Table 5.
Results of secondary outcome variables: visual acuity (VA) and serum levels of HbA1c in the two study groups.
| Outcomes | Baseline | 6 Months | 12 Months | 18 Months | 24 Months |
|---|---|---|---|---|---|
| VA in decimal system | |||||
| DHA group, no. eyes | 152 | 139 | 127 | 121 | 107 |
| Mean (SD) | 0.73 (0.22) | 0.71 (0.24) | 0.68 (0.21) | 0.64 (0.19) | 0.65 (0.22) |
| Within-group p value * | 0.147 | 0.003 | <0.001 | 0.001 | |
| Placebo group, no. eyes | 160 | 152 | 134 | 129 | 118 |
| Mean (SD) | 0.74 (0.25) | 0.71 (0.25) | 0.68 (0.26) | 0.67 (0.22) | 0.69 (0.23) |
| Within-group p value * | 0.190 | 0.003 | <0.001 | <0.001 | |
| Between-group p value † | 0.732 | 0.984 | 0.881 | 0.372 | 0.213 |
| VA in logMAR system | |||||
| DHA group, no. eyes | 152 | 139 | 127 | 120 | 104 |
| Mean (SD) | 0.16 (0.16) | 0.19 (0.16) | 0.19 (0.14) | 0.21 (0.13) | 0.21 (0.17) |
| Within-group p value * | 0.011 | 0.021 | <0.001 | 0.012 | |
| Placebo group, no. eyes | 156 | 152 | 134 | 125 | 112 |
| Mean (SD) | 0.17 (0.17) | 0.19 (0.16) | 0.21 (0.20) | 0.20 (0.14) | 0.19 (0.17) |
| Within-group p value * | 0.168 | 0.019 | <0.001 | 0.002 | |
| Between-group p value † | 0.969 | 0.848 | 0.689 | 0.365 | 0.313 |
| Serum levels of HbA1c, % | |||||
| DHA group, no. patients | 77 | 62 | 60 | 51 | 47 |
| Mean (SD) | 8.38 (1.80) | 7.84 (1.52) | 7.69 (1.65) | 7.64 (1.12) | 7.67 (1.25) |
| Within-group p value * | 0.059 | 0.001 | 0.010 | 0.072 | |
| Placebo group, no. patients | 80 | 63 | 67 | 60 | 52 |
| Mean (SD) | 7.95 (1.68) | 7.82 (1.63) | 7.68 (1.33) | 7.61 (1.25) | 7.45 (1.19) |
| Within-group p value * | 0.139 | 0.030 | 0.124 | 0.036 | |
| Between-group p value † | 0.173 | 0.959 | 0.590 | 0.627 | 0.396 |
* Wilcoxon signed-rank test; † Mann–Whitney U test; DHA: docosahexaenoic acid; SD: standard deviation. LogMAR: logarithm of the minimum angle of resolution; VA: visual acuity.