Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study

Inclusion criteria

• Age 18 to 80 years (inclusive), gender unrestricted;
• Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity < 0.05 in both eyes;
• Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
• Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
• Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP < 21 mmHg);
• Normal structure and function of the retina and optic nerve, with preserved visual potential;
• Willing to participate in this study and have signed the written informed consent form.

Exclusion criteria

• Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
• Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
• Patients with unhealed wound following allogeneic penetrating keratoplasty.
• Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
• Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
• Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator.
• Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator.
• Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator.
• Patients with severe coagulation disorders, judged ineligible by the investigator.
• Patients with absolute glaucoma, judged ineligible by the investigator.
• Patients with severe systemic diseases and a life expectancy of < 2 years.
• Pregnant or lactating females.
• Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required.
• Other patients considered ineligible for this clinical trial by the investigator.