Myopia
Conditions
Interventions
Optimized Design Group 2:Digitally Customized Orthokeratology Lens with Optimized Design 2
Optimized Design Group 3:Digitally Customized Orthokeratology Lens with Optimized Design 3
Control Group:Digitally Customized Orthokeratology Lens with Conventional Design
Optimized Design Group 1:Digitally Customized Orthokeratology Lens with Optimized Design 1
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
8 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Age between 8 and 15 years, regardless of gender. 2. Bilateral myopia between -1.00D and -4.00D, astigmatism <= 1.50D, and anisometropia < 1.00D. 3. Able to complete the 1-year follow-up. 4. Able to understand the purpose of the study and voluntarily participate, with informed consent signed by both participants and their guardians.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic conditions causing immunodeficiency or those affecting orthokeratology lens wear (such as diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric disorders, or acute/chronic sinusitis within 2 years). 2. Corneal abnormalities: history of corneal surgery, corneal trauma, reduced corneal sensation, corneal infection, or dry eye syndrome. 3. Best-corrected distance visual acuity below 1.0 (decimal visual acuity scale). 4. Corneal flat curvature 45.00D. 5. Patients with unstable refractive error. 6. Irregular corneal astigmatism. 7. Manifest strabismus. 8. Abnormal intraocular pressure (normal range: 10–21 mmHg). 9. Corneal endothelial cell density less than 2000 cells/mm². 10. Rigid contact lens (including orthokeratology lenses) wear within the past 30 days. 11. History of allergy to contact lenses or contact lens care solutions. 12. Current or anticipated use of medications during the study period that may cause dry eye or affect vision and corneal curvature (e.g., immunosuppressants, corticosteroids, or ocular hypotensive agents). 13. Participation in other pharmaceutical clinical trials within 3 months prior to screening, medical device clinical trials within 30 days prior to screening, or using other myopia control methods such as pharmaceutical or optical interventions. 14. Pregnant, breastfeeding, or planning pregnancy in the near future at enrollment. 15. Unable to adhere to follow-up visits as instructed. 16. Unable to understand the reversible and limited nature of myopia correction using orthokeratology lenses. 17. Examination indicating other contraindications for lens wear (e.g., significant corneal epithelial fluorescein staining) or other conditions unsuitable for orthokeratology lens use. 18. Any other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anterior segment parameters;Areal Summed Corneal Power Shift (ASCPS);Refractive error;Visual acuity;Adverse events; | — |
Countries
China
Contacts
Public ContactYang Xiao
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed