Mydriatic efficacy, the number of patients for whom the capsulorhexis was successfully performed without any additional mydriatic treatment
| Mydrane group | Reference group | Between-group difference* (%) | Non-inferiority testing† 95% CI | |
|---|---|---|---|---|
| ITT | N=272 | N=283 | ||
| N (%) of patients | 267 (98.2) | 267 (94.3) | 3.8 | −4.5% to 12.1% |
| 95% CI | 95.8 to 99.4 | 91.0 to 96.7 | Non-inferiority verified | |
| mITT | N=268 | N=281 | ||
| N (%) of patients | 265 (98.9) | 266 (94.7) | 4.2 | −4.2% to 12.6% |
| 95% CI | 96.8 to 99.8 | 91.3 to 97.0 | Non-inferiority verified | |
| PP | N=254 | N=234 | ||
| N (%) of patients | 251 (98.8) | 222 (94.9) | 3.9 | −4.9% to 12.8% |
| 95% CI | 96.6 to 99.8 | 91.2 to 97.3 | Non-inferiority verified |
The non-inferiority was verified if the lower bound of this 95% CI was at least −7.5%.
*Mydrane—reference.
†Non-inferiority was based on the exact 95% CI of the between-group difference in responder rates and tested with a non-inferiority margin of −7.5%.
ITT, intent-to-treat set of patients; mITT, modified intent-to-treat set of patients; Mydrane group, patients who received an intracameral injection of a standardised combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% just after the first incision; PP, per protocol; Reference group, patients who received a standard topical regimen of one drop each, of tropicamide 0.5% and phenylephrine 10% repeated three times at 10 min intervals beginning 30 min before surgery.