Luminopia One Pilot Study
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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
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Condition or disease | Intervention/treatment | Phase |
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Amblyopia | Device: Luminopia One | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment Regimen A
Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.
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Device: Luminopia One
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied. |
- 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
- 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
- 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
- Adherence [ Time Frame: 12 weeks ]Duration spent using the device divided by duration of treatment prescribed (objectively monitored)

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
Study Director: | David Hunter, MD PhD | Boston Children's Hospital |
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 |
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 |
Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vision Disorders Sensation Disorders Neurologic Manifestations Eye Diseases |