ametropia
Conditions
Interventions
experimental group:Wear orthokeratology lenses( Mode: ACC )
control group:Wear orthokeratology lenses(Mode: NOR )
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age old and = 45 years old; 2. The spherical degree of correction in both eyes was -4.00D or less, and the subjective refraction of left and right eyes’ best corrected visual acuity=5.0 (Standard logarithmic visual acuity chart, five-point record) 3. The degree of cylindrical mirror, astigmatism with rule < 1.75D, inverse astigmatism < 1.00D; 4. Be able to understand the purpose of the trial and be willing to participate in this clinical validation, the subject himself or his legal guardian signed the informed consent, and can cooperate with the entire test process (12 months) 5. Environmental conditions, sanitary conditions and working conditions can meet the wearing requirements of this product.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic diseases that cause immunosuppression or affect orthokeratology (such as acute and chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.); Or other medical conditions that researchers believe are not suitable for wearing rigid breathable contact lenses for orthokeratology; 2. Patients with certain eye diseases, such as acute or chronic eye inflammation, dry eye (tear film rupture time TBUT 21mmHg, or IOP difference =5mmHg); 12. Fundus abnormalities have clinical significance; 13. Corneal curvature less than 39.00D, or higher than 48.00D; 14. Unstable diopter; 15. Only one eye meets the inclusion criteria; 16. Other conditions for which the investigator determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Residual diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal Topography;Lens center positioning; | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed