ATS8: Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Study Details
Study Description
Brief Summary
The purpose of the study is:
-
To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
-
To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.
Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.
In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.
The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Atropine Atropine 1% once each weekend day in the sound eye |
Drug: Atropine
Atropine 1% once each weekend day
|
| Active Comparator: Atropine plus plano Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye |
Drug: Atropine
Atropine 1% once each weekend day
Device: Plano Lens
Plano lens for the sound eye
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity Mean Score in the Amblyopic Eye [18 weeks]
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
- Visual Acuity Distribution in the Amblyopic Eye [18 weeks]
Visual 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
- Mean Change in Visual Acuity in the Amblyopic Eye [baseline to 18 weeks]
Acuity 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.
- Distribution of Change in Visual Acuity in the Amblyopic Eye [baseline to 18 weeks]
Acuity 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.
Secondary Outcome Measures
- Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia [18 weeks]
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.
- Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only [18 weeks]
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.
- Mean Change in Visual Acuity in the Sound Eye [baseline to 18 weeks]
Acuity 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.
- Distribution of Change in Visual Acuity in the Sound Eye [baseline to 18 weeks]
Acuity 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.
- Visual Acuity Distribution in the Sound Eye [18 weeks]
Acuity 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
-
Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
-
Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Exclusion Criteria:
-
Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
-
No myopia in amblyopic eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern California College of Optometry | Fullerton | California | United States | 92831 |
| 2 | UT Southwestern Medical Center | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- Jaeb Center for Health Research
- National Eye Institute (NEI)
Investigators
- Study Chair: David Weakley, M.D., UT Southwestern Medical Center
- Study Chair: Susan A. Cotter, O.D., Southern California College of Optometry at Marshall B. Ketchum University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEI-115
- 2U10EY011751
Study Results
Participant Flow
| Recruitment Details | 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). |
|---|---|
| Pre-assignment Detail | Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization. |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Period Title: Overall Study | ||||
| STARTED | 90 | 90 | 26 | 34 |
| 5 Week Visit | 85 | 86 | 26 | 30 |
| 10 Week Visit | 86 | 85 | 24 | 29 |
| 18 Week Primary Outcome Visit | 84 | 88 | 24 | 31 |
| Partial Responder Phase (Post 18 Weeks) | 16 | 13 | 9 | 11 |
| COMPLETED | 84 | 88 | 24 | 31 |
| NOT COMPLETED | 6 | 2 | 2 | 3 |
Baseline Characteristics
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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 of all reporting groups |
| Overall Participants | 90 | 90 | 26 | 34 | 240 |
| Age (Count of Participants) | |||||
| <=18 years |
90
100%
|
90
100%
|
26
100%
|
34
100%
|
240
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
5.2
(1.1)
|
5.1
(1.0)
|
4.5
(0.9)
|
4.4
(1.0)
|
5.0
(1.1)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
47
52.2%
|
47
52.2%
|
8
30.8%
|
16
47.1%
|
118
49.2%
|
| Male |
43
47.8%
|
43
47.8%
|
18
69.2%
|
18
52.9%
|
122
50.8%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| White |
75
83.3%
|
70
77.8%
|
23
88.5%
|
28
82.4%
|
196
81.7%
|
| African-American |
1
1.1%
|
4
4.4%
|
1
3.8%
|
3
8.8%
|
9
3.8%
|
| Hispanic or Latino |
12
13.3%
|
14
15.6%
|
2
7.7%
|
3
8.8%
|
31
12.9%
|
| Asian |
1
1.1%
|
2
2.2%
|
0
0%
|
0
0%
|
3
1.3%
|
| Unknown / Not reported |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
89
98.9%
|
90
100%
|
26
100%
|
34
100%
|
239
99.6%
|
| Canada |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| Cause of Amblyopia (participants) [Number] | |||||
| Strabismus |
38
42.2%
|
37
41.1%
|
10
38.5%
|
11
32.4%
|
96
40%
|
| Anisometropia |
32
35.6%
|
30
33.3%
|
5
19.2%
|
8
23.5%
|
75
31.3%
|
| Strabismus and anisometropia |
20
22.2%
|
23
25.6%
|
11
42.3%
|
15
44.1%
|
69
28.8%
|
| Distance Visual Acuity in Amblyopic Eye (participants) [Number] | |||||
| 20/400 (worse) |
0
0%
|
0
0%
|
0
0%
|
8
23.5%
|
8
3.3%
|
| 20/320 |
0
0%
|
0
0%
|
8
30.8%
|
2
5.9%
|
10
4.2%
|
| 20/250 |
0
0%
|
0
0%
|
1
3.8%
|
3
8.8%
|
4
1.7%
|
| 20/200 |
0
0%
|
0
0%
|
5
19.2%
|
5
14.7%
|
10
4.2%
|
| 20/160 |
0
0%
|
0
0%
|
5
19.2%
|
5
14.7%
|
10
4.2%
|
| 20/125 |
0
0%
|
0
0%
|
7
26.9%
|
11
32.4%
|
18
7.5%
|
| 20/100 |
7
7.8%
|
15
16.7%
|
0
0%
|
0
0%
|
22
9.2%
|
| 20/80 |
14
15.6%
|
15
16.7%
|
0
0%
|
0
0%
|
29
12.1%
|
| 20/63 |
29
32.2%
|
28
31.1%
|
0
0%
|
0
0%
|
57
23.8%
|
| 20/50 |
24
26.7%
|
17
18.9%
|
0
0%
|
0
0%
|
41
17.1%
|
| 20/40 (better) |
16
17.8%
|
15
16.7%
|
0
0%
|
0
0%
|
31
12.9%
|
| Distance Visual Acuity in Sound Eye (participants) [Number] | |||||
| 20/40 (worse) |
3
3.3%
|
3
3.3%
|
4
15.4%
|
7
20.6%
|
17
7.1%
|
| 20/32 |
18
20%
|
18
20%
|
11
42.3%
|
12
35.3%
|
59
24.6%
|
| 20/25 |
27
30%
|
28
31.1%
|
8
30.8%
|
7
20.6%
|
70
29.2%
|
| 20/20 |
31
34.4%
|
33
36.7%
|
3
11.5%
|
8
23.5%
|
75
31.3%
|
| 20/16 (better) |
11
12.2%
|
8
8.9%
|
0
0%
|
0
0%
|
19
7.9%
|
| Prior Treatment for Amblyopia at Enrollment (participants) [Number] | |||||
| None |
76
84.4%
|
72
80%
|
24
92.3%
|
28
82.4%
|
200
83.3%
|
| Patching |
9
10%
|
12
13.3%
|
1
3.8%
|
6
17.6%
|
28
11.7%
|
| Atropine |
1
1.1%
|
2
2.2%
|
0
0%
|
0
0%
|
3
1.3%
|
| Patching and Atropine |
4
4.4%
|
4
4.4%
|
1
3.8%
|
0
0%
|
9
3.8%
|
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) (participants) [Number] | |||||
| 0 to < +1.00 D |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| +1.00 to < +2.00 D |
0
0%
|
6
6.7%
|
1
3.8%
|
0
0%
|
7
2.9%
|
| +2.00 D to < +3.00 D |
8
8.9%
|
6
6.7%
|
3
11.5%
|
0
0%
|
17
7.1%
|
| +3.00 D to < +4.00 D |
13
14.4%
|
15
16.7%
|
3
11.5%
|
4
11.8%
|
35
14.6%
|
| >= +4.00 D |
68
75.6%
|
63
70%
|
19
73.1%
|
30
88.2%
|
180
75%
|
| Refractive Error in Sound Eye (spherical equivalent/diopters) (participants) [Number] | |||||
| + 1.50 to < + 2.00 D |
17
18.9%
|
23
25.6%
|
6
23.1%
|
6
17.6%
|
52
21.7%
|
| + 2.00 D to < + 3.00 D |
14
15.6%
|
19
21.1%
|
8
30.8%
|
5
14.7%
|
46
19.2%
|
| +3.00 D to < + 4.00 D |
20
22.2%
|
12
13.3%
|
2
7.7%
|
8
23.5%
|
42
17.5%
|
| >= + 4.00 D |
39
43.3%
|
36
40%
|
10
38.5%
|
15
44.1%
|
100
41.7%
|
| Distance Visual Acuity in Amblyopic Eye (log of min angle of resolution (logMAR)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log of min angle of resolution (logMAR)] |
0.47
(0.12)
|
0.50
(0.13)
|
0.99
(0.16)
|
1.01
(0.20)
|
0.61
(0.27)
|
| Distance Visual Acuity in Sound Eye (log of min angle of resolution (logMAR)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log of min angle of resolution (logMAR)] |
0.07
(0.10)
|
0.07
(0.10)
|
0.16
(0.09)
|
0.15
(0.11)
|
.09
(.11)
|
| Intereye Acuity Difference (logMAR lines) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [logMAR lines] |
4.0
(1.2)
|
4.3
(1.3)
|
8.3
(1.7)
|
8.6
(2.2)
|
5.2
(2.4)
|
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) (diopters) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [diopters] |
4.99
(1.66)
|
4.94
(1.81)
|
5.25
(2.09)
|
5.36
(1.29)
|
5.05
(1.72)
|
| Refractive Error in Sound Eye (spherical equivalent/diopters) (diopters) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [diopters] |
3.71
(1.71)
|
3.54
(1.86)
|
3.60
(2.18)
|
3.71
(1.58)
|
3.63
(1.79)
|
Outcome Measures
| Title | Visual Acuity Mean Score in the Amblyopic Eye |
|---|---|
| Description | 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 |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| Mean (Standard Deviation) [logMAR units] |
0.23
(0.16)
|
0.22
(0.20)
|
0.54
(0.26)
|
0.50
(0.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model. The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.21 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.3 | |
| Confidence Interval |
() 95% -0.2 to 0.8 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.24 |
|
| Estimation Comments | The difference was calculated as atropine plus plano group minus atropine group | |
| Title | Visual Acuity Distribution in the Amblyopic Eye |
|---|---|
| Description | Visual 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 |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| 20/400 (worse) |
0
0%
|
0
0%
|
0
0%
|
1
2.9%
|
| 20/320 |
0
0%
|
0
0%
|
0
0%
|
1
2.9%
|
| 20/250 |
0
0%
|
0
0%
|
1
3.8%
|
2
5.9%
|
| 20/200 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 20/160 |
0
0%
|
1
1.1%
|
2
7.7%
|
1
2.9%
|
| 20/125 |
0
0%
|
1
1.1%
|
4
15.4%
|
4
11.8%
|
| 20/100 |
2
2.2%
|
1
1.1%
|
1
3.8%
|
2
5.9%
|
| 20/80 |
2
2.2%
|
4
4.4%
|
1
3.8%
|
2
5.9%
|
| 20/63 |
4
4.4%
|
6
6.7%
|
5
19.2%
|
2
5.9%
|
| 20/50 |
6
6.7%
|
7
7.8%
|
5
19.2%
|
4
11.8%
|
| 20/40 |
18
20%
|
9
10%
|
3
11.5%
|
0
0%
|
| 20/32 |
28
31.1%
|
24
26.7%
|
1
3.8%
|
8
23.5%
|
| 20/25 |
12
13.3%
|
19
21.1%
|
0
0%
|
1
2.9%
|
| 20/20 |
11
12.2%
|
12
13.3%
|
1
3.8%
|
1
2.9%
|
| 20/16 (better) |
1
1.1%
|
4
4.4%
|
0
0%
|
2
5.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .03 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | proportion 20/25 as a function of treatment group controlling for baseline acuity | |
| Title | Mean Change in Visual Acuity in the Amblyopic Eye |
|---|---|
| Description | Acuity 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. |
| Time Frame | baseline to 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| Mean (Standard Deviation) [logMAR units] |
2.4
(1.4)
|
2.8
(1.8)
|
4.5
(3.1)
|
5.1
(3.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Severe Amblyopia |
|---|---|---|
| Comments | 95% confidence interval calculated within treatment group on the amount of change from baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.5 | |
| Confidence Interval |
(2-Sided) 95% 3.2 to 5.8 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 3.1 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|
| Comments | 95% confidence interval calculated within treatment group on the amount of change from baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.1 | |
| Confidence Interval |
(2-Sided) 95% 3.7 to 6.4 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 3.7 |
|
| Estimation Comments | ||
| Title | Distribution of Change in Visual Acuity in the Amblyopic Eye |
|---|---|
| Description | Acuity 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. |
| Time Frame | baseline to 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| -3 (worse) |
0
0%
|
1
1.1%
|
0
0%
|
0
0%
|
| -2 |
0
0%
|
0
0%
|
0
0%
|
1
2.9%
|
| -1 |
2
2.2%
|
2
2.2%
|
0
0%
|
1
2.9%
|
| 0 |
4
4.4%
|
5
5.6%
|
2
7.7%
|
2
5.9%
|
| +1 |
18
20%
|
11
12.2%
|
2
7.7%
|
3
8.8%
|
| +2 |
18
20%
|
19
21.1%
|
3
11.5%
|
1
2.9%
|
| +3 |
22
24.4%
|
18
20%
|
3
11.5%
|
2
5.9%
|
| +4 |
17
18.9%
|
18
20%
|
4
15.4%
|
3
8.8%
|
| >= +5 (better) |
3
3.3%
|
14
15.6%
|
3
11.5%
|
3
8.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | proportion 20/25 as a function of treatment group controlling for baseline acuity | |
| Title | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia |
|---|---|
| Description | 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. |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not reported among subjects with severe amblyopia |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 0 | 0 |
| Failed black & white shape identification pretest |
3
3.3%
|
4
4.4%
|
||
| >800 arcsec (worst) |
40
44.4%
|
41
45.6%
|
||
| 800 arcsec |
7
7.8%
|
10
11.1%
|
||
| 400 arcsec |
11
12.2%
|
12
13.3%
|
||
| 200 arcsec |
10
11.1%
|
6
6.7%
|
||
| 100 arcsec |
4
4.4%
|
10
11.1%
|
||
| 60 arcsec |
5
5.6%
|
1
1.1%
|
||
| 40 arcsec (best) |
2
2.2%
|
1
1.1%
|
||
| Not done |
2
2.2%
|
3
3.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | All patients without respect to cause of amblyopia. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group | |
| Title | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only |
|---|---|
| Description | 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. |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not reported among subjects with severe amblyopia |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 29 | 30 | 0 | 0 |
| Failed black & white shape identification pretest |
0
0%
|
0
0%
|
||
| >800 arcsec (worst) |
7
7.8%
|
9
10%
|
||
| 800 arcsec |
2
2.2%
|
3
3.3%
|
||
| 400 arcsec |
5
5.6%
|
6
6.7%
|
||
| 200 arcsec |
8
8.9%
|
3
3.3%
|
||
| 100 arcsec |
3
3.3%
|
6
6.7%
|
||
| 60 arcsec |
1
1.1%
|
1
1.1%
|
||
| 40 arcsec (best) |
2
2.2%
|
1
1.1%
|
||
| Not done |
1
1.1%
|
1
1.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | Among anisometropic patients only | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group | |
| Title | Mean Change in Visual Acuity in the Sound Eye |
|---|---|
| Description | Acuity 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. |
| Time Frame | baseline to 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| Mean (Standard Deviation) [logMAR units] |
0.4
(0.9)
|
0.0
(1.0)
|
0.10
(0.12)
|
0.15
(0.15)
|
| Title | Distribution of Change in Visual Acuity in the Sound Eye |
|---|---|
| Description | Acuity 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. |
| Time Frame | baseline to 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| -4 (worse) |
1
1.1%
|
1
1.1%
|
0
0%
|
0
0%
|
| -3 |
0
0%
|
1
1.1%
|
0
0%
|
0
0%
|
| -2 |
0
0%
|
3
3.3%
|
1
3.8%
|
4
11.8%
|
| -1 |
3
3.3%
|
12
13.3%
|
0
0%
|
2
5.9%
|
| 0 |
49
54.4%
|
50
55.6%
|
11
42.3%
|
13
38.2%
|
| +1 |
24
26.7%
|
17
18.9%
|
9
34.6%
|
12
35.3%
|
| +2 |
6
6.7%
|
4
4.4%
|
3
11.5%
|
0
0%
|
| +3 (better) |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Atropine-Moderate Amblyopia, Atropine Plus Plano-Moderate Amblyopia |
|---|---|---|
| Comments | Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups; Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Visual Acuity Distribution in the Sound Eye |
|---|---|
| Description | Acuity 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 |
| Time Frame | 18 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia |
|---|---|---|---|---|
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) |
| Measure Participants | 84 | 88 | 24 | 31 |
| 20/63 (worse) |
1
1.1%
|
1
1.1%
|
0
0%
|
1
2.9%
|
| 20/50 |
0
0%
|
3
3.3%
|
1
3.8%
|
3
8.8%
|
| 20/40 |
2
2.2%
|
3
3.3%
|
1
3.8%
|
4
11.8%
|
| 20/32 |
10
11.1%
|
16
17.8%
|
6
23.1%
|
7
20.6%
|
| 20/25 |
14
15.6%
|
22
24.4%
|
8
30.8%
|
7
20.6%
|
| 20/20 |
36
40%
|
28
31.1%
|
6
23.1%
|
7
20.6%
|
| 20/16 (better) |
21
23.3%
|
15
16.7%
|
2
7.7%
|
2
5.9%
|
Adverse Events
| Time Frame | Adverse events were collected through the 18wk outcome visit. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia | ||||
| Arm/Group Description | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 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 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 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) | ||||
All Cause Mortality |
||||||||
| Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/90 (0%) | 0/90 (0%) | 0/26 (0%) | 0/34 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Atropine-Moderate Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine Plus Plano-Severe Amblyopia | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/90 (8.9%) | 1/90 (1.1%) | 1/26 (3.8%) | 5/34 (14.7%) | ||||
| Eye disorders | ||||||||
| Light sensitivity | 8/90 (8.9%) | 8 | 1/90 (1.1%) | 1 | 1/26 (3.8%) | 1 | 5/34 (14.7%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Raymond Kraker |
|---|---|
| Organization | Jaeb Center for Health Research |
| Phone | 813-975-8690 |
| pedig@jaeb.org |
- NEI-115
- 2U10EY011751