Table 2.
Baseline Characteristics of Treatment and Control Groups in Primary Cohort
| Patching (N=87) | Control (N=93) | |
|---|---|---|
| Gender: Female n (%) | 37 (43) | 52 (56) |
| Race / Ethnicity n (%) | ||
| White | 70 (80) | 75 (81) |
| African-American | 5 (6) | 6 (6) |
| Hispanic or Latino | 10 (11) | 6 (6) |
| Asian | 0 | 2 (2) |
| More than one race | 1 (1) | 4 (4) |
| Unknown/not reported | 1 (1) | 0 |
| Age at Randomization n (%) | ||
| 3 to <4 years | 11 (13) | 12 (13) |
| 4 to <5 years | 18 (21) | 23 (25) |
| 5 to <6 years | 37 (43) | 33 (35) |
| 6 to <7 years | 16 (18) | 17 (18) |
| 7 to <8 years | 5 (6) | 8 (9) |
| Mean (SD*) years | 5.4 (1.0) | 5.3 (1.1) |
| Prior treatment for amblyopia at enrollment n (%) | ||
| None | 78 (90) | 82 (88) |
| Patching | 6 (7) | 9 (10) |
| Atropine | 0 | 1 (1) |
| Patching and Atropine | 3 (3) | 1 (1) |
| Cause of Amblyopia n (%) | ||
| Strabismus | 21 (24) | 21 (23) |
| Anisometropia | 39 (45) | 45 (48) |
| Strabismus and anisometropia | 27 (31) | 27 (29) |
| Distance Visual Acuity in Amblyopic Eye n (%) | ||
| 20/400 | 1 (1) | 1 (1) |
| 20/320 | 0 | 2 (2) |
| 20/250 | 1 (1) | 4 (4) |
| 20/200 | 1 (1) | 3 (3) |
| 20/160 | 3 (3) | 2 (2) |
| 20/125 | 9 (10) | 6 (6) |
| 20/100 | 8 (9) | 6 (6) |
| 20/80 | 17 (20) | 7 (8) |
| 20/63 | 25 (29) | 25 (27) |
| 20/50 | 7 (8) | 17 (18) |
| 20/40 | 15 (17) | 19 (20) |
| 20/32 | 0 | 1 (1) |
| Mean (SD) logMAR† | 0.56 (0.20) | 0.55 (0.25) |
| Approximate Snellen Equivalent | 20/80+2 | 20/80+2 |
| Distance Visual Acuity in Sound Eye n (%) | ||
| 20/40 | 4 (5) | 3 (3) |
| 20/32 | 11 (13) | 6 (6) |
| 20/25 | 14 (16) | 24 (26) |
| 20/20 | 41 (47) | 34 (37) |
| 20/16 | 17 (20) | 26 (28) |
| Mean (SD) logMAR | 0.04 (0.11) | 0.02 (0.10) |
| Approximate Snellen Equivalent | 20/20-2 | 20/20-1 |
| Interocular Acuity Difference At Randomization | ||
| Mean (SD) lines | 5.3 (1.9) | 5.3 (2.3) |
| Refractive Error in Amblyopic Eye at Enrollment n (%) | ||
| <0 | 0 | 2 (2) |
| 0 to <+1.00D‡ | 3 (3) | 3 (3) |
| +1.00 to <+2.00D | 5 (6) | 3 (3) |
| +2.00 to <+3.00D | 6 (7) | 6 (6) |
| +3.00 to <+4.00D | 7 (8) | 9 (10) |
| >+4.00D | 66 (76) | 70 (75) |
| Mean (SD) spherical equivalent | 5.12 (2.16) | 4.74 (2.11) |
| Refractive Error in Sound Eye at Enrollment n (%) | ||
| <0 | 0 | 1 (1) |
| 0 to <+1.00D | 12 (14) | 13 (14) |
| +1.00 to <+2.00D | 23 (26) | 24 (26) |
| +2.00 to <+3.00D | 21 (24) | 23 (25) |
| +3.00 to <+4.00D | 6 (7) | 10 (11) |
| >+4.00D | 25 (29) | 22 (24) |
| Mean (SD) spherical equivalent | 2.89 (2.13) | 2.57 (1.74) |
| In Spectacle Phase Prior to Trial n (%) | 72 (83) | 83 (89) |
*
SD = Standard Deviation
†
logMAR = logarithm of the minimum angle of resolution
‡
D = diopter