Xenogenic Keratoplasty From Porcine Cornea (XKFPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Zuguo Liu, 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.

Condition or disease Intervention/treatment Phase
Porcine Corneal Xenograph Genetic: Xenogenic cornea Genetic: homogenic cornea Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of rejection in three months after keratoplasty [ Time Frame: 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 :
  1. Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01443559

China, Fujian
Xiamen University Affiliated Xiamen Eye Center
Xiamen, Fujian, China, 361005
Sponsors and Collaborators
Xiamen University
Study Director: Zuguo Liu, PhD Eye Institute of Xiamen University

Responsible Party: Zuguo Liu, Dean of Xiamen University Medical School, Xiamen University Identifier: NCT01443559     History of Changes
Other Study ID Numbers: EIXM-XKFPC-20110901
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by Zuguo Liu, Xiamen University: