Myopia
Conditions
Interventions
Control group:Single-vision Frame Glasses
Intervention group:Digital Defocus Myopia Control Software + Single-vision Frame Glasses
Sponsors
Eye Hospital of Wen Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 14 years old (inclusive) at enrollment, regardless of gender. 2. Binocular cycloplegic refraction meeting the requirements below: -5.00 D = -2.50 D; Anisometropia = 4.9. 4. Able to understand the trial objectives, voluntarily participate in the trial, and sign the informed consent form (ICF) together with their legal guardians.
Exclusion criteria
Exclusion criteria: 1. dominant strabismus and/or amblyopia; 2. congenital colour vision disorders (colour blindness); 3. the presence of ocular or systemic diseases that, in the judgement of the investigator, may affect vision, e.g. glaucoma, uveitis, scleritis, cone cornea, diabetes mellitus, autoimmune disorders (e.g. ankylosing spondylitis, multiple sclerosis, desiccation syndrome, systemic lupus erythematosus, etc); 4. the presence of any ocular, systemic or neurodevelopmental disease that may be associated with myopia or affect refractive development, e.g. vitreous haemorrhage, cataracts, central corneal scarring, ptosis, eyelid haemangiomas, Marfan Syndrome, Down's Syndrome, Stickler's Syndrome, ocular albinism, retinopathy of prematurity changes, etc; 5. previous eye surgery that, in the judgement of the Investigator, has affected visual function; 6. wear keratoplasty, myopia-controlled soft contact lenses and myopia-controlled frames within 1 month prior to screening, or have received red light therapy for myopia; 7. those who have used, or plan to use during the study period, medications that may affect vision (e.g., atropine, pirenzepine, etc.) within 1 month prior to screening, with the exception of medications used to dilate the pupil; 8. those who have had an allergic reaction to pupil dilating drugs (e.g. atropine, cyclopentolate or tropicamide) 9. photophobia or inability to open the eyes normally; 10. a history of epilepsy or psychosis or cognitive impairment that would interfere with the collection of data for the study 11. implanted electronic devices (e.g., pacemakers) in the body; 12. participation in a clinical trial of another drug within 3 months and a clinical trial of another medical device within 30 days prior to screening; and 13. any other condition that the investigator considers inappropriate for participation in the clinical trial. *For ophthalmological examinations, subjects must meet all inclusion criteria and none of the exclusion criteria in either eye to be eligible for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in cycloplegic objective spherical equivalent refractive power from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in axial length from baseline ;Change in non-cycloplegic spherical equivalent refractive power from baseline;Evaluation of Functionality and Usability of Digital Defocus Myopia Control Software; | — |
Countries
China
Contacts
Public ContactQu Jia
Eye Hospital of Wen Medical University
Outcome results
None listed