Table 1: Audit against gold standard group of patients treated with Mydrane™ in phase 3 randomised controlled study [2].
| Labetoulle [2] | Audit | |
|---|---|---|
| Demographics | ||
| Number of operations completed | 268 | 129 |
| Percentage of females | 59.3 | 56.6 |
| Mean age ± SD in years | 69.2 ± 9.4 | 76.3 ± 10.2 |
| Factors affecting mydriasis | ||
| Percentage of diabetics | Unknown | 20.9 |
| Percentage of patients treated with tamsulosin | Unknown | 8.5 |
| Percentage of patients with pseudoexfoliation | 0 | 0.8 |
| Primary outcome | ||
| Percentage of successful operations (completed without additional mydriatic) | 98.9 | 96.1 |
| Percentage of patients with pupils > 6 mm at T3 | 96.8 | 84.5 |
| Percentage of patients with pupils < 5 mm at T4 | 0 | 4.59 |
| Percentage of patients with pupils < 5 mm at T5 | 0.4 | 6.80 |
| Mean pupil diameter at T3 ± SD (mm) | 7.67 ± 0.87 | 6.90 ± 1.05 |
| Mean pupil diameter at T4 ± SD (mm) | 7.71 ± 0.91 | 7.03 ± 1.07 |
| Mean pupil diameter at T5 ± SD (mm) | 7.46 ± 0.96 | 6.89 ± 1.22 |
| Clinical outcomes | ||
| Posterior capsule rupture (%) | 1 (0.4) | 0 (0) |
| Retained lens material requiring further surgery (%) | 0 (0) | 1 (0.8) |