Amblyopia
Conditions
Keywords
Amblyopia, Atropine, Patching
Brief summary
The purpose of this study is: * To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds. * To determine the maximum improvement in vision of the amblyopic eye with each treatment. * To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.
Detailed description
Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the critical period for visual development in humans. This belief, however, was not based on adequate prospectively-collected data. To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to \<18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to \<13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to \<13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P\<0.001). In the 13 to \<18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=0.03). Most patients, including responders, were left with a residual visual acuity deficit. The use of multiple modalities (patching, atropine, near visual activities) in the treatment regimen for the 7 to \<13 year olds in this trial (ATS3) was an effort to maximize the therapeutic response. Patients age 13 years and older were prescribed patching but not atropine because of concern that the continual optical blur from the atropine could have a deleterious effect on their ability to drive and perform other activities. Prescribed patching was 2 to 6 hours a day to limit patch wear to non-school hours and because our prior studies of 3 to \<7 year olds demonstrated that as little as two hours of patching a day (when combined with near visual activities) is as effective as a greater number of hours. Instructing patients to perform at least one hour of near activities while wearing the patch was based on the unproven clinical opinion that near activities can augment the effect of the occlusion therapy. A PEDIG pilot study suggested that near activities are beneficial and this question of benefit of near activities is currently being studied in another randomized clinical trial. Atropine placed in the sound eye once a day and two days a week has been demonstrated in younger children to be beneficial to the acuity of the amblyopic eye, presumably due to its cycloplegic effect of blurring vision in the sound eye especially at near fixation. In a study comparing daily and weekend atropine, daily atropine was not found to be superior. The unanswered question from this completed clinical trial is whether prescribing patching or atropine alone could have produced a response similar to the combination therapy, or whether in this age group, one treatment is better than the other. A poll of PEDIG investigators at an investigator meeting on January 15, 2005 indicated that very few are following the treatment regimen used in the prior study (ATS3); rather, most are prescribing monotherapy-either patching or atropine-as the initial treatment for amblyopia in the 7 to \<13 year age range. Thus, a trial comparing atropine and patching as amblyopia treatments in 7 to \<13 year olds is needed. 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 are: 1) Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day without the aid of reading glasses (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) and 2) Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and \> 4 hours per day for severe amblyopes at 5 weeks if acuity not improved by at least 5 letters). Optional Ancillary Study As part of the optic nerve imaging ancillary study, retinal nerve fiber layer imaging using optical coherence tomography will be performed on some patients. This will be optional for patients at participating sites. The procedure is not part of standard care. The subject's pupils will need to be dilated, if not already dilated as part of the exam. Testing of both eyes can be completed in about 15 minutes.
Interventions
DRUGAtropine
Atropine 1% each weekend day in the sound eye
DEVICEPatching
Patching 2 hours per day
PROCEDURENear activities
near visual activities for at least one hour per day
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
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Age 7 to 12 years old (inclusive) * Amblyopia associated with strabismus, anisometropia, or both * Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive) * Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better) * Interocular difference \>=15 letters (3 lines) * Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable Inclusion Criteria for Optional Ancillary Study: * Enrolled into the main study * Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error) * Birth weight \>1500 grams * No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy
Exclusion criteria
* Amblyopia treatment (other than spectacles) in the last 6 months * Myopia (more than -0.25D spherical equivalent) in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
| Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 17 weeks | Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response. |
| Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | 17 weeks | Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response. |
| Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 17 or 19 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. |
| Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
| Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
| Mean Visual Acuity in the Fellow Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 17 or 19 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. |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 17 or 19 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. |
| Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 17 weeks | Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response. |
Countries
United States
Participant flow
Recruitment details
Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).
Pre-assignment details
Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.
Participants by arm
| Arm | Count |
|---|---|
| Patching-Moderate Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100) | 98 |
| Atropine-Moderate Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100). | 95 |
| Patching-Severe Amblyopia Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400) | 18 |
| Atropine-Severe Amblyopia Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400). | 22 |
| Total | 233 |
Baseline characteristics
| Characteristic | Patching-Moderate Amblyopia | Total | Atropine-Severe Amblyopia | Patching-Severe Amblyopia | Atropine-Moderate Amblyopia |
|---|---|---|---|---|---|
| Age, Continuous | 8.9 years STANDARD_DEVIATION 1.5 | 9.0 years STANDARD_DEVIATION 1.6 | 9.2 years STANDARD_DEVIATION 1.8 | 9.5 years STANDARD_DEVIATION 1.5 | 9.1 years STANDARD_DEVIATION 1.6 |
| Age, Customized 10 to <11 years | 8 participants | 24 participants | 2 participants | 4 participants | 10 participants |
| Age, Customized 11 to <12 years | 8 participants | 18 participants | 1 participants | 2 participants | 7 participants |
| Age, Customized 12 to <13 years | 6 participants | 18 participants | 3 participants | 1 participants | 8 participants |
| Age, Customized 7 to <8 years | 35 participants | 78 participants | 9 participants | 6 participants | 28 participants |
| Age, Customized 8 to <9 years | 24 participants | 54 participants | 4 participants | 0 participants | 26 participants |
| Age, Customized 9 to <10 years | 17 participants | 41 participants | 3 participants | 5 participants | 16 participants |
| Cause of Amblyopia Anisometropia | 46 participants | 92 participants | 9 participants | 6 participants | 31 participants |
| Cause of Amblyopia Strabismus | 28 participants | 69 participants | 4 participants | 4 participants | 33 participants |
| Cause of Amblyopia Strabismus and anisometropia | 24 participants | 72 participants | 9 participants | 8 participants | 31 participants |
| Distance Visual Acuity in Amblyopic Eye 20/100 (48 to 52 letters) | 6 participants | 19 participants | 0 participants | 0 participants | 13 participants |
| Distance Visual Acuity in Amblyopic Eye 20/125 (43 to 47 letters) | 0 participants | 12 participants | 9 participants | 3 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/160 (38 to 42 letters) | 0 participants | 9 participants | 4 participants | 5 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/200 (33 to 37 letters) | 0 participants | 11 participants | 3 participants | 8 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/250 (28 to 32 letters) | 0 participants | 6 participants | 4 participants | 2 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/320 (23 to 27 letters) | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/400 (18 to 22 letters) (worse) | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/40 (68 to 72 letters) (best) | 20 participants | 39 participants | 0 participants | 0 participants | 19 participants |
| Distance Visual Acuity in Amblyopic Eye 20/50 (63 to 67 letters) | 33 participants | 61 participants | 0 participants | 0 participants | 28 participants |
| Distance Visual Acuity in Amblyopic Eye 20/63 (58 to 62 letters) | 24 participants | 46 participants | 0 participants | 0 participants | 22 participants |
| Distance Visual Acuity in Amblyopic Eye 20/80 (53 to 57 letters) | 15 participants | 28 participants | 0 participants | 0 participants | 13 participants |
| Distance Visual Acuity in Amblyopic Eye | 62.4 ETDRS letter score STANDARD_DEVIATION 5.7 | 57.9 ETDRS letter score STANDARD_DEVIATION 11.1 | 37.5 ETDRS letter score STANDARD_DEVIATION 7.5 | 37.5 ETDRS letter score STANDARD_DEVIATION 5 | 61.7 ETDRS letter score STANDARD_DEVIATION 6.6 |
| Distance Visual Acuity in Fellow Eye 20/12 (93 to 97 letters) (best) | 2 participants | 4 participants | 0 participants | 0 participants | 2 participants |
| Distance Visual Acuity in Fellow Eye 20/16 (88 to 92 letters) | 36 participants | 82 participants | 11 participants | 9 participants | 26 participants |
| Distance Visual Acuity in Fellow Eye 20/20 (83 to 87 letters) | 43 participants | 103 participants | 5 participants | 8 participants | 47 participants |
| Distance Visual Acuity in Fellow Eye 20/25 (78 to 82 letters) | 17 participants | 44 participants | 6 participants | 1 participants | 20 participants |
| Distance Visual Acuity in Fellow Eye 20/32 (73 to 77 letters) (worse) | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Distance Visual Acuity in Fellow Eye | 86.0 ETDRS letter score STANDARD_DEVIATION 3.6 | 85.9 ETDRS letter score STANDARD_DEVIATION 3.6 | 85.5 ETDRS letter score STANDARD_DEVIATION 4 | 87.0 ETDRS letter score STANDARD_DEVIATION 3.5 | 85.7 ETDRS letter score STANDARD_DEVIATION 3.4 |
| Intereye Acuity Difference | 23.5 ETDRS letter score STANDARD_DEVIATION 6.8 | 28.0 ETDRS letter score STANDARD_DEVIATION 11.7 | 47.5 ETDRS letter score STANDARD_DEVIATION 9.5 | 49.5 ETDRS letter score STANDARD_DEVIATION 5.5 | 24.0 ETDRS letter score STANDARD_DEVIATION 7 |
| Prior Treatment for Amblyopia at Enrollment Atropine | 2 participants | 3 participants | 0 participants | 1 participants | 0 participants |
| Prior Treatment for Amblyopia at Enrollment None | 71 participants | 170 participants | 18 participants | 13 participants | 68 participants |
| Prior Treatment for Amblyopia at Enrollment Patching | 16 participants | 37 participants | 3 participants | 2 participants | 16 participants |
| Prior Treatment for Amblyopia at Enrollment Patching and atropine | 9 participants | 23 participants | 1 participants | 2 participants | 11 participants |
| Race/Ethnicity, Customized African-American | 8 participants | 22 participants | 1 participants | 2 participants | 11 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 20 participants | 46 participants | 3 participants | 0 participants | 23 participants |
| Race/Ethnicity, Customized More than one race | 1 participants | 3 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Not reported | 1 participants | 3 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White | 68 participants | 158 participants | 18 participants | 16 participants | 56 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent | 3.57 diopter STANDARD_DEVIATION 2.07 | 3.95 diopter STANDARD_DEVIATION 2.16 | 4.18 diopter STANDARD_DEVIATION 1.99 | 4.97 diopter STANDARD_DEVIATION 2.5 | 4.10 diopter STANDARD_DEVIATION 2.19 |
| Refractive Error in Amblyopic Eye (spherical equivalent) < 0 Diopters (D) | 2 participants | 4 participants | 0 participants | 0 participants | 2 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent) 0 to < +1.00D | 8 participants | 20 participants | 1 participants | 1 participants | 10 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent) +1.00 to < +2.00D | 13 participants | 23 participants | 2 participants | 2 participants | 6 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent) +2.00 to < +3.00D | 10 participants | 22 participants | 3 participants | 1 participants | 8 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent) +3.00 to < +4.00D | 23 participants | 45 participants | 4 participants | 2 participants | 16 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent) >= +4.00D | 42 participants | 119 participants | 12 participants | 12 participants | 53 participants |
| Refractive Error in Fellow Eye (spherical equivalent) < 0 Diopters (D) | 1 participants | 3 participants | 0 participants | 0 participants | 2 participants |
| Refractive Error in Fellow Eye (spherical equivalent) 0 to < +1.00D | 32 participants | 74 participants | 9 participants | 4 participants | 29 participants |
| Refractive Error in Fellow Eye (spherical equivalent) +1.00 to < +2.00D | 33 participants | 63 participants | 5 participants | 8 participants | 17 participants |
| Refractive Error in Fellow Eye (spherical equivalent) +2.00 to < +3.00D | 13 participants | 25 participants | 2 participants | 1 participants | 9 participants |
| Refractive Error in Fellow Eye (spherical equivalent) +3.00 to < +4.00D | 7 participants | 17 participants | 2 participants | 2 participants | 6 participants |
| Refractive Error in Fellow Eye (spherical equivalent) >= +4.00D | 12 participants | 51 participants | 4 participants | 3 participants | 32 participants |
| Refractive Error in Fellow Eye (spherical equivalent) | 1.84 diopter STANDARD_DEVIATION 1.74 | 2.17 diopter STANDARD_DEVIATION 2 | 1.98 diopter STANDARD_DEVIATION 2.11 | 2.12 diopter STANDARD_DEVIATION 1.76 | 2.56 diopter STANDARD_DEVIATION 2.22 |
| Sex: Female, Male Female | 48 Participants | 118 Participants | 12 Participants | 4 Participants | 54 Participants |
| Sex: Female, Male Male | 50 Participants | 115 Participants | 10 Participants | 14 Participants | 41 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 | 0 / 98 | 14 / 95 | 0 / 18 | 5 / 22 |
| serious Total, serious adverse events | 0 / 98 | 0 / 95 | 0 / 18 | 0 / 22 |
Outcome results
Primary
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Time frame: Baseline to 17 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters worse | 1 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters better | 17 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters better | 22 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters worse | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters better | 21 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | +/- 4 letters | 23 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters better | 20 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | +/- 4 letters | 22 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 3 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters better | 26 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters better | 15 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters worse | 2 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters worse | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | +/- 4 letters | 2 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters worse | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters worse | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters better | 4 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters better | 2 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters better | 5 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 2 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters better | 5 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters better | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 10 to 14 letters worse | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | >=15 letters worse | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 5 to 9 letters better | 4 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | +/- 4 letters | 6 participants |
Comparison: 95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.95% CI: [-0.02, 0.18]
Primary
Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Time frame: 17 weeks
Population: Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/400 (18 to 22 letters) (worse) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/63 (58 to 62 letters) | 5 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/250 (28 to 32 letters) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/40 (68 to 72 letters) | 20 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/50 (63 to 67 letters) | 13 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/200 (33 to 37 letters) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/320 (23 to 27 letters) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/20 (83 to 87 letters) | 6 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/160 (38 to 42 letters) | 1 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/25 (78 to 82 letters) | 14 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/125 (43 to 47 letters) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/100 (48 to 52 letters) | 3 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/16 (88 to 92 letters) (best) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/32 (73 to 77 letters) | 19 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/80 (53 to 57 letters) | 3 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/400 (18 to 22 letters) (worse) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/40 (68 to 72 letters) | 15 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/32 (73 to 77 letters) | 21 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/63 (58 to 62 letters) | 12 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/160 (38 to 42 letters) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/320 (23 to 27 letters) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/80 (53 to 57 letters) | 6 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/25 (78 to 82 letters) | 10 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/50 (63 to 67 letters) | 14 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/250 (28 to 32 letters) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/16 (88 to 92 letters) (best) | 1 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/20 (83 to 87 letters) | 4 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/100 (48 to 52 letters) | 4 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/200 (33 to 37 letters) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/125 (43 to 47 letters) | 1 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/80 (53 to 57 letters) | 4 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/400 (18 to 22 letters) (worse) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/320 (23 to 27 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/250 (28 to 32 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/200 (33 to 37 letters) | 3 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/160 (38 to 42 letters) | 1 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/125 (43 to 47 letters) | 4 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/100 (48 to 52 letters) | 1 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/63 (58 to 62 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/50 (63 to 67 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/40 (68 to 72 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/32 (73 to 77 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/25 (78 to 82 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/20 (83 to 87 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/16 (88 to 92 letters) (best) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/100 (48 to 52 letters) | 2 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/125 (43 to 47 letters) | 2 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/320 (23 to 27 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/32 (73 to 77 letters) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/160 (38 to 42 letters) | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/400 (18 to 22 letters) (worse) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/25 (78 to 82 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/200 (33 to 37 letters) | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/250 (28 to 32 letters) | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/16 (88 to 92 letters) (best) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/50 (63 to 67 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/63 (58 to 62 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/80 (53 to 57 letters) | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/20 (83 to 87 letters) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 20/40 (68 to 72 letters) | 0 participants |
Comparison: 95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.95% CI: [-0.03, 0.17]
Primary
Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Time frame: Baseline to 17 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 8.6 ETDRS letter score | Standard Deviation 7.8 |
| Atropine-Moderate Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 7.6 ETDRS letter score | Standard Deviation 7.5 |
| Patching-Severe Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 9.0 ETDRS letter score | Standard Deviation 6.5 |
| Atropine-Severe Amblyopia | Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | 7.5 ETDRS letter score | Standard Deviation 10.5 |
Comparison: The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.95% CI: [-0.7, 3.1]ANCOVA
Primary
Mean Visual Acuity in the Amblyopic Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Time frame: 17 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 71.0 ETDRS letter score | Standard Deviation 8.9 |
| Atropine-Moderate Amblyopia | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 69.2 ETDRS letter score | Standard Deviation 9.2 |
| Patching-Severe Amblyopia | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 46.0 ETDRS letter score | Standard Deviation 6 |
| Atropine-Severe Amblyopia | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 45.0 ETDRS letter score | Standard Deviation 14 |
Secondary
Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)
Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Time frame: 17 weeks
Population: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | 2.28 Units on a scale | Standard Deviation 0.68 |
| Atropine-Moderate Amblyopia | Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | 2.22 Units on a scale | Standard Deviation 0.8 |
Comparison: Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.p-value: 0.7Wilcoxon (Mann-Whitney)
Secondary
Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)
Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Time frame: 17 weeks
Population: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 2.59 Units on a scale | Standard Deviation 0.93 |
| Atropine-Moderate Amblyopia | Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 2.03 Units on a scale | Standard Deviation 0.82 |
Comparison: Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)
Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Time frame: 17 weeks
Population: Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 2.37 Units on a scale | Standard Deviation 0.75 |
| Atropine-Moderate Amblyopia | Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 1.91 Units on a scale | Standard Deviation 0.75 |
Comparison: Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Time frame: Baseline to 17 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | +/- 4 letters | 69 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters better | 11 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters worse | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 4 participants |
| Patching-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters better | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | +/- 4 letters | 72 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters better | 9 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 7 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters worse | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters better | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | +/- 4 letters | 8 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters worse | 0 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 1 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters better | 4 participants |
| Patching-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters better | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters better | 4 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 5 to 9 letters worse | 2 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters worse | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | +/- 4 letters | 11 participants |
| Atropine-Severe Amblyopia | Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | >=10 letters better | 2 participants |
Comparison: 95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.95% CI: [0.4, 2.2]ANCOVA
Secondary
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Time frame: 17 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/50 (63 to 67 letters) (worse) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/16 (88 to 92 letters) | 42 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/20 (83 to 87 letters) | 31 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/40 (68 to 72 letters) | 0 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/12 (93 to 97 letters) (best) | 4 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/32 (73 to 77 letters) | 2 participants |
| Patching-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/25 (78 to 82 letters) | 5 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/16 (88 to 92 letters) | 29 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/25 (78 to 82 letters) | 12 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/32 (73 to 77 letters) | 4 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/20 (83 to 87 letters) | 42 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/12 (93 to 97 letters) (best) | 1 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/50 (63 to 67 letters) (worse) | 0 participants |
| Atropine-Moderate Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/40 (68 to 72 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/40 (68 to 72 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/50 (63 to 67 letters) (worse) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/32 (73 to 77 letters) | 0 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/25 (78 to 82 letters) | 1 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/20 (83 to 87 letters) | 4 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/16 (88 to 92 letters) | 5 participants |
| Patching-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/12 (93 to 97 letters) (best) | 3 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/32 (73 to 77 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/12 (93 to 97 letters) (best) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/16 (88 to 92 letters) | 11 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/40 (68 to 72 letters) | 1 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/50 (63 to 67 letters) (worse) | 0 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/20 (83 to 87 letters) | 4 participants |
| Atropine-Severe Amblyopia | Distribution of Visual Acuity in the Fellow Eye at 17 Weeks | 20/25 (78 to 82 letters) | 2 participants |
Secondary
Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Time frame: Baseline to 17 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 1.5 ETDRS letter score | Standard Deviation 3.1 |
| Atropine-Moderate Amblyopia | Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 0.3 ETDRS letter score | Standard Deviation 3.5 |
| Patching-Severe Amblyopia | Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 1.0 ETDRS letter score | Standard Deviation 3 |
| Atropine-Severe Amblyopia | Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks | 1.0 ETDRS letter score | Standard Deviation 5 |
Secondary
Mean Visual Acuity in the Fellow Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Time frame: 17 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patching-Moderate Amblyopia | Mean Visual Acuity in the Fellow Eye at 17 Weeks | 87.3 ETDRS letter score | Standard Deviation 3.8 |
| Atropine-Moderate Amblyopia | Mean Visual Acuity in the Fellow Eye at 17 Weeks | 85.8 ETDRS letter score | Standard Deviation 3.9 |
| Patching-Severe Amblyopia | Mean Visual Acuity in the Fellow Eye at 17 Weeks | 88.5 ETDRS letter score | Standard Deviation 5 |
| Atropine-Severe Amblyopia | Mean Visual Acuity in the Fellow Eye at 17 Weeks | 86.5 ETDRS letter score | Standard Deviation 6.5 |
Secondary
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia 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: 17 or 19 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 800 arcsec | 3 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 400 arcsec | 5 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 200 arcsec | 7 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 100 arcsec | 9 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 60 arcsec | 6 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 40 arcsec (best) | 7 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | Failed black & white shape identification pretest | 0 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | >800 arcsec (worse) | 5 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | >800 arcsec (worse) | 6 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 800 arcsec | 1 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 60 arcsec | 0 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 400 arcsec | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | Failed black & white shape identification pretest | 0 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 200 arcsec | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 40 arcsec (best) | 5 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 100 arcsec | 8 Participants |
Comparison: Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Stereoacuity is scored as seconds of arc with values of: \<800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; \<800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as within one level meaning change was -1, 0, or +1.
Time frame: 17 or 19 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >= 2 levels worse | 4 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Within 1 level | 57 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >= 2 levels better | 17 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >= 2 levels worse | 9 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Within 1 level | 54 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >= 2 levels better | 18 Participants |
Comparison: To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zerop-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zerop-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate 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: 17 or 19 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Failed black & white shape identification pretest | 1 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 200 arcsec | 10 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 800 arcsec | 9 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 100 arcsec | 9 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >800 arcsec (worse) | 26 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 60 arcsec | 7 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 400 arcsec | 9 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 40 arcsec (best) | 13 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 400 arcsec | 14 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Failed black & white shape identification pretest | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | >800 arcsec (worse) | 34 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 800 arcsec | 3 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 40 arcsec (best) | 9 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 200 arcsec | 10 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 100 arcsec | 12 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 60 arcsec | 2 Participants |
Comparison: Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).p-value: 0.96Wilcoxon (Mann-Whitney)
Secondary
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
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: 17 or 19 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | Failed black & white shape identification pretest | 1 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | >800 arcsec (worse) | 21 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 800 arcsec | 6 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 400 arcsec | 4 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 200 arcsec | 3 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 100 arcsec | 0 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 60 arcsec | 1 Participants |
| Patching-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 40 arcsec (best) | 6 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 40 arcsec (best) | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | Failed black & white shape identification pretest | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 200 arcsec | 6 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | >800 arcsec (worse) | 28 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 60 arcsec | 2 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 800 arcsec | 2 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 100 arcsec | 4 Participants |
| Atropine-Moderate Amblyopia | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 400 arcsec | 10 Participants |
Comparison: Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.p-value: 0.99Wilcoxon (Mann-Whitney)