myopia
Conditions
Interventions
Experimental group:Temporary correction of myopia with rigid breathable contact lens for orthokeratology produced by Sichuan Xingtai Pule Medical Technology Co., LTD
Control group:Temporary correction of myopia with rigid breathable contact lens for orthokeratology produced by Eyebright (Beijing) Medical Technology Co., LTD
Sponsors
Optometry Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age 8-40 years old (including the boundary value), binocular myopia, gender unlimited; 2. Stable dioptometry in both eyes with myopia between -4.00D and -6.00D (excluding -4.00D); Column mirror, cis astigmatism = 5.0 (1.0 for decimal); 4. Patients with corneal curvature between 40.00D and 46.00D; 5. Subjects who have completed at least 1 year of follow-up and can wear lenses as required; 6. Be able to understand the purpose of the study, voluntarily participate in the study and have informed consent signed by the subject and/or his legal guardian.
Exclusion criteria
Exclusion criteria: 1. Have worn rigid contact lenses (including orthokeratology lenses) within the past 1 month; 2. Patients with systemic diseases that cause immune deficiency or affect orthokeratology (e.g. diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.); Acute and chronic sinusitis within 1 year); 3. Corneal abnormalities: have received corneal surgery, or plan to receive corneal refractive surgery in the near future, or have a history of corneal trauma; Subjects with active keratitis (e.g., corneal infection, etc.), decreased corneal perception; Have a history of eye trauma or intraocular surgery; Fundus lesions, and other organic eye diseases; 4. The following conditions exist in the eyes: (1) Eye abnormalities or infections within 30 days prior to screening; (2) Any eye diseases, injuries or structural abnormalities that will affect the cornea, conjunctivitis or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis and other inflammation, glaucoma; (3) Dry eyes (tear film rupture time (BUT) 21 mmHg or binocular pressure difference > 5 mmHg); 7. Corneal endothelial cell density < 2000 cells/mm2; 8. Patients who have been using drugs (atropine, immunosuppressants, glucocorticoids, antibacterial drugs, intraocular hypertension drugs, etc.) within the last 1 month or need to use drugs (atropine, immunosuppressants, glucocorticoids, etc.) that may cause dry eyes or affect vision and corneal curvature; 9. Allergic to contact lens or contact lens solution; 10. long-term exposure to dry environment or occupation affecting orthokeratoscope wearing; 11. Patients whose examination results suggest other contraindications (such as obvious fluorescent staining of corneal epithelium) or who are not suitable for wearing orthokeratology lenses; 12. Pregnant or lactating women and those who have pregnancy plans during the experiment; 13. Participants in clinical trials of other drugs within 3 months or clinical trials of other medical devices within 30 days prior to screening; 14. Other conditions in which a single eye meets the inclusion criteria or the investigator determines that the subject is not suitable for inclusion; 15. Participants considered unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of 30 days wearing glasses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Naked vision;Diopter;Corneal topographic map parameter changes; | — |
Countries
China
Contacts
Public ContactJiang Jun
Optometry Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed