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Luminopia One Amblyopia Vision Improvement Study

NCT03608150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-03-20

Study results available
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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.

Conditions

  • Amblyopia

Interventions

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)

Sponsors & Collaborators

  • Luminopia

    lead INDUSTRY

Principal Investigators

  • Scott Xiao · Luminopia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608150 on ClinicalTrials.gov