A second generation of artificial cornea (Biokpro II)

Area of Science:

• Ophthalmology
• Biomaterials Science
• Corneal Research

Background:

• Artificial cornea (keratoprosthesis) development aims to restore vision in severe corneal diseases.
• Second-generation designs focus on improved biocompatibility and integration with ocular tissues.
• Colonizable designs seek to promote host tissue ingrowth for enhanced stability.

Purpose of the Study:

• To evaluate the clinical performance and safety of a novel, second-generation colonizable artificial cornea in human subjects.
• To assess the integration, visual outcomes, and anatomical stability of the implant.
• To investigate the role of epithelial cell coverage on implant success.

Main Methods:

• Human implantation of a novel artificial cornea (polydimethylsiloxane optic with expanded polytetrafluoroethylene skirt).
• Clinical evaluation including visual acuity, intraocular pressure, and anatomical stability assessment.
• Follow-up of 13 patients for an average of 6 months.

Main Results:

• 11 out of 13 patients showed clinical stability after 7 months.
• Seven patients experienced improvements in visual acuity, with a mean final corrected acuity of 20/200.
• Five anatomical failures occurred, including extrusions and infections. Epithelial cells did not migrate onto the optical core.

Conclusions:

• The new artificial cornea demonstrates potential for vision restoration but requires further refinement.
• Long-term implant stability appears dependent on the formation of a stable epithelial layer over the device.
• Further research is needed to optimize epithelial integration for improved clinical outcomes.