myopia
Conditions
Interventions
Experimental group:Specialty-designed Orthokeratology Lens Group are precision-customized by incorporating adjustments to the Base Curve (BC). The daily wearing duration at night exceeds 8 hours.
Control group:Regular Orthokeratology Lens Group: The daily wearing duration at night exceeds 8 hours.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Patients with binocular myopia within -1.00D to -3.00D and astigmatism within -1.50D, who need orthokeratology lens fitting and voluntarily participate with informed consent signed by themselves or their legal guardians. 2. Patients whose visual acuity can reach 1.0 or above when corrected by frame glasses. 3. Patients with corneal curvature between 40.00D and 46.00D. 4. Patients not using medications that affect or may affect orthokeratology lens wearing and may alter normal ocular physiology. 5. Patients whose environmental, hygienic, and working conditions can meet the wearing requirements of orthokeratology lenses. 6. Patients with good compliance who can timely and regularly visit medical institutions as required.
Exclusion criteria
Exclusion criteria: 1. Patients under 8 years of age. 2. Use of medications that affect or may affect the wearing of orthokeratology lenses and may alter normal ocular physiology. 3. Patients who do not meet the inclusion criteria. 4. Active corneal infection or other acute/chronic anterior segment inflammations. 5. Use of medications that may cause dry eye or affect vision and corneal curvature, etc. 6. Corneal endothelial cell density less than 2,000 cells/mm². 7. Corneal abnormalities; obvious corneal epithelial fluorescence staining; history of corneal surgery or trauma; active keratitis (e.g., corneal infection), decreased corneal sensation. 8. Other ocular diseases: such as dacryocystitis, eyelid diseases and abnormalities, abnormal intraocular pressure, glaucoma, etc. 9. Systemic diseases causing immunodeficiency or affecting orthokeratology (e.g., acute/chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, etc.). 10. History of allergy to contact lenses or contact lens care solutions. 11. Pregnant women, lactating women, or those planning to become pregnant in the near future. 12. Patients deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Countries
China
Contacts
Public ContactZhujianfeng
Shanghai Eye Disease Prevention and Treatment Center
Outcome results
None listed