Table 3.
Cumulative and persistent events compared with IOS SPE
| Parameter | Observed AE rates (N = 339), n (%) | SPE rate (%)a | P valueb |
| Cumulative | |||
| Cystoid macular edema | 8 (2.4) | 3.0 | .7988 |
| Hypopyon | 0 | 0.3 | NE |
| Endophthalmitis | 0 | 0.1 | NE |
| Lens dislocated from the posterior chamber | 0 | 0.1 | NE |
| Pupillary block | 0 | 0.1 | NE |
| Retinal detachment | 1 (0.3) | 0.3 | .6389 |
| Secondary surgical intervention | 13 (3.8) | 0.8 | <.0001 |
| Persistent | |||
| Corneal stromal edema | 0 | 0.3 | NE |
| Cystoid macular edema | 3 (0.9) | 0.5 | .2413 |
| Iritis | 0 | 0.3 | NE |
| Raised IOP requiring treatment | 0 | 0.4 | NE |
AE = adverse event; NE = not evaluable; SPE = Safety and Performance Endpoint
a
The ISO standard SPE rate in ISO 11979-7:2006(E)
b
p value based on a 1-sided exact binomial test comparing the proportion of eyes with the event to the ISO standard SPE rate. The null hypothesis: observed AE rate ≤SPE rate for the specific AE.