Myopia
Conditions
Interventions
Red Light Group B:Prescription single-vision glasses combined with LED red light (4 J/cm2)
Red Light Group A:Prescription single-vision glasses combined with LED red light (2 J/cm2)
control group:Available only with single-vision lenses
Red Light Group D:Prescription single-vision glasses combined with LED red light (8J/cm2)
Red Light Group C:Prescription single-vision glasses combined with LED red light (6J/cm2)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Age 6 to 12 years at enrollment; gender is not restricted; 2.Individuals diagnosed with myopia according to the “Guidelines for the Prevention and Control of Myopia” issued by the General Office of the National Health Commission (Guo Wei Ban Yi Han [2024] No. 168); (i.e., when the eye is in a relaxed state, parallel lightpassing through the ocular refractive system and focusing in front of the retina is termed myopia; based on the equivalent spherical (SE) power measured after ciliary muscle paralysis, myopia is classified into three categories: low myopia, moderate myopia, and high myopia. Low myopia ranges from 50 to 300 diopters, moderate myopia ranges from 300 to 600 diopters, and high myopia exceeds 600 diopters); 3.Computerized refraction after bilateral ciliary muscle paralysis: -0.75D = SE < -5.00D; 4.Computerized refraction after bilateral cycloplegia with anisometropia SE < 1.5 D; 5.Computerized refraction after bilateral cycloplegia with bilateral cylindrical power = 2.50 D; 6.Best-corrected visual acuity in both eyes = 5.0; 7.Intraocular pressure in both eyes = 10 mmHg and = 21 mmHg; 8.No other organic lesions in either eye that affect visual acuity; 9.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 |
|---|---|
| Equipment defect rate;Change in axial length from baseline;Pathological changes in fundus photography;Choroidal Thickness Measurement;Equivalent spherical power;Incidence of adverse events;Best-corrected visual acuity;Morphological Structure of the Retinal Layers on OCT; | — |
Countries
China
Contacts
Public ContactJie Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed