Bioengineered Corneas Entering the Clinical Realm

Abstract

Rapid progress is being made in developing bioengineered corneas to restore vision in patients with corneal opacity or irregularities that result in blindness. Human donor corneas have served well in the past for corneal transplant surgery and surgical innovation, especially lamellar endothelial replacement which has helped to improve outcomes. However, the massive shortage of suitable donor tissue combined with the expense and technical challenges of eye-banking leaves a substantial proportion of the world’s population without access to treatment. This is mainly the case in lower-income nations, where corneal blindness is most prevalent. This chapter reviews the many different advances in the development of bioengineered substitutes for improving or replacing the human cornea for vision restoration. Cell-based therapies are part of mainstream clinical practice for replacing the corneal epithelium. Recent trials show promise for endothelial replacement, and 3D printing of the corneal stroma has begun. Traditional keratoprostheses that are well-established but lack bio-integration with host tissue are now being designed to encourage seamless integration. Cell-free pro-regeneration implants have been used successfully in human trials and allow incorporation of bioactive substances. Finally, the regulatory pathway should be a consideration in bioengineering corneal substitutes or implants.