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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to < 10 years.
Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity.
The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes.
The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model.
Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.
Amblyopia is the most common cause of monocular visual impairment in children, estimated to affect as many as 3.6% of the childhood population. The natural history of amblyopia is relatively unknown although it has been reported that visual acuity may deteriorate further without treatment.
Although occlusion or patching of the sound eye has been the mainstay for amblyopia therapy, alternative treatment such as pharmacological or optical penalization may be as effective. In a randomized, controlled clinical trial of 419 children, 3 years to less than 7 years old with moderate amblyopia, patching was compared to atropine. Although improvement with atropine was initially slower, both treatments produced similar improvement after 6 months.
Although both patching and atropine have been proven effective for treating amblyopia, neither treatment is without adverse side effects. Patching is associated with compliance difficulties, the need for continuous monitoring, and social stigma. Negative side effects observed in children treated with atropine include light sensitivity, facial flushing, and fever. In a randomized clinical trial comparing patching to atropine as a treatment for amblyopia, a questionnaire to assess the impact of patching and atropine treatment on the child and family indicated that both treatments were well tolerated overall, however, patching had lower compliance and higher social stigma than atropine.
Bangerter filters, also known as Bangerter foils, have been used mainly as secondary amblyopia therapy following patching or atropine to either further improve or maintain the visual gain. One advantage of Bangerter filters compared to patching is that the lower density filters are not readily apparent and therefore would be expected to increase patient compliance due to reduced social stigma. Another advantage of Bangerter filters is that there is no opportunity for skin irritation from bandage adhesive, a commonly-reported side effect of patching. In addition, there is a theoretical advantage that Bangerter filters are less disruptive to binocular function during treatment compared to other modalities such as patching.
Few data are available comparing Bangerter filters with patching for the treatment of amblyopia. Bonsall randomized 14 patients, 3 to 10 years old, with previously untreated strabismic/anisometropic amblyopia to either 6 hours of daily patching or full-time Bangerter filters. Baseline amblyopic eye acuity was 20/30 to 20/400 for the patching group and 20/30 to 20/200 for the Bangerter group. The Bangerter filter prescribed was the minimum density foil needed to elicit a switch in fixation from the sound eye to the amblyopic eye. Visual acuity was measured every 6-8 weeks until the amblyopic eye visual acuity was equal to that of the sound eye, an improvement that was achieved in 5 of the 14 at the time the study was stopped. The average time to achieve equal vision between the amblyopic and sound eyes was about 4.5 months (142 days) for the foil group versus about 9 months (272 days) for the patching group. Both forms of therapy were equally tolerated. Despite good preliminary data, a large randomized clinical trial comparing the effectiveness of Bangerter filters to patching for the treatment of amblyopia has yet to be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patching | Active Comparator | 2 hours daily patching of the sound eye plus one hour near activities while patching |
|
| Bangerter filters | Active Comparator | Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bangerter filters | Device | Bangerter filter worn on sound eye spectacle lens full time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | 24 weeks |
| Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | 24 weeks |
| Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline. | Baseline to 24 weeks |
| Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Interocular Difference at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line). |
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Inclusion Criteria:
Age 3 to < 10 years
Amblyopia associated with strabismus, anisometropia, or both
No ocular cause apparent for reduced visual acuity
Visual acuity 20/40 to 20/80 (71 to 54 letters inclusive) in amblyopic eye
Visual acuity 20/40 or better (>= 69 letters) in sound eye
Interocular difference >= 3 logMAR lines (>= 15 letters)
No amblyopia treatment other than spectacles in last 6 months
*Any treatment more than 6 months prior to enrollment is acceptable
Currently wearing spectacles
Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual acuity documented to be stable
No myopia > -6.00 D spherical equivalent in either eye
Cycloplegic refraction within 6 months prior to enrollment
Ocular examination within 6 months prior to enrollment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P. Rutstein, O.D., M.S. | University of Alabama at Birmingham | Study Chair |
| Graham E. Quinn, M.D., MSCE | Children's Hospital of Philadelphia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20163869 | Result | Pediatric Eye Disease Investigator Group Writing Committee; Rutstein RP, Quinn GE, Lazar EL, Beck RW, Bonsall DJ, Cotter SA, Crouch ER, Holmes JM, Hoover DL, Leske DA, Lorenzana IJ, Repka MX, Suh DW. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology. 2010 May;117(5):998-1004.e6. doi: 10.1016/j.ophtha.2009.10.014. Epub 2010 Feb 16. | |
| 21419678 | Result | Rutstein RP, Foster NC, Cotter SA, Kraker RT, Lee DH, Melia M, Quinn GE, Tamkins SM, Wallace DK; Pediatric Eye Disease Investigator Group. Visual acuity through Bangerter filters in nonamblyopic eyes. J AAPOS. 2011 Apr;15(2):131-4. doi: 10.1016/j.jaapos.2010.11.015. Epub 2011 Mar 21. |
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At enrollment, subjects were required to have been wearing spectacles with optimal correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic visual acuity at 2 consecutive visits at least 4 weeks apart).
Eligibility criteria included age 3 to <10 years, visual acuity in the amblyopic eye 20/40 to 20/80, fellow eye visual acuity of 20/40 or better, interocular acuity difference of 3 or more lines, and the presence or history of strabismus and/or anisometropia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patching | 2 hours daily patching of the sound eye plus one hour near activities while patching |
| FG001 | Bangerter Filters | Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patching | 2 hours daily patching of the sound eye plus one hour near activities while patching |
| BG001 | Bangerter Filters | Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Posted | Number | participants | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patching | 2 hours daily patching of the sound eye plus one hour near activities while patching |
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Compliance assessment was based on parents' diaries and judgment by the researchers. Because we did not use an objective method to measure occlusion or spectacle wear, we cannot guarantee that the patients adhered to their prescribed regimens.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Kraker, MSPH | Jaeb Center for Health Research | 813-875-8690 | pedig@jaeb.org |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Patching | Device | 2 hours daily patching of the sound eye |
|
|
| Near activities | Procedure | one hour near visual activities |
|
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). |
| Baseline to 24 weeks |
| 24 weeks |
| Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line). | 24 weeks |
| Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | 24 weeks |
| Distribution of Subjects With 3 or More Lines of Improvement | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Baseline to 24 weeks |
| Distribution of Patient Characteristics at the 24-week Outcome Exam. | The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment). | 24 weeks |
| Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Baseline to 24 weeks |
| Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It 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). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved). | Baseline to 24 weeks |
| Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It 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). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved). | Baseline to 24 weeks |
| Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Baseline to 24 weeks |
| Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Baseline to 24 weeks |
| Impact of Treatment on Patient and Family at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means. | 6 weeks |
| Impact of Treatment on Patient and Family at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means. | 24 weeks |
| Adverse Effects of Treatment on Patient and Family at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed. | 6 weeks |
| Adverse Effects of Treatment on Patient and Family at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed. | 24 weeks |
| Compliance With Treatment at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed. | 6 weeks |
| Compliance With Treatment at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed. | 24 weeks |
| Social Stigma From Treatment at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed. | 6 weeks |
| Social Stigma From Treatment at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed. | 24 weeks |
| 22108357 | Derived | Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Age at enrollment in years | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Prior treatment for amblyopia at enrollment | Number | participants |
|
| Cause of amblyopia | Number | participants |
|
| Distance visual acuity in amblyopic eye | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Number | participants |
|
| Mean (SD) Distance Visual Acuity in Amblyopic Eye | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Mean | Standard Deviation | logMAR |
|
| Distance visual acuity in fellow eye | Visual acuity was measured with the Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) method for subjects aged 3 to <7 years or the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) method for subjects aged 7 to <10 years. | Number | participants |
|
| Mean (SD) Distance Visual Acuity in Fellow Eye | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Mean | Standard Deviation | logMAR |
|
| Intereye acuity difference | The difference between eyes in logMAR acuity was calculated with positive values indicating sound eye better. One letter = .02 logMAR, .1 logMAR = 5 letters or one line of visual acuity. | Mean | Standard Deviation | logMAR line |
|
| Spherical equivalent in amblyopic eye | Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value | Number | diopter |
|
| Mean (SD) spherical equivalent in amblyopic eye | Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value. | Mean | Standard Deviation | diopter |
|
| Spherical equivalent in fellow eye | Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value | Number | diopter |
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| Mean (SD) spherical equivalent in fellow eye | Spherical equivalent in diopters defined from cycloplegic refraction as sphere plus half the cylinder value. | Mean | Standard Deviation | diopter |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Posted | Mean | Standard Deviation | logMAR | 24 weeks |
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| Primary | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline. | Posted | Number | participants | Baseline to 24 weeks |
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| Primary | Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Posted | Mean | Standard Deviation | logMAR line | Baseline to 24 weeks |
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| Secondary | Mean Interocular Difference at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line). | Posted | Mean | Standard Deviation | logMAR line | 24 weeks |
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| Secondary | Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line). | Posted | Number | participants | 24 weeks |
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| Secondary | Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). | Posted | Number | participants | 24 weeks |
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| Secondary | Distribution of Subjects With 3 or More Lines of Improvement | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Posted | Number | participants | Baseline to 24 weeks |
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| Secondary | Distribution of Patient Characteristics at the 24-week Outcome Exam. | The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment). | Posted | Number | participants | 24 weeks |
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| Secondary | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Posted | Mean | Standard Deviation | logMAR line | Baseline to 24 weeks |
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| Secondary | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It 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). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved). | Posted | Number | participants | Baseline to 24 weeks |
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| Secondary | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It 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). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved). | Posted | Number | participants | Baseline to 24 weeks |
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| Secondary | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Posted | Number | participants | Baseline to 24 weeks |
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| Secondary | Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line). | Posted | Mean | Standard Deviation | logMAR line | Baseline to 24 weeks |
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| Secondary | Impact of Treatment on Patient and Family at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
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| Secondary | Impact of Treatment on Patient and Family at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means. | Posted | Mean | Standard Deviation | Units on a scale | 24 weeks |
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| Secondary | Adverse Effects of Treatment on Patient and Family at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
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| Secondary | Adverse Effects of Treatment on Patient and Family at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 24 weeks |
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| Secondary | Compliance With Treatment at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
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| Secondary | Compliance With Treatment at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 24 weeks |
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| Secondary | Social Stigma From Treatment at 6 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
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| Secondary | Social Stigma From Treatment at 24 Weeks | The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed. | Posted | Mean | Standard Deviation | Units on a scale | 24 weeks |
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| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | Bangerter Filters | Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities | 0 | 89 | 0 | 89 |
Not provided
Not provided
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 1 line worse |
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| 0 lines |
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| 1 line better |
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| 2 lines better |
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| >=3 lines better |
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The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination. |
| In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed. | ANCOVA | The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity. | 0.09 | Mean Difference (Net) | 0.38 | 2-Sided | 95 | -0.06 | 0.83 | No | Superiority or Other |
| Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity. | Mixed Models Analysis | 0.20 | 95 | No | Superiority or Other |
| The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye. | ANCOVA | 0.49 | 95 | No | Superiority or Other |
| The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model. | ANCOVA | 0.21 | 95 | No | Superiority or Other |
| Regression, Cox |
| 0.28 |
| 95 |
| No |
| Superiority or Other |
| White, non-Hispanic |
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| Non-white or Hispanic |
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| Age at enrollment: 3 to <5 yrs |
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| Age at enrollment: 5 to <7 yrs |
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| Age at enrollment: 7 to <10 yrs |
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| Prior treatment for amblyopia: No |
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| Prior treatment for amblyopia: Yes |
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| Cause of amblyopia: Strabismus |
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| Cause of amblyopia: Anisometropia |
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| Cause of amblyopia: Strabismus and anisometropia |
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| Distance VA in amblyopic eye: 20/80 (worse) |
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| Distance VA in amblyopic eye: 20/63 |
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| Distance VA in amblyopic eye: 20/50 |
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| Distance VA in amblyopic eye: 20/40 (best) |
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| White, non-Hispanic |
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| Non-white or Hispanic |
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| Age at enrollment: 3 to <5 yrs |
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| Age at enrollment: 5 to <7 yrs |
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| Age at enrollment: 7 to <10 yrs |
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| Prior treatment for amblyopia: No |
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| Prior treatment for amblyopia: Yes |
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| Cause of amblyopia: Strabismus |
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| Cause of amblyopia: Anisometropia |
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| Cause of amblyopia: Strabismus and anisometropia |
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| Distance VA in amblyopic eye: 20/80 (worse) |
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| Distance VA in amblyopic eye: 20/63 |
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| Distance VA in amblyopic eye: 20/50 |
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| Distance VA in amblyopic eye: 20/40 (best) |
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| >=2 levels worsened |
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| >=2 levels worsened |
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| 1 line worse |
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| 0 lines |
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| 1 line better |
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| 2 lines better |
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| 3 lines or better |
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| Fisher Exact |
| 0.21 |
| 95 |
| No |
| Superiority or Other |