Myopia
Conditions
Interventions
Subject Device Group: Apply red light to the eyes for 3 minutes per session, twice daily, 5 days per week (maximum of 2 times per day, up to 10 times in a 7-day period), ensuring at least a 4-hour int
Sponsors
ELLENBOGEN Nir
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An informed consent form must be read, understood, and signed by the patient's parent(s) or legal guardian (hereinafter referred to as "guardian"), and the assent form must be read and signed by the patient. The original copy must be received by the investigator(s). 2. Patients who can understand that the study is a randomized trial. 3. Patients who, in the opinion of the investigator(s), are capable and willing to follow the instructions of the study protocol. 4. Patients aged> = 6 and <= 12 years (elementary school grades 1-6) at the time of informed consent. 5. Patients whose biological parents and themselves are all ethnically Japanese. 6. Patients with a spherical equivalent (SE) in both eyes under cycloplegia of -6.00 D < SE =< -1.00 D. 7. Patients with astigmatism within +/-1.50 D. 8. Patients with anisometropia =<1.50 D. 9. Patients with corrected visual acuity of at least 1.0 in each eyes. If vision is corrected with contact lenses, patients must be able to switch to single vision spectacles (SVS) during the study period. 10. Patients with a normal fundus and no retinal abnormalities. 11. Patients who have a Wi-Fi environment at home.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently receiving, or have previously received, treatment to suppress myopia progression (e.g., orthokeratology, low-dose atropine eye drops or other mydriatics, multifocal soft contact lenses). 2. Patients with strabismus or abnormalities in binocular function. 3. Patients with a history of intraocular surgery. 4. Patients with any ocular or non-ocular disease, history thereof, or other findings that may interfere with participation in the study (e.g., keratoconus). 5. Patients with an opaque or cloudy cornea. 6. Patients with pathological myopia accompanied by fundus lesions (e.g., diffuse chorioretinal atrophy, focal chorioretinal atrophy, lacquer cracks, myopic macular neovascularization). 7. Patients with a history of hypersensitivity or allergic reaction to atropine, cyclopentolate, or local anesthetics. 8. Patients with a history of photosensitivity. 9. Patients with retinopathy, cataract, or other intraocular diseases. 10. Patients with optic nerve disorders or congenital optic nerve disorders. 11. Patients with a family history of hereditary chorioretinal diseases. 12. Patients who have received medication for asthma within one year prior to the start of the study. (except for medication with non-anticholinergic properties) 13. Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in cycloplegic spherical equivalent (SE) at Visit 6 (24 months after the start of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in axial length (AL) at Visit 6 (24 months after the start of treatment) | — |
Contacts
Public ContactMaiko Toriumi
A2 Healthcare Corporation
Outcome results
None listed