Myopia
Conditions
Interventions
investigational group:The investigational product is worn on the cornea per prescription from doctors.
Control group:The investigational product is worn on the cornea per prescription from doctors.
Sponsors
The Eye hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all following inclusion criteria: 1.Age >=8 years old, gender is not limited; 2.Subjects Have myopia -0.75D to -4.00D (including -0.75D and -4.00D) and astigmatism =1.50D in both eyes determined by manifest refraction examination; 3.Subjects Are willing to comply with the overnight wear schedule and study visit schedule; 4.Subjects Are able to understand and sign the assent and/or consent document by the subjects themselves or their legal guardians. Note: When minors (8<= age <18) are involved as subjects, it is imperative to acquire informed assent and consent from both the minors and their legal guardians, followed by signing the informed consent forms. When adults (age = 18) are involved as subjects, it is imperative to acquire informed consent from the adults themselves, followed by signing the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet the following exclusion criteria shall not be included in this study: 1.Only one eye meets the inclusion criteria; 2.Have any systemic disease diagnosis that may cause immunosuppression or have an impact on orthokeratology contact lens use (such as Diabetes Mellitus, Down Syndrome, Rheumatoid Arthritis, acute or chronic sinusitis (within 1 year), or others as determined by the investigator); 3.Have any corneal abnormalities, who have previously undergone corneal surgery, or who have a history of corneal trauma or corneal hypoesthesia; 4.Any of the following active eye conditions: ?Bacterial, fungal, viral or other corneal infections; ?Acute, subacute or chronic inflammation or infection of the anterior segment of the eye; ?Any eye disease, injury or structural abnormality affecting the cornea, conjunctiva or eyelid, such as dacryocystitis, acute conjunctivitis, blepharitis or other inflammation, or glaucoma; ?Dry eye disease (tear film break-up time (TBUT) =5 seconds); ?Corneal staining = grade 2; ?Pathological eye congestion or redness. 5.Any patient whose best corrected distant visual acuity is less than 5.0 (5-mark record, equal to LogMAR 0); 6.Flat corneal curvature 48.00D; 7.Subjects with unstable myopic refractive error (per investigators’ decision); 8.Subjects with irregular corneal astigmatism; 9.Subjects with strabismus; 10.Subjects with abnormal intraocular pressure (IOP) defined as 21 mmHg, or an IOP difference between the two eyes of >5 mmHg; 11.Subjects with a corneal endothelial cell density of less than 2000/mm2; 12.Subjects who have worn orthokeratology lenses or rigid gas-permeable lenses within the past 30 days; or soft contact lenses in the last 7 days. 13.Subjects with a history of allergy to contact lenses, or contact lenses care products; 14.Subjects who are using or need to use drugs (immunosuppressants, glucocorticoids, IOP lowering medications, etc.) that may cause dry eyes or affect the visual acuity and corneal curvature (except mydriatic drugs used before visual examination) during the planned study; 15.Subjects participating in other drug clinical trials within 3 months before screening and/or other medical device clinical trials within 30 days except for participation in soft contact lens trials, in which case only those within Page 11 of 95 the past week will be excluded; 16.Pregnant women or breastfeeding women, or planning to become pregnant during the study; 17.Subjects unable to be followed up as advised by the physicians; 18.Subjects unable to understand the limitations and reversibility of wearing orthokeratology lenses to correct myopia; 19.Subjects with examination results suggesting the presence of other contraindications for wearing orthokeratology lenses in the opinion of the investigator; 20.Other conditions for which the investigators determine the subjects are unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product effective rate at 30 days after wearing ortho-k lenses (at the subject level).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Product effective rate at 30 days after wearing ortho-k lenses (at the eye level);;Proportion of eyes with uncorrected visual acuity greater than or equal to 4.9 (5-mark record, equal to LogMAR 0.1) at 30 days after wearing ortho-k lenses;Proportion of eyes with residual diopter less than ±0.50D based on manifest refraction compared to baseline at 30 days after wearing ortho-k lenses;Proportion of eyes with uncorrected visual acuities at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing ortho-k lenses;Proportion of eyes diopters based on manifest refraction at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing ortho-k lenses;Proportion of eyes with changes in corneal curvature (flat Ks, steep Ks, and corneal astigmatism) measured by corneal topography at 1 day, 1 week, 2 weeks, 30 days, 3 months, 6 months, 9 months, and 12 months after wearing ortho-k lenses; | — |
Countries
China
Contacts
Public ContactJun Jiang
The Eye hospital, Wenzhou Medical University
Outcome results
None listed