Trial Outcomes & Findings for Regimens of Intermittent Occlusion Therapy for Amblyopia in Children (NCT NCT02767856)
NCT ID: NCT02767856
Last Updated: 2022-07-25
Results Overview
visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
4 weeks for the Intense Group and 12 weeks for the Standard Group
Results posted on
2022-07-25
Participant Flow
Participant milestones
| Measure |
Intense 12-hour IO-therapy Group
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
7
|
12
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
Reasons for withdrawal
| Measure |
Intense 12-hour IO-therapy Group
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Regimens of Intermittent Occlusion Therapy for Amblyopia in Children
Baseline characteristics by cohort
| Measure |
Intense 12-hour IO-therapy Group
n=18 Participants
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
n=14 Participants
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
5.7 years
STANDARD_DEVIATION 1.4 • n=39 Participants
|
6.0 years
STANDARD_DEVIATION 1.5 • n=41 Participants
|
5.8 years
STANDARD_DEVIATION 1.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Visual acuity at baseline
|
0.38 logMAR
STANDARD_DEVIATION 0.11 • n=39 Participants
|
0.385 logMAR
STANDARD_DEVIATION 0.11 • n=41 Participants
|
0.38 logMAR
STANDARD_DEVIATION 0.11 • n=35 Participants
|
PRIMARY outcome
Timeframe: 4 weeks for the Intense Group and 12 weeks for the Standard Groupvisual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
Outcome measures
| Measure |
Intense 12-hour IO-therapy Group
n=7 Participants
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
n=12 Participants
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Visual Acuity Improvement
|
0.17 logMAR
Standard Deviation 0.11
|
0.13 logMAR
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 4 weeks for the Intense Group and 12 weeks for the Standard GroupStereoacuity in arcsec was converted to log scale. so log10(stereo) will be reported. The higher value indicates a poorer binocular visual function.
Outcome measures
| Measure |
Intense 12-hour IO-therapy Group
n=7 Participants
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
n=11 Participants
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Stereoacuity Test
|
3.04 log(arcsec)
Standard Deviation 0.78
|
3.16 log(arcsec)
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 4 weeks for the Intense Group and 12 weeks for the Standard GroupObjective total treatment hours at the primary outcome visit measured with a microsensor
Outcome measures
| Measure |
Intense 12-hour IO-therapy Group
n=6 Participants
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
n=10 Participants
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Objective Total Treatment Hours
|
135.5 hour
Standard Deviation 30.5
|
109.2 hour
Standard Deviation 58.7
|
SECONDARY outcome
Timeframe: 4 weeks for the Intense Group and 12 weeks for the Standard Groupobjective adherence measured with a microsensor to the treatment regimen
Outcome measures
| Measure |
Intense 12-hour IO-therapy Group
n=6 Participants
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
IO-therapy Glasses
|
Standard 4-hour IO-therapy Group
n=10 Participants
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
IO-therapy Glasses
|
|---|---|---|
|
Objective Adherence
|
43.0 percent
Standard Deviation 12.7
|
54.1 percent
Standard Deviation 40.6
|
Adverse Events
Intense 12-hour IO-therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard 4-hour IO-therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jingyun Wang
State University of New York College of Optometry
Phone: 212-938-5759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place