Myopia
Conditions
Interventions
Control group:Wearing iBright?Rigid Gas Permeable Contact Lens for Orthokeratology
Experimental group:Wearing Star Diffusion? Dual-Effect Defocus Soft Contact Lenses
Sponsors
Beijing Childrens Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Age between 8 and 16 years, male or female; 2. After cycloplegic subjective refraction, spherical equivalent refraction of both eyes between -1.00 D and -6.00 D (inclusive); cylinder power <=1.50 D; anisometropia <= 1.00 D. 3. Best corrected visual acuity with spectacles of 0.0 LogMAR or better in each eye; best corrected visual acuity with contact lenses of 0.1 LogMAR or better in each eye. 4. Corneal curvature between 40.00 D and 46.00 D; 5. Able to comply with the contact lens wearing requirements during the study period, and to notify the investigator if discontinuation is necessary. 6. Patients and their guardians are willing to complete follow-up visits and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Premature infants (born before 30 weeks of gestation or with birth weight < 1500 g). 2. Use of any myopia control products (e.g., specially designed myopia control spectacles including frame lenses, orthokeratology lenses, rigid gas permeable contact lenses, multifocal contact lenses, progressive addition lenses; or atropine-like medications) within the past 1 month, or ongoing use at the time of enrollment, which in the investigator's judgment may affect the study results. 3. Participants who appear to have poor personal hygiene that, in the investigator's judgment, would preclude contact lens wear. 4. Presence of ocular or systemic abnormalities that may affect visual function or refractive development and that, in the investigator's judgment, would preclude contact lens wear. 5. History of intraocular surgery. 6. Presence of any contraindication to contact lens wear. 7. Manifest strabismus or binocular vision abnormality. 8. Known allergy to fluorescein, oxybuprocaine, proparacaine, tropicamide, or contact lens care products. 9. Use of any systemic or topical ophthalmic medications, or over-the-counter artificial tears, that may interfere with contact lens wear, tear film production, pupil size, accommodation, refractive status, or require lens removal during wear. 10. Keratoconus or irregular cornea. 11. History of decreased corneal sensitivity, corneal ulcer, corneal infiltration, ocular viral or fungal infection, or other recurrent ocular infections. 12. Any other conditions that, in the investigator's judgment, would preclude contact lens wear.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Choroidal thickness;Visual acuity;Visual quality;Slit lamp;Axial length;Refraction;Corneal endothelium;Intraocular pressure;Tear Film Evaluation; | — |
Countries
China
Contacts
Public ContactYu Jifeng
Beijing Childrens Hospital,Capital Medical University
Outcome results
None listed