Efficacy and Safety of Nanoparticle Loteprednol Etabonate Compared to Vehicle in Post-cataract Surgery Pain and Anterior Chamber Inflammation Management: A Systematic Review and Meta-Analysis.

Cataracts are a leading cause of blindness worldwide, with phacoemulsification being the most widely used surgical method for cataract extraction due to its proven effectiveness. Managing postoperative inflammation following ocular surgery is crucial, and topical ocular corticosteroids have become an essential part of this therapeutic approach. This review aims to evaluate the efficacy and safety of nanoparticle-sized loteprednol etabonate (LE) formulations in comparison to a placebo, utilizing a systematic review and meta-analysis. We conducted a comprehensive search across Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), EBSCO, and ClinicalTrials.gov. Only randomized controlled trials (RCTs) that compared nanoparticle-sized LE formulations with placebo were included. Efficacy was measured by the resolution of anterior chamber cells (ACC) and anterior chamber flare (ACF), as well as pain relief. Safety was assessed by tracking adverse events (AEs). The risk of bias was evaluated using the Cochrane risk of bias tool. Eight RCTs involving 2,375 participants met our criteria. The meta-analysis revealed that both 0.38% and 1.00% LE formulations significantly improved ACC resolution, with the 1.00% formulation showing a higher efficacy (relative risk (RR)=1.87, 95% confidence interval (CI): 1.58-2.2, P<0.01, I²=40%). Furthermore, the 1.00% LE formulation was more effective in relieving pain compared to placebo (RR=1.52, 95% CI: 1.39-1.66, P<0.01, I²=20%). Both LE formulations were associated with few adverse events, and the 1.00% LE formulation had a lower risk of such events compared to placebo. However, no significant differences were observed in terms of joint swelling, stiffness, or mortality. In conclusion, our meta-analysis supports the use of nanoparticle-sized LE for managing inflammation and pain post-cataract surgery, with the 1.00% formulation proving to be more effective than both 0.38% LE and placebo. Both formulations were found to be generally safe, though additional research is needed to further evaluate long-term outcomes and safety.