Trial Outcomes & Findings for Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia (NCT NCT00587171)
NCT ID: NCT00587171
Last Updated: 2016-07-13
Results Overview
Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
TERMINATED
PHASE3
19 participants
17 weeks
2016-07-13
Participant Flow
Nineteen subjects were recruited by 7 community based or institutional based sites between April 2008 and March 2009.
At enrollment, subjects were required to have been treated with at least 16 weeks of single vision spectacles (if needed) or until visual acuity was documented to be stable. The child must have had access to a computer on a daily basis.
Participant milestones
| Measure |
Active
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Active
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia
Baseline characteristics by cohort
| Measure |
Active
n=9 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=10 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Age, Customized
7 years old
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
8 years old
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
9 years old
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
10 years old
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
11 years old
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
12 years old
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Cause of Amblyopia
Anisometropia
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Cause of Amblyopia
Strabismus
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cause of Amblyopia
Strabismus and anisometropia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Distance visual acuity in amblyopic eye
20/100 (48 to 52 letters) (worse)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Distance visual acuity in amblyopic eye
20/80 (53 to 57 letters)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Distance visual acuity in amblyopic eye
20/63 (58 to 62 letters)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Distance visual acuity in amblyopic eye
20/50 (63 to 67 letters)
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Distance visual acuity in amblyopic eye
20/40 (68 to 72 letters) (best)
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Mean (SD) Distance Visual Acuity in Amblyopic Eye
|
62.3 letters
STANDARD_DEVIATION 6.8 • n=5 Participants
|
61.9 letters
STANDARD_DEVIATION 7.9 • n=7 Participants
|
62.1 letters
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Distance visual acuity in fellow eye
20/40 (68 to 72 letters) (worse)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Distance visual acuity in fellow eye
20/32 (73 to 77 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Distance visual acuity in fellow eye
20/25 (78 to 82 letters)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Distance visual acuity in fellow eye
20/20 (83 to 87 letters)
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Distance visual acuity in fellow eye
20/16 (88 to 92 letters) (best)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Mean (SD) Distance Visual Acuity in Fellow Eye
|
85.3 letters
STANDARD_DEVIATION 3.6 • n=5 Participants
|
86.2 letters
STANDARD_DEVIATION 4.0 • n=7 Participants
|
85.8 letters
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Mean (SD) Intereye Acuity Difference
|
23.0 letters
STANDARD_DEVIATION 6.5 • n=5 Participants
|
24.3 letters
STANDARD_DEVIATION 8.8 • n=7 Participants
|
23.7 letters
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Randot Preschool stereoacuity
40 arcsec
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
60 arcsec
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
100 arcsec
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
200 arcsec
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
400 arcsec
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
800 arcsec
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
>800 arcsec
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Randot Preschool stereoacuity
Failed pretest
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/80 (53 to 57 letters) (worse)
|
0 participants
|
1 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/63 (58 to 62 letters)
|
1 participants
|
0 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/50 (63 to 67 letters)
|
0 participants
|
2 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/40 (68 to 72 letters)
|
3 participants
|
1 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/32 (73 to 77 letters)
|
0 participants
|
2 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/25 (78 to 82 letters)
|
2 participants
|
2 participants
|
|
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
20/20 (83 to 87 letters) (best)
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome
|
75.6 letters
Standard Deviation 9.7
|
72.0 letters
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
>=1 letter worse
|
0 participants
|
0 participants
|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
0 letters
|
0 participants
|
0 participants
|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
1 to 4 letters better
|
0 participants
|
2 participants
|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
5 to 9 letters better
|
4 participants
|
4 participants
|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
10 to 14 letters better
|
1 participants
|
2 participants
|
|
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
>=15 letters better
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks
|
12.0 letters
Standard Deviation 5.3
|
8.8 letters
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Fellow Eye Visual Acuity at 17 Weeks
20/25 (78 to 82 letters) (worse)
|
2 participants
|
0 participants
|
|
Distribution of Fellow Eye Visual Acuity at 17 Weeks
20/20 (83 to 87 letters)
|
1 participants
|
4 participants
|
|
Distribution of Fellow Eye Visual Acuity at 17 Weeks
20/16 (88 to 92 letters)
|
5 participants
|
2 participants
|
|
Distribution of Fellow Eye Visual Acuity at 17 Weeks
20/12 (93 to 97 letters) (best)
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks
|
86.5 letters
Standard Deviation 4.1
|
89.8 letters
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks
Within 4 letters
|
7 participants
|
7 participants
|
|
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks
5 to 9 letters better
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks
|
0.4 letters
Standard Deviation 2.8
|
2.9 letters
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD) of Intereye Visual Acuity at 17 Weeks
|
10.9 letters
Standard Deviation 9.2
|
17.8 letters
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks
|
11.6 letters
Standard Deviation 4.2
|
5.9 letters
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 17 weeksThe Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=9 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
40 arcsec (best)
|
2 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
60 arcsec
|
1 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
100 arcsec
|
2 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
200 arcsec
|
0 participants
|
4 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
400 arcsec
|
2 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
800 arcsec
|
1 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
>800 arcsec (worse)
|
0 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity at 17 Weeks
Failed pretest
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksThe Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Active
n=8 Participants
2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
|
Control
n=8 Participants
2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
|
|---|---|---|
|
Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks
2 or more levels worse
|
1 participants
|
2 participants
|
|
Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks
Within 1 level
|
4 participants
|
4 participants
|
|
Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks
2 or more levels better
|
3 participants
|
2 participants
|
Adverse Events
Active
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond Kraker, M.S.P.H.
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place