Xenogenic Keratoplasty From Porcine Cornea (XKFPC)

Xiamen University

Status and phase

Suspended

Phase 1

Conditions

Porcine Corneal Xenograph

Treatments

Genetic: homogenic cornea

Genetic: Xenogenic cornea

Study type

Interventional

Funder types

Other

Identifiers

NCT01443559

EIXM-XKFPC-20110901

Details and patient eligibility

About

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.

Full description

Acellular porcine cornea eligibility criteria:

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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