Myopia
Conditions
Interventions
experimental group:Wear orthokeratology lenses (Mode: Ortholens)
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age =8 weeks old, both sexes; 2. The contact lens diopter of both eyes of the patients was within the applicable parameters of the study lenses (myopic diopter between -0.50D and -4.00D (including -0.50D and -4.00D astigmatism diopter within 1.50D (including 1.50D) 3. Able to complete 12 months of follow-up; 4. Able to understand the purpose of the trial, voluntarily participate in the study, and informed consent was signed by the subject himself or his legal guardian. Note: Minors aged 8 years or older but under 18 years old should be subject to informed consent from themselves and their guardians Informed consent was signed. Adults over 18 years old as subjects should obtain their own informed consent and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. One eye met the inclusion criteria; 2. Immunocompromised patients with systemic diseases or orthokeratology (e.g. previous diabetes mellitus) Disease, Down syndrome, rheumatoid arthritis, mental illness, etc., with acute and chronic sinuses within 1 year Inflammation and so on 3. Patients with corneal abnormalities, previous corneal surgery or a history of corneal trauma or decreased corneal sensation 4. The following ocular conditions are present: Acute anterior segment Subacute or chronic inflammation or infection; Any eye condition, injury, or structural abnormality that affects the cornea, conjunctiva, or eyelids (e.g., dacryocystitis, acute conjunctivitis, blepharitis and other inflammations, glaucoma, etc. Dry eye (TBUT=2 seconds Active bacterial, fungal, viral, and other corneal infections Pathological redness or redness of the eyes. 5. Patients with best corrected distance visual acuity less than fractional visual acuity 1.0; 6. Patients with refractive instability; 7. Patients with irregular corneal astigmatism; 8. Patients with overt strabismus; 9. Abnormal intraocular pressure (The normal range of intraocular pressure is 10-21 mmHg, the difference in intraocular pressure between the two eyes should be less than 5 mmHg; 10. Patients with corneal endothelial cell density less than 2000 cells /mm2; 11. Patients who have worn orthokeratology lenses within the past 30 days; 12. Patients with a history of allergy to contact lenses or contact lens solution; 13. Medications that may cause dry eye or affect vision and corneal curvature are being used or required during the study (immunosuppressant, glucocorticoid, intraocular pressure lowering drugs, etc.) 14. Enrollment in other drug clinical trials within 3 months before screening, and enrollment in other medical device clinical trials within 30 days before screening; 15. Pregnant, lactating or planning to become pregnant in the near future; 16. Unable to follow doctor's advice; 17. Unable to understand the limitations and reversibility of orthokeratology for myopia; 18. Findings suggest other contraindications to wear (e.g., significant fluorescent staining of the corneal epithelium or inappropriate fitting of the orthokeratology lenses); 19. Other circumstances in which the patient was judged by the investigator to be ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Residual diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Product efficiency when wearing glasses for 30 days;Diopter; | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed