Luminopia One Amblyopia Vision Improvement Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Amblyopia

Clinical Trial Details

NCT number	NCT03608150
Study type	Interventional
Source	Luminopia
Contact
Status	Completed
Phase	N/A
Start date	January 16, 2019
Completion date	July 31, 2020

View Details

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