Xenogenic Keratoplasty From Porcine Cornea

Xiamen University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Porcine Corneal Xenograph

Interventions

Xenogenic corneaGENETIC

lamellar acellular xenogenic corneas were sterilised by radiation

homogenic corneaGENETIC

homogenic corneas were sterilised by radiation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Xiamen University Affiliated Xiamen Eye Center

Xiamen, Fujian, China

Outcomes

Primary Outcomes

Rate of rejection in three months after keratoplasty

1. Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line. 2. Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing.

Time frame: three months after lamellar keratoplasty

Secondary Outcomes

Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy

Shapes and location: 1. Sub-epithelial nerve plex is in the depth between 35um to 65um shaping like white thin line with branches in vivo confocal microscopy. 2. Sromal nerve is in the stromal layer(about 70um to 500um) shaping like white thick trunk with branches in vivo confocal microscopy. 3. Stromal keratocytes is in the stromal layer like white rod-shape in vivo confocal microscopy.

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.