Xenogenic Keratoplasty From Porcine Cornea (XKFPC)
|ClinicalTrials.gov Identifier: NCT01443559|
Recruitment Status : Suspended (there was not enough patients recruited in this study)
First Posted : September 29, 2011
Last Update Posted : July 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Porcine Corneal Xenograph||Genetic: Xenogenic cornea Genetic: homogenic cornea||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
|Experimental: Xenogenic cornea||
Genetic: Xenogenic cornea
lamellar acellular xenogenic corneas were sterilised by radiation
|Active Comparator: human cornea||
Genetic: homogenic cornea
homogenic corneas were sterilised by radiation
- Rate of rejection in three months after keratoplasty [ Time Frame: three months after lamellar 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.
- Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy [ Time Frame: one year ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443559
|Xiamen University Affiliated Xiamen Eye Center|
|Xiamen, Fujian, China, 361005|
|Study Director:||Zuguo Liu, PhD||Eye Institute of Xiamen University|