Macular and choroidal thickness after intracameral moxifloxacin for prevention of postcataract endophthalmitis.

PURPOSE: To determine any changes in macular or choroidal thickness associated with the use of intracameral moxifloxacin as postcataract endophthalmitis prophylaxis. SETTING: University of Campinas, Campinas, São Paulo, Brazil. DESIGN: Prospective, randomized, partially masked, single-site clinical trial. METHODS: Phacoemulsification surgery patients in the experimental group (Group A) received a 0.03 mL intracameral injection of undiluted moxifloxacin from a sealed bottle immediately after phacoemulsification surgery (150 µg in 0.03 mL-Vigamox solution), whereas the control group (Group B) did not. Investigators evaluated in masked fashion macular and choroidal thickness using spectral-domain optical coherence tomography preoperatively and postoperatively. RESULTS: A total of 93 patients were included (48 in Group A and 45 in Group B). Baseline parameters were similar between the groups. Either of the 2 parameters assessed differed statistically between the groups or preoperatively vs postoperatively. On postoperative day 30, central macular thickness was 8.85 ± 14.78 µm in Group A and 10.26 ± 22.44 µm in Group B (P = .7232); choroidal thickness as measured by enhanced depth imaging (EDI) was 1.45 ± 16.13 µm in Group A and 3.74 ± 16.15 in Group B (P = .5017). On postoperative day 60, central macular thickness was 19.53 ± 39.28 µm in Group A and 17.14 ± 53.68 µm in Group B (P = .8363); EDI was 5.08 ± 21.96 µm in Group A and 5.24 ± 15.8 in Group B (P = .9752). CONCLUSIONS: The application of intracameral injection of 0.03 mL of undiluted 0.5% moxifloxacin during phacoemulsification surgery as endophthalmitis prophylaxis induced no changes in macular or choroidal thickness.

Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial.

PURPOSE: To evaluate the safety and efficacy of intracameral (IC) 0.5% moxifloxacin in the prevention of post-cataract endophthalmitis. SETTING: University of Campinas, São Paulo, Brazil. DESIGN: Prospective randomized partially masked single-site clinical trial. METHODS: Patients who had phacoemulsification were randomized into two groups in block sizes of 4. Group A (moxifloxacin group) consisted of patients who received an IC injection of 0.03 mL (150 µg) of undiluted 0.5% moxifloxacin at the end of surgery. Group B (control group) consisted of patients who received no IC medication. The postoperative prescription for both groups consisted of 0.5% moxifloxacin and 0.1% dexamethasone. Patients were monitored for 6 weeks after surgery. The primary outcome was the incidence of acute endophthalmitis in each group. Secondary outcomes were corrected distance visual acuity (CDVA), endothelial cell density (ECD), intraocular pressure (IOP), and central corneal thickness (CCT). RESULTS: The study comprised 3640 eyes from 3640 patients. There were 1818 patients in Group A and 1822 patients in Group B. The incidence of endophthalmitis within 6 weeks of follow-up was 1 (0.05%) of 1818 eyes in the moxifloxacin group and 7 (0.38%) of 1822 eyes in the control group (P = .035). There was no significant difference in CDVA (P = .202), ECD (P = .482), IOP (P = .105), or CCT (P = .558). No ocular or systemic study-related adverse events were observed. CONCLUSIONS: The IC injection of undiluted 0.5% moxifloxacin can be safely applied as the last step of phacoemulsification. It was found to be effective in reducing the risk for endophthalmitis. This study represents the first controlled randomized clinical trial to evaluate the safety and efficacy of IC moxifloxacin in the prevention of post-cataract endophthalmitis.