Xenogenic Keratoplasty From Porcine Cornea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Porcine Corneal Xenograph

Intervention / Treatment
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* Genetic: Xenogenic cornea
* Genetic: homogenic cornea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenogenic cornea<br> | Genetic: Xenogenic cornea<br>* lamellar acellular xenogenic corneas were sterilised by radiation<br>|
| Active Comparator: human cornea<br> | Genetic: homogenic cornea<br>* homogenic corneas were sterilised by radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rejection in three months after keratoplasty | Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line. Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing. | three months after lamellar keratoplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy | Shapes and location: Sub-epithelial nerve plex is in the depth between 35um to 65um shaping like white thin line with branches in vivo confocal microscopy. Sromal nerve is in the stromal layer(about 70um to 500um) shaping like white thick trunk with branches in vivo confocal microscopy. Stromal keratocytes is in the stromal layer like white rod-shape in vivo confocal microscopy. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xenogenic