Xenogenic Keratoplasty From Porcine Cornea

Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer

Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.

Acellular porcine cornea eligibility criteria:

1. fresh porcine cornea,
2. porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
3. porcine cornea keeping integrative corneal epithelium and endothelium,
4. acellular porcine cornea keeping transparent.

Inclusion Criteria:

• Patients with severe infectious corneal ulcer
• The ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment
• The infected corneas have risks of penetrating
• The depth of ulcers are less than 400um
• The bridge of the ulcers is away from corneal limbal more than 1mm
• Patients aged 18 or older
• Patients able and willing to sign the informed consent form

Exclusion Criteria:

• Patients with severe infectious corneal ulcer in stable stage
• Patients with corneal ulcers after viruses infection, such as herpes simplex virus
• Patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation
• The ulcers are not cover pupil zone and will not result in visional defect in future
• The depth of ulcer is less than 50um
• Patients has history of keratoplasty surgery