Xenogenic Keratoplasty From Porcine Cornea

Phase 1

Suspended

• Conditions: Porcine Corneal Xenograph
• Interventions: Genetic: homogenic cornea; Genetic: Xenogenic cornea

• Registration Number: NCT01443559
• Lead Sponsor: Xiamen University

Brief Summary

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

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
human cornea	homogenic cornea	-
Xenogenic cornea	Xenogenic cornea	-

Primary Outcome Measures

Name	Time	Method
Rate of rejection in three months after keratoplasty	three months after lamellar 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.

Secondary Outcome Measures

Name	Time	Method
Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy	one year	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.

Trial Locations

Locations (1)

Xiamen University Affiliated Xiamen Eye Center; 🇨🇳 Xiamen, Fujian, China