A novel intralamellar semi‐bioresorbable keratoprosthesis—Part A: Design conception, material perspective, and device manufacturing

Abstract Corneal diseases are a significant cause of visual impairment and blindness. The first‐line treatment for corneal opacity is penetrating keratoplasty (human donor cornea transplantation). At present, keratoprosthesis (KPro), an artificial cornea, is the last resort for correcting end‐stage corneal blindness and is usually supported by donor tissue. This article describes a new intralamellar tissue‐free KPro design concept and its preparation method. Wherein, an injection‐molding route is adopted to create a mechanically and structurally stable near‐KPro geometry using a photo‐polymerized poly(2‐hydroxyethyl methacrylate) (pHEMA) with 4% Bisphenol A dimethacrylate (BisMA) crosslinked (PC4) hydrogel composition. Prior to this, the physico‐mechanical properties of crosslinked hydrogels matching corneal tissue are identified, and the surface morphological characteristics of silk cocoon membranes are ascertained in choosing suitable KPro materials. Cytocompatibility tests on PC4 and silk‐incorporated PC4 hydrogels using rabbit corneal fibroblast cell‐line evidenced enhancement in cell growth on silk‐PC4 surfaces. Furthermore, near KPro geometry is surface‐profiled to create a one‐of‐a‐kind design with clear optics and a silk‐bioactivated composite‐based haptic‐flange hydrogel network containing site‐specific submillimeter‐scale perforations to improve tissue integration. Considering this unique KPro geometry, the optic‐haptic‐flange construct is a tissue‐free semi‐bioresorbable hydrogel device presumed to provide stability under the influence of intraocular pressure (IOP) and eyelid shear. Through this study, it is identified new KPro materials facilitate significant cytocompatibility while complimented with site‐specific novel design would offer tissue ingrowth with gradual resorption of silk, leaving behind a stable intralamellar tissue integrated with hydrogel when implanted in the corneal niche.