Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.

Reporting Groups

	Description
Patching-Moderate Amblyopia	Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
Patching-Severe Amblyopia	Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
Atropine-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).

Participant Flow:   Overall Study

	Patching-Moderate Amblyopia	Atropine-Moderate Amblyopia	Patching-Severe Amblyopia	Atropine-Severe Amblyopia
STARTED	98 [1]	95 [1]	18 [2]	22 [2]
5 Week Visit	91	89	17	19
COMPLETED	84 [3]	88 [3]	13 [3]	20 [3]
NOT COMPLETED	14	7	5	2

Reporting Groups

	Description
Patching-Moderate Amblyopia	Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
Patching-Severe Amblyopia	Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
Atropine-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).

Baseline Measures

	Patching-Moderate Amblyopia	Atropine-Moderate Amblyopia	Patching-Severe Amblyopia	Atropine-Severe Amblyopia	Total
Number of Participants   [units: participants]	98	95	18	22	233
Age [1] [units: years] Mean ± Standard Deviation	8.9  ± 1.5	9.1  ± 1.6	9.5  ± 1.5	9.2  ± 1.8	9.0  ± 1.6
Age, Customized [1] [units: participants]
7 to <8 years	35	28	6	9	78
8 to <9 years	24	26	0	4	54
9 to <10 years	17	16	5	3	41
10 to <11 years	8	10	4	2	24
11 to <12 years	8	7	2	1	18
12 to <13 years	6	8	1	3	18
Gender   [units: participants]
Female	48	54	4	12	118
Male	50	41	14	10	115
Race/Ethnicity, Customized   [units: participants]
White	68	56	16	18	158
African-American	8	11	2	1	22
Hispanic or Latino	20	23	0	3	46
Asian	0	1	0	0	1
More than one race	1	2	0	0	3
Not reported	1	2	0	0	3
Cause of Amblyopia   [units: participants]
Strabismus	28	33	4	4	69
Anisometropia	46	31	6	9	92
Strabismus and anisometropia	24	31	8	9	72
Distance Visual Acuity in Amblyopic Eye [2] [units: participants]
20/400 (18 to 22 letters) (worse)	0	0	0	1	1
20/320 (23 to 27 letters)	0	0	0	1	1
20/250 (28 to 32 letters)	0	0	2	4	6
20/200 (33 to 37 letters)	0	0	8	3	11
20/160 (38 to 42 letters)	0	0	5	4	9
20/125 (43 to 47 letters)	0	0	3	9	12
20/100 (48 to 52 letters)	6	13	0	0	19
20/80 (53 to 57 letters)	15	13	0	0	28
20/63 (58 to 62 letters)	24	22	0	0	46
20/50 (63 to 67 letters)	33	28	0	0	61
20/40 (68 to 72 letters) (best)	20	19	0	0	39
Distance Visual Acuity in Fellow Eye [2] [units: participants]
20/32 (73 to 77 letters) (worse)	0	0	0	0	0
20/25 (78 to 82 letters)	17	20	1	6	44
20/20 (83 to 87 letters)	43	47	8	5	103
20/16 (88 to 92 letters)	36	26	9	11	82
20/12 (93 to 97 letters) (best)	2	2	0	0	4
Prior Treatment for Amblyopia at Enrollment   [units: participants]
None	71	68	13	18	170
Patching	16	16	2	3	37
Atropine	2	0	1	0	3
Patching and atropine	9	11	2	1	23
Refractive Error in Amblyopic Eye (spherical equivalent) [3] [units: participants]
< 0 Diopters (D)	2	2	0	0	4
0 to < +1.00D	8	10	1	1	20
+1.00 to < +2.00D	13	6	2	2	23
+2.00 to < +3.00D	10	8	1	3	22
+3.00 to < +4.00D	23	16	2	4	45
>= +4.00D	42	53	12	12	119
Refractive Error in Fellow Eye (spherical equivalent) [3] [units: participants]
< 0 Diopters (D)	1	2	0	0	3
0 to < +1.00D	32	29	4	9	74
+1.00 to < +2.00D	33	17	8	5	63
+2.00 to < +3.00D	13	9	1	2	25
+3.00 to < +4.00D	7	6	2	2	17
>= +4.00D	12	32	3	4	51
Distance Visual Acuity in Amblyopic Eye [2] [units: ETDRS letter score] Mean ± Standard Deviation	62.4  ± 5.7	61.7  ± 6.6	37.5  ± 5.0	37.5  ± 7.5	57.9  ± 11.1
Distance Visual Acuity in Fellow Eye [2] [units: ETDRS letter score] Mean ± Standard Deviation	86.0  ± 3.6	85.7  ± 3.4	87.0  ± 3.5	85.5  ± 4.0	85.9  ± 3.6
Intereye Acuity Difference [4] [units: ETDRS letter score] Mean ± Standard Deviation	23.5  ± 6.8	24.0  ± 7.0	49.5  ± 5.5	47.5  ± 9.5	28.0  ± 11.7
Refractive Error in Amblyopic Eye (spherical equivalent [3] [units: diopter] Mean ± Standard Deviation	3.57  ± 2.07	4.10  ± 2.19	4.97  ± 2.50	4.18  ± 1.99	3.95  ± 2.16
Refractive Error in Fellow Eye (spherical equivalent) [3] [units: diopter] Mean ± Standard Deviation	1.84  ± 1.74	2.56  ± 2.22	2.12  ± 1.76	1.98  ± 2.11	2.17  ± 2.00

1.  Primary:

Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks   [ Time Frame: 17 weeks ]

2.  Primary:

Mean Visual Acuity in the Amblyopic Eye at 17 Weeks   [ Time Frame: 17 weeks ]

3.  Primary:

Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]

4.  Primary:

Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]

5.  Secondary:

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia   [ Time Frame: 17 or 19 weeks ]

6.  Secondary:

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only   [ Time Frame: 17 or 19 weeks ]

7.  Secondary:

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism   [ Time Frame: 17 or 19 weeks ]

8.  Secondary:

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia   [ Time Frame: 17 or 19 weeks ]

9.  Secondary:

Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

10.  Secondary:

Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

11.  Secondary:

Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)   [ Time Frame: 17 weeks ]

12.  Secondary:

Distribution of Visual Acuity in the Fellow Eye at 17 Weeks   [ Time Frame: 17 weeks ]

13.  Secondary:

Mean Visual Acuity in the Fellow Eye at 17 Weeks   [ Time Frame: 17 weeks ]

14.  Secondary:

Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]

15.  Secondary:

Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks   [ Time Frame: Baseline to 17 weeks ]