Patients with myopia who require temporary vision correction.
Conditions
Interventions
experimental group : wear the rigid gas permeable contact lenses for orthokeratology every night for up to 12 hours.
control group:wear the rigid gas permeable contact lenses for orthokeratology every night for up to 12 hours.
Sponsors
Eye Hosipital,WMU Zhejiang Eye Hispital
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Age = 8 years old, any gender, 2.Patients with refractive power within the applicable range of the study lenses, myopia up to -4.00D (including -4.00D), and total astigmatism not exceeding 1.75D (including 1.75D), 3.Able to complete the 12-month follow-up, and 4.Able to understand the purpose of the trial, voluntarily participate, and have the informed consent form signed by the participant or their legal guardian. Note: For participants aged 8 years or older but under 18 years, the informed consent of both the participant and their guardian should be obtained, and the informed consent form should be signed. For participants who are 18 years or older, the informed assent of the participant should be obtained, and the informed assent form should be signed.
Exclusion criteria
Exclusion criteria: 1.Only one eye meets the inclusion criteria, 2.Patients with systemic diseases resulting in immunodeficiency or affecting orthokeratology treatment (e.g., history of diabetes, Down syndrome, rheumatoid arthritis, mental illness, acute or chronic sinusitis within the past 2 years), 3.Patients with corneal abnormalities, history of corneal surgery, history of corneal trauma, or reduced corneal sensitivity, 4.Eye conditions with the following states: ·Acute, subacute, or chronic inflammation or infection of the anterior segment, ·Any eye diseases, injuries, or structural abnormalities affecting the cornea, conjunctiva, or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis, various inflammations, glaucoma, etc, ·Dry eye syndrome (tear film break-up time [TBUT] = 5 seconds), ·Active corneal infections caused by bacteria, fungi, viruses, etc, ·Pathological conjunctival congestion or redness. 5.Best-corrected distance visual acuity less than 1.0 (decimal visual acuity chart), 6.Corneal curvature outside the range of 39.00D to 48.00D, 7.Patients with unstable refractive error, 8.Patients with irregular corneal astigmatism, 9.Patients with manifest strabismus, 10.Patients with abnormal intraocular pressure (normal range: 10-21 mmHg, with a difference of less than 5 mmHg between both eyes), 11.Patients with corneal endothelial cell density less than 2000 cells/mm², 12.Patients who have worn rigid contact lenses (including corneal reshaping lenses) in the past 30 days, 13. Patients with a history of allergies to contact lenses or contact lens care solutions; 14. Patients who are currently using or need to use drugs (immunosuppressants, glucocorticoids, intraocular pressure lowering drugs, etc.) that may cause dry eyes or affect vision and corneal curvature during research; 15. Those who participate in clinical trials of other drugs within 3 months before screening, and those who participate in clinical trials of other medical devices within 30 days; 16. At the time of enrollment, she was pregnant, breastfeeding, or recently planned to become pregnant; 17. Those who cannot follow up according to medical advice; 18. Those who cannot understand the limitations and reversibility of correcting myopia with corneal reshaping lenses; 19. The examination results indicate other contraindications to wearing corneal epithelium (such as obvious fluorescence staining of the corneal epithelium) or patients who are not suitable for wearing corneal reshaping lenses; 20. Other situations where the researcher determines that the patient is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy rate (at the patient level) after 30 days of lens wear.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Product efficacy (at 30 days of wearing) at the level of individual cases: Efficacy = Number of eyes meeting the " efficacious " criteria for both unaided visual acuity and refractive error / Total number of eyes × 100%;Unaided visual acuity of subjects at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing the lenses.;Refractive error of subjects at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing the lenses.;Corneal topography of subjects at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing the lenses.;Corneal curvature and other factors reflected by corneal topography in subjects at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing the lenses.; | — |
Countries
CHINA
Contacts
Public ContactJingjing Xu
Eye Hosipital,WMU Zhejiang Eye Hispital
Outcome results
None listed