Trial Outcomes & Findings for Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old (NCT NCT00944710)
NCT ID: NCT00944710
Last Updated: 2019-03-06
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
73 participants
10 weeks after randomization
2019-03-06
Participant Flow
Between November 2009 and August 2013, 73 participants from 20 sites were randomly assigned to either augmenting weekend atropine by changing the lens over the fellow eye to plano (n=33) or continuing with weekend atropine with best spectacle correction (n=40).
Prior to being considered for the randomized trial, participants who had not completed at least 12 weeks of atropine were enrolled into a run-in phase and treated with weekend atropine 1% ophthalmic solution and spectacles based upon a recent cycloplegic refraction, with follow up every 6 weeks until no improvement
Participant milestones
| Measure |
Control
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
10-week Primary Outcome
STARTED
|
40
|
33
|
|
10-week Primary Outcome
COMPLETED
|
40
|
33
|
|
10-week Primary Outcome
NOT COMPLETED
|
0
|
0
|
|
12-week Visit (Off-treatment)
STARTED
|
40
|
33
|
|
12-week Visit (Off-treatment)
COMPLETED
|
40
|
33
|
|
12-week Visit (Off-treatment)
NOT COMPLETED
|
0
|
0
|
|
Additional Post 10-week Primary Outcome
STARTED
|
40
|
33
|
|
Additional Post 10-week Primary Outcome
Eligible to Enter Post 10-week Phase
|
24
|
26
|
|
Additional Post 10-week Primary Outcome
COMPLETED
|
23
|
22
|
|
Additional Post 10-week Primary Outcome
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
Baseline characteristics by cohort
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 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
|
5.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.8 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
5.8 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Age, Customized
3 to <4 years
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
4 to <5 years
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
5 to <6 years
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
6 to <7 years
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Customized
>=7 years
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
33 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Duration of Atropine Treatment Prior to Randomization
12 to <15 weeks
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Duration of Atropine Treatment Prior to Randomization
15 to <21 weeks
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Duration of Atropine Treatment Prior to Randomization
21 to <27 weeks
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Duration of Atropine Treatment Prior to Randomization
27 to 84 weeks
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Duration of Atropine Treatment Prior to Randomization
|
24.0 weeks
STANDARD_DEVIATION 11.2 • n=5 Participants
|
26.4 weeks
STANDARD_DEVIATION 14.6 • n=7 Participants
|
25.0 weeks
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Cause of Amblyopia
Strabismus
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Cause of Amblyopia
Anisometropia
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Cause of Amblyopia
Strabismus and Anisometropia
|
21 participants
n=5 Participants
|
14 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/160
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/125
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/100
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/80
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/63
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/50
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/40
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
20/32
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Distance Visual Acuity in the Amblyopic Eye at Randomization
|
0.48 logMAR
STANDARD_DEVIATION 0.19 • n=5 Participants
|
0.48 logMAR
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.48 logMAR
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
Distance Visual Acuity in the Fellow Eye at Randomization
20/32
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Distance Visual Acuity in the Fellow Eye at Randomization
20/25
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Distance Visual Acuity in the Fellow Eye at Randomization
20/20
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Distance Visual Acuity in the Fellow Eye at Randomization
20/16
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Distance Visual Acuity in the Fellow Eye at Randomization
|
0.04 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.05 logMAR
STANDARD_DEVIATION 0.10 • n=7 Participants
|
0.05 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Interocular Eye Visual Acuity Difference at Randomization
|
4.4 logMAR lines
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.4 logMAR lines
STANDARD_DEVIATION 1.7 • n=7 Participants
|
4.4 logMAR lines
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
0 to <+1.00 D
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
+1.00 to <+2.00 D
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
+2.00 to <+3.00 D
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
+3.00 to <+4.00 D
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
+4.00 D or more
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye at Enrollment
|
5.73 diopters
STANDARD_DEVIATION 1.62 • n=5 Participants
|
5.84 diopters
STANDARD_DEVIATION 1.89 • n=7 Participants
|
5.78 diopters
STANDARD_DEVIATION 1.74 • n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment
+1.50 to <+2.00 D
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment
+2.00 to <+3.00 D
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment
+3.00 to <+4.00 D
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment
+4.00 D or more
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye at Enrollment
|
3.95 diopters
STANDARD_DEVIATION 1.60 • n=5 Participants
|
4.55 diopters
STANDARD_DEVIATION 2.28 • n=7 Participants
|
4.22 diopters
STANDARD_DEVIATION 1.95 • 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/50
|
6 participants
|
6 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/200
|
0 participants
|
1 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/160
|
2 participants
|
0 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/125
|
1 participants
|
2 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/100
|
4 participants
|
0 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/80
|
5 participants
|
4 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/63
|
3 participants
|
4 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/40
|
11 participants
|
4 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/32
|
3 participants
|
6 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/25
|
3 participants
|
5 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/20
|
1 participants
|
1 participants
|
|
Distribution of 10-week Amblyopic-Eye Visual Acuity
20/16
|
0 participants
|
0 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean 10-week Amblyopic-Eye Visual Acuity
|
0.42 logMAR
Standard Deviation 0.22
|
0.37 logMAR
Standard Deviation 0.23
|
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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
3 or more lines worse
|
0 participants
|
0 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
2 lines worse
|
1 participants
|
2 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
1 line worse
|
4 participants
|
3 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
No change
|
14 participants
|
6 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
1 line improved
|
12 participants
|
13 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
2 lines improved
|
7 participants
|
2 participants
|
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
3 or more lines improved
|
1 participants
|
7 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization
|
0.6 logMAR lines
Standard Deviation 1.1
|
1.1 logMAR lines
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationPopulation: The analysis includes data from participants who completed a 10-week exam.
The proportion of participants who achieved 20/25 or better visual acuity 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 was 20/25 or better since 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization
|
4 participants
|
6 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationThe distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. 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 frequency of atropine administration.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Spectacle Compliance at 10 Weeks by Treatment Group
Excellent
|
39 participants
|
30 participants
|
|
Spectacle Compliance at 10 Weeks by Treatment Group
Good
|
1 participants
|
1 participants
|
|
Spectacle Compliance at 10 Weeks by Treatment Group
Fair
|
0 participants
|
1 participants
|
|
Spectacle Compliance at 10 Weeks by Treatment Group
Poor
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)The 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 frequency of atropine administration.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Average Spectacle Compliance by Treatment Group
Excellent
|
39 participants
|
30 participants
|
|
Average Spectacle Compliance by Treatment Group
Good
|
1 participants
|
2 participants
|
|
Average Spectacle Compliance by Treatment Group
Fair
|
0 participants
|
0 participants
|
|
Average Spectacle Compliance by Treatment Group
Poor
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomizationThe distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. 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 frequency of atropine administration.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Atropine Compliance at 10 Weeks by Treatment Group
Excellent
|
38 participants
|
31 participants
|
|
Atropine Compliance at 10 Weeks by Treatment Group
Good
|
2 participants
|
2 participants
|
|
Atropine Compliance at 10 Weeks by Treatment Group
Fair
|
0 participants
|
0 participants
|
|
Atropine Compliance at 10 Weeks by Treatment Group
Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)The 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 frequency of atropine administration.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Average Atropine Compliance by Treatment Group
Excellent
|
39 participants
|
29 participants
|
|
Average Atropine Compliance by Treatment Group
Good
|
1 participants
|
4 participants
|
|
Average Atropine Compliance by Treatment Group
Fair
|
0 participants
|
0 participants
|
|
Average Atropine Compliance by Treatment Group
Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationDistribution of Interocular Difference Between Eyes at 12-week Exam
Outcome measures
| Measure |
Control
n=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Interocular Difference at 12-week Exam
0 or less lines
|
3 participants
|
2 participants
|
|
Distribution of Interocular Difference at 12-week Exam
1 line
|
2 participants
|
2 participants
|
|
Distribution of Interocular Difference at 12-week Exam
2 lines
|
6 participants
|
8 participants
|
|
Distribution of Interocular Difference at 12-week Exam
3 lines
|
6 participants
|
8 participants
|
|
Distribution of Interocular Difference at 12-week Exam
4 lines
|
5 participants
|
4 participants
|
|
Distribution of Interocular Difference at 12-week Exam
5 lines
|
5 participants
|
5 participants
|
|
Distribution of Interocular Difference at 12-week Exam
6 or more lines
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationMean Interocular Difference Between Eyes at 12-week Exam
Outcome measures
| Measure |
Control
n=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Interocular Difference at 12-week Exam
|
4.3 logMAR lines
Standard Deviation 2.6
|
3.3 logMAR lines
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationFollowing the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of 12-week Fellow-Eye Visual Acuity
20/40
|
1 participants
|
0 participants
|
|
Distribution of 12-week Fellow-Eye Visual Acuity
20/32
|
0 participants
|
4 participants
|
|
Distribution of 12-week Fellow-Eye Visual Acuity
20/25
|
10 participants
|
7 participants
|
|
Distribution of 12-week Fellow-Eye Visual Acuity
20/20
|
19 participants
|
14 participants
|
|
Distribution of 12-week Fellow-Eye Visual Acuity
20/16
|
10 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationOutcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Fellow-Eye Visual Acuity at 12-week Exam
|
0.01 logMAR
Standard Deviation 0.09
|
0.02 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationOutcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
3 or more lines worse
|
1 participants
|
0 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
2 lines worse
|
0 participants
|
0 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
1 line worse
|
1 participants
|
2 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
No change
|
23 participants
|
22 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
1 line improved
|
12 participants
|
7 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
2 lines improved
|
3 participants
|
2 participants
|
|
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
3 or more lines improved
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationOutcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
|
0.4 change in lines
Standard Deviation 0.9
|
0.3 change in lines
Standard Deviation 0.7
|
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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Atropine duration prior to randomization:15-<21wks
|
6 participants
|
9 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Atropine duration prior to randomization:21-<27wks
|
12 participants
|
9 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Atropine duration prior to randomization:27-84 wks
|
10 participants
|
10 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Fellow-eye SE RE at enrollment: <+3.00 Diopters(D)
|
10 participants
|
7 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D
|
12 participants
|
13 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Fellow-eye SE RE at enrollment: +4.50 to +6.00 D
|
12 participants
|
4 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Fellow-eye SE RE at enrollment: >+6.00 D
|
5 participants
|
9 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Gender: Female
|
21 participants
|
19 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Gender: Male
|
18 participants
|
14 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Race/Ethnicity: White (non-Hispanic)
|
32 participants
|
29 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Race/Ethnicity: Non-White/Hispanic
|
7 participants
|
4 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 3 to <4 years
|
5 participants
|
4 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 4 to <5 years
|
7 participants
|
6 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 5 to <6 years
|
9 participants
|
9 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 6 to <7 years
|
7 participants
|
5 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Age at randomization: 7 years or older
|
11 participants
|
9 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic-eye VA at randomization: 20/80 or worse
|
11 participants
|
10 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic-eye VA at randomization: 20/63
|
9 participants
|
8 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic-eye VA at randomization: 20/50
|
7 participants
|
8 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Amblyopic-eye VA at randomization: 20/40 or better
|
12 participants
|
7 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Strabismus
|
8 participants
|
13 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Anisometropia
|
10 participants
|
6 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Cause of amblyopia: Combined mechanism
|
21 participants
|
14 participants
|
|
Distribution of Baseline Characteristics at the 10-week Outcome
Atropine duration prior to randomization:12-<15wks
|
11 participants
|
5 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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Strabismus
|
0.48 logMAR
Standard Deviation 0.23
|
0.46 logMAR
Standard Deviation 0.16
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Atropine duration prior to randomization:21-<27wks
|
0.43 logMAR
Standard Deviation 0.12
|
0.53 logMAR
Standard Deviation 0.12
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Atropine duration prior to randomization:27-84 wks
|
0.46 logMAR
Standard Deviation 0.18
|
0.47 logMAR
Standard Deviation 0.19
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D
|
0.50 logMAR
Standard Deviation 0.18
|
0.51 logMAR
Standard Deviation 0.16
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Fellow-eye SE RE at enrollment: +4.50 to +6.00 D
|
0.53 logMAR
Standard Deviation 0.17
|
0.45 logMAR
Standard Deviation 0.24
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Gender: Female
|
0.51 logMAR
Standard Deviation 0.19
|
0.46 logMAR
Standard Deviation 0.14
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Gender: Male
|
0.45 logMAR
Standard Deviation 0.19
|
0.51 logMAR
Standard Deviation 0.19
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Race/Ethnicity: White (non-Hispanic)
|
0.50 logMAR
Standard Deviation 0.19
|
0.49 logMAR
Standard Deviation 0.17
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Race/Ethnicity: Non-White/Hispanic
|
0.41 logMAR
Standard Deviation 0.18
|
0.43 logMAR
Standard Deviation 0.05
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 3 to <4 years
|
0.58 logMAR
Standard Deviation 0.22
|
0.48 logMAR
Standard Deviation 0.17
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 4 to <5 years
|
0.50 logMAR
Standard Deviation 0.13
|
0.58 logMAR
Standard Deviation 0.23
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 5 to <6 years
|
0.46 logMAR
Standard Deviation 0.21
|
0.42 logMAR
Standard Deviation 0.10
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 6 to <7 years
|
0.43 logMAR
Standard Deviation 0.18
|
0.50 logMAR
Standard Deviation 0.12
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Fellow-eye SE RE at enrollment: <+3.00 Diopters(D)
|
0.41 logMAR
Standard Deviation 0.20
|
0.49 logMAR
Standard Deviation 0.20
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Fellow-eye SE RE at enrollment: >+6.00 D
|
0.48 logMAR
Standard Deviation 0.25
|
0.47 logMAR
Standard Deviation 0.11
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Age at randomization: 7 years or older
|
0.48 logMAR
Standard Deviation 0.21
|
0.48 logMAR
Standard Deviation 0.18
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Anisometropia
|
0.42 logMAR
Standard Deviation 0.13
|
0.35 logMAR
Standard Deviation 0.11
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Cause of amblyopia: Combined mechanism
|
0.51 logMAR
Standard Deviation 0.20
|
0.56 logMAR
Standard Deviation 0.15
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Atropine duration prior to randomization:12-<15wks
|
0.54 logMAR
Standard Deviation 0.23
|
0.38 logMAR
Standard Deviation 0.11
|
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Atropine duration prior to randomization:15-<21wks
|
0.53 logMAR
Standard Deviation 0.23
|
0.51 logMAR
Standard Deviation 0.18
|
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=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Race/Ethnicity: White (non-Hispanic)
|
0.5 logMAR lines
Standard Deviation 1.1
|
1.1 logMAR lines
Standard Deviation 1.8
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Anisometropia
|
0.8 logMAR lines
Standard Deviation 0.9
|
1.0 logMAR lines
Standard Deviation 1.9
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Combined mechanism
|
0.7 logMAR lines
Standard Deviation 1.1
|
0.6 logMAR lines
Standard Deviation 1.6
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Atropine duration prior to randomization:12-<15wks
|
1.1 logMAR lines
Standard Deviation 0.7
|
1.2 logMAR lines
Standard Deviation 1.8
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Atropine duration prior to randomization:15-<21wks
|
-0.3 logMAR lines
Standard Deviation 1.0
|
1.7 logMAR lines
Standard Deviation 2.2
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Atropine duration prior to randomization:21-<27wks
|
0.6 logMAR lines
Standard Deviation 1.3
|
1.2 logMAR lines
Standard Deviation 1.5
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Atropine duration prior to randomization:27-84 wks
|
0.6 logMAR lines
Standard Deviation 0.8
|
0.5 logMAR lines
Standard Deviation 1.6
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Fellow-eye SE RE at enrollment: <+3.00 Diopters(D)
|
0.7 logMAR lines
Standard Deviation 1.3
|
1.0 logMAR lines
Standard Deviation 2.7
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Fellow-eye SE RE at enrollment: +4.50 to +6.00 D
|
0.4 logMAR lines
Standard Deviation 0.9
|
1.3 logMAR lines
Standard Deviation 2.6
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Fellow-eye SE RE at enrollment: >+6.00 D
|
0.6 logMAR lines
Standard Deviation 1.1
|
1.3 logMAR lines
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Gender: Female
|
0.2 logMAR lines
Standard Deviation 1.0
|
1.2 logMAR lines
Standard Deviation 1.6
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Gender: Male
|
1.0 logMAR lines
Standard Deviation 1.0
|
1.1 logMAR lines
Standard Deviation 2.0
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Race/Ethnicity: Non-White/Hispanic
|
0.9 logMAR lines
Standard Deviation 1.2
|
1.0 logMAR lines
Standard Deviation 2.2
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 3 to <4 years
|
0.2 logMAR lines
Standard Deviation 0.8
|
1.3 logMAR lines
Standard Deviation 1.3
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 4 to <5 years
|
04 logMAR lines
Standard Deviation 1.5
|
0.7 logMAR lines
Standard Deviation 2.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 5 to <6 years
|
0.8 logMAR lines
Standard Deviation 1.3
|
1.2 logMAR lines
Standard Deviation 1.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 6 to <7 years
|
0.3 logMAR lines
Standard Deviation 0.5
|
2.4 logMAR lines
Standard Deviation 2.0
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Age at randomization: 7 years or older
|
0.9 logMAR lines
Standard Deviation 0.9
|
0.6 logMAR lines
Standard Deviation 1.7
|
|
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
|
0.5 logMAR lines
Standard Deviation 0.7
|
1.0 logMAR lines
Standard Deviation 2.4
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic-eye VA at randomization: 20/63
|
0.4 logMAR lines
Standard Deviation 1.3
|
1.5 logMAR lines
Standard Deviation 1.7
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Amblyopic-eye VA at randomization: 20/50
|
1.0 logMAR lines
Standard Deviation 1.3
|
1.3 logMAR lines
Standard Deviation 1.7
|
|
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
|
0.5 logMAR lines
Standard Deviation 1.1
|
0.7 logMAR lines
Standard Deviation 1.0
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Cause of amblyopia: Strabismus
|
0.1 logMAR lines
Standard Deviation 1.1
|
1.7 logMAR lines
Standard Deviation 1.8
|
|
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D
|
0.7 logMAR lines
Standard Deviation 1.2
|
1.0 logMAR lines
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)Population: 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=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/200
|
0 participants
|
1 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/80
|
6 participants
|
1 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/63
|
1 participants
|
4 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/160
|
2 participants
|
0 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/125
|
1 participants
|
0 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/100
|
3 participants
|
1 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/50
|
8 participants
|
5 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/40
|
10 participants
|
3 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/32
|
3 participants
|
10 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/25
|
5 participants
|
5 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/20
|
1 participants
|
3 participants
|
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
20/16
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)Population: 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. 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=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit
|
0.40 logMAR
Standard Deviation 0.23
|
0.29 logMAR
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)Population: 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=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
1 line worse
|
4 participants
|
3 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
No change
|
12 participants
|
3 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
1 line improved
|
12 participants
|
6 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
3 or more lines worse
|
0 participants
|
0 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
2 lines worse
|
1 participants
|
1 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
2 lines improved
|
9 participants
|
6 participants
|
|
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
3 or more lines improved
|
2 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)Population: 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=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=30 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit
|
0.8 logMAR lines
Standard Deviation 1.2
|
1.9 logMAR lines
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)Outcome measures
| Measure |
Control
n=39 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
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 Outcome Visit
|
11 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationPopulation: The analysis includes all participants who completed the 12-week exam.
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of \>800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.
Outcome measures
| Measure |
Control
n=40 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
Failed pretest
|
4 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
100 arcsec
|
1 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
>800 arcsec: Nil
|
7 participants
|
10 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
>800 arcsec: 3000 arcsec
|
14 participants
|
12 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
800 arcsec
|
7 participants
|
3 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
400 arcsec
|
4 participants
|
3 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
200 arcsec
|
0 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
60 arcsec
|
2 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
40 arcsec
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationPopulation: The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 12-week exam.
Outcome measures
| Measure |
Control
n=10 Participants
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=6 Participants
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
>800 arcsec: 3000 arcsec
|
2 participants
|
2 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
800 arcsec
|
3 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
40 arcsec
|
1 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
Failed pretest
|
0 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
>800 arcsec: Nil
|
1 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
400 arcsec
|
2 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
200 arcsec
|
0 participants
|
0 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
100 arcsec
|
0 participants
|
1 participants
|
|
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
60 arcsec
|
1 participants
|
1 participants
|
Adverse Events
Control
Intensified Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=40 participants at risk
Weekend atropine 1%
Atropine: Weekend atropine 1%
|
Intensified Treatment
n=33 participants at risk
Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye
|
|---|---|---|
|
Eye disorders
Light Sensitivity
|
2.5%
1/40
|
18.2%
6/33
|
|
Eye disorders
New ocular deviation or worsening of preexisting deviation by at least 10 PD
|
10.0%
4/40
|
9.1%
3/33
|
Additional Information
Raymond 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