NCT03608150

Luminopia One Amblyopia Vision Improvement Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Luminopia · Industry
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

Detailed description

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Luminopia One	Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
DEVICE	Refractive Correction	Standard of care refractive correction (ex. spectacles)

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2018-07-31
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study