Preclinical Biocompatibility And Biosafety Evaluation Of A New Foldable Brown Diaphragm Intraocular Lens: An In Vitro And In Vivo Study

A new foldable brown diaphragm intraocular lens (IOL) was preclinically evaluated in vitro and in vivo by comparing its biocompatibility and biosafety with those of a commercially available IOL.

An in vitro and in vivo preclinical study.

The new brown-diaphragm IOL is made of hydrophobic acrylic material, with incorporating a transparent optical zone and surrounding brown diaphragm. Cellular experiments evaluating lens epithelial cell morphology, adhesion, and migration were conducted to exclude cytotoxic effects. Twelve New Zealand rabbits had the new IOL implanted in one eye and another 12 had a commercially available foldable IOL implanted, followed by slit-lamp evaluations of inflammatory reactions and capsular opacification. Corneal endothelial cells density was measured. Aqueous humor was obtained weekly for LC-MS/MS analysis to identify dye leakage from the IOL. HE staining of ocular tissue and SEM of the IOL surface were performed after 12 weeks of observation.

In vivo experiments showed there were no statistically significant differences between the two groups in terms of postoperative inflammation and capsular biocompatibility. There were no significant changes in corneal endothelial cell density between before and after surgery in either group. LC-MS/MS analysis showed that the target dye was not detected in aqueous humor samples. Histopathology of ocular sections and SEM imaging of IOL surfaces showed similar changes in both groups.

The newly-invented IOL showed good biocompatibility and biosafety. Combined with its foldability and peripheral shading, it could be a new choice for patients with iris defects.