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Luminopia One Pilot Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT02782117

Luminopia One Pilot Study

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 popula...

Lead sponsor: Luminopia•9 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Luminopia

Collaborators

Boston Children's Hospital

Age

4 - 12 years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 9, 2020Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment84

Start dateAug 2017

Last updatedJul 9, 2020

Condition

Locations shown

Eye Physicians of Central Florida

Maitland, Florida

Wheaton Eye Clinic

Chicago, Illinois

Indiana University

Bloomington, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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