Preclinical biocompatibility and biosafety evaluation of a new foldable brown diaphragm intraocular lens: An in vitro and in vivo study

Abstract Background 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. Methods The new foldable iris‐diaphragm IOL is composed of hydrophobic acrylic material, with 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 underwent implantation of a brown diaphragm IOL in one eye, whilst an additional 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 before and after implantation. Aqueous humour samples were obtained weekly for liquid chromatography–tandem mass spectrometry (LC–MS/MS) analysis to investigate dye leakage from the brown‐diaphragm IOL. Following 12 weeks of observation, haematoxylin and eosin staining of ocular tissue and scanning electron microscopy (SEM) of the IOL surface were performed. Results Results from in vivo experiments found no statistically significant differences between the two groups in terms of postoperative inflammation and capsular biocompatibility. No significant changes in corneal endothelial cell density were observed in either group before and after surgery. LC–MS/MS analysis showed that the target dye was not detected in aqueous humour samples. Histopathology of ocular sections and SEM imaging of IOL surfaces showed similar changes in both groups. Conclusions 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.