Amblyopia
Conditions
Keywords
Amblyopia, Patching, Bangerter filters
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBangerter filters
Bangerter filter worn on sound eye spectacle lens full time
DEVICEPatching
2 hours daily patching of the sound eye
PROCEDURENear activities
one hour near visual activities
Sponsors
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No
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
* Current vision therapy or orthoptics * Ocular cause for reduced visual acuity * Prior intraocular or refractive surgery * Known skin reactions to patch or bandage adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 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). |
| Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks | 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). |
| Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 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. |
| Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Patient Characteristics at the 24-week Outcome Exam. | 24 weeks | 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). |
| Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | 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). |
| Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | Baseline to 24 weeks | 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). |
| Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | Baseline to 24 weeks | 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). |
| Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 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). |
| Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 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). |
| Impact of Treatment on Patient and Family at 6 Weeks | 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. |
| Mean Interocular Difference at 24 Weeks | 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). |
| Adverse Effects of Treatment on Patient and Family at 6 Weeks | 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. |
| Adverse Effects of Treatment on Patient and Family at 24 Weeks | 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. |
| Compliance With Treatment at 6 Weeks | 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. |
| Compliance With Treatment at 24 Weeks | 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. |
| Social Stigma From Treatment at 6 Weeks | 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. |
| Social Stigma From Treatment at 24 Weeks | 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. |
| Impact of Treatment on Patient and Family at 24 Weeks | 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. |
| Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks | 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). |
| Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks | 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). |
| Distribution of Subjects With 3 or More Lines of Improvement | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Patching 2 hours daily patching of the sound eye plus one hour near activities while patching | 97 |
| Bangerter Filters Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities | 89 |
| Total | 186 |
Baseline characteristics
| Characteristic | Bangerter Filters | Patching | Total |
|---|---|---|---|
| Age, Continuous | 6.3 years STANDARD_DEVIATION 1.67 | 6.3 years STANDARD_DEVIATION 1.62 | 6.3 years STANDARD_DEVIATION 1.64 |
| Age, Customized 3 to <7 years | 57 participants | 62 participants | 119 participants |
| Age, Customized 7 to <10 years | 32 participants | 35 participants | 67 participants |
| Cause of amblyopia Anisometropia | 39 participants | 42 participants | 81 participants |
| Cause of amblyopia Strabismus | 23 participants | 27 participants | 50 participants |
| Cause of amblyopia Strabismus and anisometropia | 27 participants | 28 participants | 55 participants |
| Distance visual acuity in amblyopic eye 20/40 (0.34 - 0.28 logMAR) (best) | 22 participants | 21 participants | 43 participants |
| Distance visual acuity in amblyopic eye 20/50 (0.44 - 0.36 logMAR) | 24 participants | 22 participants | 46 participants |
| Distance visual acuity in amblyopic eye 20/63 (0.54 - 0.46 logMAR) | 27 participants | 31 participants | 58 participants |
| Distance visual acuity in amblyopic eye 20/80 (0.62 - 0.56 logMAR) (worse) | 16 participants | 23 participants | 39 participants |
| Distance visual acuity in fellow eye 20/16 (-0.06 to -0.14 logMAR) (best) | 18 participants | 20 participants | 38 participants |
| Distance visual acuity in fellow eye 20/20 (0.04 to -0.04 logMAR) | 40 participants | 42 participants | 82 participants |
| Distance visual acuity in fellow eye 20/25 (0.14 to 0.06 logMAR) | 19 participants | 17 participants | 36 participants |
| Distance visual acuity in fellow eye 20/32 (0.24 to 0.16 logMAR) | 9 participants | 16 participants | 25 participants |
| Distance visual acuity in fellow eye 20/40 (0.32 to 0.26 logMAR) (worse) | 3 participants | 2 participants | 5 participants |
| Intereye acuity difference | 4.1 logMAR line STANDARD_DEVIATION 1.1 | 4.2 logMAR line STANDARD_DEVIATION 1.1 | 4.1 logMAR line STANDARD_DEVIATION 1.1 |
| Mean (SD) Distance Visual Acuity in Amblyopic Eye | 0.44 logMAR STANDARD_DEVIATION 0.1 | 0.46 logMAR STANDARD_DEVIATION 0.1 | 0.45 logMAR STANDARD_DEVIATION 0.1 |
| Mean (SD) Distance Visual Acuity in Fellow Eye | 0.03 logMAR STANDARD_DEVIATION 0.1 | 0.04 logMAR STANDARD_DEVIATION 0.1 | 0.04 logMAR STANDARD_DEVIATION 0.1 |
| Mean (SD) spherical equivalent in amblyopic eye | 4.15 diopter STANDARD_DEVIATION 2.57 | 4.41 diopter STANDARD_DEVIATION 2.21 | 4.29 diopter STANDARD_DEVIATION 2.38 |
| Mean (SD) spherical equivalent in fellow eye | 2.49 diopter STANDARD_DEVIATION 2.13 | 2.81 diopter STANDARD_DEVIATION 2.14 | 2.66 diopter STANDARD_DEVIATION 2.14 |
| Prior treatment for amblyopia at enrollment Atropine | 3 participants | 2 participants | 5 participants |
| Prior treatment for amblyopia at enrollment None | 72 participants | 83 participants | 155 participants |
| Prior treatment for amblyopia at enrollment Patching | 5 participants | 8 participants | 13 participants |
| Prior treatment for amblyopia at enrollment Patching and atropine | 9 participants | 4 participants | 13 participants |
| Race/Ethnicity, Customized African-American | 1 participants | 13 participants | 14 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 participants | 11 participants | 26 participants |
| Race/Ethnicity, Customized More than 1 race | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Unknown / not reported | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 69 participants | 67 participants | 136 participants |
| Region of Enrollment United States | 89 participants | 97 participants | 186 participants |
| Sex: Female, Male Female | 36 Participants | 48 Participants | 84 Participants |
| Sex: Female, Male Male | 53 Participants | 49 Participants | 102 Participants |
| Spherical equivalent in amblyopic eye <0.00 | 8 diopter | 3 diopter | 11 diopter |
| Spherical equivalent in amblyopic eye 0 to < +1.00 | 2 diopter | 2 diopter | 4 diopter |
| Spherical equivalent in amblyopic eye +1.00 to < +2.00 | 1 diopter | 8 diopter | 9 diopter |
| Spherical equivalent in amblyopic eye +2.00 to < +3.00 | 10 diopter | 6 diopter | 16 diopter |
| Spherical equivalent in amblyopic eye +3.00 to < +4.00 | 13 diopter | 10 diopter | 23 diopter |
| Spherical equivalent in amblyopic eye >= +4.00 | 55 diopter | 68 diopter | 123 diopter |
| Spherical equivalent in fellow eye <0.00 | 5 diopter | 1 diopter | 6 diopter |
| Spherical equivalent in fellow eye 0 to < +1.00 | 16 diopter | 18 diopter | 34 diopter |
| Spherical equivalent in fellow eye +1.00 to < +2.00 | 21 diopter | 25 diopter | 46 diopter |
| Spherical equivalent in fellow eye +2.00 to < +3.00 | 12 diopter | 13 diopter | 25 diopter |
| Spherical equivalent in fellow eye +3.00 to < +4.00 | 13 diopter | 8 diopter | 21 diopter |
| Spherical equivalent in fellow eye >= +4.00 | 22 diopter | 32 diopter | 54 diopter |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 97 | 0 / 89 |
| serious Total, serious adverse events | 0 / 97 | 0 / 89 |
Outcome results
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.
Time frame: Baseline to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 1 line worse | 5 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 1 line better | 12 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 2 lines worse | 2 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 2 lines better | 20 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 0 lines | 8 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | >=3 lines better | 33 participants |
| Bangerter | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | >= 3 lines worse | 1 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | >=3 lines better | 37 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | >= 3 lines worse | 0 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 2 lines worse | 0 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 1 line worse | 1 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 0 lines | 4 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 1 line better | 19 participants |
| Patching | Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks | 2 lines better | 27 participants |
Comparison: Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).p-value: 0.02Regression, Logistic
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).
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/125 (0.84 to 0.76 logMAR) (worse) | 1 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/100 (0.74 to 0.66 logMAR) | 3 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/80 (0.64 to 0.56 logMAR) | 3 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/63 (0.54 to 0.46 logMAR) | 7 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/50 (0.44 to 0.36 logMAR) | 5 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/40 (0.34 to 0.26 logMAR) | 19 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/32 (0.24 to 0.16 logMAR) | 14 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/25 (0.14 to 0.06 logMAR) | 20 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/20 (0.04 to -0.04 logMAR) | 9 participants |
| Bangerter | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/16 (-0.06 to -0.14 logMAR) (best) | 0 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/25 (0.14 to 0.06 logMAR) | 17 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/125 (0.84 to 0.76 logMAR) (worse) | 0 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/40 (0.34 to 0.26 logMAR) | 19 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/100 (0.74 to 0.66 logMAR) | 0 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/16 (-0.06 to -0.14 logMAR) (best) | 4 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/80 (0.64 to 0.56 logMAR) | 1 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/32 (0.24 to 0.16 logMAR) | 20 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/63 (0.54 to 0.46 logMAR) | 8 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/20 (0.04 to -0.04 logMAR) | 7 participants |
| Patching | Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks | 20/50 (0.44 to 0.36 logMAR) | 12 participants |
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks | 1.9 logMAR line | Standard Deviation 1.6 |
| Patching | Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks | 2.3 logMAR line | Standard Deviation 1.3 |
Comparison: 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.ANCOVA
Comparison: In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.p-value: 0.0995% CI: [-0.06, 0.83]ANCOVA
Comparison: 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.p-value: 0.2Mixed Models Analysis
Comparison: 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.p-value: 0.49ANCOVA
Comparison: 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.p-value: 0.21ANCOVA
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).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks | 0.25 logMAR | Standard Deviation 0.19 |
| Patching | Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks | 0.23 logMAR | Standard Deviation 0.16 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Adverse Effects of Treatment on Patient and Family at 24 Weeks | 1.9 Units on a scale | Standard Deviation 0.7 |
| Patching | Adverse Effects of Treatment on Patient and Family at 24 Weeks | 2.2 Units on a scale | Standard Deviation 0.6 |
Comparison: A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.p-value: 0.01t-test, 2 sided
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Adverse Effects of Treatment on Patient and Family at 6 Weeks | 2.2 Units on a scale | Standard Deviation 0.7 |
| Patching | Adverse Effects of Treatment on Patient and Family at 6 Weeks | 2.2 Units on a scale | Standard Deviation 0.6 |
Comparison: A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.p-value: 0.9t-test, 2 sided
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Compliance With Treatment at 24 Weeks | 2.1 Units on a scale | Standard Deviation 0.9 |
| Patching | Compliance With Treatment at 24 Weeks | 2.6 Units on a scale | Standard Deviation 0.9 |
Comparison: A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.p-value: 0.001t-test, 2 sided
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Compliance With Treatment at 6 Weeks | 2.3 Units on a scale | Standard Deviation 1 |
| Patching | Compliance With Treatment at 6 Weeks | 2.5 Units on a scale | Standard Deviation 0.8 |
Comparison: A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.p-value: 0.12t-test, 2 sided
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 1 line worse | 17 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 1 line better | 20 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 2 lines worse | 1 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 2 lines better | 4 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 0 lines | 39 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 3 lines or better | 0 participants |
| Bangerter | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 3 lines or worse | 0 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 3 lines or better | 1 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 3 lines or worse | 0 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 2 lines worse | 5 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 1 line worse | 8 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 0 lines | 40 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 1 line better | 23 participants |
| Patching | Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 2 lines better | 11 participants |
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | >=2 levels improved | 12 participants |
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | Within 1 level | 61 participants |
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | >=2 levels worsened | 3 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | >=2 levels improved | 15 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | Within 1 level | 58 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects | >=2 levels worsened | 7 participants |
Comparison: A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.p-value: 0.9Wilcoxon rank-sum
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | >=2 levels improved | 7 participants |
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | Within 1 level | 25 participants |
| Bangerter | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | >=2 levels worsened | 1 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | >=2 levels improved | 9 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | Within 1 level | 21 participants |
| Patching | Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus | >=2 levels worsened | 4 participants |
Comparison: A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.p-value: 0.88Wilcoxon rank-sum
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).
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Male | 47 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Strabismus | 21 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 5 to <7 yrs | 31 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Anisometropia | 36 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Non-white or Hispanic | 17 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Strabismus and anisometropia | 24 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 7 to <10 yrs | 29 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/80 (worse) | 15 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | White, non-Hispanic | 63 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/63 | 25 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Prior treatment for amblyopia: No | 65 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/50 | 20 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 3 to <5 yrs | 21 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/40 (best) | 21 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Prior treatment for amblyopia: Yes | 16 participants |
| Bangerter | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Female | 34 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Prior treatment for amblyopia: Yes | 13 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Male | 45 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | White, non-Hispanic | 61 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Non-white or Hispanic | 26 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 3 to <5 yrs | 23 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 5 to <7 yrs | 34 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Age at enrollment: 7 to <10 yrs | 31 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Prior treatment for amblyopia: No | 75 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Female | 43 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Strabismus | 23 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Anisometropia | 39 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Cause of amblyopia: Strabismus and anisometropia | 26 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/80 (worse) | 22 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/63 | 29 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/50 | 17 participants |
| Patching | Distribution of Patient Characteristics at the 24-week Outcome Exam. | Distance VA in amblyopic eye: 20/40 (best) | 20 participants |
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).
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bangerter | Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks | 29 participants |
| Patching | Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks | 27 participants |
Comparison: Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.p-value: 0.86Regression, Logistic
Comparison: The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.p-value: 0.28Regression, Cox
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bangerter | Distribution of Subjects With 3 or More Lines of Improvement | 31 participants |
| Patching | Distribution of Subjects With 3 or More Lines of Improvement | 31 participants |
Comparison: Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.p-value: 0.61Regression, Logistic
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).
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bangerter | Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks | 15 participants |
| Patching | Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks | 10 participants |
Comparison: Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.p-value: 0.27Regression, Logistic
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Impact of Treatment on Patient and Family at 24 Weeks | 1.9 Units on a scale | Standard Deviation 1 |
| Patching | Impact of Treatment on Patient and Family at 24 Weeks | 2.3 Units on a scale | Standard Deviation 1.1 |
Comparison: A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.p-value: <0.001t-test, 2 sided
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Impact of Treatment on Patient and Family at 6 Weeks | 2.1 Units on a scale | Standard Deviation 1.1 |
| Patching | Impact of Treatment on Patient and Family at 6 Weeks | 2.3 Units on a scale | Standard Deviation 1 |
Comparison: A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.p-value: 0.03t-test, 2 sided
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Female | 2.1 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Male | 1.7 logMAR line | Standard Deviation 1.6 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | White, non-Hispanic | 1.8 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Non-white or Hispanic | 2.1 logMAR line | Standard Deviation 1.4 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 3 to <5 yrs | 2.1 logMAR line | Standard Deviation 1.9 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 5 to <7 yrs | 2.1 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 7 to <10 yrs | 1.5 logMAR line | Standard Deviation 1.3 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Prior treatment for amblyopia: No | 1.9 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Prior treatment for amblyopia: Yes | 2.0 logMAR line | Standard Deviation 1.4 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Strabismus | 2.2 logMAR line | Standard Deviation 1.5 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Anisometropia | 1.5 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Strabismus and anisometropia | 2.2 logMAR line | Standard Deviation 1.5 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/80 (worse) | 2.3 logMAR line | Standard Deviation 2 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/63 | 1.8 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/50 | 1.7 logMAR line | Standard Deviation 1.7 |
| Bangerter | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/40 (best) | 1.9 logMAR line | Standard Deviation 1 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/40 (best) | 2.0 logMAR line | Standard Deviation 1.1 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Female | 2.4 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Prior treatment for amblyopia: Yes | 1.7 logMAR line | Standard Deviation 1 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Male | 2.2 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/80 (worse) | 2.3 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | White, non-Hispanic | 2.3 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Strabismus | 2.4 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Non-white or Hispanic | 2.4 logMAR line | Standard Deviation 1.3 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/50 | 2.3 logMAR line | Standard Deviation 1.4 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 3 to <5 yrs | 2.7 logMAR line | Standard Deviation 1.4 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Anisometropia | 2.4 logMAR line | Standard Deviation 1.4 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 5 to <7 yrs | 2.5 logMAR line | Standard Deviation 1.2 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Distance VA in amblyopic eye: 20/63 | 2.5 logMAR line | Standard Deviation 1.5 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Age at enrollment: 7 to <10 yrs | 1.8 logMAR line | Standard Deviation 1.2 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Cause of amblyopia: Strabismus and anisometropia | 2.1 logMAR line | Standard Deviation 1.2 |
| Patching | Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics | Prior treatment for amblyopia: No | 2.4 logMAR line | Standard Deviation 1.3 |
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).
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 0.09 logMAR line | Standard Deviation 0.84 |
| Patching | Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks | 0.36 logMAR line | Standard Deviation 1.1 |
Comparison: A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.p-value: 0.07ANCOVA
Comparison: The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.p-value: 0.21Fisher Exact
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).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Mean Interocular Difference at 24 Weeks | 2.3 logMAR line | Standard Deviation 2 |
| Patching | Mean Interocular Difference at 24 Weeks | 2.3 logMAR line | Standard Deviation 1.5 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Social Stigma From Treatment at 24 Weeks | 1.6 Units on a scale | Standard Deviation 0.7 |
| Patching | Social Stigma From Treatment at 24 Weeks | 2.4 Units on a scale | Standard Deviation 0.8 |
Comparison: A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.p-value: <0.001t-test, 2 sided
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bangerter | Social Stigma From Treatment at 6 Weeks | 1.7 Units on a scale | Standard Deviation 0.6 |
| Patching | Social Stigma From Treatment at 6 Weeks | 2.4 Units on a scale | Standard Deviation 0.9 |
Comparison: A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.p-value: <0.001t-test, 2 sided