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Luminopia One Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782117
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Luminopia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amblyopia Device: Luminopia One Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Luminopia One Pilot Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782117


Locations
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United States, Florida
Eye Physicians of Central Florida
Maitland, Florida, United States, 32751
United States, Illinois
Wheaton Eye Clinic
Chicago, Illinois, United States, 60187
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
United States, Maryland
Kids Eye Care of Maryland
Frederick, Maryland, United States, 21703
United States, Michigan
Children's Eye Care of Michigan
Dearborn, Michigan, United States, 48124
United States, New Hampshire
Concord Eye Center
Concord, New Hampshire, United States, 03301
United States, Pennsylvania
Conestoga Eye
Lancaster, Pennsylvania, United States, 17601
United States, Texas
Houston Eye Associates
Houston, Texas, United States, 77025
United States, Virginia
Virginia Pediatric Eye Center
Virginia Beach, Virginia, United States, 23452
Sponsors and Collaborators
Luminopia
Boston Children's Hospital
Investigators
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Study Director: David Hunter, MD PhD Boston Children's Hospital
More Information
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Responsible Party: Luminopia
ClinicalTrials.gov Identifier: NCT02782117    
Other Study ID Numbers: C-AM-1C AND C-AM-1D
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases