Myopia
Conditions
Interventions
Experimental group:Wear orthokeratology lenses (Mode: NOP)
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients over the age of 8; (2) Patients with binocular myopia up to -4.00D (including -4.00D), (3) Patients with astigmatism with rule up to 1.75D and astigmatism against rule up to -1.5D ; (4) Patients who can complete 12 months of follow-up; (5) Those who can understand the purpose of the follow-up study, voluntarily participate and have the informed consent form signed by the subjects themselves.
Exclusion criteria
Exclusion criteria: (1)Patients with systemic diseases that cause immune deficiency or have an impact on the fitting of orthokeratology lenses (e.g. acute or chronic sinusitis within 1 year, diabetes, Down's syndrome, rheumatoid arthritis, mental illness, etc.); (2)Combination of other eye diseases that affect the fitting of orthokeratology, such as dacryocystitis, eyelid disease and eyelid abnormalities, glaucoma, etc; (3)Patients with corneal abnormalities, previous corneal surgery or a history of corneal trauma, reduced corneal perception and a history of ocular trauma or intraocular surgery; (4)Patients with active corneal infections such as bacterial, fungal, viral, or other acute or chronic inflammation of the anterior segment at the time of screening; (5)Patients with a corneal curvature of less than 39.00D or greater than 48.00D; (6)Patients with a corneal endothelial cell density of less than 2000 cells/mm2; (7)Patients with fluorescent staining of the cornea, ciliary congestion, bulbar conjunctival congestion, lid conjunctival maximum reaction zone grade, corneal neovascularization > grade 1, corneal endothelial polymorphic changes > grade 3, and other slit lamp abnormalities that the investigator determines that can affect the fitting of orthokeratology lenses; (8)Patients with strabismus; (9)Patients whose BSCVA cannot reach 1.0 in either eye; (10)Patients who have been judged by the investigator to be refractively unstable; (11)Abnormal intraocular pressure (IOP 21 mmHg or bilateral IOP difference >5 mmHg); (12)Tear film breakup time (TBUT)=5 s; (13)Patients with irregular corneal astigmatism; (14)Individuals who have worn rigid contact lenses (including orthokeratology lenses) within 30 days previously; (15)Patients with a history of allergy to sodium fluorescein, contact lenses or contact lens care products; (16)Patients whose examination results suggest contraindications to fitting or unsuitability for orthokeratology lenses; (17)Individuals who, in the judgement of the investigator, during the study, are using, or need to use drugs that cause dry eyes or affect visual acuity and corneal curvature (e.g. immunosuppressants, glucocorticoids, IOP-lowering drugs, therapeutic pupil dilators, etc.); (18)Patients who have participated in a drug clinical trial within 3 months prior to screening or in another medical device clinical trial within 30 days prior to screening; (19)Pregnant women, breastfeeding or recently planned pregnancies; (20)Individuals who are unable to follow up as prescribed by the doctor; (21)Individuals who are unable to understand the limitations and reversibility of orthokeratology lenses for myopia correction; (22)Individuals with excessive sensitivity or high expectations; (23)Individuals with single eye compliance; (24)Other conditions that, in the judgment of the investigator, make the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Residual diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal K value;The shaping of lenses is neutral; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital of Wenzhou Medical University
Outcome results
None listed