Trial Outcomes & Findings for Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds (NCT NCT00315328)
NCT ID: NCT00315328
Last Updated: 2016-06-24
Results Overview
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
17 weeks
Results posted on
2016-06-24
Participant Flow
Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).
Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.
Participant milestones
| Measure |
Patching-Moderate Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
95
|
18
|
22
|
|
Overall Study
5 Week Visit
|
91
|
89
|
17
|
19
|
|
Overall Study
COMPLETED
|
84
|
88
|
13
|
20
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
Baseline characteristics by cohort
| Measure |
Patching-Moderate Amblyopia
n=98 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=95 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=18 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=22 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
9.5 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 1.6 • n=21 Participants
|
|
Age, Customized
7 to <8 years
|
35 participants
n=5 Participants
|
28 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
78 participants
n=21 Participants
|
|
Age, Customized
8 to <9 years
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
54 participants
n=21 Participants
|
|
Age, Customized
9 to <10 years
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Age, Customized
10 to <11 years
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Age, Customized
11 to <12 years
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Age, Customized
12 to <13 years
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=5 Participants
|
56 participants
n=7 Participants
|
16 participants
n=5 Participants
|
18 participants
n=4 Participants
|
158 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
46 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Cause of Amblyopia
Strabismus
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
Cause of Amblyopia
Anisometropia
|
46 participants
n=5 Participants
|
31 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
92 participants
n=21 Participants
|
|
Cause of Amblyopia
Strabismus and anisometropia
|
24 participants
n=5 Participants
|
31 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/400 (18 to 22 letters) (worse)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/320 (23 to 27 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/250 (28 to 32 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/200 (33 to 37 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/160 (38 to 42 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/125 (43 to 47 letters)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/100 (48 to 52 letters)
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/80 (53 to 57 letters)
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/63 (58 to 62 letters)
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
46 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/50 (63 to 67 letters)
|
33 participants
n=5 Participants
|
28 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/40 (68 to 72 letters) (best)
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/32 (73 to 77 letters) (worse)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/25 (78 to 82 letters)
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
44 participants
n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/20 (83 to 87 letters)
|
43 participants
n=5 Participants
|
47 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
103 participants
n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/16 (88 to 92 letters)
|
36 participants
n=5 Participants
|
26 participants
n=7 Participants
|
9 participants
n=5 Participants
|
11 participants
n=4 Participants
|
82 participants
n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/12 (93 to 97 letters) (best)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
None
|
71 participants
n=5 Participants
|
68 participants
n=7 Participants
|
13 participants
n=5 Participants
|
18 participants
n=4 Participants
|
170 participants
n=21 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Patching
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Atropine
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Prior Treatment for Amblyopia at Enrollment
Patching and atropine
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
< 0 Diopters (D)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
0 to < +1.00D
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
+1.00 to < +2.00D
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
+2.00 to < +3.00D
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
+3.00 to < +4.00D
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent)
>= +4.00D
|
42 participants
n=5 Participants
|
53 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
119 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
< 0 Diopters (D)
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
0 to < +1.00D
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
74 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
+1.00 to < +2.00D
|
33 participants
n=5 Participants
|
17 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
+2.00 to < +3.00D
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
+3.00 to < +4.00D
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
>= +4.00D
|
12 participants
n=5 Participants
|
32 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
|
62.4 ETDRS letter score
STANDARD_DEVIATION 5.7 • n=5 Participants
|
61.7 ETDRS letter score
STANDARD_DEVIATION 6.6 • n=7 Participants
|
37.5 ETDRS letter score
STANDARD_DEVIATION 5.0 • n=5 Participants
|
37.5 ETDRS letter score
STANDARD_DEVIATION 7.5 • n=4 Participants
|
57.9 ETDRS letter score
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Distance Visual Acuity in Fellow Eye
|
86.0 ETDRS letter score
STANDARD_DEVIATION 3.6 • n=5 Participants
|
85.7 ETDRS letter score
STANDARD_DEVIATION 3.4 • n=7 Participants
|
87.0 ETDRS letter score
STANDARD_DEVIATION 3.5 • n=5 Participants
|
85.5 ETDRS letter score
STANDARD_DEVIATION 4.0 • n=4 Participants
|
85.9 ETDRS letter score
STANDARD_DEVIATION 3.6 • n=21 Participants
|
|
Intereye Acuity Difference
|
23.5 ETDRS letter score
STANDARD_DEVIATION 6.8 • n=5 Participants
|
24.0 ETDRS letter score
STANDARD_DEVIATION 7.0 • n=7 Participants
|
49.5 ETDRS letter score
STANDARD_DEVIATION 5.5 • n=5 Participants
|
47.5 ETDRS letter score
STANDARD_DEVIATION 9.5 • n=4 Participants
|
28.0 ETDRS letter score
STANDARD_DEVIATION 11.7 • n=21 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent
|
3.57 diopter
STANDARD_DEVIATION 2.07 • n=5 Participants
|
4.10 diopter
STANDARD_DEVIATION 2.19 • n=7 Participants
|
4.97 diopter
STANDARD_DEVIATION 2.50 • n=5 Participants
|
4.18 diopter
STANDARD_DEVIATION 1.99 • n=4 Participants
|
3.95 diopter
STANDARD_DEVIATION 2.16 • n=21 Participants
|
|
Refractive Error in Fellow Eye (spherical equivalent)
|
1.84 diopter
STANDARD_DEVIATION 1.74 • n=5 Participants
|
2.56 diopter
STANDARD_DEVIATION 2.22 • n=7 Participants
|
2.12 diopter
STANDARD_DEVIATION 1.76 • n=5 Participants
|
1.98 diopter
STANDARD_DEVIATION 2.11 • n=4 Participants
|
2.17 diopter
STANDARD_DEVIATION 2.00 • n=21 Participants
|
PRIMARY outcome
Timeframe: 17 weeksPopulation: Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/400 (18 to 22 letters) (worse)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/320 (23 to 27 letters)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/100 (48 to 52 letters)
|
3 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/80 (53 to 57 letters)
|
3 participants
|
6 participants
|
4 participants
|
3 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/63 (58 to 62 letters)
|
5 participants
|
12 participants
|
0 participants
|
1 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/40 (68 to 72 letters)
|
20 participants
|
15 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/32 (73 to 77 letters)
|
19 participants
|
21 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/25 (78 to 82 letters)
|
14 participants
|
10 participants
|
0 participants
|
1 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/20 (83 to 87 letters)
|
6 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/16 (88 to 92 letters) (best)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/250 (28 to 32 letters)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/200 (33 to 37 letters)
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/160 (38 to 42 letters)
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/125 (43 to 47 letters)
|
0 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
20/50 (63 to 67 letters)
|
13 participants
|
14 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 17 weeksVisual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Mean Visual Acuity in the Amblyopic Eye at 17 Weeks
|
71.0 ETDRS letter score
Standard Deviation 8.9
|
69.2 ETDRS letter score
Standard Deviation 9.2
|
46.0 ETDRS letter score
Standard Deviation 6.0
|
45.0 ETDRS letter score
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
>=15 letters worse
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
5 to 9 letters better
|
22 participants
|
26 participants
|
4 participants
|
4 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
10 to 14 letters worse
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
5 to 9 letters worse
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
+/- 4 letters
|
23 participants
|
22 participants
|
2 participants
|
6 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
10 to 14 letters better
|
17 participants
|
20 participants
|
2 participants
|
3 participants
|
|
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
>=15 letters better
|
21 participants
|
15 participants
|
5 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
|
8.6 ETDRS letter score
Standard Deviation 7.8
|
7.6 ETDRS letter score
Standard Deviation 7.5
|
9.0 ETDRS letter score
Standard Deviation 6.5
|
7.5 ETDRS letter score
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 17 or 19 weeksThe Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Failed black & white shape identification pretest
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
>800 arcsec (worse)
|
26 Participants
|
34 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
800 arcsec
|
9 Participants
|
3 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
400 arcsec
|
9 Participants
|
14 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
200 arcsec
|
10 Participants
|
10 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
100 arcsec
|
9 Participants
|
12 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
60 arcsec
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
40 arcsec (best)
|
13 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 or 19 weeksThe Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=42 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=28 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
Failed black & white shape identification pretest
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
>800 arcsec (worse)
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
800 arcsec
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
400 arcsec
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
200 arcsec
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
100 arcsec
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
60 arcsec
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
40 arcsec (best)
|
7 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 or 19 weeksThe Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=42 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=60 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
60 arcsec
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
40 arcsec (best)
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
200 arcsec
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
100 arcsec
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
Failed black & white shape identification pretest
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
>800 arcsec (worse)
|
21 Participants
|
28 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
800 arcsec
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
400 arcsec
|
4 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 or 19 weeksStereoacuity is scored as seconds of arc with values of: \<800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; \<800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as "within one level" meaning change was -1, 0, or +1.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
>= 2 levels worse
|
4 Participants
|
9 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Within 1 level
|
57 Participants
|
54 Participants
|
—
|
—
|
|
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
>= 2 levels better
|
17 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=66 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=64 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)
|
2.37 Units on a scale
Standard Deviation 0.75
|
1.91 Units on a scale
Standard Deviation 0.75
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=66 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=64 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)
|
2.59 Units on a scale
Standard Deviation 0.93
|
2.03 Units on a scale
Standard Deviation 0.82
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=66 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=64 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)
|
2.28 Units on a scale
Standard Deviation 0.68
|
2.22 Units on a scale
Standard Deviation 0.80
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 weeksVisual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/50 (63 to 67 letters) (worse)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/40 (68 to 72 letters)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/32 (73 to 77 letters)
|
2 participants
|
4 participants
|
0 participants
|
1 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/25 (78 to 82 letters)
|
5 participants
|
12 participants
|
1 participants
|
2 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/20 (83 to 87 letters)
|
31 participants
|
42 participants
|
4 participants
|
4 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/16 (88 to 92 letters)
|
42 participants
|
29 participants
|
5 participants
|
11 participants
|
|
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
20/12 (93 to 97 letters) (best)
|
4 participants
|
1 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 17 weeksVisual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Mean Visual Acuity in the Fellow Eye at 17 Weeks
|
87.3 ETDRS letter score
Standard Deviation 3.8
|
85.8 ETDRS letter score
Standard Deviation 3.9
|
88.5 ETDRS letter score
Standard Deviation 5.0
|
86.5 ETDRS letter score
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
+/- 4 letters
|
69 participants
|
72 participants
|
8 participants
|
11 participants
|
|
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
>=10 letters worse
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
5 to 9 letters worse
|
4 participants
|
7 participants
|
1 participants
|
2 participants
|
|
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
5 to 9 letters better
|
11 participants
|
9 participants
|
4 participants
|
4 participants
|
|
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
>=10 letters better
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to 17 weeksVisual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Outcome measures
| Measure |
Patching-Moderate Amblyopia
n=84 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=88 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=13 Participants
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=20 Participants
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
|
1.5 ETDRS letter score
Standard Deviation 3.1
|
0.3 ETDRS letter score
Standard Deviation 3.5
|
1.0 ETDRS letter score
Standard Deviation 3.0
|
1.0 ETDRS letter score
Standard Deviation 5.0
|
Adverse Events
Patching-Moderate Amblyopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atropine-Moderate Amblyopia
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Patching-Severe Amblyopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atropine-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 |
Patching-Moderate Amblyopia
n=98 participants at risk
Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
|
Atropine-Moderate Amblyopia
n=95 participants at risk
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
|
Patching-Severe Amblyopia
n=18 participants at risk
Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
|
Atropine-Severe Amblyopia
n=22 participants at risk
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
|
|---|---|---|---|---|
|
Eye disorders
Light sensitivity
|
0.00%
0/98 • Adverse events were collected through the 17 week outcome visit.
|
14.7%
14/95 • Adverse events were collected through the 17 week outcome visit.
|
0.00%
0/18 • Adverse events were collected through the 17 week outcome visit.
|
13.6%
3/22 • Adverse events were collected through the 17 week outcome visit.
|
|
General disorders
Systemic
|
0.00%
0/98 • Adverse events were collected through the 17 week outcome visit.
|
0.00%
0/95 • Adverse events were collected through the 17 week outcome visit.
|
0.00%
0/18 • Adverse events were collected through the 17 week outcome visit.
|
9.1%
2/22 • Adverse events were collected through the 17 week outcome visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place