Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The subject is over 18 years old (including 18 years old), male or female; (2) The subjects voluntarily sign the informed consent, and provide information on the content, process and possible adverse events of the test Be fully aware of; (3) The degree of myopia in both eyes of the subject is within -1.00D ~ -12.00D (including -1.00D and -12.00D SAN),The luminosity is below -0.75D with a -0.75D sphere-column ratio of 3:1; (4) The best corrected visual acuity of all subjects with binocular frames could reach 5.0
Exclusion criteria
Exclusion criteria: (1) Subjects are using topical ophthalmic or systemic medications that may interfere with contact lens fitting (2) The subject has suffered from eye diseases within 3 months, including but not limited to ? Any active acute inflammation of the eye; ? Chronic ocular inflammation such as: chronic keratitis, chronic uveitis, chronic dacryocystitis, chronic eyelid Borderitis, greater than grade 2 giant papillary conjunctivitis, iritis, seborrheic conjunctivitis, etc. ? Other eye disorders: glaucoma, abnormal corneal sensation, dysraphism of the eyelid, ptosis, and hyperopia Strabismus, cataract, keratoconus, etc. ? Ciliary hyperemia 2 grades; ? Bulbar conjunctival congestion = 2 grade; ? Maximum reaction position of palpebral conjunctiva 2 grade; ? Corneal edema (epithelial or stromal edema) = grade 1; ? Corneal epithelial microcapsule Grade 1 ? Corneal endothelial cell density 21 mmHg or <10 mmHg in either eye, or IOP difference of 5 mmHg (5) Slit-lamp examination showed the following results ? Moderate to severe dry eye (presence of multiple quadrants of corneal damage or corneal fluorin by slit-lamp microscopy) Staining spots = 5 or Tear film Break-up Time [TBUT]<2s ? Pterygium;? Scar in the corneal visual axis; (6) subjects were allergic to contact lens materials or related care products; (7) Serious complications occurred during contact lens wearing (8) Subjects had previous corneal surgery or intraocular surgery (9) subjects who wore orthokeratology lenses within 30 days (10) those who participated in drug clinical trials within 3 months or other medical device clinical trials within 1 month Subjects (11) pregnant, lactating or planning to become pregnant in the near future (12) The subject's living or working environment is not suitable for wearing soft contact lenses, such as diffuse dust and drugs in the air Products, aerosols (such as hair spray, volatile chemicals), dust, etc (13) other conditions judged by the investigator as not suitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| corrected visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| corrected visual acuity; | — |
Countries
China
Contacts
Eye Hospital, Wenzhou Medical University