Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 6 to 12 years at enrollment; gender is not restricted; 2.Computerized refraction after bilateral ciliary muscle paralysis: -0.75D = 5.0; 6.Intraocular pressure in both eyes >= 10 mmHg and <= 21 mmHg; 7.No other organic lesions in either eye that affect visual acuity; 8.The subject and guardian understand the purpose of this trial and have signed the informed consent form; the subject is able to cooperate with treatment and related ophthalmic examinations, and will not take any myopia prevention or control measures other than those specified in the study protocol during the entire study period.
Exclusion criteria
Exclusion criteria: 1.Individuals diagnosed with manifest strabismus; 2.Congenital color vision deficiency (color blindness); 3.Any eye disease or ophthalmic surgery (including strabismus surgery) that may be associated with myopia or affect refractive development, as well as systemic or other conditions such as Marfan syndrome, retinopathy of prematurity, or diabetes; 4.Eye injuries or diseases of the cornea, conjunctiva, or eyelids (including keratoconus and herpetic keratitis), or retinal lesions, which the investigator assesses as likely to affect study results; 5.Use of any myopia control measures other than single-vision lenses within the past 3 months; 6.Having undergone binocular vision training or flip-card training within the past 1 month; 7.Photophobia or inability to open the eyes normally; 8.Any anatomical, skin, or other conditions that may interfere with the wearing of spectacles; 9.Participation in another clinical trial within 3 months prior to enrollment; 10.The subject has acute or chronic diseases (including other currently existing acute or chronic pain) or psychiatric disorders, etc., which may increase the risks associated with study participation or the use of the investigational product, or may affect the interpretation of study results, and which, in the judgment of the investigator or a designated medically qualified person, render the subject unsuitable for enrollment in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in axial length from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Equivalent spherical power;Choroidal Thickness Measurement;Pathological changes in fundus photography;Visual quality;Best corrected visual acuity;Incidence of adverse events; | — |
Countries
China
Contacts
Eye Hospital, Wenzhou Medical University