Table 2.
Neurovisual and developmental profile of the samples at T 0 and T 1
| Primary outcomes | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Treatment group (n=30) | T 1 vs T 0 | Comparison group (n=30) | T 1 vs T 0 | Treatment vs comparison group at T 0 | Interaction time×group | ||||
| T 0 | T 1 |
Δ time (95% CI) p |
T 0 | T 1 |
Δ time (95% CI) p |
Δ treatment (95% CI) p |
ΔΔ (95% CI) p |
||
| Visual acuity (cycles per degree) | 2.36 (1.57–3.16) | 4.16 (3.18–5.15) |
1.80 (0.94–2.66) <0.01 |
2.63 (1.84–3.42) | 3.84 (3.10–4.59) |
1.21 (0.64–1.79) <0.01 |
−0.26 (−1.38 to 0.86) 0.645 |
0.58 (−0.45 to 1.62) 0.267 |
|
| Contrast sensitivity a (%) | 15.15 (8.29–27.68) | 4.05 (2.28–7.20) |
0.27 (0.16–0.46) <0.01 |
11.75 (6.59–20.94) | 4.40 (2.44–7.97) |
0.38 (0.23 to 0.61) <0.01 |
0.37 (−0.82 to 1.56) 0.546 |
−0.49 (−1.52 to 0.54) 0.353 |
|
| Visual fixation b | 2.00 (1.96–2.04) | 1.14 (0.88–1.40) |
−0.86 (−1.10 to −0.62) <0.01 |
1.98 (1.92–2.04) | 1.66 (1.20–2.12) |
−0.32 (−0.75 to 0.10) 0.138 |
0.02 (−0.05 to 0.08) 0.583 |
−0.53 (−1.02 to −0.04) 0.033 |
|
| Smooth pursuit c | 2.24 (1.89–2.59) | 1.53 (1.08–1.99) |
−0.71 (−1.10 to −0.32) <0.01 |
2.04 (1.93–2.14) | 1.90 (1.72–2.08) |
−0.14 (−0.30 to 0.03) 0.098 |
0.21 (−0.15 to 0.56) 0.258 |
−0.57 (−0.96 to −0.18) <0.01 |
|
| Saccades d | 3.87 (3.47–4.27) | 2.77 (2.24–3.29) |
−1.10 (−1.76 to −0.44) <0.01 |
3.77 (3.35–4.19) | 3.50 (3.05–3.95) |
−0.27 (−0.88 to 0.35) 0.396 |
0.10 (−0.48 to 0.68) 0.735 |
−0.83 (−1.74 to 0.07) 0.071 |
|
| Secondary outcomes | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| T 0 | T 1 |
Δ time (CI) p |
T 0 | T 1 |
Δ time (95% CI) p |
Δ treatment (95% CI) p |
ΔΔ (95% CI) p |
||
| Developmental quotient GMDS (SS) | 83.35 (77.03–89.68) | 87.43 (80.35–94.51) |
4.08 (−1.23 to 9.39) 0.131 |
84.03 (77.11–90.95) | 73.63 (65.84–81.42) |
−10.40 (−17.44 to −3.35) <0.01 |
−0.67 (−14.49 to 13.14) 0.924 |
14.48 (5.78–23.17) <0.01 |
|
| Motor | 81.44 (72.97–89.90) | 82.82 (75.67–89.97) |
1.38 (−5.95 to 8.72) 0.710 |
80.81 (73.66–87.97) | 74.19 (64.87–83.51) |
−6.63 (−14.51 to 1.26) 0.099 |
0.62 (−15.01 to 16.25) 0.938 |
8.01 (−2.61 to 18.62) 0.139 |
|
| Personal–social | 88.49 (80.60–96.38) | 91.06 (81.82–100.31) |
2.57 (−4.20 to 9.34) 0.453 |
81.79 (74.15–89.43) | 76.97 (67.93–86.01) |
−4.83 (−15.51 to 5.86) 0.372 |
6.70 (−8.61 to 22.01) 0.391 |
7.40 (−5.10 to 19.89) 0.246 |
|
| Language | 89.75 (83.31–96.18) | 90.66 (83.83–97.49) |
0.91 (−5.73 to 7.56) 0.786 |
92.17 (84.56–99.78) | 74.35 (64.51–84.20) |
−17.81 (−27.63 to −8.00) <0.01 |
−2.42 (−17.99 to 13.15) 0.761 |
18.73 (6.98–30.47) <0.01 |
|
| H–E GMDS (SS) | 75.18 (67.91–82.45) | 82.99 (75.26–90.72) |
7.81 (1.81–13.80) 0.011 |
78.68 (70.72–86.64) | 70.63 (61.54–79.72) |
−8.05 (−15.67 to −0.43) 0.038 |
3.50 (−18.61 to 11.62) 0.651 |
15.86 (6.23–25.48) <0.01 |
|
| Performance GMDS (SS) | 80.51 (73.89–87.14) | 89.53 (81.81–97.25) |
9.01 (3.08–14.95) <0.01 |
84.50 (77.93–91.07) | 76.29 (68.45–84.13) |
−8.21 (−15.36 to −1.07) 0.025 |
−3.99 (−18.45 to 10.48) 0.589 |
17.23 (8.01–26.44) <0.01 |
|
Bold type indicates statistically significant p‐values. Data are mean (95% CI), unless otherwise indicated.
Contrast sensitivity was analysed on a log scale and therefore the effect is reported as a ratio.
Visual fixation was categorized in ordinal scores: 1, stable; 2, mildly impaired; 3, severely impaired.
Smooth pursuit was categorized in ordinal scores: 1, present; 2, mildly impaired; 3, severely impaired.
Reactive saccades were categorized in ordinal scores: 1, present; 2, normometric with increased latency; 3 dysmetric but with normal latency; 4, dysmetric with increased latency; 5, absent. T 0, developmental quotient at baseline; T 1, developmental quotient after 6mo; Δ, change; CI, confidence interval; ΔΔ, interaction estimate, that is (T1 vs T0)treatment–(T1 vs T0); GMDS, Griffiths Mental Developmental Scales; SS, standard scores; H–E, hand–eye coordination.