Luminopia One Amblyopia Vision Improvement Study
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|ClinicalTrials.gov Identifier: NCT03608150|
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : September 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Device: Luminopia One Device: Refractive Correction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- 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.
- 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.
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
|Study Director:||Scott Xiao||Luminopia|