Evaluation for endotoxin in intraocular materials used during phacoemulsification surgery using a recombinant factor C assay.

Abstract

Objective: Cataract surgery remains the sole method to resolve blindness secondary to cataract formation. One complication includes fibrin web formation post-operatively. This study aimed to investigate the presence of endotoxin within materials used during cataract surgery as a possible cause of fibrin web phenomenon.

Methods: Preservative-free epinephrine, heparin, viscoelastic devices, and intraocular lenses were collected for evaluation. Various manufacturers and manufacturing lot numbers were used when available. Viscosity of viscoelastics was reduced by incubating samples with human recombinant hyaluronidase. Intraocular product (IOL) packaging fluid was collected and stored for testing. The IOLs were then washed with a sterile balanced salt solution, incubated at 37°C for 48 h, and then fluid was collected for testing to mimic intraocular placement. Samples were tested using a commercially available rFC kit. Fluorescence was measured at time zero and after 1 h using a fluorescence microplate reader. The change in fluorescence was corrected for blank fluorescence and plotted to a standard curve.

Results: Endotoxin levels were below the limit of detection (0.05 EU/mL) in all samples. Incubation of IOLs at intraocular temperature did not increase extraction of endotoxin.

Conclusion: Endotoxin was not identified in any tested sample, including those used in cases of fibrin web formation post-phacoemulsification. As fibrin webs are often observed episodically, it is possible that endotoxin levels may vary between batches, or that endotoxin is not related to fibrin formation.