Trial Outcomes & Findings for Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia (NCT NCT02687581)
NCT ID: NCT02687581
Last Updated: 2022-11-22
Results Overview
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
12± 1 weeks after treatment
Results posted on
2022-11-22
Participant Flow
Participant milestones
| Measure |
12-hour IO-therapy Glasses
wear IO-therapy glasses for 12-hour
IO-therapy Glasses: 12-hour of 50% intermittent occlusion therapy on the fellow eye.
|
6-hour Patching
wear the eye patch for 6-hour
patch: 6-hour of eye patch on the fellow eye
|
Deprivation Amblyopia
This group observes if the patients with deprivation amblyopia (amblyopia post-cataract surgery) could improve with IO-therapy glasses.
|
Myopic Anisometropic Amblyopia
This group observes if patients with myopic anisometropic amblyopia can improve vision with IO-therapy glasses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
12-hour IO-therapy Glasses
wear IO-therapy glasses for 12-hour
IO-therapy Glasses: 12-hour of 50% intermittent occlusion therapy on the fellow eye.
|
6-hour Patching
wear the eye patch for 6-hour
patch: 6-hour of eye patch on the fellow eye
|
Deprivation Amblyopia
This group observes if the patients with deprivation amblyopia (amblyopia post-cataract surgery) could improve with IO-therapy glasses.
|
Myopic Anisometropic Amblyopia
This group observes if patients with myopic anisometropic amblyopia can improve vision with IO-therapy glasses
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
0
|
|
Overall Study
the device is too small for the patient.
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia
Baseline characteristics by cohort
| Measure |
12-hour IO-therapy Glasses
n=2 Participants
wear IO-therapy glasses for 12-hour
IO-therapy Glasses: 12-hour of 50% intermittent occlusion therapy on the fellow eye.
|
6-hour Patching
n=4 Participants
wear the eye patch for 6-hour
patch: 6-hour of eye patch on the fellow eye
|
Deprivation Amblyopia
n=2 Participants
wear IO-therapy glasses depends on the severity of amblyopia. If severe, wear 12 hours; if moderate, wear 4 hours.
|
Myopic Anisometropic Amblyopia
n=3 Participants
wear IO-therapy glasses depends on the severity of amblyopia. If severe, wear 12 hours; if moderate, wear 4 hours.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
4.7 Year
STANDARD_DEVIATION 0.2 • n=5 Participants
|
5.4 Year
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.8 Year
STANDARD_DEVIATION 0.1 • n=5 Participants
|
5.9 Year
STANDARD_DEVIATION 0.6 • n=4 Participants
|
5.7 Year
STANDARD_DEVIATION 1.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
visual acuity of amblyopic eye
|
1.10 logMAR
STANDARD_DEVIATION 0.28 • n=5 Participants
|
0.86 logMAR
STANDARD_DEVIATION 0.17 • n=7 Participants
|
0.75 logMAR
STANDARD_DEVIATION 0.35 • n=5 Participants
|
0.5 logMAR
STANDARD_DEVIATION 0.17 • n=4 Participants
|
0.71 logMAR
STANDARD_DEVIATION 0.29 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12± 1 weeks after treatmentVisual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Outcome measures
| Measure |
12-hour IO-therapy Glasses
n=2 Participants
wear IO-therapy glasses for 12-hour
IO-therapy Glasses: 12-hour of 50% intermittent occlusion therapy on the fellow eye.
|
6-hour Patching
n=4 Participants
wear the eye patch for 6-hour
patch: 6-hour of eye patch on the fellow eye
|
Deprivation Amblyopia
n=2 Participants
This group observes the efficacy of IO-therapy glasses in children with deprivation amblyopia (amblyopia post-cataract surgery).
|
Myopic Anisometropic Amblyopia
n=3 Participants
This group observes the efficacy of IO-therapy glasses in children with myopic anisometropic amblyopia.
|
|---|---|---|---|---|
|
Visual Acuity Improvement
|
0.05 logMAR
Standard Deviation 0.07
|
0.17 logMAR
Standard Deviation 0.23
|
0.05 logMAR
Standard Deviation 0.07
|
0.1 logMAR
Standard Deviation 0.26
|
Adverse Events
12-hour IO-therapy Glasses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6-hour Patching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deprivation Amblyopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Myopic Anisometropic Amblyopia
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