Xenogenic Keratoplasty From Porcine Cornea (XKFPC)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|