Trial Outcomes & Findings for Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children (NCT NCT00525174)

Last Updated: 2016-07-13

Results Overview

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

186 participants

Primary outcome timeframe

24 weeks

Results posted on

2016-07-13

Participant Flow

Eligibility criteria included age 3 to \<10 years, visual acuity in the amblyopic eye 20/40 to 20/80, fellow eye visual acuity of 20/40 or better, interocular acuity difference of 3 or more lines, and the presence or history of strabismus and/or anisometropia.

At enrollment, subjects were required to have been wearing spectacles with optimal correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic visual acuity at 2 consecutive visits at least 4 weeks apart).

Participant milestones

Participant milestones
Measure	Patching 2 hours daily patching of the sound eye plus one hour near activities while patching	Bangerter Filters Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
Overall Study STARTED	97	89
Overall Study COMPLETED	88	81
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patching n=97 Participants 2 hours daily patching of the sound eye plus one hour near activities while patching	Bangerter Filters n=89 Participants Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities	Total n=186 Participants Total of all reporting groups
Age, Continuous	6.3 years STANDARD_DEVIATION 1.62 • n=5 Participants	6.3 years STANDARD_DEVIATION 1.67 • n=7 Participants	6.3 years STANDARD_DEVIATION 1.64 • n=5 Participants
Age, Customized 3 to <7 years	62 participants n=5 Participants	57 participants n=7 Participants	119 participants n=5 Participants
Age, Customized 7 to <10 years	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	36 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	53 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized White	67 participants n=5 Participants	69 participants n=7 Participants	136 participants n=5 Participants
Race/Ethnicity, Customized African-American	13 participants n=5 Participants	1 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized More than 1 race	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Unknown / not reported	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants	89 participants n=7 Participants	186 participants n=5 Participants
Prior treatment for amblyopia at enrollment None	83 participants n=5 Participants	72 participants n=7 Participants	155 participants n=5 Participants
Prior treatment for amblyopia at enrollment Patching	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Prior treatment for amblyopia at enrollment Atropine	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Prior treatment for amblyopia at enrollment Patching and atropine	4 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants
Cause of amblyopia Strabismus	27 participants n=5 Participants	23 participants n=7 Participants	50 participants n=5 Participants
Cause of amblyopia Anisometropia	42 participants n=5 Participants	39 participants n=7 Participants	81 participants n=5 Participants
Cause of amblyopia Strabismus and anisometropia	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
Distance visual acuity in amblyopic eye 20/80 (0.62 - 0.56 logMAR) (worse)	23 participants n=5 Participants	16 participants n=7 Participants	39 participants n=5 Participants
Distance visual acuity in amblyopic eye 20/63 (0.54 - 0.46 logMAR)	31 participants n=5 Participants	27 participants n=7 Participants	58 participants n=5 Participants
Distance visual acuity in amblyopic eye 20/50 (0.44 - 0.36 logMAR)	22 participants n=5 Participants	24 participants n=7 Participants	46 participants n=5 Participants
Distance visual acuity in amblyopic eye 20/40 (0.34 - 0.28 logMAR) (best)	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Mean (SD) Distance Visual Acuity in Amblyopic Eye	0.46 logMAR STANDARD_DEVIATION 0.10 • n=5 Participants	0.44 logMAR STANDARD_DEVIATION 0.10 • n=7 Participants	0.45 logMAR STANDARD_DEVIATION 0.10 • n=5 Participants
Distance visual acuity in fellow eye 20/40 (0.32 to 0.26 logMAR) (worse)	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Distance visual acuity in fellow eye 20/32 (0.24 to 0.16 logMAR)	16 participants n=5 Participants	9 participants n=7 Participants	25 participants n=5 Participants
Distance visual acuity in fellow eye 20/25 (0.14 to 0.06 logMAR)	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants
Distance visual acuity in fellow eye 20/20 (0.04 to -0.04 logMAR)	42 participants n=5 Participants	40 participants n=7 Participants	82 participants n=5 Participants
Distance visual acuity in fellow eye 20/16 (-0.06 to -0.14 logMAR) (best)	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Mean (SD) Distance Visual Acuity in Fellow Eye	0.04 logMAR STANDARD_DEVIATION 0.10 • n=5 Participants	0.03 logMAR STANDARD_DEVIATION 0.10 • n=7 Participants	0.04 logMAR STANDARD_DEVIATION 0.10 • n=5 Participants
Intereye acuity difference	4.2 logMAR line STANDARD_DEVIATION 1.1 • n=5 Participants	4.1 logMAR line STANDARD_DEVIATION 1.1 • n=7 Participants	4.1 logMAR line STANDARD_DEVIATION 1.1 • n=5 Participants
Spherical equivalent in amblyopic eye <0.00	3 diopter n=5 Participants	8 diopter n=7 Participants	11 diopter n=5 Participants
Spherical equivalent in amblyopic eye 0 to < +1.00	2 diopter n=5 Participants	2 diopter n=7 Participants	4 diopter n=5 Participants
Spherical equivalent in amblyopic eye +1.00 to < +2.00	8 diopter n=5 Participants	1 diopter n=7 Participants	9 diopter n=5 Participants
Spherical equivalent in amblyopic eye +2.00 to < +3.00	6 diopter n=5 Participants	10 diopter n=7 Participants	16 diopter n=5 Participants
Spherical equivalent in amblyopic eye +3.00 to < +4.00	10 diopter n=5 Participants	13 diopter n=7 Participants	23 diopter n=5 Participants
Spherical equivalent in amblyopic eye >= +4.00	68 diopter n=5 Participants	55 diopter n=7 Participants	123 diopter n=5 Participants
Mean (SD) spherical equivalent in amblyopic eye	4.41 diopter STANDARD_DEVIATION 2.21 • n=5 Participants	4.15 diopter STANDARD_DEVIATION 2.57 • n=7 Participants	4.29 diopter STANDARD_DEVIATION 2.38 • n=5 Participants
Spherical equivalent in fellow eye <0.00	1 diopter n=5 Participants	5 diopter n=7 Participants	6 diopter n=5 Participants
Spherical equivalent in fellow eye 0 to < +1.00	18 diopter n=5 Participants	16 diopter n=7 Participants	34 diopter n=5 Participants
Spherical equivalent in fellow eye +1.00 to < +2.00	25 diopter n=5 Participants	21 diopter n=7 Participants	46 diopter n=5 Participants
Spherical equivalent in fellow eye +2.00 to < +3.00	13 diopter n=5 Participants	12 diopter n=7 Participants	25 diopter n=5 Participants
Spherical equivalent in fellow eye +3.00 to < +4.00	8 diopter n=5 Participants	13 diopter n=7 Participants	21 diopter n=5 Participants
Spherical equivalent in fellow eye >= +4.00	32 diopter n=5 Participants	22 diopter n=7 Participants	54 diopter n=5 Participants
Mean (SD) spherical equivalent in fellow eye	2.81 diopter STANDARD_DEVIATION 2.14 • n=5 Participants	2.49 diopter STANDARD_DEVIATION 2.13 • n=7 Participants	2.66 diopter STANDARD_DEVIATION 2.14 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/32 (0.24 to 0.16 logMAR)	14 participants	20 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/25 (0.14 to 0.06 logMAR)	20 participants	17 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/20 (0.04 to -0.04 logMAR)	9 participants	7 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/16 (-0.06 to -0.14 logMAR) (best)	0 participants	4 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/125 (0.84 to 0.76 logMAR) (worse)	1 participants	0 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/100 (0.74 to 0.66 logMAR)	3 participants	0 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/80 (0.64 to 0.56 logMAR)	3 participants	1 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/63 (0.54 to 0.46 logMAR)	7 participants	8 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/50 (0.44 to 0.36 logMAR)	5 participants	12 participants
Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks 20/40 (0.34 to 0.26 logMAR)	19 participants	19 participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks	0.25 logMAR Standard Deviation 0.19	0.23 logMAR Standard Deviation 0.16

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks >= 3 lines worse	1 participants	0 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks 2 lines worse	2 participants	0 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks 1 line worse	5 participants	1 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks 0 lines	8 participants	4 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks 1 line better	12 participants	19 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks 2 lines better	20 participants	27 participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks >=3 lines better	33 participants	37 participants

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks	1.9 logMAR line Standard Deviation 1.6	2.3 logMAR line Standard Deviation 1.3

SECONDARY outcome

Timeframe: 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Mean Interocular Difference at 24 Weeks	2.3 logMAR line Standard Deviation 2.0	2.3 logMAR line Standard Deviation 1.5

SECONDARY outcome

Timeframe: 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=87 Participants
Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks	15 participants	10 participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=87 Participants
Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks	29 participants	27 participants

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=87 Participants
Distribution of Subjects With 3 or More Lines of Improvement	31 participants	31 participants

SECONDARY outcome

Timeframe: 24 weeks

The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to \<5 years old at the time of enrollment).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Female	34 participants	43 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Male	47 participants	45 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Cause of amblyopia: Strabismus	21 participants	23 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Cause of amblyopia: Anisometropia	36 participants	39 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Cause of amblyopia: Strabismus and anisometropia	24 participants	26 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Distance VA in amblyopic eye: 20/80 (worse)	15 participants	22 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Distance VA in amblyopic eye: 20/63	25 participants	29 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Distance VA in amblyopic eye: 20/50	20 participants	17 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. White, non-Hispanic	63 participants	61 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Non-white or Hispanic	17 participants	26 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Age at enrollment: 3 to <5 yrs	21 participants	23 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Age at enrollment: 5 to <7 yrs	31 participants	34 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Age at enrollment: 7 to <10 yrs	29 participants	31 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Prior treatment for amblyopia: No	65 participants	75 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Prior treatment for amblyopia: Yes	16 participants	13 participants
Distribution of Patient Characteristics at the 24-week Outcome Exam. Distance VA in amblyopic eye: 20/40 (best)	21 participants	20 participants

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Age at enrollment: 3 to <5 yrs	2.1 logMAR line Standard Deviation 1.9	2.7 logMAR line Standard Deviation 1.4
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Age at enrollment: 5 to <7 yrs	2.1 logMAR line Standard Deviation 1.7	2.5 logMAR line Standard Deviation 1.2
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Prior treatment for amblyopia: No	1.9 logMAR line Standard Deviation 1.7	2.4 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Prior treatment for amblyopia: Yes	2.0 logMAR line Standard Deviation 1.4	1.7 logMAR line Standard Deviation 1.0
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Cause of amblyopia: Strabismus	2.2 logMAR line Standard Deviation 1.5	2.4 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Cause of amblyopia: Anisometropia	1.5 logMAR line Standard Deviation 1.7	2.4 logMAR line Standard Deviation 1.4
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Cause of amblyopia: Strabismus and anisometropia	2.2 logMAR line Standard Deviation 1.5	2.1 logMAR line Standard Deviation 1.2
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Distance VA in amblyopic eye: 20/80 (worse)	2.3 logMAR line Standard Deviation 2.0	2.3 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Distance VA in amblyopic eye: 20/63	1.8 logMAR line Standard Deviation 1.7	2.5 logMAR line Standard Deviation 1.5
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Distance VA in amblyopic eye: 20/50	1.7 logMAR line Standard Deviation 1.7	2.3 logMAR line Standard Deviation 1.4
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Female	2.1 logMAR line Standard Deviation 1.7	2.4 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Male	1.7 logMAR line Standard Deviation 1.6	2.2 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics White, non-Hispanic	1.8 logMAR line Standard Deviation 1.7	2.3 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Non-white or Hispanic	2.1 logMAR line Standard Deviation 1.4	2.4 logMAR line Standard Deviation 1.3
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Age at enrollment: 7 to <10 yrs	1.5 logMAR line Standard Deviation 1.3	1.8 logMAR line Standard Deviation 1.2
Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics Distance VA in amblyopic eye: 20/40 (best)	1.9 logMAR line Standard Deviation 1.0	2.0 logMAR line Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline to 24 weeks

The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).

Outcome measures

Outcome measures
Measure	Bangerter n=76 Participants	Patching n=80 Participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects >=2 levels improved	12 participants	15 participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects Within 1 level	61 participants	58 participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects >=2 levels worsened	3 participants	7 participants

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=33 Participants	Patching n=34 Participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus >=2 levels improved	7 participants	9 participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus Within 1 level	25 participants	21 participants
Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus >=2 levels worsened	1 participants	4 participants

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 0 lines	39 participants	40 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 1 line better	20 participants	23 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 3 lines or worse	0 participants	0 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 2 lines worse	1 participants	5 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 1 line worse	17 participants	8 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 2 lines better	4 participants	11 participants
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks 3 lines or better	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

Outcome measures

Outcome measures
Measure	Bangerter n=81 Participants	Patching n=88 Participants
Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks	0.09 logMAR line Standard Deviation 0.84	0.36 logMAR line Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 weeks

The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.

Outcome measures

Outcome measures
Measure	Bangerter n=79 Participants	Patching n=81 Participants
Impact of Treatment on Patient and Family at 6 Weeks	2.1 Units on a scale Standard Deviation 1.1	2.3 Units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=75 Participants	Patching n=75 Participants
Impact of Treatment on Patient and Family at 24 Weeks	1.9 Units on a scale Standard Deviation 1.0	2.3 Units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 weeks

The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.

Outcome measures

Outcome measures
Measure	Bangerter n=79 Participants	Patching n=81 Participants
Adverse Effects of Treatment on Patient and Family at 6 Weeks	2.2 Units on a scale Standard Deviation 0.7	2.2 Units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=75 Participants	Patching n=75 Participants
Adverse Effects of Treatment on Patient and Family at 24 Weeks	1.9 Units on a scale Standard Deviation 0.7	2.2 Units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 6 weeks

The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.

Outcome measures

Outcome measures
Measure	Bangerter n=79 Participants	Patching n=81 Participants
Compliance With Treatment at 6 Weeks	2.3 Units on a scale Standard Deviation 1.0	2.5 Units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=75 Participants	Patching n=75 Participants
Compliance With Treatment at 24 Weeks	2.1 Units on a scale Standard Deviation 0.9	2.6 Units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 weeks

The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.

Outcome measures

Outcome measures
Measure	Bangerter n=79 Participants	Patching n=81 Participants
Social Stigma From Treatment at 6 Weeks	1.7 Units on a scale Standard Deviation 0.6	2.4 Units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Bangerter n=75 Participants	Patching n=75 Participants
Social Stigma From Treatment at 24 Weeks	1.6 Units on a scale Standard Deviation 0.7	2.4 Units on a scale Standard Deviation 0.8

Adverse Events

Patching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bangerter Filters

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, MSPH

Jaeb Center for Health Research

Phone: 813-875-8690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place