eye Hospital, WMU Zhejiang Eyehospital
Eligibility
Sex/Gender
All
Age
8 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age =8 years old, age =45 years old, regardless of gender,with written consent from their guardian required for those under 18 years old ; 2.The diopter of myopia is between -1.00D and -4.00D (including -1.00D and -4.00D), and the optimal corrected visual acuity for left and right subjective refraction is greater than or equal to 5.0; 3.Corneal curvature ranging from 40.00D to 46.00D; 4.Column mirror degree: The normal astigmatism should be less than 1.75D, and the reverse astigmatism should be less than 1.00D.
Exclusion criteria
Exclusion criteria: 1. The density of corneal endothelial cells is less than 2000/mm2; 2. Dry eye syndrome ( tear film rupture time test results less than or equal to 5 seconds); 3. Abnormal intraocular pressure (intraocular pressure21mmHg, or binocular intraocular pressure difference = 5mmHg); 4. Irregular corneal astigmatism; 5. Explicit strabismus; 6. Bacterial, fungal, viral and other active corneal infections; 7. Using drugs that may cause dry eyes or affect the eyeball or affect vision or corneal curvature, such as immunosuppressants, glucocorticoids, and lowering intraocular pressure Drugs, etc.); 8. Corneal abnormalities; Having undergone corneal surgery or a history of corneal trauma; Decreased corneal perception; 9. Other eye diseases, such as dacryocystitis, eyelid diseases, eyelid abnormalities or infections, and glaucoma, should be ruled out according to the judgment of the researcher; 10. People with systemic diseases that cause low immunity or affect corneal shaping (such as acute and chronic sinusitis, diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, psychotic patients, etc. within one year, or other diseases that researchers believe cannot wear hard gas permeable contact lenses for corneal shaping; 11. Have a history of allergies to contact lenses or contact lens care solutions; 12. Pregnancy, lactation, or planned pregnancy in the near future; 13. After considering the corneal parameters, morphological characteristics, and refractive examination results of the examination results, the researchers believe that subjects who wear rigid breathable contact lenses for corneal shaping are not allowed to wear them; 14. Those who have worn rigid breathable contact lenses or rigid contact lenses for corneal shaping within 30 days, or those who have worn soft hydrophilic contact lenses within 10 days; 15. Those who participate in clinical trials of other drugs three months before screening, and those who participate in clinical trials of other medical devices within 30 days; 16. Only those who meet the inclusion criteria for one eye; 17. Poor compliance and inability to visit medical institutions in a timely and regular manner as required. 18. Other situations where the researcher determines that the patient is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency of wearing products for 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| UCVA;diopter; Corneal Topography; | — |
Countries
China
Contacts
Public ContactXinjie Mao
Eye Hospital, WMU Zhejiang Eyehospital
Outcome results
None listed