Myopia
Conditions
Interventions
RC-Optimized Design Group:RC-optimized orthokeratology wear
Standard Design Group:Standard orthokeratology wear
Sponsors
Tianjin Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. The age is greater than 8 years and less than 12 years; 2. Spherical power: -0.75 D to -4.50 D (both eyes); Astigmatism: WTR = 2:1; Best-corrected visual acuity >= 1.0 (each eye); 3. Anisometropia (SER) <= 1.00 D; 4. They were volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians
Exclusion criteria
Exclusion criteria: 1. History of corneal surgery within the past year; 2. Eyelid abnormalities or infections; 3. Clinically significant slit-lamp examination findings (specific requirements detailed in Protocol Appendix III); 4. Any other active ocular disease; 5. Endothelial cell density 21 mmHg, or an interocular IOP difference >= 5 mmHg); 9. Specific ocular conditions: acute or chronic ocular inflammation, vernal keratoconjunctivitis, glaucoma, or use of medication for dry eye within the past 30 days; 10. Concurrent use of therapeutic ophthalmic drops, including antibiotics, corticosteroids, or compound eye drops containing corticosteroids; 11. Use of any medication that may affect ocular health or contact lens wear; 12. Flat corneal curvature (K) 48.00 D; 13.History of orthokeratology or rigid gas permeable contact lens wear within the past 30 days (including trial participants) or participation in soft hydrophilic contact lens trials within the past 10 days; 14. Participation in any drug clinical trial within the past 90 days; 15. History of allergy to contact lenses and/or lens care products; 16. Examination findings indicating contraindications or unsuitability for orthokeratology lens wear; 17. Only one eye meeting the inclusion criteria; 18. Inability to attend regular follow-up eye examinations (or, for minors, inability of a guardian to accompany them regularly); 19. Any other reason the investigator considers the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate, defined as achieving uncorrected visual acuity >=0.8 and residual refraction (in spherical equivalent) within +/-0.50 D;Visual Quality Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial length;Intraocular pressure;Contrast Sensitivity;Corneal endothelial cell parameters;Wavefront aberration;Retinal Defocus; | — |
Countries
China
Contacts
Public ContactYang Xiaoyan
Tianjin Eye Hospital
Outcome results
None listed