myopia
Conditions
Interventions
Orthokeratology Lens Group:Orthokeratology Lens
Low-Intensity LED Red Light Group:Low-Intensity LED Red Light
Combined Low-Intensity LED Red Light and Orthokeratology Lens Group:Combined Low-Intensity LED Red Light and Orthokeratology Lens
Sponsors
Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Written informed consent has been obtained from the children and their legal guardians. 2.Children aged 8 to 12 years (inclusive). 3.Cycloplegic refraction with autorefractor showing spherical equivalent: -6.00D = spherical equivalent = -1.00D in both eyes. 4.Cycloplegic refraction with autorefractor showing astigmatism = 2.50D in both eyes. 5.Best corrected visual acuity (BCVA) of = 0.8 in both eyes (logMAR 0.1; Snellen 20/25). 6.Anisometropia = 1.50D between both eyes. 7.Meeting the fitting requirements for orthokeratology lenses, and parents or guardians are able to manage the lens wearing and care procedures. 8.Willing to refrain from other treatment methods during the study period.
Exclusion criteria
Exclusion criteria: 1.Subjects who may have eye diseases affecting vision or refractive errors (e.g., cataracts or other lens injuries, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.). 2.Patients with photosensitivity, Tourette syndrome, ADHD, and psoriasis; 3.Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardio-pulmonary dysfunction, severe liver or kidney dysfunction, acute or chronic sinusitis, or a history of diabetes. 4.Having manifest strabismus or any other pathological changes or acute inflammatory diseases of the eyes in both eyes; 5.Currently using medications that may cause dry eye or affect vision and corneal curvature. 6.Corneal endothelial cell density less than 2000 cells/mm². 7.Abnormal cornea: significant corneal epithelial fluorescein staining; history of corneal surgery or corneal trauma; active keratitis (e.g., corneal infection); reduced corneal sensitivity. 8.Other eye diseases: such as dacryocystitis, eyelid diseases and abnormalities, abnormal intraocular pressure, and glaucoma. 9.History of allergy to contact lenses or contact lens care solutions. 10.Use of myopia control treatments within the past 3 months, including pharmacological treatments (e.g., atropine or pirenzepine) and device treatments (e.g., orthokeratology lenses, multifocal soft lenses, multifocal rigid lenses, or functional frame glasses).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sphere equivalent after cycloplegia;Optical Coherence mography;Best corrected visual acuity;Adverse event; | — |
Countries
China
Contacts
Public ContactWang Xiaojuan
Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
Outcome results
None listed