Luminopia One Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Regimen A

Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.

Group Type EXPERIMENTAL

Luminopia One

Intervention Type DEVICE

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

Interventions

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Luminopia One

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No