Trial Outcomes & Findings for Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old (NCT NCT00315302)
NCT ID: NCT00315302
Last Updated: 2016-07-19
Results Overview
Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
18 weeks
Results posted on
2016-07-19
Participant Flow
Between Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).
Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.
Participant milestones
| Measure |
Atropine-Moderate Amblyopia
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
26
|
34
|
|
Overall Study
5 Week Visit
|
85
|
86
|
26
|
30
|
|
Overall Study
10 Week Visit
|
86
|
85
|
24
|
29
|
|
Overall Study
18 Week Primary Outcome Visit
|
84
|
88
|
24
|
31
|
|
Overall Study
Partial Responder Phase (Post 18 Weeks)
|
16
|
13
|
9
|
11
|
|
Overall Study
COMPLETED
|
84
|
88
|
24
|
31
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Baseline characteristics by cohort
| Measure |
Atropine-Moderate Amblyopia
n=90 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=90 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=26 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=34 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
90 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
240 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
5.2 years
STANDARD_DEVIATION 1.1 • n=93 Participants
|
5.1 years
STANDARD_DEVIATION 1.0 • n=4 Participants
|
4.5 years
STANDARD_DEVIATION 0.9 • n=27 Participants
|
4.4 years
STANDARD_DEVIATION 1.0 • n=483 Participants
|
5.0 years
STANDARD_DEVIATION 1.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
118 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
122 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
196 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African-American
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Unknown / Not reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=93 Participants
|
90 participants
n=4 Participants
|
26 participants
n=27 Participants
|
34 participants
n=483 Participants
|
239 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Cause of Amblyopia
Strabismus
|
38 participants
n=93 Participants
|
37 participants
n=4 Participants
|
10 participants
n=27 Participants
|
11 participants
n=483 Participants
|
96 participants
n=36 Participants
|
|
Cause of Amblyopia
Anisometropia
|
32 participants
n=93 Participants
|
30 participants
n=4 Participants
|
5 participants
n=27 Participants
|
8 participants
n=483 Participants
|
75 participants
n=36 Participants
|
|
Cause of Amblyopia
Strabismus and anisometropia
|
20 participants
n=93 Participants
|
23 participants
n=4 Participants
|
11 participants
n=27 Participants
|
15 participants
n=483 Participants
|
69 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/400 (worse)
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
8 participants
n=483 Participants
|
8 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/320
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
8 participants
n=27 Participants
|
2 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/250
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
4 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/200
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/160
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/125
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
7 participants
n=27 Participants
|
11 participants
n=483 Participants
|
18 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/100
|
7 participants
n=93 Participants
|
15 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
22 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/80
|
14 participants
n=93 Participants
|
15 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
29 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/63
|
29 participants
n=93 Participants
|
28 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
57 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/50
|
24 participants
n=93 Participants
|
17 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
41 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/40 (better)
|
16 participants
n=93 Participants
|
15 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
31 participants
n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
20/40 (worse)
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
7 participants
n=483 Participants
|
17 participants
n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
20/32
|
18 participants
n=93 Participants
|
18 participants
n=4 Participants
|
11 participants
n=27 Participants
|
12 participants
n=483 Participants
|
59 participants
n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
20/25
|
27 participants
n=93 Participants
|
28 participants
n=4 Participants
|
8 participants
n=27 Participants
|
7 participants
n=483 Participants
|
70 participants
n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
20/20
|
31 participants
n=93 Participants
|
33 participants
n=4 Participants
|
3 participants
n=27 Participants
|
8 participants
n=483 Participants
|
75 participants
n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
20/16 (better)
|
11 participants
n=93 Participants
|
8 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
19 participants
n=36 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
None
|
76 participants
n=93 Participants
|
72 participants
n=4 Participants
|
24 participants
n=27 Participants
|
28 participants
n=483 Participants
|
200 participants
n=36 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Patching
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
1 participants
n=27 Participants
|
6 participants
n=483 Participants
|
28 participants
n=36 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Atropine
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
3 participants
n=36 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Patching and Atropine
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
9 participants
n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
0 to < +1.00 D
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+1.00 to < +2.00 D
|
0 participants
n=93 Participants
|
6 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+2.00 D to < +3.00 D
|
8 participants
n=93 Participants
|
6 participants
n=4 Participants
|
3 participants
n=27 Participants
|
0 participants
n=483 Participants
|
17 participants
n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+3.00 D to < +4.00 D
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
3 participants
n=27 Participants
|
4 participants
n=483 Participants
|
35 participants
n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
>= +4.00 D
|
68 participants
n=93 Participants
|
63 participants
n=4 Participants
|
19 participants
n=27 Participants
|
30 participants
n=483 Participants
|
180 participants
n=36 Participants
|
|
Refractive Error in Sound Eye (spherical equivalent/diopters)
+ 1.50 to < + 2.00 D
|
17 participants
n=93 Participants
|
23 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
52 participants
n=36 Participants
|
|
Refractive Error in Sound Eye (spherical equivalent/diopters)
+ 2.00 D to < + 3.00 D
|
14 participants
n=93 Participants
|
19 participants
n=4 Participants
|
8 participants
n=27 Participants
|
5 participants
n=483 Participants
|
46 participants
n=36 Participants
|
|
Refractive Error in Sound Eye (spherical equivalent/diopters)
+3.00 D to < + 4.00 D
|
20 participants
n=93 Participants
|
12 participants
n=4 Participants
|
2 participants
n=27 Participants
|
8 participants
n=483 Participants
|
42 participants
n=36 Participants
|
|
Refractive Error in Sound Eye (spherical equivalent/diopters)
>= + 4.00 D
|
39 participants
n=93 Participants
|
36 participants
n=4 Participants
|
10 participants
n=27 Participants
|
15 participants
n=483 Participants
|
100 participants
n=36 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
|
0.47 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.12 • n=93 Participants
|
0.50 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.13 • n=4 Participants
|
0.99 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.16 • n=27 Participants
|
1.01 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.20 • n=483 Participants
|
0.61 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.27 • n=36 Participants
|
|
Distance Visual Acuity in Sound Eye
|
0.07 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.10 • n=93 Participants
|
0.07 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.10 • n=4 Participants
|
0.16 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.09 • n=27 Participants
|
0.15 log of min angle of resolution (logMAR)
STANDARD_DEVIATION 0.11 • n=483 Participants
|
.09 log of min angle of resolution (logMAR)
STANDARD_DEVIATION .11 • n=36 Participants
|
|
Intereye Acuity Difference
|
4.0 logMAR lines
STANDARD_DEVIATION 1.2 • n=93 Participants
|
4.3 logMAR lines
STANDARD_DEVIATION 1.3 • n=4 Participants
|
8.3 logMAR lines
STANDARD_DEVIATION 1.7 • n=27 Participants
|
8.6 logMAR lines
STANDARD_DEVIATION 2.2 • n=483 Participants
|
5.2 logMAR lines
STANDARD_DEVIATION 2.4 • n=36 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
|
4.99 diopters
STANDARD_DEVIATION 1.66 • n=93 Participants
|
4.94 diopters
STANDARD_DEVIATION 1.81 • n=4 Participants
|
5.25 diopters
STANDARD_DEVIATION 2.09 • n=27 Participants
|
5.36 diopters
STANDARD_DEVIATION 1.29 • n=483 Participants
|
5.05 diopters
STANDARD_DEVIATION 1.72 • n=36 Participants
|
|
Refractive Error in Sound Eye (spherical equivalent/diopters)
|
3.71 diopters
STANDARD_DEVIATION 1.71 • n=93 Participants
|
3.54 diopters
STANDARD_DEVIATION 1.86 • n=4 Participants
|
3.60 diopters
STANDARD_DEVIATION 2.18 • n=27 Participants
|
3.71 diopters
STANDARD_DEVIATION 1.58 • n=483 Participants
|
3.63 diopters
STANDARD_DEVIATION 1.79 • n=36 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.
Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Visual Acuity Mean Score in the Amblyopic Eye
|
0.23 logMAR units
Standard Deviation 0.16
|
0.22 logMAR units
Standard Deviation 0.20
|
0.54 logMAR units
Standard Deviation 0.26
|
0.50 logMAR units
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: 18 weeksVisual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Visual Acuity Distribution in the Amblyopic Eye
20/400 (worse)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/320
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/250
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/200
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/160
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/125
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/100
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/80
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/63
|
4 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/50
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/40
|
18 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/32
|
28 Participants
|
24 Participants
|
1 Participants
|
8 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/25
|
12 Participants
|
19 Participants
|
0 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/20
|
11 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Amblyopic Eye
20/16 (better)
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: baseline to 18 weeksAcuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Mean Change in Visual Acuity in the Amblyopic Eye
|
2.4 logMAR units
Standard Deviation 1.4
|
2.8 logMAR units
Standard Deviation 1.8
|
4.5 logMAR units
Standard Deviation 3.1
|
5.1 logMAR units
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: baseline to 18 weeksAcuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
+4
|
17 Participants
|
18 Participants
|
4 Participants
|
3 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
-3 (worse)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
-2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
-1
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
0
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
+1
|
18 Participants
|
11 Participants
|
2 Participants
|
3 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
+2
|
18 Participants
|
19 Participants
|
3 Participants
|
1 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
+3
|
22 Participants
|
18 Participants
|
3 Participants
|
2 Participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye
>= +5 (better)
|
3 Participants
|
14 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Not reported among subjects with severe amblyopia
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
Failed black & white shape identification pretest
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
>800 arcsec (worst)
|
40 Participants
|
41 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
400 arcsec
|
11 Participants
|
12 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
200 arcsec
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
100 arcsec
|
4 Participants
|
10 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
60 arcsec
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
40 arcsec (best)
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
Not done
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
800 arcsec
|
7 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Not reported among subjects with severe amblyopia
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=29 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=30 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
Failed black & white shape identification pretest
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
>800 arcsec (worst)
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
200 arcsec
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
60 arcsec
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
40 arcsec (best)
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
800 arcsec
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
400 arcsec
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
100 arcsec
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
Not done
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 18 weeksAcuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Mean Change in Visual Acuity in the Sound Eye
|
0.4 logMAR units
Standard Deviation 0.9
|
0.0 logMAR units
Standard Deviation 1.0
|
0.10 logMAR units
Standard Deviation 0.12
|
0.15 logMAR units
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: baseline to 18 weeksAcuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Distribution of Change in Visual Acuity in the Sound Eye
-4 (worse)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
-2
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
-1
|
3 Participants
|
12 Participants
|
0 Participants
|
2 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
0
|
49 Participants
|
50 Participants
|
11 Participants
|
13 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
+1
|
24 Participants
|
17 Participants
|
9 Participants
|
12 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
+3 (better)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
-3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Change in Visual Acuity in the Sound Eye
+2
|
6 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 weeksAcuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
Outcome measures
| Measure |
Atropine-Moderate Amblyopia
n=84 Participants
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=24 Participants
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=31 Participants
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Visual Acuity Distribution in the Sound Eye
20/25
|
14 Participants
|
22 Participants
|
8 Participants
|
7 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/40
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/32
|
10 Participants
|
16 Participants
|
6 Participants
|
7 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/20
|
36 Participants
|
28 Participants
|
6 Participants
|
7 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/16 (better)
|
21 Participants
|
15 Participants
|
2 Participants
|
2 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/63 (worse)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Visual Acuity Distribution in the Sound Eye
20/50
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Atropine-Moderate Amblyopia
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Atropine Plus Plano-Moderate Amblyopia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Atropine-Severe Amblyopia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Atropine Plus Plano-Severe Amblyopia
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atropine-Moderate Amblyopia
n=90 participants at risk
Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine Plus Plano-Moderate Amblyopia
n=90 participants at risk
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Severe Amblyopia
n=26 participants at risk
Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
|
Atropine Plus Plano-Severe Amblyopia
n=34 participants at risk
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
|
|---|---|---|---|---|
|
Eye disorders
Light sensitivity
|
8.9%
8/90 • Number of events 8 • Adverse events were collected through the 18wk outcome visit.
|
1.1%
1/90 • Number of events 1 • Adverse events were collected through the 18wk outcome visit.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through the 18wk outcome visit.
|
14.7%
5/34 • Number of events 5 • Adverse events were collected through the 18wk outcome visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place