Amblyopia
Conditions
Keywords
Amblyopia, Atropine, Plano lens
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.
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.
Interventions
DRUGAtropine
Atropine 1% once each weekend day
DEVICEPlano Lens
Plano lens for the sound eye
Sponsors
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
United States
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 details
Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.
Participants by arm
| Arm | Count |
|---|---|
| Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 90 |
| Atropine Plus Plano-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 90 |
| Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 26 |
| Atropine Plus Plano-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400) | 34 |
| Total | 240 |
Baseline characteristics
| Characteristic | Total | Atropine Plus Plano-Severe Amblyopia | Atropine Plus Plano-Moderate Amblyopia | Atropine-Severe Amblyopia | Atropine-Moderate Amblyopia |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 240 Participants | 34 Participants | 90 Participants | 26 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.0 years STANDARD_DEVIATION 1.1 | 4.4 years STANDARD_DEVIATION 1 | 5.1 years STANDARD_DEVIATION 1 | 4.5 years STANDARD_DEVIATION 0.9 | 5.2 years STANDARD_DEVIATION 1.1 |
| Cause of Amblyopia Anisometropia | 75 participants | 8 participants | 30 participants | 5 participants | 32 participants |
| Cause of Amblyopia Strabismus | 96 participants | 11 participants | 37 participants | 10 participants | 38 participants |
| Cause of Amblyopia Strabismus and anisometropia | 69 participants | 15 participants | 23 participants | 11 participants | 20 participants |
| Distance Visual Acuity in Amblyopic Eye 20/100 | 22 participants | 0 participants | 15 participants | 0 participants | 7 participants |
| Distance Visual Acuity in Amblyopic Eye 20/125 | 18 participants | 11 participants | 0 participants | 7 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/160 | 10 participants | 5 participants | 0 participants | 5 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/200 | 10 participants | 5 participants | 0 participants | 5 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/250 | 4 participants | 3 participants | 0 participants | 1 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/320 | 10 participants | 2 participants | 0 participants | 8 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/400 (worse) | 8 participants | 8 participants | 0 participants | 0 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/40 (better) | 31 participants | 0 participants | 15 participants | 0 participants | 16 participants |
| Distance Visual Acuity in Amblyopic Eye 20/50 | 41 participants | 0 participants | 17 participants | 0 participants | 24 participants |
| Distance Visual Acuity in Amblyopic Eye 20/63 | 57 participants | 0 participants | 28 participants | 0 participants | 29 participants |
| Distance Visual Acuity in Amblyopic Eye 20/80 | 29 participants | 0 participants | 15 participants | 0 participants | 14 participants |
| Distance Visual Acuity in Amblyopic Eye | 0.61 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.27 | 1.01 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.2 | 0.50 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.13 | 0.99 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.16 | 0.47 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.12 |
| Distance Visual Acuity in Sound Eye 20/16 (better) | 19 participants | 0 participants | 8 participants | 0 participants | 11 participants |
| Distance Visual Acuity in Sound Eye 20/20 | 75 participants | 8 participants | 33 participants | 3 participants | 31 participants |
| Distance Visual Acuity in Sound Eye 20/25 | 70 participants | 7 participants | 28 participants | 8 participants | 27 participants |
| Distance Visual Acuity in Sound Eye 20/32 | 59 participants | 12 participants | 18 participants | 11 participants | 18 participants |
| Distance Visual Acuity in Sound Eye 20/40 (worse) | 17 participants | 7 participants | 3 participants | 4 participants | 3 participants |
| Distance Visual Acuity in Sound Eye | .09 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.11 | 0.15 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.11 | 0.07 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.1 | 0.16 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.09 | 0.07 log of min angle of resolution (logMAR) STANDARD_DEVIATION 0.1 |
| Intereye Acuity Difference | 5.2 logMAR lines STANDARD_DEVIATION 2.4 | 8.6 logMAR lines STANDARD_DEVIATION 2.2 | 4.3 logMAR lines STANDARD_DEVIATION 1.3 | 8.3 logMAR lines STANDARD_DEVIATION 1.7 | 4.0 logMAR lines STANDARD_DEVIATION 1.2 |
| Prior Treatment for Amblyopia at Enrollment Atropine | 3 participants | 0 participants | 2 participants | 0 participants | 1 participants |
| Prior Treatment for Amblyopia at Enrollment None | 200 participants | 28 participants | 72 participants | 24 participants | 76 participants |
| Prior Treatment for Amblyopia at Enrollment Patching | 28 participants | 6 participants | 12 participants | 1 participants | 9 participants |
| Prior Treatment for Amblyopia at Enrollment Patching and Atropine | 9 participants | 0 participants | 4 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized African-American | 9 Participants | 3 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 31 Participants | 3 Participants | 14 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized Unknown / Not reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 196 Participants | 28 Participants | 70 Participants | 23 Participants | 75 Participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) 0 to < +1.00 D | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +1.00 to < +2.00 D | 7 participants | 0 participants | 6 participants | 1 participants | 0 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +2.00 D to < +3.00 D | 17 participants | 0 participants | 6 participants | 3 participants | 8 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +3.00 D to < +4.00 D | 35 participants | 4 participants | 15 participants | 3 participants | 13 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) >= +4.00 D | 180 participants | 30 participants | 63 participants | 19 participants | 68 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) | 5.05 diopters STANDARD_DEVIATION 1.72 | 5.36 diopters STANDARD_DEVIATION 1.29 | 4.94 diopters STANDARD_DEVIATION 1.81 | 5.25 diopters STANDARD_DEVIATION 2.09 | 4.99 diopters STANDARD_DEVIATION 1.66 |
| Refractive Error in Sound Eye (spherical equivalent/diopters) + 1.50 to < + 2.00 D | 52 participants | 6 participants | 23 participants | 6 participants | 17 participants |
| Refractive Error in Sound Eye (spherical equivalent/diopters) + 2.00 D to < + 3.00 D | 46 participants | 5 participants | 19 participants | 8 participants | 14 participants |
| Refractive Error in Sound Eye (spherical equivalent/diopters) +3.00 D to < + 4.00 D | 42 participants | 8 participants | 12 participants | 2 participants | 20 participants |
| Refractive Error in Sound Eye (spherical equivalent/diopters) >= + 4.00 D | 100 participants | 15 participants | 36 participants | 10 participants | 39 participants |
| Refractive Error in Sound Eye (spherical equivalent/diopters) | 3.63 diopters STANDARD_DEVIATION 1.79 | 3.71 diopters STANDARD_DEVIATION 1.58 | 3.54 diopters STANDARD_DEVIATION 1.86 | 3.60 diopters STANDARD_DEVIATION 2.18 | 3.71 diopters STANDARD_DEVIATION 1.71 |
| Region of Enrollment Canada | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 239 participants | 34 participants | 90 participants | 26 participants | 89 participants |
| Sex: Female, Male Female | 118 Participants | 16 Participants | 47 Participants | 8 Participants | 47 Participants |
| Sex: Female, Male Male | 122 Participants | 18 Participants | 43 Participants | 18 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 90 | 1 / 90 | 1 / 26 | 5 / 34 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 | 0 / 26 | 0 / 34 |
Outcome results
Primary
Distribution of Change in Visual Acuity in the Amblyopic Eye
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -2 | 0 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +4 | 17 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | >= +5 (better) | 3 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -1 | 2 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +1 | 18 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | 0 | 4 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -3 (worse) | 0 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +2 | 18 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +3 | 22 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -1 | 2 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -3 (worse) | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +4 | 18 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | 0 | 5 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -2 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +3 | 18 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | >= +5 (better) | 14 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +1 | 11 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +2 | 19 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -2 | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -1 | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +2 | 3 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -3 (worse) | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | 0 | 2 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +3 | 3 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +1 | 2 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +4 | 4 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | >= +5 (better) | 3 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | >= +5 (better) | 3 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -2 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -1 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | 0 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +1 | 3 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +2 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +3 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | +4 | 3 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye | -3 (worse) | 0 Participants |
Comparison: 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 groupp-value: 0.39Regression, Logistic
Primary
Mean Change in Visual Acuity in the Amblyopic Eye
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye | 2.4 logMAR units | Standard Deviation 1.4 |
| Atropine Plus Plano-Moderate Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye | 2.8 logMAR units | Standard Deviation 1.8 |
| Atropine-Severe Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye | 4.5 logMAR units | Standard Deviation 3.1 |
| Atropine Plus Plano-Severe Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye | 5.1 logMAR units | Standard Deviation 3.7 |
Comparison: 95% confidence interval calculated within treatment group on the amount of change from baseline95% CI: [3.2, 5.8]
Comparison: 95% confidence interval calculated within treatment group on the amount of change from baseline95% CI: [3.7, 6.4]
Primary
Visual Acuity Distribution in the Amblyopic Eye
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/16 (better) | 1 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/20 | 11 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/50 | 6 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/25 | 12 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/160 | 0 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/320 | 0 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/40 | 18 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/400 (worse) | 0 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/125 | 0 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/63 | 4 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/200 | 0 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/32 | 28 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/100 | 2 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/80 | 2 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/250 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/25 | 19 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/80 | 4 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/63 | 6 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/50 | 7 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/320 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/400 (worse) | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/250 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/40 | 9 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/200 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/16 (better) | 4 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/160 | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/20 | 12 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/32 | 24 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/125 | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/100 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/40 | 3 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/250 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/20 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/400 (worse) | 0 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/200 | 0 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/160 | 2 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/125 | 4 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/100 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/80 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/63 | 5 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/50 | 5 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/320 | 0 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/32 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/25 | 0 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/16 (better) | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/250 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/40 | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/125 | 4 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/160 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/320 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/32 | 8 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/200 | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/400 (worse) | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/16 (better) | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/25 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/63 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/20 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/50 | 4 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/80 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Amblyopic Eye | 20/100 | 2 Participants |
Comparison: 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 groupp-value: 0.03Regression, Logistic
Primary
Visual Acuity Mean Score in the Amblyopic Eye
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Visual Acuity Mean Score in the Amblyopic Eye | 0.23 logMAR units | Standard Deviation 0.16 |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Mean Score in the Amblyopic Eye | 0.22 logMAR units | Standard Deviation 0.2 |
| Atropine-Severe Amblyopia | Visual Acuity Mean Score in the Amblyopic Eye | 0.54 logMAR units | Standard Deviation 0.26 |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Mean Score in the Amblyopic Eye | 0.50 logMAR units | Standard Deviation 0.38 |
Comparison: 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.p-value: 0.2195% CI: [-0.2, 0.8]ANCOVA
Secondary
Distribution of Change in Visual Acuity in the Sound Eye
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +2 | 6 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +3 (better) | 1 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -3 | 0 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | 0 | 49 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -2 | 0 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -1 | 3 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -4 (worse) | 1 Participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +1 | 24 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -1 | 12 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -3 | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -4 (worse) | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -2 | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | 0 | 50 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +2 | 4 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +1 | 17 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +3 (better) | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +3 (better) | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | 0 | 11 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -1 | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -3 | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +1 | 9 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +2 | 3 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -4 (worse) | 0 Participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -2 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +3 (better) | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -1 | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -4 (worse) | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -3 | 0 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | -2 | 4 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | 0 | 13 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +1 | 12 Participants |
| Atropine Plus Plano-Severe Amblyopia | Distribution of Change in Visual Acuity in the Sound Eye | +2 | 0 Participants |
Comparison: 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 groupsp-value: 0.003Fisher Exact
Secondary
Mean Change in Visual Acuity in the Sound Eye
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Mean Change in Visual Acuity in the Sound Eye | 0.4 logMAR units | Standard Deviation 0.9 |
| Atropine Plus Plano-Moderate Amblyopia | Mean Change in Visual Acuity in the Sound Eye | 0.0 logMAR units | Standard Deviation 1 |
| Atropine-Severe Amblyopia | Mean Change in Visual Acuity in the Sound Eye | 0.10 logMAR units | Standard Deviation 0.12 |
| Atropine Plus Plano-Severe Amblyopia | Mean Change in Visual Acuity in the Sound Eye | 0.15 logMAR units | Standard Deviation 0.15 |
Secondary
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
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
Population: Not reported among subjects with severe amblyopia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | >800 arcsec (worst) | 7 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 100 arcsec | 3 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 400 arcsec | 5 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 60 arcsec | 1 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 800 arcsec | 2 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 40 arcsec (best) | 2 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 200 arcsec | 8 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | Not done | 1 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | Failed black & white shape identification pretest | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | Not done | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | Failed black & white shape identification pretest | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | >800 arcsec (worst) | 9 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 800 arcsec | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 400 arcsec | 6 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 200 arcsec | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 100 arcsec | 6 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 60 arcsec | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 40 arcsec (best) | 1 Participants |
Comparison: Among anisometropic patients onlyp-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Time frame: 18 weeks
Population: Not reported among subjects with severe amblyopia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | >800 arcsec (worst) | 40 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 100 arcsec | 4 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 400 arcsec | 11 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 60 arcsec | 5 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 800 arcsec | 7 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 40 arcsec (best) | 2 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 200 arcsec | 10 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | Not done | 2 Participants |
| Atropine-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | Failed black & white shape identification pretest | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | Not done | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | Failed black & white shape identification pretest | 4 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | >800 arcsec (worst) | 41 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 800 arcsec | 10 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 400 arcsec | 12 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 200 arcsec | 6 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 100 arcsec | 10 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 60 arcsec | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 40 arcsec (best) | 1 Participants |
Comparison: All patients without respect to cause of amblyopia.p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary
Visual Acuity Distribution in the Sound Eye
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/63 (worse) | 1 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/32 | 10 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/40 | 2 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/16 (better) | 21 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/20 | 36 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/25 | 14 Participants |
| Atropine-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/50 | 0 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/16 (better) | 15 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/63 (worse) | 1 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/50 | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/40 | 3 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/32 | 16 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/25 | 22 Participants |
| Atropine Plus Plano-Moderate Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/20 | 28 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/32 | 6 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/63 (worse) | 0 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/16 (better) | 2 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/25 | 8 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/20 | 6 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/40 | 1 Participants |
| Atropine-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/50 | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/40 | 4 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/20 | 7 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/32 | 7 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/63 (worse) | 1 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/25 | 7 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/16 (better) | 2 Participants |
| Atropine Plus Plano-Severe Amblyopia | Visual Acuity Distribution in the Sound Eye | 20/50 | 3 Participants |