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 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 efficacy 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. By leveraging a custom-designed mould and a continuous polymerisation process, C-Clear was fabricated 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. Recent advances in cell engineering and stem cell technology have further enhanced the potential of artificial corneas by promoting in vivo tissue integration and improving biocompatibility. [26][27][28] Nevertheless, overcoming critical obstacles, such as immune rejection and long-term integration with the host tissue, remains crucial for achieving clinical success. 11,29,30 Despite these technological advancements, current artificial corneal production relies primarily on mould-based manufacturing methods. Although these methods offer scalability and high throughput, they present challenges related to material uniformity, reproducibility, and structural integrity. 31,32 Consequently, there is growing interest in additive manufacturing techniques, such as three-dimensional (3D) printing, which enables the customisation of artificial corneas with greater control over their optical and mechanical properties. 33- 35 However, issues concerning contamination, reproducibility, and large-scale manufacturing remain unresolved and necessitate