Myopia
Conditions
Interventions
Trial Group:Optimized Reverse Curve (RC) Design Orthokeratology Lens
Control Group:Conventional orthokeratology lens
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Age 8–14 years, regardless of sex, with written informed consent from a legal guardian; 2. Bilateral spherical refractive error between -1.00 D and -4.00 D after cycloplegia, with-the-rule astigmatism = 1.0 in both eyes with spectacles; 4. Ability to understand the purpose of the clinical trial, willingness to participate voluntarily, provision of signed informed consent by a legally authorized representative (LAR), and ability to complete scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Subjects with systemic diseases that may affect the eyes, such as sinusitis, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, or other conditions deemed by the investigator as contraindications for orthokeratology lens wear; 2. Subjects with certain ocular disorders: acute or chronic ocular inflammation, vernal keratoconjunctivitis, glaucoma, dry eye requiring pharmacological intervention within 30 days; 3. Subjects requiring concurrent use of therapeutic eye drops, including antibiotics, corticosteroids, or combination eye drops containing corticosteroids; 4. Abnormal intraocular pressure (IOP 21 mmHg, or inter-eye IOP difference >= 5 mmHg); 5. Subjects who have worn orthokeratology lenses or rigid contact lenses within 30 days (including those participating in clinical trials), or subjects who have participated in soft hydrogel contact lens clinical trials within 10 days; 6. Subjects who have participated in drug clinical trials within 90 days; 7. Subjects using medications affecting the eyes or contact lens wear; 8. History of corneal surgery within 1 year; 9. Eyelid abnormalities or infections; 10. Clinically significant findings on slit-lamp examination; 11. Subjects with history of allergy to contact lenses and/or care products; 12. Subjects with contraindications or unsuitability for orthokeratology lens wear as indicated by examination results (e.g., suspected keratoconus or keratoconus in thin corneas); 13. Subjects unable to attend regular eye examinations (or guardians of minors unable to accompany minors for regular examinations); 14. Corneal flat keratometry 48.00 D; 15. Subjects with other active ocular diseases; 16. Endothelial cell count < 2,500 cells/mm^2; 17. Tear film break-up time <= 5 seconds; 18. Subjects deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in axial length (AL) from baseline at 12 months of lens wear; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal topography at 12 months of lens wear;Visual quality assessment at 12 months of lens wear;Peripheral retinal defocus (MRT) at 12 months of lens wear; | — |
Countries
China
Contacts
Public ContactZhang Yu
Peking University Third Hospital
Outcome results
None listed