Luminopia One Pilot Study

NCT02782117 | Completed FDA Device

• 1 other identifier: C-AM-1C AND C-AM-1D
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (3)

• Amblyopic eye best-corrected visual acuity

  8 weeks

• Amblyopic eye best-corrected visual acuity

  4 weeks

• Adherence

  12 weeks

Study Arms (1)

Treatment Regimen A

EXPERIMENTAL

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

Device: Luminopia One

Interventions

Luminopia One DEVICE

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

Treatment Regimen A

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Luminopia: lead
• Boston Children's Hospital: collaborator

Study Sites (9)

Eye Physicians of Central Florida

Maitland, Florida, 32751, United States

Location

Wheaton Eye Clinic

Chicago, Illinois, 60187, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

Kids Eye Care of Maryland

Frederick, Maryland, 21703, United States

Location

Children's Eye Care of Michigan

Dearborn, Michigan, 48124, United States

Location

Concord Eye Center

Concord, New Hampshire, 03301, United States

Location

Conestoga Eye

Lancaster, Pennsylvania, 17601, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Virginia Pediatric Eye Center

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

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

Study Officials

• David Hunter, MD PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 25, 2016
• Study Start: August 1, 2017
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)