Myopia
Conditions
Interventions
control group:Euclid Systems Corporation Orthokeratology
Sponsors
Affiliated Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The spherical degree of myopia in both eyes is between -1.00~-4.00D (including -1.00D and -4.00D); 2. If there is astigmatism in both eyes, the astigmatism along the rule should be less than or equal to 1.5D, and the astigmatism against the rule should be less than 1.00D; 3. Be able to understand the purpose of this clinical trial, participate voluntarily and sign the informed consent form by the patient or his legal guardian, and be able to complete the follow-up on time.
Exclusion criteria
Exclusion criteria: 1. Children under the age of 8 years; 2. Patients with systemic diseases that cause immunocompromised, or have an impact on orthokeratology (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.); 3. Combined with corneal abnormalities; such as active keratitis (such as corneal infection, etc.), corneal dystrophy, keratoconus, corneal leukoplakia, corneal hyposensitivity, etc., or have received corneal surgery, or have a history of corneal trauma; 4. Combined with other eye diseases, such as dacryocystitis, dry eye, conjunctivitis, blepharitis, uveitis and other inflammations, glaucoma, cataract, fundus disease, eye tumor, eye trauma, dominant strabismus patients; and any ocular disease that affects visual function; 5. Abnormal intraocular pressure ( intraocular pressure 21 mmHg or intraocular pressure difference >= 5 mmHg); 6. Subjects who have worn rigid contact lenses (including orthokeratology lenses) within the past 30 days; 7. Those who participated in clinical trials of other drugs or medical devices within 30 days before screening; 8. Subjects who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature during the study; 9. Those who have a history of ocular trauma or intraocular surgery; 10. Those with a history of allergy to contact lenses or contact lens care solutions; 11. Subjects with contraindications or unsuitable for wearing orthokeratology lenses; 12. Those who are unsupervised or cannot be followed up as ordered by the doctor; 13. Those with high sensitivity or high expectations; 14. Those who cannot understand the limitations and reversibility of orthokeratology to correct myopia; 15. There are pregnancy plans and women who are pregnant and breastfeeding; 16. Other conditions that the investigator judges that the patient is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Naked eye vision; | — |
Countries
China
Contacts
Public ContactChen Hao
Affiliated Eye Hospital of Wenzhou Medical University
Outcome results
None listed