Myopia
Conditions
Interventions
Group 1:compression factor=1.75D
Group 2:compression factor=0.75D
Sponsors
Wuhan Children's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children and adolescents aged =8 years, regardless of gender; 2. Patients with bilateral contact lens prescriptions within the study lens parameters (myopia = -5.00D, including -5.00D; total astigmatism = 1.50D, including 1.50D); 3. Able to complete 12 months of follow-up; 4. Capable of understanding the trial's purpose, voluntarily participating, and having the subject or their legal guardian sign the informed consent form. Note: For subjects aged 8 years or above but under 18 years, informed consent must be obtained from both the subject and their guardian, with both parties signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Only one eye meets the selection criteria; 2. Patients with systemic diseases causing immunosuppression or conditions affecting orthokeratology (e.g., acute or chronic sinusitis within the past two years, acute allergic conjunctivitis, perennial allergic conjunctivitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, attention deficit hyperactivity disorder, psychiatric disorders, etc.); 3. Patients with corneal abnormalities, prior corneal surgery, history of corneal trauma (with residual scarring), or diminished corneal sensation (facial paralysis or ptosis); 4. Patients presenting with any of the following ocular conditions: (1) Acute, subacute, or chronic inflammation/infection of the anterior segment; (2) Any ocular disease, injury, or structural abnormality affecting the cornea, conjunctiva, or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis, or other inflammatory conditions, glaucoma, etc.; (3) Dry eye syndrome (tear break-up time TBUT = 10? for distance or near vision); 10. Patients with abnormal intraocular pressure (IOP > 21 mmHg); 11. Patients with corneal endothelial cell density < 2000 cells/mm^2; 12. Patients who have worn orthokeratology lenses within the preceding 30 days; 13. Patients with a history of allergy to contact lenses or contact lens solutions; 14. Patients currently using, or planning to use during the study, medications that may cause dry eye or affect visual acuity (excluding mydriatic agents used prior to visual acuity testing) or medications affecting corneal curvature (e.g., immunosuppressants, glucocorticoids, intraocular pressure-lowering agents); 15. Participants who have enrolled in other drug clinical trials within the preceding 3 months or other medical device clinical trials within the preceding 30 days; 16. Participants currently using low-concentration atropine; 17. Individuals unable to attend follow-up appointments as instructed; 18. Individuals unable to comprehend the limitations and reversibility of orthokeratology for myopia correction; 19. Patients with examination findings indicating other contraindications for lens wear (e.g., significant corneal epithelial fluorescence staining) or unsuitability for orthokeratology lenses; 20. Other circumstances where the investigator deems the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity ;Diopter;Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| corneal topography;corneal endothelial;accommodative; | — |
Countries
China
Contacts
Public ContactHong Jie
Wuhan Children's Hospital
Outcome results
None listed