Myopia
Conditions
Interventions
Intervention Group:The experimental group wears Pnuotong High-Order Aspheric Soft Hydrophilic Contact Lenses, with an intervention duration of 1 year. Best corrected visual acuity and corresponding re
2. Best corrected visual acuity decreases by >= 2 lines compared to the previous visit
3. Refractive error changes by +/- 0.25^D, but best corrected visual acuity improves by more than 1 line
4. The investigator determines that an adjustment is necessary.
Control Group:The control group wears Pnuotong Orthokeratology Rigid Gas Permeable Contact Lenses, with an intervention duration of 1 year. Lens fitting is performed based on examination results, and
actual service life should follow the recommendations of the ophthalmologist, and proper cleaning and storage procedures as outlined in the product instructions must be strictly adhered to.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 8 and 15 years, regardless of gender. 2. After cycloplegic refraction, the spherical equivalent of both eyes ranges from -0.75 D to -6.00 D (inclusive), with anisometropia 4.00 D, the ratio of the absolute value of the spherical power to the absolute value of the cylindrical power must be >= 4:1. 4. Best corrected visual acuity (BCVA) with spectacles is 1.0 (20/20) or better in each eye; best corrected visual acuity with contact lenses is 0.8 (20/25) or better in each eye. 5. Corneal curvature ranges from 40.00 D to 46.00 D. 6. Ability to comply with the wear schedule during the study period (soft contact lenses: at least 10 hours daily; orthokeratology lenses: 8–10 hours nightly). 7. The patient and their legal guardian are willing to complete all study visits and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Premature birth (born before 30 weeks of gestation or with a birth weight < 1500 g) 2. Use of any myopia control intervention (e.g., specially designed spectacles or contact lenses including orthokeratology lenses, RGP lenses, multifocal contact lenses, or progressive addition lenses) or atropine-based pharmaceuticals within the past month, which in the investigator's judgement could affect the trial outcomes. 3. Poor personal hygiene, as determined by the investigator, rendering the subject unsuitable for contact lens wear. 4. Ocular or systemic abnormalities that, in the investigator's opinion, could affect visual function or refractive development. 5. Any contraindications for contact lens wear. 6. Manifest strabismus. 7. Keratoconus or irregular cornea. 8. Known hypersensitivity to fluorescein, oxybuprocaine, proparacaine, tropicamide, or any components of the contact lens care products. 9. Use of any systemic or topical ocular medication (including over-the-counter artificial tears) that could interfere with contact lens wear, tear film production, pupil size, accommodation, refractive status, or that would require lens removal during wear time. 10. History of reduced corneal sensitivity, corneal ulcer, corneal infiltration, viral or fungal ocular infection, or other recurrent ocular infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the change in axial length from baseline between the two groups for the right and left eyes after one year of lens wear; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected Visual Acuity (UCVA) at Each Follow-up Visit After Orthokeratology Lens Wear;Corrected visual acuity with lenses at each follow-up visit after soft hydrophilic contact lens wear;Refraction at each follow-up visit before and after lens wear;Choroidal thickness at each follow-up visit before and after lens wear;Corneal topography at each follow-up visit before and after lens wear;Higher-order aberrations (HOAs) at each follow-up visit before and after lens wear;Subjective visual quality questionnaire scores at each follow-up visit before and after lens wear; | — |
Countries
China
Contacts
Public ContactWang Kai
Peking University People's Hospital
Outcome results
None listed