Table 1.
Baseline Characteristics for Randomized Participants by Treatment Group.
| Binocular Treatmenta (n=92) | Continued Spectaclesa (n=90) | |||
|---|---|---|---|---|
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| N | % | N | % | |
|
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| Sex: Female | 50 | 54% | 46 | 51% |
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| Age (Years) | ||||
| 4 to <5 | 12 | 13% | 17 | 19% |
| 5 to <6 | 39 | 42% | 41 | 46% |
| 6 to <7 | 41 | 45% | 32 | 36% |
| Mean (SD) | 5.8 (0.7) | 5.7 (0.7) | ||
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| Race/Ethnicity | ||||
| White | 75 | 82% | 74 | 82% |
| Black/African American | 2 | 2% | 5 | 6% |
| Hispanic | 12 | 13% | 8 | 9% |
| Asian | 1 | 1% | 2 | 2% |
| More than one race | 2 | 2% | 1 | 1% |
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| Prior Amblyopia Treatment b | ||||
| None | 33 | 36% | 32 | 36% |
| Patching | 39 | 42% | 40 | 44% |
| Atropine | 2 | 2% | 2 | 2% |
| Patching & Atropine | 15 | 16% | 15 | 17% |
| Other | 2 | 2% | 0 | 0% |
| Patching & Other | 1 | 1% | 1 | 1% |
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| Prior Binocular Treatment | 0 | 0% | 0 | 0% |
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| Distance Amblyopic-eye VA | ||||
| 20/200 | 1 | 1% | 2 | 2% |
| 20/160 | 2 | 2% | 3 | 3% |
| 20/125 | 7 | 8% | 3 | 3% |
| 20/100 | 3 | 3% | 4 | 4% |
| 20/80 | 9 | 10% | 9 | 10% |
| 20/63 | 24 | 26% | 24 | 27% |
| 20/50 | 27 | 29% | 26 | 29% |
| 20/40 | 19 | 21% | 19 | 21% |
| Mean (SD) LogMAR | 0.48 (0.16) | 0.48 (0.17) | ||
| Snellen equivalent | 20/63 | 20/63 | ||
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| Distance Fellow-eye VA | ||||
| Mean (SD) LogMAR | 0.00 (0.08) | -0.00 (0.09) | ||
| Snellen equivalent | 20/20 | 20/20 | ||
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| Interocular Difference (Lines): Mean (SD) | 4.8 (1.7) | 4.9 (1.7) | ||
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| Stereoacuity: Nil | 27 | 30% | 22 | 27% |
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| Stereoacuity (Seconds of Arc): Median (Range) | 800 (40 to Nil) | 800 (40 to Nil) | ||
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| Amblyopia Cause | ||||
| Strabismus | 15 | 16% | 15 | 17% |
| Anisometropia | 61 | 66% | 54 | 60% |
| Combined mechanism | 16 | 17% | 21 | 23% |
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| Distance SPCT: Maximum angle of deviation (Δ) | ||||
| Orthotropic | 73 | 79% | 76 | 84% |
| 1 to 4 | 15 | 16% | 11 | 12% |
| 5 to 9 | 3 | 3% | 2 | 2% |
| ≥ 10 | 1 | 1% | 1 | 1% |
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| Near SPCT: Maximum angle of deviation (Δ) | ||||
| Orthotropic | 72 | 78% | 75 | 83% |
| 1 to 4 | 20 | 22% | 15 | 17% |
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| Amblyopic-eye Spherical Equivalent (Diopters) | ||||
| Mean (SD) | 4.49 (1.75) | 4.45 (2.76) | ||
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| Fellow-eye Spherical Equivalent (Diopters) | ||||
| Mean (SD) | 2.41 (1.67) | 2.67 (1.99) | ||
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| Spherical Equivalent Anisometropia (Diopters) | ||||
| Mean (SD) | 2.12 (1.52) | 2.25 (1.51) | ||
logMAR = logarithm of minimum angle of resolution; Δ = prism diopters; SD = standard deviation; SPCT = simultaneous prism and cover test; VA = visual acuity.
a
Two participants in the binocular treatment group and one in the control treatment group were found to be ineligible after enrollment because their visual acuity did not meet stability criteria prior to enrollment.
b
Other amblyopia treatment included plano (or reduced plus) lens wear, fogging (Bangerter filter, tape, optical), or vision therapy (home or office).