Safety of intracameral moxifloxacin in the pediatric population: an equivalence study.

PURPOSE: To investigate whether the safety of intracameral moxifloxacin (IC-Mox) was equivalent to subconjunctival antibiotics (SC-Abs) in pediatric lens surgery.

SETTING

The Hospital for Sick Children, Toronto, Canada.

DESIGN

Retrospective consecutive cohort study.

METHODS

This equivalence study compared 95% CI in the difference between the preoperative and postoperative safety variables of best corrected visual acuity (BCVA), intraocular pressure (IOP), central corneal thickness (CCT), endothelial cell density (ECD), corneal edema, and anterior chamber (AC) inflammation in IC-Mox with SC-Abs. The zone of clinical equivalence for BCVA was set at ±0.2 logarithm of the minimum angle of resolution, IOP at ±3 mm Hg, CCT at ±30 μm, and ECD at ±400 cells/mm.

RESULTS

The charts of 358 patients undergoing lens-related surgeries were reviewed. Of 317 eyes (215 patients) included, 170 eyes received IC-Mox and 147 eyes had SC-Abs. The mean age was 4.9 and 5.1 years with a mean follow-up of 19 and 34.4 months (P < .001) in IC-Mox and SC-Ab groups, respectively. The 95% CIs for the change from preoperative to postoperative safety parameters between IC-Mox and SC-Abs were all in the zones of clinical equivalence (BCVA, P = 0.75; highest IOP in the first 6 weeks postoperatively, P = 0.27; IOP at the last visit, P = 0.74; CCT, P = 0.89; and ECD, P = 0.76). During the first 6 weeks postoperatively, there was no difference in corneal edema (P = .69) and AC flare (P = .4) between IC-Mox and SC-Ab groups, whereas AC cellular activity was significantly higher in the SC-Ab group (P = .028).

CONCLUSIONS

IC-Mox prophylaxis in pediatric patients showed equivalent postoperative safety outcomes when compared with SC-Abs. The use of IC-Mox (250 μg) for endophthalmitis prophylaxis appears to be safe in the pediatric population.