Luminopia One Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02782117

Enrollment

Registered

2016-05-25

Start date

2017-08-01

Completion date

2019-02-06

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Brief summary

A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

Interventions

DEVICELuminopia One

Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Inclusion criteria

Major Eligibility Criteria: * Age 4 to \<8 years (phase 1) or age 4 to \<13 years (phase 2) * Monocular amblyopia associated with anisometropia, strabismus or both combined * Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR) * Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2) * Interocular BCVA difference ≥3 lines (≥0.3 logMAR) * Visual acuity stability in current refractive correction (phase 2) * Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Design outcomes

Primary

Measure	Time frame	Description
Amblyopic eye best-corrected visual acuity	12 weeks	Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Secondary

Measure	Time frame	Description
Amblyopic eye best-corrected visual acuity	8 weeks	Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Adherence	12 weeks	Duration spent using the device divided by duration of treatment prescribed (objectively monitored)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026