pre-myopia or myopia
Conditions
Interventions
Conduct of a game program using SaMD
Sponsors
Matsumura Saiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female children aged 5 to 12 years at the time of consent 2) Participants with pre-myopia or myopia through refraction testing under cycloplegia Pre-myopia: Objective equivalent spherical power -0.50 D Myopia: Objective equivalent spherical power -6.00 D 3) Participants with anisometropia within 2.50D. 4) Participants with best corrected visual acuity better than 0 on the logMAR in both eyes 5) Participants deemed eligible by a physician to participate in the eye movement program using ROD-001 6) Written informed consent from participants's guardian or legally acceptable representative have been obtained
Exclusion criteria
Exclusion criteria: 1) Participants with coexisting ocular diseases such as strabismus, amblyopia, or nystagmus 2) Participants with a history of ophthalmic surgery, including eyelid surgery, strabismus surgery, intraocular surgery, or refractive surgery 3) Participants with concomitant ocular diseases involving the cornea, lens, retina, iris, or ciliary body 4) Participants who previously receive treatments for slowing myopia progression within 30 days before Visit2. 5) Participants determined by the investigator to have difficulty in obtaining reliable measurements of choroidal thickness and choroidal blood flow. 6) Participants who have participated in another clinical trial within 3 months before Visit 2 7) Participants who the principal/sub investigator has determined are not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in choroidal thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in choroidal blood flow | — |
Contacts
Public ContactMaiko Hattori
Ark Medical Solutions Inc.
Outcome results
None listed