Myopia
Conditions
Interventions
Experimental group (part A):Wear orthokeratology rigid gas permeable contact lenses (DK180)
Control group (part A):Wear orthokeratology rigid gas permeable contact lenses (XO)
Experimental group (part B):Wear orthokeratology rigid gas permeable contact lenses (DK180)
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age= 8 years old, gender is not limited; (2) The spherical power of subjective refraction is within -0.50D to -6.00D (including both ends), and the cylindrical power of subjective refraction is within 3.50D (including 3.50D), where: Part A: The cylindrical power of subjective refraction of both eyes is within 1.50D (including 1.50D); Part B: At least one eye of the cylindrical power of subjective refraction is 1.50D~3.50D (excluding 1.50D, including 3.50D). (3) Patients able to understand the purpose of the trial, willing to participate, sign the informed consent form personally or by their legal guardian, and able to complete postoperative follow-up on time.
Exclusion criteria
Exclusion criteria: (1) Best corrected distance visual acuity > 0.0 logMAR; (2) The corneal endothelial cell density 21mmHg or intraocular pressure difference between both eyes = 5mmHg; (8) Those who have systemic diseases that cause immunocompromise, or who have an impact on the wearing of orthokeratology lenses (such as active acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, psychopaths, etc.); (9) Have a history of allergy to contact lenses or contact lens care solution; (10) Drugs that may affect the wearing of orthokeratology lenses, cause dry eyes, affect vision and corneal curvature, or change normal ocular physiology (such as immunosuppressants, glucocorticoids, intraocular blood pressure lowering drugs, therapeutic mydriatic agents within one month, etc.) that may affect the wearing of orthokeratology lenses, cause dry eye, affect vision and corneal curvature, or change normal ocular physiology; (11) The living or working environment is not suitable for wearing contact lenses, such as dust, medicines, aerosols, dust, etc., in the air, or in a high-pollution environment with windy sand and contact chemical gases for a long time; (12) Less than 1 week for soft contact lenses, less than 2 weeks for rigid gas permeable contact lenses (RGP), and less than 30 days for orthokeratology lenses; (13) Those who have participated in clinical trials of other drugs or medical devices within 30 days before screening; (14) Those who have high sensitivity and high expectations, or those who have severe anxiety, depression and other psychological or mental illnesses; (15) Those who are unable to understand the limitations and reversibility of orthokeratology lenses in correcting myopia; (16) Pregnant or lactating females, or those who plan to become pregnant in the near future; (17) Other circumstances judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of subjects with orthokeratology rigid gas permeable contact lenses at 30th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Refraction;Corneal topography;Uncorrected distance visual acuity;Efficacy of eyes with orthokeratology rigid gas permeable contact lenses at 30th day; | — |
Countries
China
Contacts
Public ContactXinjie Mao
Eye Hospital of Wenzhou Medical University
Outcome results
None listed