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Trial record 1 of 1 for:    ATS18
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Study of Binocular Computer Activities for Treatment of Amblyopia (ATS18)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02200211
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : October 15, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Amblyopia
Interventions Device: iPad®
Other: Patching 2 hours per day, 7 days per week
Enrollment 485
Recruitment Details

Two separate sub-studies based on age at enrollment

Younger Cohort defined as 5 to <13 years of age Older Cohort defined as 13 to <17 years of age

Pre-assignment Details  
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Hide Arm/Group Description

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Period Title: Overall Study
Started 190 195 40 60
Included in 16-week Primary Analysis [1] 177 186 39 56
Completed [2] 182 188 39 58
Not Completed 8 7 1 2
Reason Not Completed
Lost to Follow-up             7             7             1             2
Withdrawal by Subject             1             0             0             0
[1]
16-week visits completed within pre-specified analysis window (148-196 days after randomization)
[2]
Completed 16-week study
Arm/Group Title Binocular Treatment Younger Cohort (5 to <13 Years) Patching Treatment Younger Cohort (5 to <13 Years) Binocular Treatment Older Cohort (13 to <17 Years) Patching Treatment Older Cohort (13 to <17 Years) Total
Hide Arm/Group Description

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Total of all reporting groups
Overall Number of Baseline Participants 190 195 40 60 485
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
<=18 years
190
 100.0%
195
 100.0%
40
 100.0%
60
 100.0%
485
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
8.4  (1.8) 8.6  (2.0) 14.3  (1.1) 14.3  (1.1) 9.7  (2.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age at enrollment, years : 5 to <7 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
43 50 0 0 93
Age at enrollment, years : 7 to <9 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
78 62 0 0 140
Age at enrollment, years : 9 to <13 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
69 83 0 0 152
Age at enrollment, years : 13 to <17 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
0 0 40 60 100
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
Female 98 89 16 26 229
Male 92 106 24 34 256
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
134 145 30 43 352
Black/African American Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
11 12 2 4 29
Hispanic or Latino Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
33 24 8 11 76
Asian, American Indian, Alaskan Native Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
9 6 0 1 16
>1 Race Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
2 5 0 1 8
Unknown/not reported Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
1 3 0 0 4
Distance Amblyopic-Eye Visual Acuity  
Measure Type: Count of Participants
Unit of measure:  Participants
20/200 (33-37 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
5
   2.6%
4
   2.1%
0
   0.0%
2
   3.3%
11
   2.3%
20/160 (38-42 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
6
   3.2%
7
   3.6%
2
   5.0%
5
   8.3%
20
   4.1%
20/125 (43-47 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
8
   4.2%
4
   2.1%
4
  10.0%
8
  13.3%
24
   4.9%
20/100 (48-52 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
16
   8.4%
12
   6.2%
3
   7.5%
4
   6.7%
35
   7.2%
20/80 (53-57 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
30
  15.8%
24
  12.3%
7
  17.5%
12
  20.0%
73
  15.1%
20/63 (58-62 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
37
  19.5%
46
  23.6%
6
  15.0%
10
  16.7%
99
  20.4%
20/50 (63-67 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
61
  32.1%
52
  26.7%
12
  30.0%
14
  23.3%
139
  28.7%
20/40 (68-72 Letters) Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
27
  14.2%
46
  23.6%
6
  15.0%
5
   8.3%
84
  17.3%
Baseline Stereoacuity (Seconds of Arc)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
4000 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
69
  36.3%
57
  29.2%
16
  40.0%
29
  48.3%
171
  35.3%
2000 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
28
  14.7%
37
  19.0%
3
   7.5%
7
  11.7%
75
  15.5%
800 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
18
   9.5%
26
  13.3%
5
  12.5%
4
   6.7%
53
  10.9%
400 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
17
   8.9%
19
   9.7%
7
  17.5%
7
  11.7%
50
  10.3%
200 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
23
  12.1%
18
   9.2%
2
   5.0%
4
   6.7%
47
   9.7%
100 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
23
  12.1%
23
  11.8%
6
  15.0%
6
  10.0%
58
  12.0%
60 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
10
   5.3%
9
   4.6%
1
   2.5%
1
   1.7%
21
   4.3%
40 Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
2
   1.1%
6
   3.1%
0
   0.0%
2
   3.3%
10
   2.1%
[1]
Measure Description:

Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

Baseline Stereoacuity (Seconds of Arc)   [1] [2] 
Median (Full Range)
Unit of measure:  Seconds of Arc
All participants Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
2000
(40 to 4000)
800
(40 to 4000)
800
(60 to 4000)
2000
(40 to 4000)
NA [3] 
(40 to 4000)
Participants with no history of strabismus Number Analyzed 107 participants 92 participants 22 participants 29 participants 250 participants
400
(40 to 4000)
400
(40 to 4000)
400
(60 to 4000)
800
(60 to 4000)
NA [3] 
(40 to 4000)
[1]
Measure Description:

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measured as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool (scores: 800, 400, 200, 100, 60 and 40) stereoacuity test methods as previously described. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores (Nil was assigned a score of 4000) to the log scale to calculate descriptive statistics (reported as seconds of arc).

[2]
Measure Analysis Population Description:

Descriptive statistics were computed for baseline stereoacuity by treatment group for all participants and a subset of participants with no history of strabismus.

The younger (age 5 to <7 years) and older (age 7 to <13 years) were analyzed as separate study cohorts.

Results of the descriptive analyses are reported as seconds of arc.

[3]
No overall median was calculated because the younger (age 5 to <7 years) and older (age 7 to <13 years) were analyzed as separate age cohorts in effectively separate studies.
Amblyopia Cause  
Measure Type: Count of Participants
Unit of measure:  Participants
Strabismus Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
22
  11.6%
44
  22.6%
5
  12.5%
9
  15.0%
80
  16.5%
Anisometropia Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
107
  56.3%
92
  47.2%
22
  55.0%
29
  48.3%
250
  51.5%
Strabismus/anisometropia combined Number Analyzed 190 participants 195 participants 40 participants 60 participants 485 participants
61
  32.1%
59
  30.3%
13
  32.5%
22
  36.7%
155
  32.0%
1.Primary Outcome
Title Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Overall Number of Participants Analyzed 177 186
Mean (95% Confidence Interval)
Unit of Measure: LogMAR lines
Adjusted for baseline VA and age
1.05
(0.85 to 1.24)
1.35
(1.17 to 1.54)
Unadjusted
1.08
(0.86 to 1.29)
1.32
(1.14 to 1.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (1-Sided) 95%
0.53
Estimation Comments A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (1-Sided) 95%
0.53
Estimation Comments A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (1-Sided) 95%
0.54
Estimation Comments A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to <20 weeks after randomization).
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (1-Sided) 95%
0.56
Estimation Comments A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (1-Sided) 95%
0.53
Estimation Comments A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).
Type of Statistical Test Non-Inferiority
Comments Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (1-Sided) 95%
0.55
Estimation Comments A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.04 to 0.58
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.
2.Primary Outcome
Title Mean Amblyopic Eye Visual Acuity (Younger Cohort)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.

Time Frame 16 Weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Overall Number of Participants Analyzed 177 186
Mean (Standard Deviation)
Unit of Measure: LogMAR
0.41  (0.21) 0.35  (0.20)
3.Primary Outcome
Title Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change in amblyopic-eye visual acuity from baseline to 16 weeks from participants who completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)
Arm/Group Title Binocular Treatment Older Patching Treatment Older
Hide Arm/Group Description:

Age 13 to <17

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Age 13 to <17

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Overall Number of Participants Analyzed 39 56
Mean (95% Confidence Interval)
Unit of Measure: letters
Unadjusted
3.5
(1.3 to 5.7)
6.5
(4.4 to 8.5)
Adjusted for baseline visual acuity
3.7
(1.3 to 6.0)
6.3
(4.4 to 8.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments a priori threshold for statistical significance: 2-sided type I error rate of 5%
Method ANCOVA
Comments Adjusted for baseline amblyopic-eye visual acuity.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.7 to 0.3
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.9 to 0.5
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-5.9 to 0.3
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.0 to 1.2
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-5.5 to 0.5
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older, Patching Treatment Older
Comments An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-5.7 to 0.4
Estimation Comments A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.
4.Primary Outcome
Title Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)
Arm/Group Title Binocular Treatment Older Patching Treatment Older
Hide Arm/Group Description:

Age 13 to <17

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Age 13 to <17

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Overall Number of Participants Analyzed 39 56
Mean (Standard Deviation)
Unit of Measure: letters
62.0  (9.7) 62.5  (11.6)
5.Primary Outcome
Title Distribution of Change in Amblyopic-eye Visual Acuity
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186 39 56
Measure Type: Count of Participants
Unit of Measure: Participants
≥ 3 LogMAR lines (≥ 15 letters) better
19
  10.7%
29
  15.6%
2
   5.1%
7
  12.5%
2 LogMAR lines (10-14 letters) better
32
  18.1%
36
  19.4%
4
  10.3%
10
  17.9%
1 LogMAR line (5-9 letters) better
47
  26.6%
46
  24.7%
9
  23.1%
19
  33.9%
0 LogMAR line (within 4 letters)
64
  36.2%
69
  37.1%
22
  56.4%
18
  32.1%
1 LogMAR line (5-9 letters) worse
12
   6.8%
6
   3.2%
1
   2.6%
1
   1.8%
2 LogMAR lines (10-14 letters) worse
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
≥3 LogMAR lines (≥ 15 letters) worse
2
   1.1%
0
   0.0%
1
   2.6%
1
   1.8%
6.Primary Outcome
Title Distribution of Amblyopic-eye Visual Acuity
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).

Time Frame At 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186 39 56
Measure Type: Count of Participants
Unit of Measure: Participants
20/200 (33-37 letters)
2
   1.1%
1
   0.5%
1
   2.6%
1
   1.8%
20/160 (38-42 letters)
2
   1.1%
3
   1.6%
0
   0.0%
1
   1.8%
20/125 (43-47 letters)
10
   5.6%
2
   1.1%
2
   5.1%
4
   7.1%
20/100 (48-52 letters)
12
   6.8%
7
   3.8%
4
  10.3%
7
  12.5%
20/80 (53-57 letters)
18
  10.2%
17
   9.1%
5
  12.8%
8
  14.3%
20/63 (58-62 letters)
25
  14.1%
22
  11.8%
5
  12.8%
4
   7.1%
20/50 (63-67 letters)
30
  16.9%
38
  20.4%
11
  28.2%
9
  16.1%
20/40 (68-72 letters)
32
  18.1%
37
  19.9%
6
  15.4%
7
  12.5%
20/32 (73-77 letters)
33
  18.6%
27
  14.5%
4
  10.3%
11
  19.6%
20/25 (78-82 letters)
8
   4.5%
22
  11.8%
0
   0.0%
3
   5.4%
20/20 (83-87 letters)
3
   1.7%
10
   5.4%
1
   2.6%
1
   1.8%
20/16 (88-92 letters)
2
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).

Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).

Time Frame Baseline and 16-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to <20 weeks after randomization).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186 39 56
Measure Type: Count of Participants
Unit of Measure: Participants
51
  28.8%
65
  34.9%
6
  15.4%
17
  30.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to <7, 7 to <13 years) and baseline visual acuity (treated as a continuous covariate).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5
Confidence Interval (2-Sided) 95%
-4 to 13
Estimation Comments Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -15
Confidence Interval (2-Sided) 95%
-31 to 2
Estimation Comments Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.
8.Secondary Outcome
Title Number of Participants With Resolution of Amblyopia
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.

Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.

Time Frame 16-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to <20 weeks after randomization).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186 39 56
Measure Type: Count of Participants
Unit of Measure: Participants
8
   4.5%
18
   9.7%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to <7, 7 to <13 years) and baseline visual acuity (20/40, 20/50 or worse).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2
Confidence Interval (2-Sided) 95%
-1 to 5
Estimation Comments Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.
9.Secondary Outcome
Title Time Course of Visual Acuity Improvement
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.

Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included participants with at least one follow-up visit (completed within the analysis window). There were 6 participants (4 in the binocular group, 2 in the patching group) who were excluded from the time course analysis because they did not have any follow-up exams.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Overall Number of Participants Analyzed 186 193
Mean (Standard Deviation)
Unit of Measure: logMAR lines
4-week visit Number Analyzed 176 participants 188 participants
0.53  (1.14) 0.76  (1.09)
8-week visit Number Analyzed 172 participants 186 participants
0.76  (1.18) 1.03  (1.23)
12-week visit Number Analyzed 178 participants 187 participants
0.90  (1.37) 1.21  (1.26)
16-week visit Number Analyzed 177 participants 186 participants
1.08  (1.45) 1.32  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p>0.05), no further comparisons would be performed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments For testing the interaction term, the a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments Previously described above in the Statistical Analysis Overview section.
10.Secondary Outcome
Title Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to <7 yrs, 7 to <13 yrs) and prior amblyopia treatment (yes/no).

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization). Formal subgroup analyses are adjusted for baseline covariates of visual acuity and age.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186
Mean (Standard Deviation)
Unit of Measure: LogMAR lines
Female Number Analyzed 89 participants 83 participants
1.2  (1.5) 1.4  (1.2)
Male Number Analyzed 88 participants 103 participants
1.0  (1.4) 1.3  (1.3)
White/Non-Hispanic Number Analyzed 122 participants 139 participants
1.0  (1.5) 1.3  (1.2)
Non-White or Hispanic Number Analyzed 54 participants 44 participants
1.2  (1.5) 1.3  (1.4)
Age at baseline: 5 to <7 years Number Analyzed 39 participants 49 participants
1.9  (1.8) 2.0  (1.4)
Age at baseline: 7 to <13 years Number Analyzed 138 participants 137 participants
0.8  (1.2) 1.1  (1.1)
Baseline amblyopic-eye VA: 20/80 to 20/200 Number Analyzed 64 participants 50 participants
1.1  (1.6) 1.3  (1.3)
Baseline amblyopic-eye VA: 20/63 Number Analyzed 32 participants 45 participants
1.3  (1.6) 1.4  (1.3)
Baseline amblyopic-eye VA: 20/50 Number Analyzed 55 participants 50 participants
1.0  (1.3) 1.3  (1.3)
Baseline amblyopic-eye VA: 20/40 Number Analyzed 26 participants 41 participants
0.8  (1.2) 1.2  (1.2)
Baseline stereoacuity: Nil Number Analyzed 68 participants 55 participants
0.7  (1.3) 1.1  (1.1)
Baseline stereoacuity: Better than Nil Number Analyzed 109 participants 131 participants
1.3  (1.5) 1.4  (1.3)
No presence of a near heterotropia at baseline Number Analyzed 122 participants 117 participants
1.1  (1.3) 1.3  (1.2)
Presence of a near heterotropia at baseline Number Analyzed 55 participants 69 participants
0.9  (1.7) 1.4  (1.3)
No prior amblyopia treatment Number Analyzed 41 participants 39 participants
1.9  (1.5) 2.2  (1.3)
Prior amblyopia treatment Number Analyzed 136 participants 147 participants
0.8  (1.4) 1.1  (1.2)
Baseline: Age 5 to <7 yrs, no prior treatment Number Analyzed 19 participants 19 participants
2.5  (1.5) 2.8  (0.8)
Baseline: Age 5 to <7 yrs, prior treatment Number Analyzed 20 participants 30 participants
1.4  (1.9) 1.4  (1.4)
Baseline: Age 7 to <13 yrs, no prior treatment Number Analyzed 22 participants 20 participants
1.3  (1.2) 1.5  (1.3)
Baseline: Age 7 to <13 yrs, prior treatment Number Analyzed 116 participants 117 participants
0.7  (1.2) 1.0  (1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.
Method ANCOVA
Comments Previously described in the Statistical Analysis Overview.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.
Method ANCOVA
Comments Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the analyses in the older cohort, the level of VA is measured as letter scores (previously defined) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).
Arm/Group Title Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 39 56
Mean (Standard Deviation)
Unit of Measure: Letters
Female 1.0  (6.8) 6.0  (6.7)
Male 5.0  (6.4) 6.8  (8.4)
White/Non-Hispanic 3.6  (7.1) 6.4  (7.6)
Non-White or Hispanic 3.2  (6.1) 6.7  (8.2)
Baseline amblyopic-eye VA: 20/80 to 20/200 5.2  (7.8) 7.1  (8.3)
Baseline amblyopic-eye VA: 20/63 3.2  (2.8) 5.0  (10.6)
Baseline amblyopic-eye VA: 20/50 2.9  (4.2) 6.0  (4.4)
Baseline amblyopic-eye VA: 20/40 -0.4  (10.9) 6.8  (6.4)
No prior amblyopia treatment 2.9  (6.4) 10.3  (8.0)
Prior amblyopia treatment 3.6  (7.0) 6.0  (7.6)
Baseline stereoacuity: Nil 4.1  (7.7) 5.7  (7.6)
Baseline stereoacuity: Better than Nil 3.0  (6.2) 7.2  (7.8)
No presence of a near heterotropia at baseline 2.0  (6.1) 5.6  (8.1)
Presence of a near heterotropia at baseline 5.7  (7.4) 7.9  (6.9)
12.Secondary Outcome
Title Distribution of Stereoacuity Scores
Hide Description

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.

Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
Missing/Not done
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
4000 seconds of arc
62
  34.1%
50
  26.6%
13
  33.3%
25
  43.1%
2000 seconds of arc
32
  17.6%
32
  17.0%
6
  15.4%
11
  19.0%
800 seconds of arc
19
  10.4%
28
  14.9%
6
  15.4%
7
  12.1%
400 seconds of arc
14
   7.7%
17
   9.0%
3
   7.7%
4
   6.9%
200 seconds of arc
15
   8.2%
27
  14.4%
2
   5.1%
2
   3.4%
100 seconds of arc
17
   9.3%
19
  10.1%
6
  15.4%
2
   3.4%
60 seconds of arc
10
   5.5%
11
   5.9%
2
   5.1%
2
   3.4%
40 seconds of arc
12
   6.6%
4
   2.1%
1
   2.6%
5
   8.6%
13.Secondary Outcome
Title Median Stereoacuity Score (Seconds of Arc)
Hide Description

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Participants who completed stereoacuity testing at the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).

Descriptive analyses were repeated for a subset of participants with no history of strabismus.

Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 181 188 39 58
Median (Full Range)
Unit of Measure: Seconds of arc
All participants Number Analyzed 181 participants 188 participants 39 participants 58 participants
2000
(40 to 4000)
800
(40 to 4000)
800
(40 to 4000)
2000
(40 to 4000)
Participants with no history of strabismus Number Analyzed 104 participants 90 participants 27 participants 21 participants
400
(40 to 4000)
400
(40 to 4000)
400
(40 to 4000)
2000
(40 to 4000)
14.Secondary Outcome
Title Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Hide Description

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.

Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to a subset of participants (no history of strabismus) who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 105 90 21 27
Measure Type: Count of Participants
Unit of Measure: Participants
Missing/Not done
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
4000 seconds of arc
23
  21.9%
13
  14.4%
4
  19.0%
10
  37.0%
2000 seconds of arc
14
  13.3%
12
  13.3%
1
   4.8%
4
  14.8%
800 seconds of arc
12
  11.4%
14
  15.6%
4
  19.0%
3
  11.1%
400 seconds of arc
10
   9.5%
10
  11.1%
2
   9.5%
1
   3.7%
200 seconds of arc
12
  11.4%
17
  18.9%
2
   9.5%
1
   3.7%
100 seconds of arc
14
  13.3%
15
  16.7%
5
  23.8%
1
   3.7%
60 seconds of arc
9
   8.6%
6
   6.7%
2
   9.5%
2
   7.4%
40 seconds of arc
10
   9.5%
3
   3.3%
1
   4.8%
5
  18.5%
15.Secondary Outcome
Title Distribution of Change in Stereoacuity Scores From Baseline
Hide Description

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores.

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 181 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
2 or more levels worse
19
  10.5%
24
  12.8%
4
  10.3%
8
  13.8%
Within 1 level
130
  71.8%
122
  64.9%
29
  74.4%
38
  65.5%
2 or more levels better
32
  17.7%
42
  22.3%
6
  15.4%
12
  20.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments The a priori threshold for statistical significance was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments A priori threshold for statistical significance was 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Hide Description

Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.

Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.

For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores.

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included a subset of participants with no history of strabismus who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 104 90 21 27
Measure Type: Count of Participants
Unit of Measure: Participants
2 or more levels worse
12
  11.5%
14
  15.6%
2
   9.5%
4
  14.8%
Within 1 level
67
  64.4%
58
  64.4%
15
  71.4%
16
  59.3%
2 or more levels better
25
  24.0%
18
  20.0%
4
  19.0%
7
  25.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments The a priori threshold for statistical significance was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments A priori threshold for statistical significance was 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)
Hide Description

Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.

The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.

The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).

Post hoc analysis: 4-week fellow-eye contrast.

Time Frame Entire study period, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The descriptive analysis included data from participants in the binocular treatment group who had log file data available.
Arm/Group Title Binocular Treatment Younger Binocular Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Overall Number of Participants Analyzed 176 38
Measure Type: Count of Participants
Unit of Measure: Participants
Completed >75% prescribed game play Number Analyzed 176 participants 38 participants
39
  22.2%
5
  13.2%
Fellow-eye contrast of 100% (16 weeks) Number Analyzed 176 participants 38 participants
86
  48.9%
23
  60.5%
Fellow-eye contrast of 20% or worse (16 weeks) Number Analyzed 176 participants 38 participants
31
  17.6%
3
   7.9%
Fellow-eye contrast of 100% (4 weeks) Number Analyzed 173 participants 36 participants
35
  20.2%
6
  16.7%
18.Secondary Outcome
Title Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)
Hide Description

Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.

The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.

Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.

Time Frame Entire study period, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The descriptive analysis included data from participants in the binocular treatment group who had log file data available.
Arm/Group Title Binocular Treatment Younger Binocular Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Overall Number of Participants Analyzed 176 38
Median (Inter-Quartile Range)
Unit of Measure: % of prescribed treatment completed
46
(20 to 72)
21
(13 to 38)
19.Other Pre-specified Outcome
Title Percentage of Participants Reporting >75% of Prescribed Treatment Completed (Subjective Measures of Adherence)
Hide Description

Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.

Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.

At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.

Time Frame 16 Weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The descriptive analysis included data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 177 186 39 56
Measure Type: Count of Participants
Unit of Measure: Participants
118
  66.7%
172
  92.5%
24
  61.5%
42
  75.0%
20.Other Pre-specified Outcome
Title Participants Who Received Non-protocol, Alternative Treatment During the Study
Hide Description

Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.

The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.

Time Frame Entire study period, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in the study.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 190 195 40 60
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
21.Other Pre-specified Outcome
Title Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline
Hide Description Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children <7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.
Time Frame 16-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
2 lines (10-14 letters) better
6
   3.3%
2
   1.1%
0
   0.0%
2
   3.4%
1 line (5-9 letters) better
36
  19.8%
30
  16.0%
10
  25.6%
9
  15.5%
0 line (within 4 letters)
128
  70.3%
133
  70.7%
29
  74.4%
46
  79.3%
1 line (5-9 letters) worse
11
   6.0%
22
  11.7%
0
   0.0%
1
   1.7%
2 lines (10-14 letters) worse
1
   0.5%
1
   0.5%
0
   0.0%
0
   0.0%
22.Other Pre-specified Outcome
Title Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Younger Cohort)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.

For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.

Time Frame 16-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188
Mean (95% Confidence Interval)
Unit of Measure: logMAR lines
0.30
(0.20 to 0.40)
0.14
(0.04 to 0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.02 to 0.30
Estimation Comments A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.
23.Other Pre-specified Outcome
Title Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Older Cohort)
Hide Description

Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.

For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.

Time Frame 16-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 39 58
Mean (95% Confidence Interval)
Unit of Measure: Letters
2.2
(1.2 to 3.1)
2.0
(1.3 to 2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.1 to 1.3
Estimation Comments A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.
24.Other Pre-specified Outcome
Title Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd
Hide Description

Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).

Participants were classified according to whether they met the any of the following criteria at the 16-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
16
   8.8%
11
   5.9%
3
   7.7%
3
   5.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
25.Other Pre-specified Outcome
Title Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Parent-reported)
Hide Description A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants whose parent completed a 16-week diplopia assessment.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 187 38 57
Measure Type: Count of Participants
Unit of Measure: Participants
No diplopia
176
  96.7%
185
  98.9%
37
  97.4%
56
  98.2%
Diplopia: Less than once a week
5
   2.7%
0
   0.0%
1
   2.6%
1
   1.8%
Diplopia: Once a week
1
   0.5%
2
   1.1%
0
   0.0%
0
   0.0%
Diplopia: Once a day
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diplopia: Up to 10 times a day
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diplopia: >10 times a day
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
All the time
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
26.Other Pre-specified Outcome
Title Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Participant-reported)
Hide Description A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed a 16-week diplopia assessment.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
No diplopia
166
  91.2%
181
  96.3%
37
  94.9%
56
  96.6%
Diplopia: Less than once a week
5
   2.7%
3
   1.6%
0
   0.0%
0
   0.0%
Diplopia: Once a week
5
   2.7%
3
   1.6%
2
   5.1%
1
   1.7%
Diplopia: Once a day
2
   1.1%
1
   0.5%
0
   0.0%
0
   0.0%
Diplopia: Up to 10 times a day
3
   1.6%
0
   0.0%
0
   0.0%
1
   1.7%
Diplopia: >10 times a day
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
All the time
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Younger, Patching Treatment Younger
Comments The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Binocular Treatment Older Cohort, Patching Treatment Older Cohort
Comments The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
27.Other Pre-specified Outcome
Title Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (Parent-reported)
Hide Description A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time Frame Across study follow-up visits, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants whose parent completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week)
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
No diplopia
172
  94.5%
182
  96.8%
38
  97.4%
54
  93.1%
Diplopia: Less than once a week
6
   3.3%
4
   2.1%
0
   0.0%
2
   3.4%
Diplopia: Once a week
2
   1.1%
1
   0.5%
1
   2.6%
1
   1.7%
Diplopia: Once a day
2
   1.1%
0
   0.0%
0
   0.0%
1
   1.7%
Diplopia: Up to 10 times a day
0
   0.0%
1
   0.5%
0
   0.0%
0
   0.0%
Diplopia: >10 times a day
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
All the time
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
28.Other Pre-specified Outcome
Title Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (Participant-reported)
Hide Description A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time Frame Across study follow-up visits, up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week) during the study.
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Cohort Patching Treatment Older Cohort
Hide Arm/Group Description:

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week
Overall Number of Participants Analyzed 182 188 39 58
Measure Type: Count of Participants
Unit of Measure: Participants
No diplopia
153
  84.1%
167
  88.8%
36
  92.3%
50
  86.2%
Diplopia: Less than once a week
6
   3.3%
10
   5.3%
1
   2.6%
1
   1.7%
Diplopia: Once a week
10
   5.5%
4
   2.1%
0
   0.0%
3
   5.2%
Diplopia: Once a day
8
   4.4%
5
   2.7%
2
   5.1%
3
   5.2%
Diplopia: Up to 10 times a day
3
   1.6%
2
   1.1%
0
   0.0%
1
   1.7%
Diplopia: >10 times a day
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
All the time
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Hide Arm/Group Description

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

iPad®: Binocular therapy on iPad®

Patching 2 hours per day, 7 days per week

Patching 2 hours per day, 7 days per week

All-Cause Mortality
Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/195 (0.00%)   0/40 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Binocular Treatment Younger Patching Treatment Younger Binocular Treatment Older Patching Treatment Older
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/195 (0.00%)   0/40 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: rkraker@jaeb.org
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02200211    
Other Study ID Numbers: ATS18
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2014
First Posted: July 25, 2014
Results First Submitted: March 1, 2018
Results First Posted: October 15, 2018
Last Update Posted: February 27, 2019