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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 designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe 2 hours daily patching as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye with this regimen. In a randomized trial conducted by PEDIG comparing patching regimens, 71 of 92 patients with moderate amblyopia (77%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of patching 2 hours daily.2 In another PEDIG randomized trial comparing patching to spectacles alone after a period of refractive adaptation, patients were treated with 2 hours daily patching and followed every 5 weeks until there was no improvement in amblyopic eye acuity. Fifty-five of 70 patients with moderate amblyopia (79%) and 14 of 14 patients with severe amblyopia (100%) had best-measured amblyopic eye visual acuity of 20/32 or worse after a median treatment period of 10 weeks.3 When improvement with initial therapy stops and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage for additional months, or combining treatments. Many clinicians will choose to increase the dosage of the current treatment, in part because families have become comfortable with that particular mode of treatment. However, it is unknown whether increasing occlusion dosage will improve amblyopic eye visual acuity in these patients. We are unaware of any reports of response to intensified treatment of amblyopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 2 hours daily patching |
|
| Intensified treatment | Active Comparator | 42 hours per week of patching (averaging 6 hours daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Patch | Device | 42 hours patching per week (averaging 6 hours patching daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of 10-week Amblyopic Eye Visual Acuity | The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | 10 weeks after randomization |
| Mean 10-week Amblyopic Eye Visual Acuity | The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | 10 weeks after randomization |
| Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization | The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Prescribed Patching by Treatment Group at 10 Weeks | The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day. |
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Inclusion Criteria:
Major Eligibility Criteria for Run-in Phase
Age 3 to < 8 years
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
Amblyopia treatment within the past 6 months subject to the following stipulations:
No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
No simultaneous treatment with patching and atropine
No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
Maximum level of treatment within the past 6 months:
Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.
Eligibility Criteria for Randomization:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David K. Wallace, M.D. | Duke University Eye Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California College of Optometry | Fullerton | California | 92831 | United States | ||
| Duke University Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25695355 | Background | Wallace DK, Lazar EL, Crouch ER 3rd, Hoover DL, Kraker RT, Tamkins SM; Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015 May;133(5):606-9. doi: 10.1001/jamaophthalmol.2015.6. No abstract available. | |
| 23755872 | Result | Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Holmes JM, Repka MX, Cotter SA, Chen AM, Kraker RT, Beck RW, Clarke MP, Lorenzana IJ, Petersen DB, Roberts JT, Suh DW. A randomized trial of increasing patching for amblyopia. Ophthalmology. 2013 Nov;120(11):2270-7. doi: 10.1016/j.ophtha.2013.04.008. Epub 2013 Jun 4. |
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In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=29
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Prior to being considered for the randomized trial, participants who had not already completed at least 12 weeks of 2 hours of daily patching were enrolled into a run-in phase and treated with 2 hours of daily patching (and spectacles if needed) with follow-up every 6 weeks until no improvement.
Between September 2009 and December 2012, 45 sites randomized 169 participants to either increase patching time to an average of 6 hours per day (n=86) or continue 2 hours daily patching (n=83).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 2 hours daily patching |
| FG001 | Intensified Treatment | 42 hours per week of patching (averaging 6 hours daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10-week Primary Outcome |
| |||||||||||||||||||
| Post-10 Week Primary Outcome |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 2 hours daily patching |
| BG001 | Intensified Treatment | 42 hours per week of patching (averaging 6 hours daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 10-week Amblyopic Eye Visual Acuity | The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | Posted | Number | participants | 10 weeks after randomization |
|
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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 | Control | 2 hours daily patching |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New ocular deviation or worsening of preexisting deviation by at least 10 pd | Eye disorders | Non-systematic Assessment |
A potential study limitation is that compliance with patching was based on discussions with the parent and by reviewing study calendars maintained by the parent, which not an objective measure of compliance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Kraker, M.S.P.H., Director of PEDIG Coordinating Center | Jaeb Center for Health Research | (813) 975-8690 | rkraker@jaeb.org |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Eye Patch | Device | 2 hours patching daily |
|
|
| Randomization to 10 weeks |
| Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization | The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | Randomization to 10 weeks |
| 10 weeks after randomization |
| Average Compliance With Prescribed Patching by Treatment Group | The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day. | 10 weeks after randomization or later |
| Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization | The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | 10 weeks after randomization |
| Treatment Group Comparison of 10-week Interocular Difference | The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | 10 weeks after randomization |
| Distribution of Baseline Characteristics at the 10-week Outcome | The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis. | 10 weeks after randomization |
| Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome | Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | 10 weeks after randomization |
| Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics | A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | 10 weeks after randomization |
| Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.) | 10 weeks after randomization or later |
| Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization. | 10 weeks after randomization or later |
| Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.) | Randomization to 10 weeks or later |
| Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.) | 10 weeks after randomization or later |
| Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained. | 10 weeks after randomization or later |
| Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome | 10 weeks after randomization |
| Mean Best Fellow Eye Visual Acuity at 10-week Outcome | 10 weeks after randomization |
| Distribution of Best Fellow Eye Visual Acuity at Final Visit | 10 weeks after randomization or later |
| Mean Best Fellow Eye Visual Acuity at Final Visit | 10 weeks after randomization or later |
| Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks | 10 weeks after randomization |
| Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks | 10 weeks after randomization |
| Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit | 10 weeks after randomization or later |
| Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit | 10 weeks after randomization or later |
| Distribution of Randot Preschool Stereoacuity Scores at Randomization | The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800. We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing. The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank. | Randomization |
| Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks | 10 weeks after randomization |
| Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization | 10 weeks after randomization |
| Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia | Randomization |
| Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia | 10 weeks after randomization |
| Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia | 10 weeks after randomization |
| Durham |
| North Carolina |
| 27710 |
| United States |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Baseline age reflects age at randomization. The age eligibility requirement at enrollment was 3 to <8 years old, however, there were 7 participants who were enrolled into the run-in phase that were 8 years old by the time they were randomized. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Enrollment Disposition | Participants were classified into 3 groups (no current treatment, on treatment, ready for randomization) according to their treatment disposition at enrollment. | Number | participants |
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| Duration of patching prior to randomization (weeks) | Number | participants |
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| Duration of patching prior to randomization (weeks) | Mean | Standard Deviation | Weeks |
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| Amblyopia Cause | Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both: Criteria for strabismus: At least one of the following:
Criteria for anisometropia: At least one of the following:
| Number | participants |
|
| Best distance visual acuity in the amblyopic eye at randomization | Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester. Best amblyopic eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization. | Number | participants |
|
| Best distance visual acuity in the amblyopic eye at randomization | Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester. Best amblyopic eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization. | Mean | Standard Deviation | logMAR |
|
| Best distance visual acuity in the fellow eye at randomization | Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester. Best fellow eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization. | Number | participants |
|
| Best distance visual acuity in the fellow eye at randomization | Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester. Best fellow eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization. | Mean | Standard Deviation | logMAR |
|
| Best interocular eye visual acuity difference at randomization | Best interocular eye visual acuity difference was computed as difference between the best amblyopic eye visual acuity and the best fellow eye visual acuity at randomization. | Mean | Standard Deviation | logMAR lines |
|
| Refractive error in amblyopic eye at enrollment | Number | participants |
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| Refractive error in amblyopic eye at enrollment | Mean | Standard Deviation | Diopters |
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| Refractive error in fellow eye at enrollment | Number | participants |
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| Refractive error in fellow eye at enrollment | Mean | Standard Deviation | Diopters |
|
2 hours daily patching |
| OG001 | Intensified Treatment | 42 hours per week of patching (averaging 6 hours daily) |
|
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| Secondary | Compliance With Prescribed Patching by Treatment Group at 10 Weeks | The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Average Compliance With Prescribed Patching by Treatment Group | The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day. | Posted | Number | participants | 10 weeks after randomization or later |
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| Secondary | Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization | The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Treatment Group Comparison of 10-week Interocular Difference | The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | Posted | Mean | Standard Deviation | logMAR lines | 10 weeks after randomization |
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| Secondary | Distribution of Baseline Characteristics at the 10-week Outcome | The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis. | The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | Posted | Number | participants | 10 weeks after randomization |
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| Primary | Mean 10-week Amblyopic Eye Visual Acuity | The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | Posted | Mean | Standard Deviation | logMAR | 10 weeks after randomization |
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| Primary | Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization | The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | Posted | Number | participants | Randomization to 10 weeks |
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| Primary | Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization | The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | Posted | Mean | Standard Deviation | logMAR lines | Randomization to 10 weeks |
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| Secondary | Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome | Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis. | Posted | Mean | Standard Deviation | logMAR | 10 weeks after randomization |
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| Secondary | Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics | A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. | The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks after randomization |
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| Secondary | Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.) | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Number | participants | 10 weeks after randomization or later |
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| Secondary | Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization. | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | Posted | Mean | Standard Deviation | logMAR | 10 weeks after randomization or later |
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| Secondary | Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.) | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Number | participants | Randomization to 10 weeks or later |
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| Secondary | Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.) | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Mean | Standard Deviation | logMAR lines | 10 weeks after randomization or later |
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| Secondary | Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit | Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained. | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Number | participants | 10 weeks after randomization or later |
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| Secondary | Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome | The analysis includes data from participants who completed a 10-week exam. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Mean Best Fellow Eye Visual Acuity at 10-week Outcome | The analysis includes data from participants who completed a 10-week exam. | Posted | Mean | Standard Deviation | logMAR | 10 weeks after randomization |
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| Secondary | Distribution of Best Fellow Eye Visual Acuity at Final Visit | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Number | participants | 10 weeks after randomization or later |
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| Secondary | Mean Best Fellow Eye Visual Acuity at Final Visit | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Mean | Standard Deviation | logMAR | 10 weeks after randomization or later |
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| Secondary | Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks | The analysis includes data from participants who completed a 10-week exam. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks | The analysis includes data from participants who completed a 10-week exam. | Posted | Mean | Standard Deviation | logMAR lines | 10 weeks after randomization |
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| Secondary | Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit | The analysis includes data from participants who completed the 10-week exam and/or a later visit. | Posted | Number | participants | 10 weeks after randomization or later |
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| Secondary | Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit | Posted | Mean | Standard Deviation | logMAR lines | 10 weeks after randomization or later |
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| Secondary | Distribution of Randot Preschool Stereoacuity Scores at Randomization | The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800. We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing. The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank. | The analysis includes all participants who completed the 10-week exam. | Posted | Number | participants | Randomization |
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| Secondary | Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks | The analysis includes all participants who completed the 10-week exam. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization | Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia | The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam. | Posted | Number | participants | Randomization |
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| Secondary | Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia | The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam. | Posted | Number | participants | 10 weeks after randomization |
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| Secondary | Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia | Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam. | Posted | Number | participants | 10 weeks after randomization |
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|
| 0 |
| 83 |
| 6 |
| 83 |
| EG001 | Intensified Treatment | 42 hours per week of patching (averaging 6 hours daily) | 0 | 86 | 4 | 86 |
Not provided
Not provided
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| Fair |
|
| Poor |
|
| Missing (Not applicable) |
|
| Fair |
|
| Poor |
|
| Missing (Not applicable) |
|
| Treatment not per protocol |
|
| Race/Ethnicity: White (non-Hispanic) |
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| Race/Ethnicity: Non-White/Hispanic |
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| Age at randomization: 3 to <5 years |
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| Age at randomization: 5 years or older |
|
| Amblyopic eye VA at randomization: 20/80 or worse |
|
| Amblyopic eye VA at randomization: 20/63 |
|
| Amblyopic eye VA at randomization: 20/50 |
|
| Amblyopic eye VA at randomization: 20/40 or better |
|
| Cause of amblyopia: Strabismus |
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| Cause of amblyopia: Anisometropia |
|
| Cause of amblyopia: Combined mechanism |
|
| 1 logMAR line worse |
|
| No change (0 logMAR line) |
|
| 1 logMAR line improved |
|
| 2 logMAR lines improved |
|
| 3 or more logMAR lines improved |
|
| Race/Ethnicity: White (non-Hispanic) |
|
| Race/Ethnicity: Non-White/Hispanic |
|
| Age at randomization: 3 to <5 years |
|
| Age at randomization: 5 years or older |
|
| Cause of amblyopia: Strabismus |
|
| Cause of amblyopia: Anisometropia |
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| Cause of amblyopia: Combined mechanism |
|
| Race/Ethnicity: White (non-Hispanic) |
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| Race/Ethnicity: Non-White/Hispanic |
|
| Age at randomization: 3 to <5 years |
|
| Age at randomization: 5 years or older |
|
| Amblyopic eye VA at randomization: 20/80 or worse |
|
| Amblyopic eye VA at randomization: 20/63 |
|
| Amblyopic eye VA at randomization: 20/50 |
|
| Amblyopic eye VA at randomization: 20/40 or better |
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| Cause of amblyopia: Strabismus |
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| Cause of amblyopia: Anisometropia |
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| Cause of amblyopia: Combined mechanism |
|
The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term. |
| ANCOVA |
The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate. |
| 0.89 |
| 95 |
| No |
| Superiority or Other |
| The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term. | ANCOVA | The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate. | 0.49 | 95 | No | Superiority or Other |
| The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term. | ANCOVA | 0.37 | 95 | No | Superiority or Other |
| The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term. | ANCOVA | The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate. | 0.50 | 95 | No | Superiority or Other |
| 20/125 |
|
| 20/100 |
|
| 20/80 |
|
| 20/63 |
|
| 20/50 |
|
| 20/40 |
|
| 20/32 |
|
| 20/25 |
|
| 20/20 |
|
| 20/16 |
|
| 1 logMAR line worse |
|
| No change (0 logMAR line) |
|
| 1 logMAR line improved |
|
| 2 logMAR lines improved |
|
| 3 or more logMAR lines improved |
|
| 20/40 |
|
| 20/32 |
|
| 20/25 |
|
| 20/20 |
|
| 20/16 |
|
| 20/40 |
|
| 20/32 |
|
| 20/25 |
|
| 20/20 |
|
| 20/16 |
|
| 1 logMAR line worse |
|
| No change (0 logMAR line) |
|
| 1 logMAR line improved |
|
| 2 logMAR lines improved |
|
| 3 or more logMAR lines improved |
|
| 1 logMAR line worse |
|
| No change (0 logMAR line) |
|
| 1 logMAR line improved |
|
| 2 logMAR lines improved |
|
| 3 or more logMAR lines improved |
|
| 800 seconds of arc |
|
| 400 seconds of arc |
|
| 200 seconds of arc |
|
| 100 seconds of arc |
|
| 60 seconds of arc |
|
| 40 seconds of arc |
|
| Not done |
|
| 800 seconds of arc |
|
| 400 seconds of arc |
|
| 200 seconds of arc |
|
| 100 seconds of arc |
|
| 60 seconds of arc |
|
| 40 seconds of arc |
|
| Not done |
|
| 2 or more levels improved |
|
| 800 seconds of arc |
|
| 400 seconds of arc |
|
| 200 seconds of arc |
|
| 100 seconds of arc |
|
| 60 seconds of arc |
|
| 40 seconds of arc |
|
| Not done |
|
| 800 seconds of arc |
|
| 400 seconds of arc |
|
| 200 seconds of arc |
|
| 100 seconds of arc |
|
| 60 seconds of arc |
|
| 40 seconds of arc |
|
| Not done |
|
| 2 or more levels improved |
|