On December 7, 2021, MIOK Keratoprosthesis was approved for listing by NMPA, the Chinese agency for regulating drugs and medical devices. MIOK Keratoprosthesis is the world’s first ever approved artificial cornea that requires no co-implantation of donor corneas, and is of great significance across the 60 million patients with corneal blindness worldwide, as MIOK Keratoprosthesis makes it no longer impossible to restore sight to patients with corneal blindness, and ease the burden on their families.
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Corneal transplantation is one of the key means to restore sight to patients with corneal blindness. However, there is a high risk for corneal grafting failures and server postoperative complications usually due to the complex immunologic responses to incompatibility in a transplanted organ. Other artificial corneas requiring co-implantation of donor corneas can not avoid such risks either. So MIOK Keratoprosthesis, an artificial cornea of 100% of non-biological materials and requiring no co-implantation of donor corneas, is an ideal option for treating patients with corneal blindness.
MIOK Keratoprosthesis is mainly made of clear PMMA plastic with excellent optical properties and tissue tolerance, and it is intended to restore sight to patients with corneal blindness by providing a transparent optical pathway through an opacified cornea in the treated eye.
With special design and processing, MIOK Keratoprosthesis delivers excellent performance in terms of transparency, light transmission and durability, in addition to high biocompatibility and ease of use for surgical operations, which make it quick integrated with surrounding tissues. With comparison with conventional corneal transplantation and other artificial corneas, MIOK Keratoprosthesis requires no co-implantation of donor cornea, which addresses the lack of donor corneas worldwide and effectively reduces the risk of severe postoperative complications and immune rejection responses. Furthermore, MIOK Keratoprosthesis is indicated to patients with corneal blindness, in cases where a corneal transplantation has failed or runs a high risk for failure, especially to patients with corneal graft failures, corneal scarring/vascularization, chemical/thermal burns, autoimmune diseases (Stevens-Johnson syndrome, pemphigoid, etc.), symblepharon, and severe dry eyes, etc. As a result, it is an effective treatment to patients with corneal blindness caused by a wide range of corneal injuries, Microkpro Medical.