Trial Outcomes & Findings for Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (NCT NCT00945100)
NCT ID: NCT00945100
Last Updated: 2016-07-13
Results Overview
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
COMPLETED
PHASE3
169 participants
10 weeks after randomization
2016-07-13
Participant Flow
Between September 2009 and December 2012, 45 sites randomized 169 participants to either increase patching time to an average of 6 hours per day (n=86) or continue 2 hours daily patching (n=83).
Prior to being considered for the randomized trial, participants who had not already completed at least 12 weeks of 2 hours of daily patching were enrolled into a run-in phase and treated with 2 hours of daily patching (and spectacles if needed) with follow-up every 6 weeks until no improvement.
Participant milestones
| Measure |
Control
2 hours daily patching
|
Intensified Treatment
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
10-week Primary Outcome
STARTED
|
83
|
86
|
|
10-week Primary Outcome
Completed, Eligible
|
55
|
63
|
|
10-week Primary Outcome
Completed, Not Eligible
|
27
|
20
|
|
10-week Primary Outcome
COMPLETED
|
82
|
83
|
|
10-week Primary Outcome
NOT COMPLETED
|
1
|
3
|
|
Post-10 Week Primary Outcome
STARTED
|
55
|
63
|
|
Post-10 Week Primary Outcome
COMPLETED
|
51
|
56
|
|
Post-10 Week Primary Outcome
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Baseline characteristics by cohort
| Measure |
Control
n=83 Participants
2 hours daily patching
|
Intensified Treatment
n=86 Participants
42 hours per week of patching (averaging 6 hours daily)
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Best distance visual acuity in the amblyopic eye at randomization
20/80
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
5.9 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
5.9 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Age, Customized
3 to <4 years
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Age, Customized
4 to <5 years
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
5 to <6 years
|
27 participants
n=5 Participants
|
19 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
6 to <7 years
|
17 participants
n=5 Participants
|
25 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Age, Customized
7 to 8 years
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
57 participants
n=5 Participants
|
66 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
82 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Enrollment Disposition
No current treatment
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Enrollment Disposition
On treatment
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Enrollment Disposition
Ready for randomization
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Duration of patching prior to randomization (weeks)
12 to <16 weeks
|
14 participants
n=5 Participants
|
21 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Duration of patching prior to randomization (weeks)
16 to <25 weeks
|
39 participants
n=5 Participants
|
31 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Duration of patching prior to randomization (weeks)
25 weeks or more
|
30 participants
n=5 Participants
|
34 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Duration of patching prior to randomization (weeks)
|
24.5 Weeks
STANDARD_DEVIATION 10.7 • n=5 Participants
|
24.4 Weeks
STANDARD_DEVIATION 11.9 • n=7 Participants
|
24.4 Weeks
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Amblyopia Cause
Strabismus
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Amblyopia Cause
Anisometropia
|
41 participants
n=5 Participants
|
34 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Amblyopia Cause
Strabismus and Anisometropia
|
26 participants
n=5 Participants
|
36 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/160
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/125
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/100
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/63
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/50
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/40
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
20/32
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Best distance visual acuity in the amblyopic eye at randomization
|
0.43 logMAR
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.45 logMAR
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.44 logMAR
STANDARD_DEVIATION 0.16 • n=5 Participants
|
|
Best distance visual acuity in the fellow eye at randomization
20/32
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Best distance visual acuity in the fellow eye at randomization
20/25
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Best distance visual acuity in the fellow eye at randomization
20/20
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Best distance visual acuity in the fellow eye at randomization
20/16
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Best distance visual acuity in the fellow eye at randomization
|
-0.01 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.00 logMAR
STANDARD_DEVIATION 0.09 • n=7 Participants
|
-0.01 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Best interocular eye visual acuity difference at randomization
|
4.4 logMAR lines
STANDARD_DEVIATION 1.6 • n=5 Participants
|
4.5 logMAR lines
STANDARD_DEVIATION 1.7 • n=7 Participants
|
4.5 logMAR lines
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
0 to <+1.00D
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
+1.00 D to <+2.00 D
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
+2.00 D to <+3.00 D
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
+3.00 D to <+4.00 D
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
+4.00 D or more
|
54 participants
n=5 Participants
|
70 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Refractive error in amblyopic eye at enrollment
|
4.58 Diopters
STANDARD_DEVIATION 2.26 • n=5 Participants
|
5.27 Diopters
STANDARD_DEVIATION 1.94 • n=7 Participants
|
4.93 Diopters
STANDARD_DEVIATION 2.12 • n=5 Participants
|
|
Refractive error in fellow eye at enrollment
<0 D
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
0 to <+1.00D
|
22 participants
n=5 Participants
|
14 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
+1.00 D to <+2.00 D
|
30 participants
n=5 Participants
|
19 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
+2.00 D to <+3.00 D
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
+3.00 D to <+4.00 D
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
+4.00 D or more
|
16 participants
n=5 Participants
|
26 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Refractive error in fellow eye at enrollment
|
2.10 Diopters
STANDARD_DEVIATION 1.86 • n=5 Participants
|
2.89 Diopters
STANDARD_DEVIATION 2.06 • n=7 Participants
|
2.50 Diopters
STANDARD_DEVIATION 2.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks after randomizationPopulation: The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/16
|
0 participants
|
0 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/200
|
1 participants
|
0 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/160
|
0 participants
|
0 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/125
|
3 participants
|
3 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/100
|
3 participants
|
2 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/80
|
8 participants
|
4 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/63
|
6 participants
|
9 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/50
|
19 participants
|
15 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/40
|
23 participants
|
20 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/32
|
14 participants
|
15 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/25
|
3 participants
|
12 participants
|
|
Distribution of 10-week Amblyopic Eye Visual Acuity
20/20
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 10 weeks after randomizationPopulation: The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean 10-week Amblyopic Eye Visual Acuity
|
0.38 logMAR
Standard Deviation 0.19
|
0.33 logMAR
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Randomization to 10 weeksPopulation: The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
3 or more logMAR lines worse
|
1 participants
|
0 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
2 logMAR lines worse
|
3 participants
|
2 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
1 logMAR line worse
|
13 participants
|
7 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
No change (0 logMAR line)
|
19 participants
|
17 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
1 logMAR line improved
|
31 participants
|
23 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
2 logMAR lines improved
|
13 participants
|
19 participants
|
|
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
3 or more logMAR lines improved
|
2 participants
|
14 participants
|
PRIMARY outcome
Timeframe: Randomization to 10 weeksPopulation: The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
|
0.5 logMAR lines
Standard Deviation 1.2
|
1.2 logMAR lines
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationThe distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Excellent
|
66 participants
|
59 participants
|
|
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Good
|
10 participants
|
14 participants
|
|
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Fair
|
0 participants
|
5 participants
|
|
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Poor
|
2 participants
|
4 participants
|
|
Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Missing (Not applicable)
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterThe distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Average Compliance With Prescribed Patching by Treatment Group
Fair
|
1 participants
|
4 participants
|
|
Average Compliance With Prescribed Patching by Treatment Group
Excellent
|
65 participants
|
60 participants
|
|
Average Compliance With Prescribed Patching by Treatment Group
Good
|
11 participants
|
15 participants
|
|
Average Compliance With Prescribed Patching by Treatment Group
Poor
|
2 participants
|
4 participants
|
|
Average Compliance With Prescribed Patching by Treatment Group
Missing (Not applicable)
|
3 participants
|
0 participants
|
|
Average Compliance With Prescribed Patching by Treatment Group
Treatment not per protocol
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
|
15 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Treatment Group Comparison of 10-week Interocular Difference
|
3.7 logMAR lines
Standard Deviation 2.2
|
3.2 logMAR lines
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 5 years or older
|
62 participants
0.11
|
59 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic eye VA at randomization: 20/80 or worse
|
12 participants
|
15 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic eye VA at randomization: 20/50
|
26 participants
|
24 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic eye VA at randomization: 20/40 or better
|
27 participants
|
22 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Anisometropia
|
40 participants
|
31 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Combined mechanism
|
26 participants
|
36 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Gender: Female
|
43 participants
0.17
|
41 participants
0.16
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Gender: Male
|
39 participants
0.13
|
41 participants
0.14
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Race/Ethnicity: White (non-Hispanic)
|
56 participants
0.16
|
63 participants
0.14
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Race/Ethnicity: Non-White/Hispanic
|
26 participants
0.14
|
19 participants
0.17
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 3 to <5 years
|
20 participants
0.17
|
23 participants
0.15
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic eye VA at randomization: 20/63
|
17 participants
|
21 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Strabismus
|
16 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Gender: Male
|
0.41 logMAR
Standard Deviation 0.13
|
0.44 logMAR
Standard Deviation 0.14
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Anisometropia
|
0.39 logMAR
Standard Deviation 0.11
|
0.43 logMAR
Standard Deviation 0.13
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Gender: Female
|
0.44 logMAR
Standard Deviation 0.17
|
0.45 logMAR
Standard Deviation 0.16
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Race/Ethnicity: White (non-Hispanic)
|
0.42 logMAR
Standard Deviation 0.16
|
0.45 logMAR
Standard Deviation 0.14
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Race/Ethnicity: Non-White/Hispanic
|
0.43 logMAR
Standard Deviation 0.14
|
0.43 logMAR
Standard Deviation 0.17
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 3 to <5 years
|
0.45 logMAR
Standard Deviation 0.14
|
0.44 logMAR
Standard Deviation 0.12
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 5 years or older
|
0.42 logMAR
Standard Deviation 0.16
|
0.45 logMAR
Standard Deviation 0.16
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Strabismus
|
0.46 logMAR
Standard Deviation 0.17
|
0.43 logMAR
Standard Deviation 0.15
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Combined mechanism
|
0.47 logMAR
Standard Deviation 0.19
|
0.46 logMAR
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=82 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Gender: Female
|
0.4 units on a scale
Standard Deviation 1.3
|
1.4 units on a scale
Standard Deviation 1.3
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Gender: Male
|
0.7 units on a scale
Standard Deviation 1.1
|
0.9 units on a scale
Standard Deviation 1.5
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Race/Ethnicity: White (non-Hispanic)
|
0.5 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Race/Ethnicity: Non-White/Hispanic
|
0.5 units on a scale
Standard Deviation 1.6
|
1.1 units on a scale
Standard Deviation 1.3
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 3 to <5 years
|
0.9 units on a scale
Standard Deviation 1.0
|
1.5 units on a scale
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 5 years or older
|
0.4 units on a scale
Standard Deviation 1.2
|
1.0 units on a scale
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic eye VA at randomization: 20/80 or worse
|
0.7 units on a scale
Standard Deviation 1.4
|
1.3 units on a scale
Standard Deviation 1.6
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic eye VA at randomization: 20/63
|
0.7 units on a scale
Standard Deviation 1.3
|
1.6 units on a scale
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic eye VA at randomization: 20/50
|
0.4 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.1
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic eye VA at randomization: 20/40 or better
|
0.4 units on a scale
Standard Deviation 1.1
|
0.5 units on a scale
Standard Deviation 1.3
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Strabismus
|
1.1 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.3
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Anisometropia
|
0.3 units on a scale
Standard Deviation 1.2
|
1.3 units on a scale
Standard Deviation 1.5
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Combined mechanism
|
0.5 units on a scale
Standard Deviation 1.1
|
1.0 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/32
|
15 participants
|
14 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/25
|
12 participants
|
15 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/20
|
3 participants
|
5 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/16
|
1 participants
|
1 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/160
|
0 participants
|
0 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/125
|
2 participants
|
2 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/40
|
16 participants
|
21 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/200
|
1 participants
|
0 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/100
|
3 participants
|
3 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/80
|
7 participants
|
4 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/63
|
7 participants
|
7 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
20/50
|
15 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
|
0.33 logMAR
Standard Deviation 0.21
|
0.30 logMAR
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Randomization to 10 weeks or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
3 or more logMAR lines worse
|
1 participants
|
0 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
2 logMAR lines worse
|
3 participants
|
2 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
1 logMAR line worse
|
12 participants
|
6 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
No change (0 logMAR line)
|
13 participants
|
17 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
1 logMAR line improved
|
21 participants
|
16 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
2 logMAR lines improved
|
22 participants
|
21 participants
|
|
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
3 or more logMAR lines improved
|
10 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity
|
0.9 logMAR lines
Standard Deviation 1.5
|
1.5 logMAR lines
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit
|
32 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes data from participants who completed a 10-week exam.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/63
|
0 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/50
|
1 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/40
|
1 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/32
|
5 participants
|
8 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/25
|
19 participants
|
14 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/20
|
20 participants
|
31 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
20/16
|
36 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes data from participants who completed a 10-week exam.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Best Fellow Eye Visual Acuity at 10-week Outcome
|
0.00 logMAR
Standard Deviation 0.11
|
0.00 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/63
|
1 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/50
|
1 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/40
|
1 participants
|
0 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/32
|
4 participants
|
5 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/25
|
15 participants
|
18 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/20
|
20 participants
|
28 participants
|
|
Distribution of Best Fellow Eye Visual Acuity at Final Visit
20/16
|
40 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Best Fellow Eye Visual Acuity at Final Visit
|
-0.01 logMAR
Standard Deviation 0.12
|
0.00 logMAR
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes data from participants who completed a 10-week exam.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
1 logMAR line worse
|
14 participants
|
16 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
3 or more logMAR lines worse
|
1 participants
|
1 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
2 logMAR lines worse
|
0 participants
|
0 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
No change (0 logMAR line)
|
58 participants
|
49 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
1 logMAR line improved
|
8 participants
|
17 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
2 logMAR lines improved
|
1 participants
|
0 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
3 or more logMAR lines improved
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes data from participants who completed a 10-week exam.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
|
-0.10 logMAR lines
Standard Deviation 0.7
|
-0.02 logMAR lines
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterPopulation: The analysis includes data from participants who completed the 10-week exam and/or a later visit.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
No change (0 logMAR line)
|
53 participants
|
50 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
3 or more logMAR lines worse
|
2 participants
|
0 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
2 logMAR lines worse
|
1 participants
|
0 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
1 logMAR line worse
|
11 participants
|
16 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
1 logMAR line improved
|
13 participants
|
16 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
2 logMAR lines improved
|
2 participants
|
1 participants
|
|
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
3 or more logMAR lines improved
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or laterOutcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
|
-0.04 logMAR lines
Standard Deviation 0.9
|
0.02 logMAR lines
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: RandomizationPopulation: The analysis includes all participants who completed the 10-week exam.
The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of \>800. We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing. The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
Failed pretest
|
10 participants
|
7 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
> 800 seconds of arc
|
39 participants
|
47 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
800 seconds of arc
|
10 participants
|
8 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
400 seconds of arc
|
6 participants
|
5 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
200 seconds of arc
|
4 participants
|
7 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
100 seconds of arc
|
7 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
60 seconds of arc
|
2 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
40 seconds of arc
|
2 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization
Not done
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes all participants who completed the 10-week exam.
Outcome measures
| Measure |
Control
n=82 Participants
2 hours daily patching
|
Intensified Treatment
n=83 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
Failed pretest
|
8 participants
|
7 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
> 800 seconds of arc
|
33 participants
|
44 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
800 seconds of arc
|
13 participants
|
10 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
400 seconds of arc
|
10 participants
|
12 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
200 seconds of arc
|
5 participants
|
6 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
100 seconds of arc
|
11 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
60 seconds of arc
|
0 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
40 seconds of arc
|
2 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
Not done
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.
Outcome measures
| Measure |
Control
n=69 Participants
2 hours daily patching
|
Intensified Treatment
n=68 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
2 or more levels worse
|
2 participants
|
2 participants
|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
Within 1 level
|
62 participants
|
59 participants
|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
2 or more levels improved
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: RandomizationPopulation: The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.
Outcome measures
| Measure |
Control
n=40 Participants
2 hours daily patching
|
Intensified Treatment
n=32 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
100 seconds of arc
|
3 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
60 seconds of arc
|
2 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
40 seconds of arc
|
1 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
Not done
|
1 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
Failed pretest
|
3 participants
|
3 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
> 800 seconds of arc
|
15 participants
|
17 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
800 seconds of arc
|
7 participants
|
3 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
400 seconds of arc
|
5 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
200 seconds of arc
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.
Outcome measures
| Measure |
Control
n=40 Participants
2 hours daily patching
|
Intensified Treatment
n=32 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
800 seconds of arc
|
7 participants
|
4 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
400 seconds of arc
|
6 participants
|
4 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
200 seconds of arc
|
4 participants
|
3 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Not done
|
0 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Failed pretest
|
3 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
> 800 seconds of arc
|
11 participants
|
17 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
100 seconds of arc
|
7 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
60 seconds of arc
|
0 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
40 seconds of arc
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam.
Outcome measures
| Measure |
Control
n=35 Participants
2 hours daily patching
|
Intensified Treatment
n=28 Participants
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
2 or more levels worse
|
0 participants
|
2 participants
|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
Within 1 level
|
32 participants
|
22 participants
|
|
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
2 or more levels improved
|
3 participants
|
4 participants
|
Adverse Events
Control
Intensified Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=83 participants at risk
2 hours daily patching
|
Intensified Treatment
n=86 participants at risk
42 hours per week of patching (averaging 6 hours daily)
|
|---|---|---|
|
Eye disorders
New ocular deviation or worsening of preexisting deviation by at least 10 pd
|
7.2%
6/83 • Number of events 7
|
4.7%
4/86 • Number of events 7
|
Additional Information
Ray Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place