Corneal blindness is a major cause of blindness in the world and corneal transplantation is the only widely accepted treatment to restore sight in these eyes. However, it is becoming increasingly difficult for eye banks to meet the increasing demand for transplantable tissue, which is in part due to population aging. Donor tissue shortage is therefore a growing concern globally and there is a need for alternatives to human donor corneas. Biosynthetic corneal substitutes offer several significant advantages over native corneas: Large-scale production offers a powerful potential solution to the severe shortage of human donor corneas worldwide; Good manufacturing practices ensure sterility and quality control; Acellular corneal substitutes circumvent immune rejection induced by allogeneic cells; Optical and biomechanical properties of the implants can be adapted to the clinical need; and finally these corneal substitutes could benefit from new advances in biomaterials science, such as surface coating, functionalization and nanoparticles. This review highlights critical contributions from laboratories working on corneal stromal substitutes. It focuses on synthetic inert prostheses (keratoprostheses), acellular scaffolds with and without enhancement of endogenous regeneration, and cell-based replacements. Accent is put on the physical properties and biocompatibility of these biomaterials, on the functional and clinical outcome once transplanted in vivo in animal or human eyes, as well as on the main challenges of corneal stromal replacement. Regulatory and economic aspects are also discussed. All of these perspectives combined highlight the founding principles of the clinical application of corneal stromal replacement, a concept that has now become reality.

角膜失明是世界上失明的主要原因，并且角膜移植是恢复这些眼睛视力的唯一被广泛接受的治疗方法。然而，眼库很难满足对可移植组织日益增长的需求，这部分是由于人口老龄化。因此，供体组织短缺在全球日益引起关注，并且需要替代人类供体角膜的替代品。与人工角膜相比，生物合成角膜替代品具有多个重要优势：大规模生产为解决全球人类供体角膜严重短缺提供了强大的潜在解决方案。良好的生产规范可确保无菌和质量控制；脱细胞角膜替代物可避免异体细胞诱导的免疫排斥。植入物的光学和生物力学特性可以适应临床需要。最后，这些角膜替代品可以受益于生物材料科学的新进展，例如表面涂层，功能化和纳米颗粒。这篇综述重点介绍了从事角膜基质替代物研究的实验室的重要贡献。它专注于合成惰性假体（角质假体），具有和不具有增强内源性再生作用的无细胞支架以及基于细胞的替代物。强调了这些生物材料的物理特性和生物相容性，以及移植后的功能和临床效果 这篇综述重点介绍了从事角膜基质替代物研究的实验室的重要贡献。它专注于合成惰性假体（角质假体），具有和不具有增强内源性再生作用的无细胞支架以及基于细胞的替代物。强调了这些生物材料的物理特性和生物相容性，以及移植后的功能和临床效果 这篇综述重点介绍了从事角膜基质替代物研究的实验室的重要贡献。它专注于合成惰性假体（角质假体），具有和不具有增强内源性再生作用的无细胞支架以及基于细胞的替代物。强调了这些生物材料的物理特性和生物相容性，以及移植后的功能和临床效果在动物或人眼中的体内，以及对角膜基质置换的主要挑战。还讨论了监管和经济方面。所有这些观点相结合，凸显了角膜基质替代物临床应用的基础原理，这一概念现已成为现实。