Myopia
Conditions
Sponsors
Affiliated Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years old, gender is not limited; 2. In the subjective optometry, the degree of myopia in both eyes of the subject is within -4.00D (including -4.00D), and the degree of astigmatism is within 1.50D (including 1.50D); 3. Able to complete the 12-month follow-up; 4. Able to understand the purpose of the experiment, participate voluntarily and have the informed consent signed by himself or his legal guardian.
Exclusion criteria
Exclusion criteria: 1. One eye meets the selection criteria; 2. Suffering from systemic diseases causing low immunity, or affecting corneal shaping (such as previously suffering from diabetes, Down syndrome, rheumatoid arthritis, mental diseases, etc., suffering from acute and chronic sinuses within one year inflammation, etc.); 3. Those who have corneal abnormalities, have undergone corneal surgery or have a history of corneal trauma, and corneal sensory impairment; 4. Eyes with the following symptoms: (1) Bacterial, fungal, viral and other active corneal infections; (2) Acute, subacute or chronic inflammation and infection of the anterior segment other than the cornea, such as acute conjunctivitis and blepharitis; (3) Any eye disease, injury, or structural abnormality that affects the cornea, conjunctiva, or eyelid, such as dacryocystitis, glaucoma; (4) Dry eye syndrome (Fluorescein Breakup Time (FBUT) = grade 2; (6) Pathological eye congestion or redness that cannot be explained above. 5. Best corrected distance visual acuity lower than decimal visual acuity 1.0; 6. The flat curvature of the cornea (measured by a keratometer) is lower than 39.00D or higher than 48.00D; 7. Those with unstable diopter; 8. Irregular corneal astigmatism; 9. Overt strabismus; 10. Abnormal intraocular pressure (normal intraocular pressure ranges from 10 to 21 mmHg, and the difference between the intraocular pressure of both eyes should be less than 5 mmHg); 11. The density of corneal endothelial cells is less than 2000 /mm2; 12. Those who have worn orthokeratology lenses in the past 30 days; 13. Those who have a history of allergy to contact lenses or contact lens care solutions; 14. Use of dry eye treatment drugs within 1 month before screening, and drugs that may affect the wearing of the test product, cause dry eye, affect vision and corneal curvature, or change normal ocular physiology (immunosuppression) drugs, glucocorticoids, ocular hypotensive drugs, therapeutic mydriatics, etc.); 15. Those who have participated in other drug clinical trials within 3 months before screening, and participated in other medical device clinical trials within 30 days (if the medical device clinical trial participated is a soft contact lens clinical trial, only those who have participated in soft contact lens clinical trials within 1 week are excluded. Sexual contact lens clinical trial); 16. Those who are pregnant, lactating or plan to become pregnant in the near future; 17. Those who cannot understand the limitations and reversibility of orthokeratology lenses to correct myopia; 18. The examination results suggest that there are other contraindications for wearing or are not suitable for wearing orthokeratology lenses; 19. Other conditions that the researchers judge are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity;residual refraction; | — |
Countries
China
Contacts
Public ContactJiang Jun
Affiliated Eye Hospital of Wenzhou Medical University
Outcome results
None listed