Evaluation of Systemic Exposure to Intracameral Tropicamide 0.02%, Phenylephrine 0.31%, and Lidocaine 1% in Pediatric Cataract Surgery.

Purpose: Pediatric cataract surgery requires mydriasis, typically achieved with eye drops. An intracameral mydriatic combining tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1% is established in adults, but not in children. We aimed to evaluate the safety profile of this intracameral mydriatic in children. Methods: We conducted a prospective observational cohort study on 40 patients, aged 8 weeks to 17 years, undergoing cataract surgery under general anesthesia (GA) and receiving 1 intracameral injection (0.1 mL) of the mydriatic. Thirteen patients underwent immediate sequential bilateral cataract surgery with a second injection to the second eye. We evaluated the incidence of hemodynamic adverse effects and assessed systemic exposure by quantification of plasma concentrations of phenylephrine and tropicamide at 4 fixed time points during the procedure. Results: The highest plasma concentrations of phenylephrine and tropicamide were detected in the youngest patients (age 8 weeks-1 year), with a significant increase from baseline (P = 0.008 and P = 0.023, respectively). In patients aged 1-6 years, significant changes were observed only in the plasma concentration of phenylephrine (P < 0.001). For patients aged 6-17 years, there was no significant rise in phenylephrine nor in tropicamide plasma concentration (P = 0.194 and P = 1.000). No clinically important changes in hemodynamic parameters occurred in any age group. Sequential bilateral administration did not result in an increase in plasma concentrations, nor in an increase of hemodynamic adverse effects. Conclusions: Intracameral mydriatic injection did not induce cardiovascular adverse events, and systemic exposure was minimal in this pediatric population undergoing cataract surgery under GA.