Trial Outcomes & Findings for Luminopia One Amblyopia Vision Improvement Study (NCT NCT03608150)
NCT ID: NCT03608150
Last Updated: 2024-03-20
Results Overview
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Luminopia One Amblyopia Vision Improvement Study
Baseline characteristics by cohort
| Measure |
Therapeutic Group
n=58 Participants
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.
|
Control Group
n=59 Participants
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)
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.2 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
6.0 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Prior Amblyopia Treatment
|
48 participants
n=5 Participants
|
43 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Outcome measures
| Measure |
Therapeutic Group
n=47 Participants
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.
|
Control Group
n=48 Participants
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)
|
|---|---|---|
|
Best-Corrected Visual Acuity of Amblyopic Eye
|
1.77 Lines of visual acuity improvement
Standard Deviation 1.56
|
0.85 Lines of visual acuity improvement
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: 12 weeksMean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Outcome measures
| Measure |
Therapeutic Group
n=47 Participants
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.
|
Control Group
n=48 Participants
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)
|
|---|---|---|
|
Best-Corrected Visual Acuity of Fellow Eye
|
0.30 Lines of visual acuity improvement
Standard Deviation 0.78
|
0.17 Lines of visual acuity improvement
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 12 weeksMean adherence with the therapeutic in treatment group.
Outcome measures
| Measure |
Therapeutic Group
n=56 Participants
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.
|
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)
|
|---|---|---|
|
Adherence
|
85 percentage of prescribed therapy
Interval 48.0 to 99.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeksMean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.
Outcome measures
| Measure |
Therapeutic Group
n=50 Participants
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.
|
Control Group
n=49 Participants
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)
|
|---|---|---|
|
Best-Corrected Visual Acuity of Amblyopic Eye
|
1.06 Lines of visual acuity improvement
Standard Deviation 1.32
|
0.37 Lines of visual acuity improvement
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 8 weeksMean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.
Outcome measures
| Measure |
Therapeutic Group
n=48 Participants
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.
|
Control Group
n=44 Participants
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)
|
|---|---|---|
|
Best-Corrected Visual Acuity of Amblyopic Eye
|
1.48 Lines of visual acuity improvement
Standard Deviation 1.25
|
0.95 Lines of visual acuity improvement
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: 12 weeksMean stereoacuity improvement from baseline after 12 weeks.
Outcome measures
| Measure |
Therapeutic Group
n=42 Participants
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.
|
Control Group
n=46 Participants
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)
|
|---|---|---|
|
Stereoacuity
|
1.0 Change in log arc seconds
Standard Deviation 5.8
|
0.8 Change in log arc seconds
Standard Deviation 2.9
|
Adverse Events
Therapeutic Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Therapeutic Group
n=51 participants at risk；n=58 participants at risk
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.
|
Control Group
n=59 participants at risk
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)
|
|---|---|---|
|
Eye disorders
New heterotropia
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
6.8%
4/59 • Number of events 4 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
|
General disorders
Headache
|
15.7%
8/51 • Number of events 9 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
|
Eye disorders
Worsening best-corrected visual acuity
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
8.5%
5/59 • Number of events 6 • Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60