Amblyopia
Conditions
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.
Detailed description
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.
Interventions
DEVICELuminopia 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.
DEVICERefractive Correction
Standard of care refractive correction (ex. spectacles)
Sponsors
Luminopia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-Corrected Visual Acuity of Amblyopic Eye | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 12 weeks | Mean adherence with the therapeutic in treatment group. |
| Best-Corrected Visual Acuity of Amblyopic Eye | 4 weeks | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol. |
| Stereoacuity | 12 weeks | Mean stereoacuity improvement from baseline after 12 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 58 |
| Control Group Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
Refractive Correction: Standard of care refractive correction (ex. spectacles) | 59 |
| Total | 117 |
Baseline characteristics
| Characteristic | Therapeutic Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 6.2 years STANDARD_DEVIATION 0.9 | 5.9 years STANDARD_DEVIATION 1.1 | 6.0 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 6 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 53 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Prior Amblyopia Treatment | 48 participants | 43 participants | 91 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 46 Participants | 96 Participants |
| Region of Enrollment United States | 58 participants | 59 participants | 117 participants |
| Sex: Female, Male Female | 23 Participants | 28 Participants | 51 Participants |
| Sex: Female, Male Male | 35 Participants | 31 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 59 |
| other Total, other adverse events | 13 / 51 | 9 / 59 |
| serious Total, serious adverse events | 0 / 58 | 0 / 59 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Group | Best-Corrected Visual Acuity of Amblyopic Eye | 1.77 Lines of visual acuity improvement | Standard Deviation 1.56 |
| Control Group | Best-Corrected Visual Acuity of Amblyopic Eye | 0.85 Lines of visual acuity improvement | Standard Deviation 1.34 |
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Group | Best-Corrected Visual Acuity of Fellow Eye | 0.30 Lines of visual acuity improvement | Standard Deviation 0.78 |
| Control Group | Best-Corrected Visual Acuity of Fellow Eye | 0.17 Lines of visual acuity improvement | Standard Deviation 0.56 |
Secondary
Adherence
Mean adherence with the therapeutic in treatment group.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Therapeutic Group | Adherence | 85 percentage of prescribed therapy |
Secondary
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Group | Best-Corrected Visual Acuity of Amblyopic Eye | 1.06 Lines of visual acuity improvement | Standard Deviation 1.32 |
| Control Group | Best-Corrected Visual Acuity of Amblyopic Eye | 0.37 Lines of visual acuity improvement | Standard Deviation 1.75 |
Secondary
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Group | Best-Corrected Visual Acuity of Amblyopic Eye | 1.48 Lines of visual acuity improvement | Standard Deviation 1.25 |
| Control Group | Best-Corrected Visual Acuity of Amblyopic Eye | 0.95 Lines of visual acuity improvement | Standard Deviation 1.63 |
Secondary
Stereoacuity
Mean stereoacuity improvement from baseline after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Group | Stereoacuity | 1.0 Change in log arc seconds | Standard Deviation 5.8 |
| Control Group | Stereoacuity | 0.8 Change in log arc seconds | Standard Deviation 2.9 |