Luminopia One Amblyopia Vision Improvement Study

The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

Inclusion criteria

• Age 4 to 7 years at the time of consent.
• Amblyopia associated with anisometropia and/or mild strabismus.
• Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
• Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
• Fellow eye BCVA 20/32 or better.
• Interocular difference ≥ 3 logMAR lines.
• Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.

Exclusion criteria

• Atropine treatment in the past 2 weeks.
• Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
• High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
• History of low adherence with amblyopia treatment or light-induced seizures.