Xenogenic Keratoplasty From Porcine Cornea (XKFPC)

This study is currently recruiting participants.

Verified September 2011 by Xiamen University

Sponsor:

Information provided by (Responsible Party):

Zuguo Liu, Xiamen University

ClinicalTrials.gov Identifier:

NCT01443559

First received: September 19, 2011

Last updated: September 29, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 19, 2011
Last Updated Date	September 29, 2011
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2011)	Rate of rejection in three months after keratoplasty [ Time Frame: three months after lamellar keratoplasty ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01443559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2011)	Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy [ Time Frame: one year ] [ Designated as safety issue: Yes ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Xenogenic Keratoplasty From Porcine Cornea
Official Title ^ICMJE	Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer
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: 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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Corneal Transplantation
Intervention ^ICMJE	Genetic: Xenogenic cornea lamellar acellular xenogenic corneas were sterilised by radiation Genetic: homogenic cornea homogenic corneas were sterilised by radiation
Study Arm (s)	Experimental: Xenogenic cornea Intervention: Genetic: Xenogenic cornea Active Comparator: human cornea Intervention: Genetic: homogenic cornea
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	December 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01443559
Other Study ID Numbers ^ICMJE	EIXM-XKFPC-20110901
Has Data Monitoring Committee	Yes
Responsible Party	Zuguo Liu, Xiamen University
Study Sponsor ^ICMJE	Xiamen University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Xiamen University
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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