NIPH Clinical Trials Search

A study to evaluate the effects of ROD-001 on choroidal thickness and choroidal blood flow

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	pre-myopia or myopia
Date of first enrollment	09/01/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Conduct of a game program using SaMD

Outcome(s)

Primary Outcome	Changes in choroidal thickness
Secondary Outcome	Changes in choroidal blood flow

Key inclusion & exclusion criteria

Age minimum	>= 5age old
Age maximum	<= 12age old
Gender	Both
Include 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 <= +0.75 D and > -0.50 D Myopia: Objective equivalent spherical power <= -0.50 D and > -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
Exclude 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