Luminopia One Amblyopia Vision Improvement Study

The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

Study Overview

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

Detailed Description

The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Jules Stein Eye Institute
  • Florida
    • Gainesville, Florida, United States, 32605
      • Family Focus Eye Care
    • Maitland, Florida, United States, 32751
      • Eye Physicians of Central Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • IU School of Optometry
  • Maryland
    • Frederick, Maryland, United States, 21703
      • Kids Eye Care of Maryland
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Specialized Pediatric Eye Care
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Children's Eye Care of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • OSU College of Optometry
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16501
      • Pediatric Ophthalmology of Erie
    • Lancaster, Pennsylvania, United States, 17601
      • Conestoga Eye
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Southampton, Pennsylvania, United States, 18966
      • Tri-County Eye Physicians
  • Texas
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital (BCM)
    • Houston, Texas, United States, 77381
      • Houston Eye Associates
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Eye Care
  • Virginia
    • Virginia Beach, Virginia, United States, 23452
      • Virginia Pediatric Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 4 to 7 years at the time of consent.
• Amblyopia associated with anisometropia and/or mild strabismus.
• Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
• Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
• Fellow eye BCVA 20/32 or better.
• Interocular difference ≥ 3 logMAR lines.
• Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.

Exclusion Criteria:

• Atropine treatment in the past 2 weeks.
• Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
• High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
• History of low adherence with amblyopia treatment or light-induced seizures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Group; Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.	Device: Luminopia One; Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
Active Comparator: Control Group; Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.	Device: Refractive Correction; Standard of care refractive correction (ex. spectacles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-Corrected Visual Acuity of Amblyopic Eye	Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.	12 weeks
Best-Corrected Visual Acuity of Fellow Eye	Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Mean adherence with the therapeutic in treatment group.	12 weeks
Best-Corrected Visual Acuity of Amblyopic Eye	Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.	4 weeks
Best-Corrected Visual Acuity of Amblyopic Eye	Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.	8 weeks
Stereoacuity	Mean stereoacuity improvement from baseline after 12 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: Luminopia
• Investigators: Study Director: Scott Xiao, Luminopia

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

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-2

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
• product manufactured in and exported from the U.S.: No