Evaluation of systemic exposure to intracameral tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% in pediatric cataract surgery: a pilot study
Mydriatic, pediatric, cataract, phenylephrine, tropicamide
Published online: May 16 2024
Abstract
Background: : Pediatric cataract is a rare disease that often requires surgery, for which an adequate and stable mydriasis is necessary. Pupil dilatation is usually achieved by the instillation of mydriatic eye drops. Intracameral Mydrane® (ICM) is a standardized mixture of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% and is to be injected into the anterior eye chamber at the beginning of surgery. Its efficacy and safety are already established in adults, but not yet for the pediatric population.
Objectives: The aim of this research was to evaluate the safety profile of ICM in children.
Setting: University Hospital of Antwerp, Belgium, single-centre, tertiary hospital.
Methods: Systemic exposure was assessed by quantification of plasma concentrations of phenylephrine and tropicamide at different time points (2, 10 and 30 minutes after ICM injection) during the procedure. The incidence of hemodynamic side effects was evaluated as an indicator of safety.
Results: The highest plasma concentrations of phenylephrine and tropicamide were detected in the youngest age group A. The increases in plasma concentrations of phenylephrine were statistically significant for the total population (p = 0.019). Clinically important changes in hemodynamic parameters related to phenylephrine or tropicamide were not detected in any age group.
Conclusions: In this pediatric population undergoing cataract surgery under general anesthesia, the administration of ICM was safe and systemic exposure was not clinically significant.
