Trial Outcomes & Findings for Binocular Dig Rush Game Treatment for Amblyopia (NCT NCT02983552)

NCT ID: NCT02983552

Last Updated: 2021-06-11

Results Overview

The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). 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. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 320 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2021-06-11

Participant Flow

138 is the number of subjects from the older cohort study. 182 is the number of subjects from the younger cohort.

Participant milestones

Measure	Binocular Computer Game Treatment- Older Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction- Older Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment- Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction- Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Overall Study STARTED	69	69	92	90
Overall Study 4 Week Visit	69	67	85	84
Overall Study 8 Week Visit	67	68	85	84
Overall Study 16 Week Visit	0	66	0	72
Overall Study COMPLETED	69	67	92	90
Overall Study NOT COMPLETED	0	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Binocular Dig Rush Game Treatment for Amblyopia

Baseline characteristics by cohort

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=69 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=92 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=90 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Total n=320 Participants Total of all reporting groups
Age, Categorical <=18 years	69 Participants n=5 Participants	69 Participants n=7 Participants	92 Participants n=5 Participants	90 Participants n=4 Participants	320 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	9.6 years STANDARD_DEVIATION 1.6 • n=5 Participants	9.6 years STANDARD_DEVIATION 1.5 • n=7 Participants	5.8 years STANDARD_DEVIATION 0.7 • n=5 Participants	5.7 years STANDARD_DEVIATION 0.7 • n=4 Participants	7.4 years STANDARD_DEVIATION 2.2 • n=21 Participants
Age, Customized Age Range · 7 to <10 years	45 Participants n=5 Participants	45 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	90 Participants n=21 Participants
Age, Customized Age Range · 10 to <13 years	24 Participants n=5 Participants	24 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	48 Participants n=21 Participants
Age, Customized Age Range · 4 to <5 years	0 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants	17 Participants n=4 Participants	29 Participants n=21 Participants
Age, Customized Age Range · 5 to <6 years	0 Participants n=5 Participants	0 Participants n=7 Participants	39 Participants n=5 Participants	41 Participants n=4 Participants	80 Participants n=21 Participants
Age, Customized Age Range · 6 to <7 years	0 Participants n=5 Participants	0 Participants n=7 Participants	41 Participants n=5 Participants	32 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	50 Participants n=5 Participants	46 Participants n=4 Participants	161 Participants n=21 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	34 Participants n=7 Participants	42 Participants n=5 Participants	44 Participants n=4 Participants	159 Participants n=21 Participants
Race/Ethnicity, Customized White	50 Participants n=5 Participants	55 Participants n=7 Participants	75 Participants n=5 Participants	74 Participants n=4 Participants	254 Participants n=21 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	37 Participants n=21 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Unknown/not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Prior Amblyopia Treatment None	4 Participants n=5 Participants	2 Participants n=7 Participants	33 Participants n=5 Participants	32 Participants n=4 Participants	71 Participants n=21 Participants
Prior Amblyopia Treatment Patching	34 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	40 Participants n=4 Participants	149 Participants n=21 Participants
Prior Amblyopia Treatment Atropine	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Prior Amblyopia Treatment Patching/Atropine	26 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	77 Participants n=21 Participants
Prior Amblyopia Treatment Patching/Other	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Prior Amblyopia Treatment Patching/Atropine/Other	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Prior Binocular Treatment	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/160	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/125	3 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/100	8 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/80	10 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	45 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/63	19 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants	24 Participants n=4 Participants	81 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/50	11 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	74 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/40	16 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	69 Participants n=21 Participants
Distance Amblyopic-eye VA (Letter Score) 20/200	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Distance Amblyopic-eye VA	0.50 logMAR STANDARD_DEVIATION 0.16 • n=5 Participants	0.52 logMAR STANDARD_DEVIATION 0.16 • n=7 Participants	0.48 logMAR STANDARD_DEVIATION 0.16 • n=5 Participants	0.48 logMAR STANDARD_DEVIATION 0.17 • n=4 Participants	0.49 logMAR STANDARD_DEVIATION 0.16 • n=21 Participants
Distance Fellow-eye VA	-0.058 logMAR STANDARD_DEVIATION 0.079 • n=5 Participants	-0.058 logMAR STANDARD_DEVIATION 0.074 • n=7 Participants	0.002 logMAR STANDARD_DEVIATION 0.083 • n=5 Participants	-0.003 logMAR STANDARD_DEVIATION 0.085 • n=4 Participants	-0.025 logMAR STANDARD_DEVIATION 0.086 • n=21 Participants
Interocular Difference (Lines)	5.57 Lines STANDARD_DEVIATION 1.83 • n=5 Participants	5.75 Lines STANDARD_DEVIATION 1.86 • n=7 Participants	4.80 Lines STANDARD_DEVIATION 4.86 • n=5 Participants	1.71 Lines STANDARD_DEVIATION 1.70 • n=4 Participants	5.19 Lines STANDARD_DEVIATION 1.81 • n=21 Participants
Stereoacuity: Nil	33 Participants n=5 Participants	33 Participants n=7 Participants	29 Participants n=5 Participants	28 Participants n=4 Participants	123 Participants n=21 Participants
Stereoacuity (Seconds of Arc)	2000 Seconds of Arc n=5 Participants	2000 Seconds of Arc n=7 Participants	800 Seconds of Arc n=5 Participants	800 Seconds of Arc n=4 Participants	2000 Seconds of Arc n=21 Participants
Amblyopia Cause Strabismus	15 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	56 Participants n=21 Participants
Amblyopia Cause Anisometropia	27 Participants n=5 Participants	39 Participants n=7 Participants	61 Participants n=5 Participants	54 Participants n=4 Participants	181 Participants n=21 Participants
Amblyopia Cause Combined-mechanism	27 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	21 Participants n=4 Participants	83 Participants n=21 Participants
Distance SPCT: Maximum angle of deviation Orthotropic	47 Participants n=5 Participants	50 Participants n=7 Participants	73 Participants n=5 Participants	76 Participants n=4 Participants	246 Participants n=21 Participants
Distance SPCT: Maximum angle of deviation 1 to 4 prism diopters	18 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	11 Participants n=4 Participants	59 Participants n=21 Participants
Distance SPCT: Maximum angle of deviation 5 to 9 prism diopters	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Distance SPCT: Maximum angle of deviation >=10 prism diopters	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Near SPCT: Maximum angle of deviation Orthotropic	44 Participants n=5 Participants	47 Participants n=7 Participants	72 Participants n=5 Participants	75 Participants n=4 Participants	238 Participants n=21 Participants
Near SPCT: Maximum angle of deviation 1 to 4 prism diopters	25 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	15 Participants n=4 Participants	82 Participants n=21 Participants
Amblyopic-eye Spherical Equivalent (Diopters)	4.35 Diopters STANDARD_DEVIATION 2.42 • n=5 Participants	4.40 Diopters STANDARD_DEVIATION 2.28 • n=7 Participants	4.49 Diopters STANDARD_DEVIATION 1.75 • n=5 Participants	4.45 Diopters STANDARD_DEVIATION 2.76 • n=4 Participants	4.43 Diopters STANDARD_DEVIATION 2.32 • n=21 Participants
Fellow-eye Spherical Equivalent (Diopters)	2.10 Diopters STANDARD_DEVIATION 2.12 • n=5 Participants	2.22 Diopters STANDARD_DEVIATION 1.99 • n=7 Participants	2.41 Diopters STANDARD_DEVIATION 1.67 • n=5 Participants	2.67 Diopters STANDARD_DEVIATION 1.99 • n=4 Participants	2.38 Diopters STANDARD_DEVIATION 1.93 • n=21 Participants
Spherical Equivalent Anisometropia (Diopters)	2.29 Diopters STANDARD_DEVIATION 1.79 • n=5 Participants	2.27 Diopters STANDARD_DEVIATION 1.62 • n=7 Participants	2.12 Diopters STANDARD_DEVIATION 1.52 • n=5 Participants	2.25 Diopters STANDARD_DEVIATION 1.51 • n=4 Participants	2.22 Diopters STANDARD_DEVIATION 1.59 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). 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.

Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort Adjusted	1.3 Letter score Interval 0.1 to 2.6	1.7 Letter score Interval 0.4 to 3.0	—	—
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort Unadjusted	1.3 Letter score Interval 0.1 to 2.6	1.7 Letter score Interval 0.4 to 3.0	—	—

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)	26.6 Letter score Standard Deviation 10.5	28.0 Letter score Standard Deviation 10.7	—	—

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).

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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort Adjusted	2.3 Letters Interval 0.7 to 3.9	2.4 Letters Interval 0.8 to 4.0	—	—
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort Unadjusted	2.3 Letters Interval 0.6 to 4.0	2.4 Letters Interval 0.9 to 4.0	—	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).

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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)	25.9 Letter score Standard Deviation 9.9	27.7 Letter score Standard Deviation 10.4	—	—

PRIMARY outcome

Timeframe: baseline and 4 weeks

The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). 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 younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.

Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort Adjusted	1.0724 logMAR Lines Interval 0.8 to 1.4	0.6053 logMAR Lines Interval 0.3 to 0.9	—	—
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort Unadjusted	1.0706 logMAR Lines Interval 0.8 to 1.4	0.6071 logMAR Lines Interval 0.3 to 0.9	—	—

PRIMARY outcome

Timeframe: 4 weeks

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 younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)	0.38 LogMAR Standard Deviation 0.22	0.42 LogMAR Standard Deviation 0.21	—	—

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).

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 younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort Adjusted	1.2614 logMAR Lines Interval 1.0 to 1.6	0.9855 logMAR Lines Interval 0.7 to 1.3	—	—
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort Unadjusted	1.2588 logMAR Lines Interval 1.0 to 1.6	0.9981 logMAR Lines Interval 0.7 to 1.3	—	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).

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 younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)	0.36 LogMAR Standard Deviation 0.22	0.38 LogMAR Standard Deviation 0.22	—	—

SECONDARY outcome

Timeframe: At 4 weeks

A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
VA Improvement at 4 Weeks Defined as a Binary Outcome	2 Participants	3 Participants	31 Participants	16 Participants

SECONDARY outcome

Timeframe: At 8 weeks

Population: Of 68 participants in the continued spectacle correction older cohort, only 67 visits were completed in the analysis window.

A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
VA Improvement at 8 Weeks Defined as a Binary Outcome	5 Participants	6 Participants	35 Participants	25 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Limited to those with follow-up visits completed within the pre-specified analysis window

Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. 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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Stereoacuity Scores at 4 Weeks 40	2 Participants	1 Participants	2 Participants	3 Participants
Distribution of Stereoacuity Scores at 4 Weeks Missing/Not done	0 Participants	0 Participants	6 Participants	8 Participants
Distribution of Stereoacuity Scores at 4 Weeks Nil	31 Participants	25 Participants	24 Participants	21 Participants
Distribution of Stereoacuity Scores at 4 Weeks 2000	11 Participants	11 Participants	8 Participants	10 Participants
Distribution of Stereoacuity Scores at 4 Weeks 800	9 Participants	5 Participants	13 Participants	7 Participants
Distribution of Stereoacuity Scores at 4 Weeks 400	7 Participants	6 Participants	10 Participants	15 Participants
Distribution of Stereoacuity Scores at 4 Weeks 200	3 Participants	5 Participants	9 Participants	9 Participants
Distribution of Stereoacuity Scores at 4 Weeks 100	4 Participants	12 Participants	10 Participants	6 Participants
Distribution of Stereoacuity Scores at 4 Weeks 60	2 Participants	2 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.

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 4-week stereoacuity scores.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=78 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=73 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Stereoacuity Scores From Baseline 2 or more levels worse	8 Participants	6 Participants	11 Participants	8 Participants
Distribution of Change in Stereoacuity Scores From Baseline Within 1 level	53 Participants	50 Participants	56 Participants	57 Participants
Distribution of Change in Stereoacuity Scores From Baseline 2 or more levels better	8 Participants	11 Participants	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Limited to those with follow-up visits completed within the pre-specified analysis window

Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. 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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Stereoacuity Scores at 8 Weeks Nil	31 Participants	24 Participants	28 Participants	25 Participants
Distribution of Stereoacuity Scores at 8 Weeks 2000	11 Participants	10 Participants	11 Participants	8 Participants
Distribution of Stereoacuity Scores at 8 Weeks 800	5 Participants	8 Participants	10 Participants	15 Participants
Distribution of Stereoacuity Scores at 8 Weeks 400	4 Participants	2 Participants	9 Participants	12 Participants
Distribution of Stereoacuity Scores at 8 Weeks 200	5 Participants	11 Participants	12 Participants	9 Participants
Distribution of Stereoacuity Scores at 8 Weeks 100	6 Participants	9 Participants	10 Participants	7 Participants
Distribution of Stereoacuity Scores at 8 Weeks 60	2 Participants	3 Participants	2 Participants	3 Participants
Distribution of Stereoacuity Scores at 8 Weeks 40	3 Participants	1 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.

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 8-week stereoacuity scores.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=72 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Stereoacuity Scores From Baseline Within 1 level	53 Participants	51 Participants	65 Participants	54 Participants
Distribution of Change in Stereoacuity Scores From Baseline 2 or more levels worse	6 Participants	3 Participants	8 Participants	3 Participants
Distribution of Change in Stereoacuity Scores From Baseline 2 or more levels better	8 Participants	14 Participants	12 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.

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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=27 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=37 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=58 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=51 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) Nil	8 Participants	7 Participants	11 Participants	8 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 400	5 Participants	4 Participants	8 Participants	10 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 60	2 Participants	1 Participants	3 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) Missing/Not Done	0 Participants	0 Participants	4 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 2000	3 Participants	5 Participants	5 Participants	7 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 800	2 Participants	3 Participants	8 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 200	1 Participants	4 Participants	9 Participants	9 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 100	4 Participants	12 Participants	10 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 40	2 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title. Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.

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 4-week stereoacuity scores.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=27 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=37 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=54 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=45 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) 2 or more levels worse	5 Participants	2 Participants	8 Participants	6 Participants
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) Within 1 level	17 Participants	27 Participants	37 Participants	34 Participants
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) 2 or more levels better	5 Participants	8 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.

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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=27 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=38 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=57 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=51 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 800	1 Participants	1 Participants	5 Participants	8 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 200	5 Participants	9 Participants	11 Participants	8 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 100	4 Participants	9 Participants	9 Participants	6 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 40	3 Participants	0 Participants	3 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) Nil	8 Participants	8 Participants	14 Participants	11 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 2000	3 Participants	7 Participants	8 Participants	4 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 400	1 Participants	1 Participants	5 Participants	8 Participants
Distribution of Stereoacuity Scores (Participants With no History of Strabismus) 60	2 Participants	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.

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 4-week stereoacuity scores.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=27 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=38 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=57 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=51 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) Within 1 level	19 Participants	31 Participants	44 Participants	34 Participants
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) 2 or more levels better	5 Participants	7 Participants	8 Participants	13 Participants
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) 2 or more levels worse	3 Participants	0 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: The control group was not prescribed binocular therapy, which is why they were not included here.

Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of >75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Completed >75% prescribed game play	40 Participants	37 Participants	—	—
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Fellow-eye contrast of 100%	30 Participants	32 Participants	—	—
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Fellow-eye contrast of 20% or worse	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: 8 weeks

Population: Data from automated iPad log files were only able to be retrieved successfully for 81 of 85 participants in the younger cohort.

Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=81 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Completed >75% prescribed game play	38 Participants	35 Participants	—	—
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Fellow-eye contrast of 100%	59 Participants	50 Participants	—	—
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast Fellow-eye contrast of 20% or worse	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 4 weeks

Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed >75% of spectacle wear at 4 weeks.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=78 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Treatment Compliance With Spectacle Wear	57 Participants	57 Participants	66 Participants	74 Participants

SECONDARY outcome

Timeframe: 8 weeks

Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed >75% of spectacle wear at 8 weeks.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=89 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=82 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Treatment Compliance With Spectacle Wear	61 Participants	62 Participants	69 Participants	78 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) Adjusted	0.1 Letters Interval -1.1 to 1.1	1.1 Letters Interval 0.1 to 2.2	—	—
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) Unadjusted	0.1 Letters Interval -1.1 to 1.3	1.1 Letters Interval 0.2 to 2.1	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=68 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) Adjusted	0.5 Letters Interval -0.5 to 1.4	1.5 Letters Interval 0.5 to 2.4	—	—
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) Unadjusted	0.5 Letters Interval -0.6 to 1.6	1.5 Letters Interval 0.7 to 2.3	—	—

SECONDARY outcome

Timeframe: 4 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.

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 4-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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Ocular Alignment at 4 Weeks	10 Participants	6 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.

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 8-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.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Ocular Alignment at 8 Weeks	9 Participants	9 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=87 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) Never	62 Participants	64 Participants	78 Participants	79 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) Less than once a week	1 Participants	0 Participants	2 Participants	2 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) Once a week	2 Participants	2 Participants	4 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) Once a day	2 Participants	1 Participants	3 Participants	3 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) Up to 10 times a day	2 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) More than 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) All the time	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=68 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) Never	63 Participants	65 Participants	78 Participants	78 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) Less than once a week	5 Participants	2 Participants	4 Participants	4 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) Once a week	0 Participants	0 Participants	1 Participants	1 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) Once a day	0 Participants	1 Participants	2 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) Up to 10 times a day	0 Participants	0 Participants	1 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) More than 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) All the time	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) Increased frequency (≥ 2 levels)	3 Participants	2 Participants	6 Participants	2 Participants
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) Similar frequency (within 1 level)	64 Participants	64 Participants	79 Participants	80 Participants
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) Reduced frequency (≥ 2 levels)	2 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=68 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) Increased frequency (≥ 2 levels)	0 Participants	1 Participants	2 Participants	1 Participants
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) Similar frequency (within 1 level)	64 Participants	66 Participants	82 Participants	80 Participants
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) Reduced frequency (≥ 2 levels)	4 Participants	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=66 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=83 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) Never	65 Participants	66 Participants	87 Participants	83 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) Less than once a week	3 Participants	0 Participants	1 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) Once a week	1 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) Once a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) Up to 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) More than 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) All the time	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) More than 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) All the time	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) Never	66 Participants	67 Participants	84 Participants	84 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) Less than once a week	1 Participants	1 Participants	2 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) Once a week	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) Once a day	0 Participants	0 Participants	0 Participants	0 Participants
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) Up to 10 times a day	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=66 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=83 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) Increased frequency (≥ 2 levels)	0 Participants	0 Participants	0 Participants	0 Participants
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) Similar frequency (within 1 level)	69 Participants	66 Participants	88 Participants	82 Participants
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) Reduced frequency (≥ 2 levels)	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.

A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) Increased frequency (≥ 2 levels)	0 Participants	0 Participants	0 Participants	0 Participants
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) Similar frequency (within 1 level)	67 Participants	68 Participants	86 Participants	83 Participants
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) Reduced frequency (≥ 2 levels)	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: There were 3 participants in the older cohort control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.

The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=83 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Frequency of Adverse Symptoms (Symptom Survey) Blurred Vision · Never	61 Participants	57 Participants	72 Participants	71 Participants
Frequency of Adverse Symptoms (Symptom Survey) Blurred Vision · Almost Never	3 Participants	8 Participants	10 Participants	6 Participants
Frequency of Adverse Symptoms (Symptom Survey) Blurred Vision · Sometimes	5 Participants	1 Participants	5 Participants	4 Participants
Frequency of Adverse Symptoms (Symptom Survey) Blurred Vision · Often	0 Participants	1 Participants	1 Participants	2 Participants
Frequency of Adverse Symptoms (Symptom Survey) Blurred Vision · Almost Always	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) Eyestrain · Never	50 Participants	46 Participants	53 Participants	58 Participants
Frequency of Adverse Symptoms (Symptom Survey) Eyestrain · Almost Never	7 Participants	13 Participants	15 Participants	19 Participants
Frequency of Adverse Symptoms (Symptom Survey) Eyestrain · Sometimes	9 Participants	7 Participants	17 Participants	6 Participants
Frequency of Adverse Symptoms (Symptom Survey) Eyestrain · Often	2 Participants	1 Participants	3 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) Eyestrain · Almost Always	1 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) Headache · Never	38 Participants	38 Participants	60 Participants	68 Participants
Frequency of Adverse Symptoms (Symptom Survey) Headache · Almost Never	20 Participants	14 Participants	14 Participants	13 Participants
Frequency of Adverse Symptoms (Symptom Survey) Headache · Sometimes	8 Participants	12 Participants	9 Participants	1 Participants
Frequency of Adverse Symptoms (Symptom Survey) Headache · Often	3 Participants	3 Participants	5 Participants	1 Participants
Frequency of Adverse Symptoms (Symptom Survey) Headache · Almost Always	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) Look Over Spectacles · Never	44 Participants	39 Participants	44 Participants	40 Participants
Frequency of Adverse Symptoms (Symptom Survey) Look Over Spectacles · Almost Never	11 Participants	9 Participants	17 Participants	19 Participants
Frequency of Adverse Symptoms (Symptom Survey) Look Over Spectacles · Sometimes	13 Participants	11 Participants	19 Participants	17 Participants
Frequency of Adverse Symptoms (Symptom Survey) Look Over Spectacles · Often	1 Participants	5 Participants	6 Participants	6 Participants
Frequency of Adverse Symptoms (Symptom Survey) Look Over Spectacles · Almost Always	0 Participants	0 Participants	2 Participants	1 Participants
Frequency of Adverse Symptoms (Symptom Survey) Take Off Spectacles · Never	43 Participants	41 Participants	43 Participants	46 Participants
Frequency of Adverse Symptoms (Symptom Survey) Take Off Spectacles · Almost Never	13 Participants	14 Participants	26 Participants	24 Participants
Frequency of Adverse Symptoms (Symptom Survey) Take Off Spectacles · Sometimes	12 Participants	9 Participants	15 Participants	11 Participants
Frequency of Adverse Symptoms (Symptom Survey) Take Off Spectacles · Often	1 Participants	0 Participants	4 Participants	1 Participants
Frequency of Adverse Symptoms (Symptom Survey) Take Off Spectacles · Almost Always	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.

The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Blurred Vision · Never	58 Participants	61 Participants	74 Participants	62 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Blurred Vision · Almost Never	7 Participants	4 Participants	5 Participants	17 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Blurred Vision · Sometimes	2 Participants	2 Participants	7 Participants	5 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Blurred Vision · Often	0 Participants	1 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Blurred Vision · Almost Always	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Eyestrain · Never	48 Participants	47 Participants	58 Participants	58 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Eyestrain · Almost Never	9 Participants	13 Participants	16 Participants	20 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Eyestrain · Sometimes	9 Participants	7 Participants	12 Participants	6 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Eyestrain · Often	1 Participants	1 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Eyestrain · Almost Always	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Headache · Almost Never	13 Participants	17 Participants	13 Participants	17 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Headache · Sometimes	8 Participants	6 Participants	10 Participants	2 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Headache · Often	2 Participants	1 Participants	1 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Headache · Almost Always	0 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Look Over Spectacles · Never	42 Participants	41 Participants	38 Participants	40 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Look Over Spectacles · Almost Never	15 Participants	11 Participants	16 Participants	17 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Look Over Spectacles · Sometimes	9 Participants	10 Participants	26 Participants	23 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Look Over Spectacles · Often	1 Participants	2 Participants	5 Participants	2 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Look Over Spectacles · Almost Always	0 Participants	1 Participants	1 Participants	2 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Take Off Spectacles · Almost Never	16 Participants	17 Participants	28 Participants	30 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Take Off Spectacles · Sometimes	10 Participants	4 Participants	8 Participants	7 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Take Off Spectacles · Often	0 Participants	1 Participants	5 Participants	3 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Take Off Spectacles · Almost Always	1 Participants	0 Participants	0 Participants	0 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Headache · Never	44 Participants	44 Participants	62 Participants	65 Participants
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks Take Off Spectacles · Never	40 Participants	43 Participants	45 Participants	44 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items.

The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=83 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Blurred Vision · Increased frequency (≥ 2 levels)	1 Participants	1 Participants	4 Participants	0 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Blurred Vision · Similar frequency (within 1 level)	62 Participants	59 Participants	73 Participants	72 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Blurred Vision · Reduced frequency (≥ 2 levels)	6 Participants	7 Participants	11 Participants	11 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Eyestrain · Increased frequency (≥ 2 levels)	1 Participants	3 Participants	9 Participants	0 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Eyestrain · Similar frequency (within 1 level)	61 Participants	52 Participants	73 Participants	73 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Eyestrain · Reduced frequency (≥ 2 levels)	7 Participants	12 Participants	6 Participants	10 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Headache · Increased frequency (≥ 2 levels)	2 Participants	2 Participants	7 Participants	0 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Headache · Similar frequency (within 1 level)	60 Participants	58 Participants	76 Participants	72 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Headache · Reduced frequency (≥ 2 levels)	7 Participants	7 Participants	5 Participants	11 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Look Over Spectacles · Increased frequency (≥ 2 levels)	2 Participants	5 Participants	4 Participants	2 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Look Over Spectacles · Similar frequency (within 1 level)	60 Participants	46 Participants	72 Participants	73 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Look Over Spectacles · Reduced frequency (≥ 2 levels)	7 Participants	13 Participants	12 Participants	8 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Take Off Spectacles · Increased frequency (≥ 2 levels)	0 Participants	0 Participants	1 Participants	0 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Take Off Spectacles · Similar frequency (within 1 level)	64 Participants	54 Participants	78 Participants	80 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks Take Off Spectacles · Reduced frequency (≥ 2 levels)	5 Participants	10 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items. One participant in the binocular treatment group did not have a completed Symptom Survey at the 8-week visit.

The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=67 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=68 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Blurred Vision · Increased frequency (≥ 2 levels)	1 Participants	2 Participants	4 Participants	2 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Blurred Vision · Similar frequency (within 1 level)	61 Participants	57 Participants	67 Participants	71 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Blurred Vision · Reduced frequency (≥ 2 levels)	5 Participants	9 Participants	15 Participants	11 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Eyestrain · Increased frequency (≥ 2 levels)	1 Participants	1 Participants	5 Participants	1 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Eyestrain · Similar frequency (within 1 level)	60 Participants	55 Participants	75 Participants	72 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Eyestrain · Reduced frequency (≥ 2 levels)	6 Participants	12 Participants	6 Participants	11 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Headache · Increased frequency (≥ 2 levels)	2 Participants	0 Participants	5 Participants	0 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Headache · Similar frequency (within 1 level)	60 Participants	59 Participants	76 Participants	77 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Headache · Reduced frequency (≥ 2 levels)	5 Participants	9 Participants	5 Participants	7 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Look Over Spectacles · Increased frequency (≥ 2 levels)	3 Participants	0 Participants	6 Participants	3 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Look Over Spectacles · Similar frequency (within 1 level)	54 Participants	50 Participants	70 Participants	76 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Look Over Spectacles · Reduced frequency (≥ 2 levels)	10 Participants	15 Participants	10 Participants	5 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Take Off Spectacles · Increased frequency (≥ 2 levels)	0 Participants	0 Participants	0 Participants	2 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Take Off Spectacles · Similar frequency (within 1 level)	62 Participants	55 Participants	76 Participants	77 Participants
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks Take Off Spectacles · Reduced frequency (≥ 2 levels)	5 Participants	10 Participants	10 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=88 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) Adjusted	0.0536 logMAR Lines Interval -0.1 to 0.2	0.1939 logMAR Lines Interval 0.02 to 0.4	—	—
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) Unadjusted	0.0682 logMAR Lines Interval -0.1 to 0.2	0.1786 logMAR Lines Interval 0.02 to 0.4	—	—

SECONDARY outcome

Timeframe: baseline and 8 weeks

The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=86 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) Adjusted	0.3160 logMAR Lines Interval 0.1 to 0.5	0.2122 logMAR Lines Interval 0.04 to 0.4	—	—
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) Unadjusted	0.3256 logMAR Lines Interval 0.1 to 0.5	0.2024 logMAR Lines Interval -0.1 to 0.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: Analyses were limited to participants who completed the 4-week visit within the pre-defined analysis window (21 to \<49 days after randomization).

The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.

Outcome measures

Measure	Binocular Computer Game Treatment Older Cohort n=69 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Older Cohort n=67 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week	Binocular Computer Game Treatment Younger Cohort n=85 Participants Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) iPad®: Binocular therapy using a Dig Rush application on an iPad®	Continued Spectacle Correction Younger Cohort n=84 Participants Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Spectacle correction: Spectacle correction for all waking hours, 7 days per week
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Overall	1.3 Letters Standard Deviation 5.3	1.7 Letters Standard Deviation 5.5	1.1 Letters Standard Deviation 1.4	0.6 Letters Standard Deviation 1.3
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Sex: Female	1.5 Letters Standard Deviation 4.6	1.8 Letters Standard Deviation 6.0	1.2 Letters Standard Deviation 1.4	0.7 Letters Standard Deviation 1.4
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Sex: Male	1.2 Letters Standard Deviation 5.8	1.6 Letters Standard Deviation 4.9	1.0 Letters Standard Deviation 1.4	0.5 Letters Standard Deviation 1.1
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Age at Randomization: 4 to <5	—	—	0.8 Letters Standard Deviation 1.2	0.8 Letters Standard Deviation 1.2
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Age at Randomization: 5 to <7	—	—	1.1 Letters Standard Deviation 1.5	0.6 Letters Standard Deviation 1.3
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Age at Randomization: 7 to <10	1.6 Letters Standard Deviation 6.0	2.0 Letters Standard Deviation 5.4	—	—
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Age at Randomization: 10 to <13	0.9 Letters Standard Deviation 3.8	1.2 Letters Standard Deviation 5.6	—	—
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Race: Non-white/Hispanic	2.5 Letters Standard Deviation 6.8	3.7 Letters Standard Deviation 7.2	1.1 Letters Standard Deviation 1.3	0.5 Letters Standard Deviation 0.8
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Race: White/Non-Hispanic	0.9 Letters Standard Deviation 4.6	1.2 Letters Standard Deviation 4.8	1.1 Letters Standard Deviation 1.5	0.6 Letters Standard Deviation 1.3
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline VA: 20/080 to 20/200	3.2 Letters Standard Deviation 5.9	1.3 Letters Standard Deviation 6.5	1.0 Letters Standard Deviation 1.3	0.7 Letters Standard Deviation 1.4
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline VA: 20/063	1.5 Letters Standard Deviation 3.7	2.5 Letters Standard Deviation 5.5	0.9 Letters Standard Deviation 1.5	0.5 Letters Standard Deviation 1.2
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline VA: 20/050	1.6 Letters Standard Deviation 4.2	0.9 Letters Standard Deviation 3.3	1.4 Letters Standard Deviation 1.5	0.5 Letters Standard Deviation 1.1
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline VA: 20/040	-1.7 Letters Standard Deviation 5.9	2.2 Letters Standard Deviation 4.5	1.1 Letters Standard Deviation 1.5	0.9 Letters Standard Deviation 1.4
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Prior Amblyopia Treatment: No	0.5 Letters Standard Deviation 3.0	5.0 Letters Standard Deviation 5.7	0.9 Letters Standard Deviation 1.1	0.6 Letters Standard Deviation 1.1
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Prior Amblyopia Treatment: Yes	1.4 Letters Standard Deviation 5.4	1.6 Letters Standard Deviation 5.5	1.2 Letters Standard Deviation 1.6	0.6 Letters Standard Deviation 1.4
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Prior Binocular Treatment: No	1.3 Letters Standard Deviation 5.3	2.2 Letters Standard Deviation 5.2	—	—
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Prior Binocular Treatment: Yes	3.0 Letters Standard Deviation 0	-5.8 Letters Standard Deviation 3.1	—	—
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline stereoacuity at near: Nil	1.6 Letters Standard Deviation 5.5	0.7 Letters Standard Deviation 5.6	0.9 Letters Standard Deviation 1.6	0.3 Letters Standard Deviation 1.2
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Baseline stereoacuity at near: Better than Nil	1.1 Letters Standard Deviation 5.2	2.5 Letters Standard Deviation 5.2	1.2 Letters Standard Deviation 1.4	0.8 Letters Standard Deviation 1.3
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Near Heterotropia at Randomization: No	2.0 Letters Standard Deviation 5.2	2.2 Letters Standard Deviation 5.6	1.1 Letters Standard Deviation 1.5	0.7 Letters Standard Deviation 1.3
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks Near Heterotropia at Randomization: Yes	0.1 Letters Standard Deviation 5.4	0.7 Letters Standard Deviation 5.1	1.1 Letters Standard Deviation 1.2	0.4 Letters Standard Deviation 1.3

Adverse Events

Binocular Computer Game Treatment Older Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continued Spectacle Correction Older Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Binocular Computer Game Treatment Younger Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continued Spectacle Correction Younger Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center

Jaeb Center for Health Research

Phone: 813-975-8690

Email: rkraker@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place