Ametropy
Conditions
Interventions
Control group:Wear the night-type control group corneal reshaping rigid gas-permeable contact lenses VML every night.
Treatment group:Wear the night-type trial group corneal reshaping rigid gas-permeable contact lenses VML every night.
Sponsors
Eye hospital.WMU Zhejiang Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years old, gender not restricted; 2. The subjective refraction of both eyes of the subjects falls within the applicable parameter range of the study lenses (myopia degree within -4.00D to -6.00D (excluding -4.00D, including -6.00D), astigmatism degree within 1.50D (including 1.50D)); 3. Able to complete the 12-month follow-up and during the wearing period, can correctly operate and follow the requirements for caring for the lenses (for minors, the guardian can provide corresponding assistance to complete the operation and care); 4. Can understand the purpose of the trial, voluntarily participate, and the informed consent form can be signed by the subject themselves or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Only one eye meets the inclusion criteria; 2. Patients with systemic diseases causing immunosuppression, or diseases that affect corneal reshaping (such as acute or chronic sinusitis within 1 year, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.); 3. Patients with corneal abnormalities, having undergone corneal surgery, or having a history of corneal trauma, or reduced corneal sensation, as evaluated by the researcher, are not suitable for wearing corneal reshaping rigid gas-permeable contact lenses; 4. Patients with the following ocular conditions: (1).Acute, subacute or chronic inflammation or infection of the anterior segment of the eye; (2).Any eye diseases, injuries or structural abnormalities that affect the cornea, conjunctiva or eyelids, such as dacryocystitis, acute conjunctivitis, abnormal intraocular pressure, blepharitis, uveitis, various inflammatory conditions, glaucoma and lacrimal system diseases, etc.; (3). Dry eye (BUT <= 5 seconds); (4).Active corneal infections caused by bacteria, fungi, or viruses; (5).Pathological eye congestion or redness; 5. Patients with the best spectacle-corrected distance visual acuity of less than 5.0 (5-point counting method) in either eye; 6. Corneal topography shows a corneal flat curvature not within the range of 39.00D to 48.00D; 7. Patients with fluctuating refractive errors; 8. Patients with irregular corneal astigmatism; 9. Patients with manifest strabismus; 10. Patients with abnormal intraocular pressure (normal intraocular pressure range is 10-21 mmHg, and the difference in intraocular pressure between both eyes should be less than 5 mmHg); 11. Patients with corneal endothelial cell density less than 2000 cells/mm^2; 12. Patients who have worn corneal reshaping rigid gas-permeable contact lenses within the past 30 days; 13. Patients who are currently using or plan to use drugs that the researcher deems may cause dry eye or affect vision (such as atropine, drugs used for dilating pupils before vision examination, except for those used for vision examination), and drugs that may affect corneal curvature (immunosuppressants, glucocorticoids, hypotensive drugs, etc.); 14. Patients who participated in other drug clinical trials within 90 days before screening, or participated in other medical device clinical trials within 30 days before screening; 15. Patients who were pregnant, breastfeeding, or planning to conceive at the time of enrollment; 16. Patients who cannot follow the instructions of the ophthalmologist or undergo regular follow-ups; 17. Patients who cannot understand the limitations and reversibility of corneal reshaping with rigid gas-permeable contact lenses for myopia correction; 18. Patients with a history of allergy to fluorescein sodium, contact lenses, or contact lens care products; 19. Patients whose environmental, hygiene, and working conditions do not meet the requirements for wearing the test equipment; 20. Other situations determined by the researcher as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The product effectiveness rate (at the subject level) after wearing the glasses for 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| The product's effectiveness (in terms of eyesight improvement) at 30 days after wearing the glasses;Uncorrected visual acuity(UCVA);Diopter;The relevant important parameters of corneal topography; | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye hospital.WMU Zhejiang Eye Hospital
Outcome results
None listed