Enhanced fabrication of dual-compartment artificial cornea C-Clear via precision moulding and continuous polymerisation: biocompatibility and functional efficacy in rabbit model

Abstract

This study introduces C-Clear, a novel artificial cornea based on a HEMA/MMA-based copolymer, developed through continuous polymerisation and moulding. C-Clear comprises a transparent optical core and porous support skirt, specifically designed to enhance tissue integration and minimise inflammatory responses. In vitro evaluations demonstrated excellent biocompatibility, characterised by high levels of cell adhesion and proliferation, while in vivo assessments using a rat subcutaneous model confirmed successful integration and biocompatibility. Furthermore, a 24-week corneal implantation study in rabbits validated the stability, safety, and functional potential of C-Clear. Serial ophthalmic examinations during this study period showed no significant progression of neovascularisation or inflammation. Histological analyses revealed exceptional optical clarity, robust integration with surrounding tissues, and an absence of notable foreign body responses. The implant achieved a retention rate of 75% over the 24 weeks, further highlighting its reliability. The custom-designed mould and continuous polymerisation process enabled the fabrication of C-Clear with superior structural stability, biocompatibility, and therapeutic efficacy. These findings highlight C-Clear as a significant advancement in artificial corneal development, addressing the global shortage of donor corneas and offering a promising solution for treating corneal blindness.