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OpenTrials
Completed

NCT Number: NCT02782117

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 population.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Physicians of Central Florida, Maitland, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Luminopia One

Device

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

Primary outcomes

  1. Amblyopic eye best-corrected visual acuity

    Time frame: 12 weeks

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

Secondary outcomes

  1. Amblyopic eye best-corrected visual acuity

    Time frame: 8 weeks

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

  2. Amblyopic eye best-corrected visual acuity

    Time frame: 4 weeks

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

  3. Adherence

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Luminopia

Industry

Collaborators

  • Boston Children's Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 25, 2016
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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