A double-blind, randomized controlled pilot study comparing the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery.

To compare the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery. In this prospective, double-blind, randomized study, patients with senile cataracts who were undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1 ml/0.5 mg; Cravit® 0.5%; Santen Pharmaceutical Ltd.) or intracameral cefazolin (0.1 ml/1 mg; generic). The endpoints were the occurrence of endophthalmitis during the 3-month follow-up period, best-corrected visual acuity (BCVA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), central corneal thickness (CCT), central foveal thickness (CFT), and cell density. A total of 50 patients (50 eyes) were enrolled, randomized, and completed the study. No cases of endophthalmitis were reported in either treatment group. There were no significant differences in BCVA, AC inflammation, IOP, CCT, CFT, or cell density between the groups at any timepoint. Importantly, no dose errors or serious adverse events were reported in either group. This study provides proof of concept that prophylactic intracameral levofloxacin (0.1 ml/0.5 mg) may have a comparable safety profile to intracameral cefazolin (0.1 ml/1 mg) in patients undergoing cataract surgery. Intracameral levofloxacin (0.1 ml/0.5 mg) may offer a viable alternative to cefazolin (0.1 ml/1 mg), particularly for patients with penicillin allergies, while also reducing the risk of dilution errors by eliminating the need for reconstitution. Larger, multicenter studies are warranted to confirm the efficacy of levofloxacin (0.1 ml/0.5 mg) in preventing endophthalmitis.NCT06710977, 02/12/2024, retrospectively registered.