Luminopia One Amblyopia Vision Improvement Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Luminopia One Amblyopia Vision Improvement Study

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Luminopia One
* Device: Refractive Correction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Group<br>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<br>* 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.<br>|
| Active Comparator: Control Group<br>Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. | Device: Refractive Correction<br>* Standard of care refractive correction (ex. spectacles)<br>|

What is the study measuring?
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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. | 4, 8, and 12 weeks | 
| Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 and 8 weeks using electronic ATS-HOTV protocol. | 4 and 8 weeks | 
| Stereoacuity | Mean stereoacuity improvement from baseline after 4, 8, and 12 weeks. | 4, 8, and 12 weeks |