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.

Study Overview

• Status: Completed
• Conditions: Amblyopia
• Intervention / Treatment: Device: Luminopia One

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Eye Physicians of Central Florida
  • Illinois
    • Chicago, Illinois, United States, 60187
      • Wheaton Eye Clinic
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University
  • Maryland
    • Frederick, Maryland, United States, 21703
      • Kids Eye Care of Maryland
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Children's Eye Care of Michigan
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Concord Eye Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Conestoga Eye
  • Texas
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
  • Virginia
    • Virginia Beach, Virginia, United States, 23452
      • Virginia Pediatric Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Regimen A; Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.	Device: Luminopia One; Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks
Adherence	Duration spent using the device divided by duration of treatment prescribed (objectively monitored)	12 weeks

Collaborators and Investigators

• Sponsor: Luminopia
• Collaborators: Boston Children's Hospital
• Investigators: Study Director: David Hunter, MD PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): February 6, 2019
• Study Completion (Actual): February 6, 2019

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: C-AM-1C AND C-AM-1D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes