Table 2

Mydriatic efficacy, the number of patients for whom the capsulorhexis was successfully performed without any additional mydriatic treatment

Mydrane groupReference groupBetween-group difference* (%)Non-inferiority testing†
95% CI
 N (%) of patients267 (98.2)267 (94.3)3.8−4.5% to 12.1%
 95% CI95.8 to 99.491.0 to 96.7Non-inferiority verified
 N (%) of patients265 (98.9)266 (94.7)4.2−4.2% to 12.6%
 95% CI96.8 to 99.891.3 to 97.0 Non-inferiority verified
 N (%) of patients251 (98.8)222 (94.9)3.9−4.9% to 12.8%
 95% CI96.6 to 99.891.2 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.