Table 3.
IOP, visual field (VF) and pattern electroretinogram (PERG) examinations over the time by group (group A: current topical therapy + PEA 600 mg one tablet a day, in the first period, and group B: current topical therapy alone, in the first period) (RE = right eye, LE = left eye).
| Group | T0 (baseline) | T4 (month 4) | T8 (month 8) | p-value |
|---|---|---|---|---|
| IOP (mmHg) | ||||
| A | < 0.001 | |||
| RE | 14 [12–16] | 13 [11–14] | 14 [12–17] | |
| LE | 15 [12–16] | 13 [12–15] | 14 [13–16] | |
| B | ||||
| RE | 15 [13–16] | 15 [14–16] | 14 [11–15] | |
| LE | 14 [12–16] | 15 [13–16] | 13 [12–15] | |
| Visual field | ||||
| MD (dB) | ||||
| A | 0.642 | |||
| RE | − 2.2 [− 3.8 to − 1.5] | − 2.5 [−4.4 to − 1.2] | − 1.9 [− 3 to − 1.2] | |
| LE | − 4.1 [−5.7 to − 0.9] | − 3.3 [− 4.7 to − 1.5] | − 1.5 [−5.2 to − 0.3] | |
| B | ||||
| RE | − 1.9 [− 4.7 to − 1.1] | − 1.8 [− 4.2 to − 1.2] | − 2 [− 2.5 to − 1.4] | |
| LE | − 3.7 [− 6.7 to − 1.9] | − 3.7 [− 7.1 to − 2.2] | − 3.6 [− 5.7 to − 2.5] | |
| PSD (dB) | ||||
| A | 0.312 | |||
| RE | 2.8 [2.2–4.5] | 2.5 [1.9–4.9] | 2.5 [2–3.1] | |
| LE | 2.4 [1.9–8.9] | 2.2 [1.7–4] | 1.9 [1.7–2.3] | |
| B | ||||
| RE | 2.7 [1.6–7.1] | 2.1 [1.7–4.2] | 1.9 [1.7–2.3] | |
| LE | 3.3 [1.9–6.6] | 3.8 [2.4–5.7] | 3.2 [1.9–5.9] | |
| Pattern electroretinogram (P-ERG) | ||||
| P50-wave amplitude (μV) | ||||
| A | < 0.001 | |||
| RE | 1.7 [0.8–2.1] | 1.9 [1.3–2.6] | 1.7 [0.8–2.1] | |
| LE | 1.1 [0.7–2.1] | 2.1 [1.4–2.8] | 1 [0.7–2.1] | |
| B | ||||
| RE | 1.6 [1–2.1] | 1.5 [1.2–1.9] | 1.8 [1.4–2.3] | |
| LE | 1.2 [0.6–1.9] | 1.3 [1.1–1.8] | 1.6 [1.4–2.5] | |
| P50-wave Latency (ms) | ||||
| A | 0.469 | |||
| RE | 57 [54–61] | 55 [54–57] | 59.5 [55–61] | |
| LE | 59 [56–60] | 55 [53–59] | 59 [56–62] | |
| B | ||||
| RE | 55 [52–61] | 56 [53–61] | 57 [53–61] | |
| LE | 55 [52–59] | 57 [54–62] | 58.5 [53–62] | |
| N95-wave Amplitude (μV) | ||||
| A | 0.257 | |||
| RE | 2.6 [1.4–3.5] | 3.1 [1.8–3.5] | 2.5 [1.7–4.2] | |
| LE | 2.6 [1.5–3.4] | 3.5 [2–3.8] | 2.3 [1.7–3.3] | |
| B | ||||
| RE | 2.7 [1.9–3.8] | 3 [2.1–3.6] | 2.9 [1.6–4.3] | |
| LE | 3.5 [1.3–5] | 2 [1.6–2.9] | 2.6 [2.1–3.2] | |
| N95-wave latency (ms) | ||||
| A | 0.173 | |||
| RE | 102 [96–107] | 101 [93–108] | 102.5 [95–106.5] | |
| LE | 100 [96–107] | 98 [95–100] | 104 [100–109] | |
| B | ||||
| RE | 103 [98–108] | 100 [95–105] | 102.5 [95–105] | |
| LE | 100 [97–109] | 98 [95–108] | 102.5 [100–108] | |
| Quality of life (NEI-VFQ 25) | ||||
| General health (GH) (score) | ||||
| A | 50 | 50 [25–75] | 50 [25–50] | 0.05 |
| B | 50 [50–75] | 50 | 50 [50–75] | |
| General vision (GV) (score) | ||||
| A | 60 [40–70] | 60 [40–60] | 60 [60–60] | 0.19 |
| B | 60 [60–60] | 60 [40–60] | 60 [60–60] | |
| Total mean (score) | ||||
| A | 63.1 [57.5–73.7] | 62.5 [61.2–76.3] | 60 [48.7–71.3] | < 0.001 |
| B | 65 [60–75] | 63.7 [57.5–70] | 67.5 [62.5–81.2] | |
All values are expressed as median [IQR]. The values obtained at the end of the PEA 600 mg intake period are reported in bold and italics. P-values refer to the comparison between treatments (see text for statistical analyses methods).