Luminopia One Pilot Study

Luminopia84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amblyopia

Interventions

Luminopia OneDEVICE

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Locations (9)

Eye Physicians of Central Florida

Maitland, Florida, United States

Wheaton Eye Clinic

Chicago, Illinois, United States

Indiana University

Bloomington, Indiana, United States

Kids Eye Care of Maryland

Frederick, Maryland, United States

Outcomes

Primary Outcomes

Amblyopic eye best-corrected visual acuity

Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Time frame: 12 weeks

Secondary Outcomes

Amblyopic eye best-corrected visual acuity

Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Time frame: 8 weeks

Amblyopic eye best-corrected visual acuity

Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Time frame: 4 weeks

Adherence

Duration spent using the device divided by duration of treatment prescribed (objectively monitored)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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