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Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00945100
First received: July 21, 2009
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: September 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Amblyopia
Intervention: Device: Eye Patch

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Participant Flow for 2 periods

Period 1:   10-week Primary Outcome
    Control   Intensified Treatment
STARTED   83   86 
Completed, Eligible   55 [1]   63 [1] 
Completed, Not Eligible   27 [2]   20 [2] 
COMPLETED   82   83 
NOT COMPLETED   1   3 
[1] Eligible for Post-10 week phase
[2] Not Eligible for Post-10 week phase

Period 2:   Post-10 Week Primary Outcome
    Control   Intensified Treatment
STARTED   55 [1]   63 [2] 
COMPLETED   51   56 
NOT COMPLETED   4   7 
[1] 27 participants were not eligible for Post 10 week Primary Outcome phase
[2] 20 participants were not eligible for Post 10 week Primary Outcome phase



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)
Total Total of all reporting groups

Baseline Measures
   Control   Intensified Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   86   169 
Age 
[Units: Participants]
     
<=18 years   83   86   169 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.9  (1.3)   5.9  (1.2)   5.9  (1.3) 
Age, Customized [1] 
[Units: Participants]
     
3 to <4 years   5   8   13 
4 to <5 years   15   15   30 
5 to <6 years   27   19   46 
6 to <7 years   17   25   42 
7 to 8 years   19   19   38 
[1]

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.

Gender 
[Units: Participants]
     
Female   43   43   86 
Male   40   43   83 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   57   66   123 
Black/African American   8   2   10 
Hispanic   14   14   28 
Asian   2   3   5 
More than one race   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   80   82   162 
United Kingdom   3   3   6 
Canada   0   1   1 
Enrollment Disposition [1] 
[Units: Participants]
     
No current treatment   48   49   97 
On treatment   18   18   36 
Ready for randomization   17   19   36 
[1] Participants were classified into 3 groups (no current treatment, on treatment, ready for randomization) according to their treatment disposition at enrollment.
Duration of patching prior to randomization (weeks) 
[Units: Participants]
     
12 to <16 weeks   14   21   35 
16 to <25 weeks   39   31   70 
25 weeks or more   30   34   64 
Duration of patching prior to randomization (weeks) 
[Units: Weeks]
Mean (Standard Deviation)
 24.5  (10.7)   24.4  (11.9)   24.4  (11.3) 
Amblyopia Cause [1] 
[Units: Participants]
     
Strabismus   16   16   32 
Anisometropia   41   34   75 
Strabismus and Anisometropia   26   36   62 
[1]

Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both:

Criteria for strabismus: At least one of the following:

  1. Heterotropia at distance and/or near fixation on examination (with or without spectacles)
  2. History of strabismus surgery
  3. Documented history which is no longer present (which in the judgement of the investigator could have caused amblyopia)

Criteria for anisometropia: At least one of the following:

  1. At least 0.50 D difference between eyes in spherical equivalent
  2. At least 1.50 D different between eyes in astigmatism in any meridian
Best distance visual acuity in the amblyopic eye at randomization [1] 
[Units: Participants]
     
20/160   2   3   5 
20/125   3   1   4 
20/100   2   7   9 
20/80   6   6   12 
20/63   17   21   38 
20/50   26   24   50 
20/40   21   18   39 
20/32   6   6   12 
[1]

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.

Best distance visual acuity in the amblyopic eye at randomization [1] 
[Units: logMAR]
Mean (Standard Deviation)
 0.43  (0.15)   0.45  (0.16)   0.44  (0.16) 
[1]

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.

Best distance visual acuity in the fellow eye at randomization [1] 
[Units: Participants]
     
20/32   5   5   10 
20/25   17   21   38 
20/20   27   26   53 
20/16   34   34   68 
[1]

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.

Best distance visual acuity in the fellow eye at randomization [1] 
[Units: logMAR]
Mean (Standard Deviation)
 -0.01  (0.09)   0.00  (0.09)   -0.01  (0.09) 
[1]

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.

Best interocular eye visual acuity difference at randomization [1] 
[Units: logMAR lines]
Mean (Standard Deviation)
 4.4  (1.6)   4.5  (1.7)   4.5  (1.7) 
[1] 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.
Refractive error in amblyopic eye at enrollment 
[Units: Participants]
     
0 to <+1.00D   9   3   12 
+1.00 D to <+2.00 D   5   3   8 
+2.00 D to <+3.00 D   2   4   6 
+3.00 D to <+4.00 D   13   6   19 
+4.00 D or more   54   70   124 
Refractive error in amblyopic eye at enrollment 
[Units: Diopters]
Mean (Standard Deviation)
 4.58  (2.26)   5.27  (1.94)   4.93  (2.12) 
Refractive error in fellow eye at enrollment 
[Units: Participants]
     
<0 D   1   1   2 
0 to <+1.00D   22   14   36 
+1.00 D to <+2.00 D   30   19   49 
+2.00 D to <+3.00 D   10   14   24 
+3.00 D to <+4.00 D   4   12   16 
+4.00 D or more   16   26   42 
Refractive error in fellow eye at enrollment 
[Units: Diopters]
Mean (Standard Deviation)
 2.10  (1.86)   2.89  (2.06)   2.50  (2.00) 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Distribution of 10-week Amblyopic Eye Visual Acuity   [ Time Frame: 10 weeks after randomization ]

Measure Type Primary
Measure Title Distribution of 10-week Amblyopic Eye Visual Acuity
Measure Description

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.

Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Distribution of 10-week Amblyopic Eye Visual Acuity 
[Units: Participants]
   
20/200   1   0 
20/160   0   0 
20/125   3   3 
20/100   3   2 
20/80   8   4 
20/63   6   9 
20/50   19   15 
20/40   23   20 
20/32   14   15 
20/25   3   12 
20/20   2   2 
20/16   0   0 

No statistical analysis provided for Distribution of 10-week Amblyopic Eye Visual Acuity



2.  Primary:   Mean 10-week Amblyopic Eye Visual Acuity   [ Time Frame: 10 weeks after randomization ]

Measure Type Primary
Measure Title Mean 10-week Amblyopic Eye Visual Acuity
Measure Description

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.

Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Mean 10-week Amblyopic Eye Visual Acuity 
[Units: logMAR]
Mean (Standard Deviation)
 0.38  (0.19)   0.33  (0.18) 


Statistical Analysis 1 for Mean 10-week Amblyopic Eye Visual Acuity
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.002
Mean Difference (Net) [5] 0.6
95% Confidence Interval 0.3 to 1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The primary 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 was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Primary:   Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization   [ Time Frame: Randomization to 10 weeks ]

Measure Type Primary
Measure Title Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
Measure Description

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.

Time Frame Randomization to 10 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization 
[Units: Participants]
   
3 or more logMAR lines worse   1   0 
2 logMAR lines worse   3   2 
1 logMAR line worse   13   7 
No change (0 logMAR line)   19   17 
1 logMAR line improved   31   23 
2 logMAR lines improved   13   19 
3 or more logMAR lines improved   2   14 

No statistical analysis provided for Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization



4.  Primary:   Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization   [ Time Frame: Randomization to 10 weeks ]

Measure Type Primary
Measure Title Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization
Measure Description

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.

Time Frame Randomization to 10 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization 
[Units: logMAR lines]
Mean (Standard Deviation)
 0.5  (1.2)   1.2  (1.4) 

No statistical analysis provided for Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization



5.  Secondary:   Compliance With Prescribed Patching by Treatment Group at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Compliance With Prescribed Patching by Treatment Group at 10 Weeks
Measure Description 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.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Compliance With Prescribed Patching by Treatment Group at 10 Weeks 
[Units: Participants]
   
Excellent   66   59 
Good   10   14 
Fair   0   5 
Poor   2   4 
Missing (Not applicable)   4   1 

No statistical analysis provided for Compliance With Prescribed Patching by Treatment Group at 10 Weeks



6.  Secondary:   Average Compliance With Prescribed Patching by Treatment Group   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Average Compliance With Prescribed Patching by Treatment Group
Measure Description 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.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Average Compliance With Prescribed Patching by Treatment Group 
[Units: Participants]
   
Excellent   65   60 
Good   11   15 
Fair   1   4 
Poor   2   4 
Missing (Not applicable)   3   0 
Treatment not per protocol   0   1 

No statistical analysis provided for Average Compliance With Prescribed Patching by Treatment Group



7.  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   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
Measure Description

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.

Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization 
[Units: Participants]
 15   33 


Statistical Analysis 1 for Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] 0.003
Risk difference (unadjusted) [5] 22
95% Confidence Interval 8 to 35
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Secondary:   Treatment Group Comparison of 10-week Interocular Difference   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Treatment Group Comparison of 10-week Interocular Difference
Measure Description 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.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Treatment Group Comparison of 10-week Interocular Difference 
[Units: logMAR lines]
Mean (Standard Deviation)
 3.7  (2.2)   3.2  (2.1) 


Statistical Analysis 1 for Treatment Group Comparison of 10-week Interocular Difference
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.01
Mean Difference (Net) [5] 0.5
95% Confidence Interval 0.1 to 1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included interocular difference at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



9.  Secondary:   Distribution of Baseline Characteristics at the 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Distribution of Baseline Characteristics at the 10-week Outcome
Measure Description 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.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Distribution of Baseline Characteristics at the 10-week Outcome 
[Units: Participants]
   
Gender: Female   43   41 
Gender: Male   39   41 
Race/Ethnicity: White (non-Hispanic)   56   63 
Race/Ethnicity: Non-White/Hispanic   26   19 
Age at randomization: 3 to <5 years   20   23 
Age at randomization: 5 years or older   62   59 
Amblyopic eye VA at randomization: 20/80 or worse   12   15 
Amblyopic eye VA at randomization: 20/63   17   21 
Amblyopic eye VA at randomization: 20/50   26   24 
Amblyopic eye VA at randomization: 20/40 or better   27   22 
Cause of amblyopia: Strabismus   16   15 
Cause of amblyopia: Anisometropia   40   31 
Cause of amblyopia: Combined mechanism   26   36 

No statistical analysis provided for Distribution of Baseline Characteristics at the 10-week Outcome



10.  Secondary:   Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Measure Description 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.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome 
[Units: logMAR]
Mean (Standard Deviation)
   
Gender: Female   0.44  (0.17)   0.45  (0.16) 
Gender: Male   0.41  (0.13)   0.44  (0.14) 
Race/Ethnicity: White (non-Hispanic)   0.42  (0.16)   0.45  (0.14) 
Race/Ethnicity: Non-White/Hispanic   0.43  (0.14)   0.43  (0.17) 
Age at randomization: 3 to <5 years   0.45  (0.14)   0.44  (0.12) 
Age at randomization: 5 years or older   0.42  (0.16)   0.45  (0.16) 
Cause of amblyopia: Strabismus   0.46  (0.17)   0.43  (0.15) 
Cause of amblyopia: Anisometropia   0.39  (0.11)   0.43  (0.13) 
Cause of amblyopia: Combined mechanism   0.47  (0.19)   0.46  (0.16) 

No statistical analysis provided for Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome



11.  Secondary:   Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Measure Description 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.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   82 
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics 
[Units: Units on a scale]
Mean (Standard Deviation)
   
Gender: Female   0.4  (1.3)   1.4  (1.3) 
Gender: Male   0.7  (1.1)   0.9  (1.5) 
Race/Ethnicity: White (non-Hispanic)   0.5  (1.0)   1.2  (1.4) 
Race/Ethnicity: Non-White/Hispanic   0.5  (1.6)   1.1  (1.3) 
Age at randomization: 3 to <5 years   0.9  (1.0)   1.5  (1.4) 
Age at randomization: 5 years or older   0.4  (1.2)   1.0  (1.4) 
Amblyopic eye VA at randomization: 20/80 or worse   0.7  (1.4)   1.3  (1.6) 
Amblyopic eye VA at randomization: 20/63   0.7  (1.3)   1.6  (1.4) 
Amblyopic eye VA at randomization: 20/50   0.4  (1.2)   1.4  (1.1) 
Amblyopic eye VA at randomization: 20/40 or better   0.4  (1.1)   0.5  (1.3) 
Cause of amblyopia: Strabismus   1.1  (1.2)   1.4  (1.3) 
Cause of amblyopia: Anisometropia   0.3  (1.2)   1.3  (1.5) 
Cause of amblyopia: Combined mechanism   0.5  (1.1)   1.0  (1.4) 


Statistical Analysis 1 for Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.89
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.49
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 4 for Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.37
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 5 for Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Measure Description 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.)
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity 
[Units: Participants]
   
20/200   1   0 
20/160   0   0 
20/125   2   2 
20/100   3   3 
20/80   7   4 
20/63   7   7 
20/50   15   11 
20/40   16   21 
20/32   15   14 
20/25   12   15 
20/20   3   5 
20/16   1   1 

No statistical analysis provided for Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity



13.  Secondary:   Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Measure Description 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.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity 
[Units: logMAR]
Mean (Standard Deviation)
 0.33  (0.21)   0.30  (0.19) 


Statistical Analysis 1 for Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
Mean Difference (Net) [4] 0.5
95% Confidence Interval 0.04 to 1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye   [ Time Frame: Randomization to 10 weeks or later ]

Measure Type Secondary
Measure Title Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye
Measure Description 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.)
Time Frame Randomization to 10 weeks or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye 
[Units: Participants]
   
3 or more logMAR lines worse   1   0 
2 logMAR lines worse   3   2 
1 logMAR line worse   12   6 
No change (0 logMAR line)   13   17 
1 logMAR line improved   21   16 
2 logMAR lines improved   22   21 
3 or more logMAR lines improved   10   21 

No statistical analysis provided for Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye



15.  Secondary:   Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity
Measure Description 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.)
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity 
[Units: logMAR lines]
Mean (Standard Deviation)
 0.9  (1.5)   1.5  (1.6) 

No statistical analysis provided for Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity



16.  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   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title 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
Measure Description 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.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
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 
[Units: Participants]
 32   42 

No statistical analysis provided for 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



17.  Secondary:   Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed a 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome 
[Units: Participants]
   
20/63   0   0 
20/50   1   0 
20/40   1   0 
20/32   5   8 
20/25   19   14 
20/20   20   31 
20/16   36   30 

No statistical analysis provided for Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome



18.  Secondary:   Mean Best Fellow Eye Visual Acuity at 10-week Outcome   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Mean Best Fellow Eye Visual Acuity at 10-week Outcome
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed a 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Best Fellow Eye Visual Acuity at 10-week Outcome 
[Units: logMAR]
Mean (Standard Deviation)
 0.00  (0.11)   0.00  (0.10) 

No statistical analysis provided for Mean Best Fellow Eye Visual Acuity at 10-week Outcome



19.  Secondary:   Distribution of Best Fellow Eye Visual Acuity at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Distribution of Best Fellow Eye Visual Acuity at Final Visit
Measure Description No text entered.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Best Fellow Eye Visual Acuity at Final Visit 
[Units: Participants]
   
20/63   1   0 
20/50   1   0 
20/40   1   0 
20/32   4   5 
20/25   15   18 
20/20   20   28 
20/16   40   32 

No statistical analysis provided for Distribution of Best Fellow Eye Visual Acuity at Final Visit



20.  Secondary:   Mean Best Fellow Eye Visual Acuity at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Mean Best Fellow Eye Visual Acuity at Final Visit
Measure Description No text entered.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Best Fellow Eye Visual Acuity at Final Visit 
[Units: logMAR]
Mean (Standard Deviation)
 -0.01  (0.12)   0.00  (0.09) 

No statistical analysis provided for Mean Best Fellow Eye Visual Acuity at Final Visit



21.  Secondary:   Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed a 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks 
[Units: Participants]
   
3 or more logMAR lines worse   1   1 
2 logMAR lines worse   0   0 
1 logMAR line worse   14   16 
No change (0 logMAR line)   58   49 
1 logMAR line improved   8   17 
2 logMAR lines improved   1   0 
3 or more logMAR lines improved   0   0 


Statistical Analysis 1 for Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] >0.99
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



22.  Secondary:   Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed a 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks 
[Units: logMAR lines]
Mean (Standard Deviation)
 -0.10  (0.7)   -0.02  (0.7) 

No statistical analysis provided for Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks



23.  Secondary:   Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Measure Description No text entered.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes data from participants who completed the 10-week exam and/or a later visit.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit 
[Units: Participants]
   
3 or more logMAR lines worse   2   0 
2 logMAR lines worse   1   0 
1 logMAR line worse   11   16 
No change (0 logMAR line)   53   50 
1 logMAR line improved   13   16 
2 logMAR lines improved   2   1 
3 or more logMAR lines improved   0   0 


Statistical Analysis 1 for Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] 0.12
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



24.  Secondary:   Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit   [ Time Frame: 10 weeks after randomization or later ]

Measure Type Secondary
Measure Title Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit
Measure Description No text entered.
Time Frame 10 weeks after randomization or later  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit 
[Units: logMAR lines]
Mean (Standard Deviation)
 -0.04  (0.9)   0.02  (0.7) 

No statistical analysis provided for Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit



25.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at Randomization   [ Time Frame: Randomization ]

Measure Type Secondary
Measure Title Distribution of Randot Preschool Stereoacuity Scores at Randomization
Measure Description

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.

Time Frame Randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes all participants who completed the 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Randot Preschool Stereoacuity Scores at Randomization 
[Units: Participants]
   
Failed pretest   10   7 
> 800 seconds of arc   39   47 
800 seconds of arc   10   8 
400 seconds of arc   6   5 
200 seconds of arc   4   7 
100 seconds of arc   7   1 
60 seconds of arc   2   0 
40 seconds of arc   2   2 
Not done   2   6 

No statistical analysis provided for Distribution of Randot Preschool Stereoacuity Scores at Randomization



26.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes all participants who completed the 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 82   83 
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks 
[Units: Participants]
   
Failed pretest   8   7 
> 800 seconds of arc   33   44 
800 seconds of arc   13   10 
400 seconds of arc   10   12 
200 seconds of arc   5   6 
100 seconds of arc   11   0 
60 seconds of arc   0   2 
40 seconds of arc   2   1 
Not done   0   1 

No statistical analysis provided for Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks



27.  Secondary:   Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 69   68 
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization 
[Units: Participants]
   
2 or more levels worse   2   2 
Within 1 level   62   59 
2 or more levels improved   5   7 


Statistical Analysis 1 for Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.28
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



28.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia   [ Time Frame: Randomization ]

Measure Type Secondary
Measure Title Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia
Measure Description No text entered.
Time Frame Randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 40   32 
Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia 
[Units: Participants]
   
Failed pretest   3   3 
> 800 seconds of arc   15   17 
800 seconds of arc   7   3 
400 seconds of arc   5   2 
200 seconds of arc   3   3 
100 seconds of arc   3   1 
60 seconds of arc   2   0 
40 seconds of arc   1   2 
Not done   1   1 

No statistical analysis provided for Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia



29.  Secondary:   Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 40   32 
Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia 
[Units: Participants]
   
Failed pretest   3   2 
> 800 seconds of arc   11   17 
800 seconds of arc   7   4 
400 seconds of arc   6   4 
200 seconds of arc   4   3 
100 seconds of arc   7   0 
60 seconds of arc   0   1 
40 seconds of arc   2   1 
Not done   0   0 

No statistical analysis provided for Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia



30.  Secondary:   Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia   [ Time Frame: 10 weeks after randomization ]

Measure Type Secondary
Measure Title Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
Measure Description No text entered.
Time Frame 10 weeks after randomization  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Control 2 hours daily patching
Intensified Treatment 42 hours per week of patching (averaging 6 hours daily)

Measured Values
   Control   Intensified Treatment 
Participants Analyzed 
[Units: Participants]
 35   28 
Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia 
[Units: Participants]
   
2 or more levels worse   0   2 
Within 1 level   32   22 
2 or more levels improved   3   4 


Statistical Analysis 1 for Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.45
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information