Table 6.
Amblyopic-Eye Visual Acuity at 26 Weeks by Treatment Group*
| Amblyopic Eye | Levodopa N=86 |
Placebo N=45 |
||
|---|---|---|---|---|
| N | % | N | % | |
| Visual Acuity | ||||
| 20/32 (73–77 letters) | 2 | 2% | 1 | 2% |
| 20/40 (68–72 letters) | 15 | 17% | 5 | 11% |
| 20/50 (63–67 letters) | 14 | 16% | 8 | 18% |
| 20/63 (58–62 letters) | 16 | 19% | 9 | 20% |
| 20/80 (53–57 letters) | 19 | 22% | 6 | 13% |
| 20/100 (48–52 letters) | 11 | 13% | 8 | 18% |
| 20/125 (43–47 letters) | 4 | 5% | 1 | 2% |
| 20/160 or worse (≤42 letters) | 5 | 6% | 7 | 16% |
| Mean (SD) letter score | 58.5 (9.3) ~20/63−1 |
55.2 (11.5) ~20/80 |
||
|
| ||||
| Change from Baseline | ||||
| 5–9 letters worse | 3 | 3% | 1 | 2% |
| within 4 letters (±4) | 36 | 42% | 23 | 51% |
| 5–9 letters better | 30 | 35% | 16 | 36% |
| 10–14 letters better | 14 | 16% | 5 | 11% |
| ≥15 letters better | 3 | 3% | 0 | 0 |
| Mean (SD) letter change | 5.0 (5.7) | 4.2 (4.7) | ||
|
| ||||
| Difference between treatment groups† | +0.9 letter | |||
|
| ||||
| 1-sided P-value | 0.17 | |||
|
| ||||
| Proportion 10 or more letters improved | 17 (20%) | 5 (11%) | ||
|
| ||||
| Treatment group difference (Levodopa – Placebo) | +9% | |||
SD = standard deviation; CI = confidence interval
*
All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 (56%) participants in the levodopa group and 24 (53%) participants in the placebo group continued study medication at the 18-week visit.
†
Positive values favor the levodopa group and negative values favor the placebo group. The treatment comparison was performed using analysis of covariance adjusting for amblyopic-eye visual acuity at randomization, with multiple imputation for missing 26-week visual acuity scores.