Luminopia One Amblyopia Vision Improvement Study
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| ClinicalTrials.gov Identifier: NCT03608150 |
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Recruitment Status :
Completed
First Posted : July 31, 2018
Last Update Posted : September 11, 2020
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Sponsor:
Luminopia
Information provided by (Responsible Party):
Luminopia
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amblyopia | Device: Luminopia One Device: Refractive Correction | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 117 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Luminopia One Amblyopia Vision Improvement Study |
| Actual Study Start Date : | January 16, 2019 |
| Actual Primary Completion Date : | July 31, 2020 |
| Actual Study Completion Date : | July 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Active Comparator: Control Group
Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
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Device: Refractive Correction
Standard of care refractive correction (ex. spectacles) |
Primary Outcome Measures :
- Best-Corrected Visual Acuity of Amblyopic Eye [ Time Frame: 12 weeks ]Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
- Best-Corrected Visual Acuity of Fellow Eye [ Time Frame: 12 weeks ]Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Secondary Outcome Measures :
- Adherence [ Time Frame: 4, 8, and 12 weeks ]Mean adherence with the therapeutic in treatment group.
- Best-Corrected Visual Acuity of Amblyopic Eye [ Time Frame: 4 and 8 weeks ]Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 and 8 weeks using electronic ATS-HOTV protocol.
- Stereoacuity [ Time Frame: 4, 8, and 12 weeks ]Mean stereoacuity improvement from baseline after 4, 8, and 12 weeks.
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| Ages Eligible for Study: | 4 Years to 7 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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): NCT03608150
Locations
Show 22 study locations
Sponsors and Collaborators
Luminopia
Investigators
| Study Director: | Scott Xiao | Luminopia |
Study Documents (Full-Text)
| Responsible Party: | Luminopia |
| ClinicalTrials.gov Identifier: | NCT03608150 |
| Other Study ID Numbers: |
C-AM-2 |
| First Posted: | July 31, 2018 Key Record Dates |
| Last Update Posted: | September 11, 2020 |
| Last Verified: | September 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 |
| Product Manufactured in and Exported from the U.S.: | No |
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 |